Trial | Phase | Enrollment | Study Type | Start Date | Status |
Buprenorphine Loading in the Emergency Department [NCT04283500] | Phase 4 | 15 participants (Actual) | Interventional | 2020-11-01 | Completed |
A Randomized, Double-Blind, Multicenter Study Evaluating The Safety and Efficacy of BTDS in Subjects With Moderate to Severe Osteoarthritis Pain. Includes a 52-Week Extension Phase. [NCT00320801] | Phase 3 | 188 participants (Actual) | Interventional | 2004-01-31 | Terminated(stopped due to This study was terminated early due to administrative reasons.) |
Randomized, Double-blind, Multicenter Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-Release (OxyIR) Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain [NCT00312221] | Phase 3 | 418 participants (Actual) | Interventional | 2004-04-30 | Terminated(stopped due to terminated early for administrative reasons unrelated to safety or efficacy) |
A Phase III Randomized Controlled Trial to Evaluate the Efficacy of Drug Treatment in Prevention of HIV Infection and Death Among Opiate Dependent Injectors [NCT00270257] | Phase 3 | 1,251 participants (Actual) | Interventional | 2008-05-31 | Terminated(stopped due to DSMB halted the study due to futility as a result of lower than anticipated HIV incidence rates) |
Safety and Efficacy of High Dose Buprenorphine Induction in Fentanyl Positive Emergency Department Patients [NCT05589181] | Phase 3 | 140 participants (Anticipated) | Interventional | 2023-04-10 | Recruiting |
Long-acting Injectable Naltrexone Induction: A Randomized Trial of Outpatient Opioid Detoxification With Naltrexone vs. Buprenorphine [NCT01377610] | Phase 1 | 150 participants (Actual) | Interventional | 2011-06-30 | Completed |
An Open-label, Rapid Initiation Study for Extended-Release Buprenorphine Subcutaneous Injection (SUBLOCADE) [NCT03993392] | Phase 4 | 26 participants (Actual) | Interventional | 2019-08-29 | Completed |
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Novel Subcutaneous Depot Formulation of Buprenorphine (INDV-6200) in Healthy Volunteers [NCT03715634] | Phase 1 | 12 participants (Actual) | Interventional | 2017-09-20 | Completed |
Suboxone and Methadone for HIV Risk Reduction in Subutex Injectors [NCT01131273] | Phase 3 | 68 participants (Actual) | Interventional | 2010-06-30 | Completed |
A Study to Assess the Pharmacokinetic Profile of an Investigational Formulation of Buprenorphine HCl/Naloxone HCl 8mg/2mg Capsules Relative to the Pharmacokinetic Profile of Suboxone® (Buprenorphine HCl/Naloxone HCl 8mg/2mg Sublingual Tablets). [NCT01260675] | | 12 participants (Actual) | Observational | 2010-12-31 | Completed |
[NCT01276431] | Phase 4 | 102 participants (Actual) | Interventional | 2011-03-31 | Completed |
A Randomized, Double-blind, Double-dummy, Active-drug-controlled, Parallel-group, Multicentre Acceptability and Safety Study of the Transfer From Subutex/Suboxone to RBP-6300 in Opioid-dependent Subjects [NCT01582347] | Phase 2 | 143 participants (Actual) | Interventional | 2012-03-31 | Completed |
A Study Examining the Pharmacodynamics Interaction Between Buprenorphine and Fentanyl [NCT03747341] | Phase 1 | 22 participants (Actual) | Interventional | 2018-03-22 | Completed |
Phase 1b Randomized, Placebo-controlled Study to Assess the Effect of a Single Dose of ASP8062 on the Multiple Dose Safety, Tolerability and Pharmacokinetics of Buprenorphine/Naloxone in Subjects With Opioid Use Disorder [NCT04447287] | Phase 1 | 23 participants (Actual) | Interventional | 2020-06-29 | Completed |
Postoperative Analgesia With Buprenorphine Transdermal System (BTDS) Versus Tramadol for Postoperative Pain Control and Quality of Life After Spinal Surgery [NCT02416804] | Phase 4 | 69 participants (Actual) | Interventional | 2015-01-31 | Completed |
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability, and Efficacy of Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Ma [NCT02696434] | Phase 3 | 101 participants (Actual) | Interventional | 2016-04-30 | Completed |
Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol [NCT03113409] | Phase 2/Phase 3 | 10 participants (Actual) | Interventional | 2017-06-01 | Terminated(stopped due to no funding available to continue) |
A Phase 3b Efficacy and Safety Study of Adjunctive ALKS 5461 in Treatment Refractory Major Depressive Disorder [NCT03188185] | Phase 3 | 278 participants (Actual) | Interventional | 2017-06-12 | Completed |
Time to Detox: A Patient-Centered Comparison of Length of Detoxification Treatment and Time to Naltrexone Maintenance Therapy in Opioid-Dependent Individuals [NCT03678792] | Phase 3 | 0 participants (Actual) | Interventional | 2019-11-15 | Withdrawn(stopped due to Infeasible to conduct at this time.) |
Buprenorphine Treatment for Prescription Opioid Dependence [NCT02187198] | Phase 3 | 9 participants (Actual) | Interventional | 2015-03-31 | Completed |
A Phase 2, Randomized, Open Label, Multiple-Dose, Comparator, Parallel-Group, Safety and Tolerance Study of Buprenorphine Sublingual Spray (0.5 mg TID) Versus Standard of Care Post-Operative Narcotic Therapy for the Treatment of Post-Operative Pain [NCT03254459] | Phase 2 | 100 participants (Actual) | Interventional | 2017-09-12 | Completed |
Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper [NCT02737826] | | 32 participants (Actual) | Interventional | 2016-05-31 | Completed |
A Method to Increase Buprenorphine Treatment Capacity [NCT03580902] | Phase 1/Phase 2 | 51 participants (Actual) | Interventional | 2019-01-22 | Completed |
An Open-Label, Depot Buprenorphine (RBP-6000) Treatment Extension Study in Subjects With Opioid Use Disorder [NCT02896296] | Phase 3 | 208 participants (Actual) | Interventional | 2016-08-17 | Completed |
An Open-Label, Multi-Center, Titration Study to Establish the Long-term Safety and Tolerability of Buprenorphine Transdermal Delivery System (BTDS) 5 mg, 10 mg, and 20 mg in Patients With Chronic Non-Malignant Pain Syndromes Responsive to Opioid Combinati [NCT01151098] | Phase 3 | 189 participants (Actual) | Interventional | 2001-04-30 | Completed |
Pilot Study to Investigate the Pharmacokinetic Characteristics of Two Buprenorphine Transdermal Patch Formulations as Compared to a Reference Patch [NCT03785613] | Phase 1 | 47 participants (Actual) | Interventional | 2005-11-07 | Completed |
Comparing Medication Maintenance in Comprehensive Community and Pharmacy Settings to Enhance Engagement [NCT03766893] | Early Phase 1 | 11 participants (Actual) | Interventional | 2018-09-01 | Completed |
Addiction, HIV and Tuberculosis in Malaysian Criminal Justice Settings [NCT03089983] | | 1,129 participants (Actual) | Interventional | 2017-08-21 | Active, not recruiting |
Measures to Improve Outcomes After an Opioid Overdose [NCT03968237] | | 200 participants (Anticipated) | Observational | 2019-08-01 | Recruiting |
Analgesic Response to Opioid Analgesics in Buprenorphine-Maintained Individuals [NCT02136784] | | 12 participants (Anticipated) | Interventional | 2014-04-30 | Recruiting |
Buprenorphine Extended-release in Jail and at Re-entry: Open-label Randomized Controlled Trial vs. Daily Sublingual Buprenorphine-naloxone [NCT03604159] | Phase 4 | 52 participants (Actual) | Interventional | 2019-06-24 | Completed |
A Phase 1, Multiple-dose, Parallel Group Study to Evaluate the Safety and Pharmacodynamic Effects of RDC-0313-buprenorphine (ALKS 33-BUP) Administered Alone and Co-administered With Cocaine to Opioid-experienced Cocaine Abusers [NCT01366001] | Phase 1 | 33 participants (Actual) | Interventional | 2011-08-31 | Completed |
Using the Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy: A Randomized Controlled Trial (The Patch BRIDGE Trial) [NCT05790252] | Phase 3 | 40 participants (Anticipated) | Interventional | 2023-06-26 | Recruiting |
Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine Following an Experimental Inflammatory Injury in Volunteers. [NCT01296334] | | 34 participants (Actual) | Interventional | 2011-02-28 | Completed |
Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine. [NCT01560442] | | 100 participants (Anticipated) | Observational | 2012-02-29 | Recruiting |
An Open-label, Treatment Extension Study for the Rapid Initiation of Extended-Release Buprenorphine Subcutaneous Injection (SUBLOCADE™) [NCT04060654] | Phase 4 | 17 participants (Actual) | Interventional | 2019-10-21 | Completed |
A Randomized, Double-Blind, Double Dummy, 6-Period, Placebo-Controlled, Crossover Study to Explore and Compare the Ventilatory Response to Hypercapnia (VRH), of Belbuca, Oxycodone Hydrochloride (HCl) and Placebo in Recreational Opioid Users [NCT03996694] | Phase 1 | 19 participants (Actual) | Interventional | 2019-07-23 | Completed |
Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine [NCT04991974] | Phase 2/Phase 3 | 360 participants (Anticipated) | Interventional | 2021-09-17 | Enrolling by invitation |
Stimulating Catheter for Lumbar Plexus Block: Better Postoperative Analgesia? [NCT02162121] | Phase 4 | 64 participants (Actual) | Interventional | 2014-05-31 | Completed |
An Open-label, Multi-center Extension Study of Probuphine in Patients With Opioid Dependence [NCT00772785] | Phase 3 | 16 participants (Actual) | Interventional | 2008-09-30 | Terminated(stopped due to This study was terminated for reasons not related to efficacy or safety) |
Adolescent Community Reinforcement Approach (A-CRA) Implementation in Combination With Buprenorphine/Naloxone for Young Adults Ages 18 to 25 With Severe Opioid Use Disorder [NCT03287180] | | 0 participants (Actual) | Interventional | 2019-01-01 | Withdrawn(stopped due to unable to enroll any participants) |
Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence [NCT02696096] | Phase 3 | 21 participants (Actual) | Interventional | 2016-08-31 | Completed |
Role of Preoperative Transdermal Buprenorphine Patch in Reducing Postoperative Opioids Consumption in Patients Undergoing Total Knee Arthroplasties - A Randomised Controlled Trial. [NCT05042648] | Phase 4 | 120 participants (Anticipated) | Interventional | 2021-12-01 | Recruiting |
An Open-Label, Long-Term Safety and Tolerability Study of Depot Buprenorphine (RBP-6000) in Treatment-Seeking Subjects With Opioid Use Disorder [NCT02510014] | Phase 3 | 775 participants (Actual) | Interventional | 2015-07-27 | Completed |
Feasibility of Pediatric Emergency Department-Initiated Treatment for Adolescents With Opioid Use Disorder [NCT04737603] | Phase 2 | 24 participants (Anticipated) | Interventional | 2024-07-30 | Not yet recruiting |
A Two-period, Randomised, Open-label, Crossover, Pharmacokinetic Study to Assess the Bioequivalence and Adhesion of Buprenorphine Transdermal System Second Generation Patch Compared With First Generation Patch, in Healthy Volunteers [NCT02268422] | Phase 1 | 104 participants (Actual) | Interventional | 2014-10-31 | Completed |
A Single Cross-Over, Open-Label Study of the Relative Bioavailability of Probuphine Versus Buprenorphine Sublingual Tablets at Steady State in Patients With Opioid Dependence [NCT00768482] | Phase 3 | 9 participants (Actual) | Interventional | 2008-09-30 | Terminated(stopped due to This study was terminated for reasons not related to efficacy or safety) |
Pharmacologically-based Strategies for Opioid Substitution Therapy During Pregnancy [NCT03831113] | Phase 2 | 30 participants (Anticipated) | Interventional | 2019-04-13 | Recruiting |
Pilot Study to Look at Feasibility of Testing and Treatment of Combination Fentanyl and Opioid Dependent Individuals With Different Buprenorphine Induction Methods [NCT04794790] | Early Phase 1 | 30 participants (Anticipated) | Interventional | 2022-05-09 | Recruiting |
Incomplete Response in Late-Life Depression: Getting to Remission With Buprenorphine [NCT02263248] | Phase 1/Phase 2 | 56 participants (Actual) | Interventional | 2014-12-31 | Completed |
Outpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder: a Randomized Double-blind Trial [NCT06067737] | Phase 2 | 90 participants (Anticipated) | Interventional | 2023-12-31 | Not yet recruiting |
Buprenorphine Treatment at Syringe Exchanges to Reduce Opioid Misuse and HIV Risk [NCT03150173] | Phase 2 | 98 participants (Actual) | Interventional | 2019-01-02 | Active, not recruiting |
A Randomized, Placebo and Active-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence [NCT01114308] | Phase 3 | 287 participants (Actual) | Interventional | 2010-04-30 | Completed |
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence [NCT00447564] | Phase 3 | 163 participants (Actual) | Interventional | 2006-10-31 | Completed |
Virginia Opioid Treatment-Emergency Department [NCT04523792] | Phase 3 | 0 participants (Actual) | Interventional | 2021-01-01 | Withdrawn(stopped due to Funder has not approved protocol) |
A Pilot Implementation Project of Methadone and Suboxone® for Injecting Drug Users in Ho Chi Minh City, Vietnam [NCT05368675] | Phase 4 | 448 participants (Actual) | Interventional | 2013-12-18 | Completed |
Treatment for Opioid Dependent Offenders [NCT01082679] | Phase 2/Phase 3 | 16 participants (Actual) | Interventional | 2009-06-30 | Completed |
New Application of Buprenorphine Patch on Painful Knee Joint in Knee Osteoarthritis Patients [NCT03947125] | | 200 participants (Anticipated) | Observational | 2019-05-15 | Not yet recruiting |
Houston Emergency Engagement System for Youths and Adolescents [NCT04811014] | Phase 4 | 15 participants (Anticipated) | Interventional | 2021-04-19 | Recruiting |
4-drug Nerve Block Versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans [NCT02891798] | Phase 3 | 98 participants (Actual) | Interventional | 2016-10-31 | Completed |
A Single Center, Open Label, Dose-titration, add-on Study Assessing the Feasibility, Safety and Therapeutic Effect of Buprenorphine in Adult Patients With Diagnosis of Major Depression. [NCT01311570] | Phase 1 | 20 participants (Anticipated) | Interventional | 2012-10-31 | Not yet recruiting |
Comparison of Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology [NCT03740243] | Phase 4 | 0 participants (Actual) | Interventional | 2018-11-30 | Withdrawn(stopped due to No enrollment) |
Comparison of Sublingual Buprenorphine With Intravenous Morphine Sulfate in Treatment of Acute Pain Due to Long Bone Fracture [NCT01298297] | Phase 4 | 80 participants (Actual) | Interventional | 2010-02-28 | Completed |
Reducing Drug Use and HIV Risk in Drug-dependent Adults Arrested for Prostitution [NCT01560221] | Phase 1 | 38 participants (Actual) | Interventional | 2012-10-31 | Completed |
A Single Center, Randomized, Double-Blind, Crossover Study to Assess Buprenorphine Accumulation and Description of Its Metabolites During Co-Medication of BTDS and Ketoconazole, Used As a CYP3A4 Inhibitor, in Healthy Subjects [NCT01259115] | Phase 1 | 20 participants (Actual) | Interventional | 2002-10-31 | Completed |
Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations [NCT03918850] | Phase 3 | 140 participants (Actual) | Interventional | 2020-07-21 | Active, not recruiting |
NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): Infant Neurodevelopmental Outcomes (INO) Sub-study [NCT03911739] | Phase 3 | 200 participants (Anticipated) | Interventional | 2021-06-14 | Recruiting |
Effective Treatment for Prescription Opioid Abuse [NCT00719095] | Phase 2 | 105 participants (Actual) | Interventional | 2006-04-30 | Completed |
A Phase 1, Open-Label, Drug-Drug Interaction Study Between Methadone and BMS-663068; and Between Buprenorphine/Naloxone and BMS-663068 [NCT02666001] | Phase 1 | 32 participants (Actual) | Interventional | 2016-01-12 | Completed |
An Open-Label, Single-Center Study to Evaluate the Exposure-Response Relationship Between the Plasma Drug Concentrations and the Change From Baseline in QTc at Steady State Following Once-daily Administration of CASSIPA® in Opioid Dependent Subjects. [NCT04088266] | Phase 4 | 0 participants (Actual) | Interventional | 2020-01-31 | Withdrawn(stopped due to Study delayed indefinetly) |
Transfer From Methadone to Buprenorphine Maintenance Treatment Using Buprenorphine Patches: A Study on Practicability With Patients Maintained With Daily Dosages Between 60mg and 100mg Methadone. [NCT00750217] | Phase 4 | 10 participants (Anticipated) | Interventional | 2008-08-31 | Recruiting |
A Single-Center, Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine (RBP-6000) Using Poly (DL-lactide-co-glycolide) Polymer of Two Different Molecular Weights (Low and High Molecular [NCT02559973] | Phase 1 | 47 participants (Actual) | Interventional | 2015-09-30 | Completed |
Evaluation of Transfer From Subutex or Other Treatment for Opioid Drug Dependence to Suboxone: Acceptability, Safety and Impact on Medication Dispensing [NCT00725608] | | 339 participants (Actual) | Observational | 2008-05-31 | Completed |
Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults [NCT04219540] | Phase 4 | 301 participants (Anticipated) | Interventional | 2021-01-07 | Recruiting |
Providing A Resource: Telemedicine at Needle Exchanges to Reach Under-served Populations - Greensboro [NCT05108935] | | 17 participants (Actual) | Interventional | 2022-02-17 | Completed |
Evaluating the Pharmacokinetics and Patient Outcomes of Buprenorphine Microdosing [NCT05307458] | | 20 participants (Anticipated) | Observational | 2022-07-01 | Recruiting |
Interaction of Buprenorphine With HIV Medications and Tuberculosis Medications [NCT00877591] | Phase 1 | 63 participants (Actual) | Interventional | 2008-04-30 | Completed |
Phase Ib/2a Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder [NCT04818086] | Phase 1/Phase 2 | 48 participants (Actual) | Interventional | 2021-05-03 | Completed |
Functional Brain Mechanisms Underlying the Anti-Suicidal Effects of Low-dose Buprenorphine in Major Depression [NCT05427981] | Phase 3 | 0 participants (Actual) | Interventional | 2022-10-10 | Withdrawn(stopped due to U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023. This study will not resume recruitment after the resumption of research.) |
A Randomized Clinical Trial to Evaluate Non-Pharmacologic and Pharmacologic Approaches for Reducing Pain and Opioid Use Among Patients Treated With Maintenance Hemodialysis [NCT04571619] | Phase 2 | 643 participants (Actual) | Interventional | 2021-01-03 | Active, not recruiting |
A Prospective, Randomized Trial of the Effect of Standard of Care Reduced Dose Versus Full Dose Buprenorphine/Naloxone in the Perioperative Period on Pain Control and Post Operative Opioid Use Disorder Symptoms [NCT03266445] | Phase 4 | 76 participants (Anticipated) | Interventional | 2018-10-05 | Not yet recruiting |
A Phase 3, Randomized, Double Blind, Multiple Dose, Parallel Group, Placebo Controlled Study of Buprenorphine Sublingual Spray (0.5 mg TID, 0.25 mg TID, and 0.125 mg TID) for the Treatment of Moderate to Severe Pain [NCT02634788] | Phase 3 | 322 participants (Actual) | Interventional | 2016-01-29 | Completed |
Butrans for Treatment of Restless Legs Syndrome [NCT02138357] | Phase 4 | 0 participants (Actual) | Interventional | 2014-04-30 | Withdrawn(stopped due to No funding) |
Influence of Cyclosporine on Buprenorphine Disposition [NCT01648270] | | 25 participants (Actual) | Interventional | 2012-04-30 | Completed |
Integrated Intervention Combining CBT4CBT-Buprenorphine + Recovery Coach for Office-based Buprenorphine [NCT04824404] | | 60 participants (Anticipated) | Interventional | 2020-12-15 | Recruiting |
Transversus Abdominis Plane Block With or Without Buprenorphine After Inguinal Hernia Surgery [NCT05549492] | Phase 1 | 64 participants (Actual) | Interventional | 2021-01-01 | Completed |
A Phase 1, Single-Dose, Double-Blind, Placebo-and Active-Controlled, Randomized, 6-way Crossover Human Abuse Liability Evaluation of ALKS 5461 [NCT02413281] | Phase 1 | 56 participants (Actual) | Interventional | 2015-03-31 | Completed |
A Randomized Controlled Trial Comparing Buprenorphine/Naloxone With Naltrexone for Treatment in Opioid Dependent Adolescents and Young Adults [NCT01015066] | Phase 4 | 0 participants (Actual) | Interventional | 2009-11-30 | Withdrawn(stopped due to Study personnel left institution, anticipated funding did not occur) |
The Impact of Pain on Behavioural Disturbances in Patients With Moderate and Severe Dementia. A Cluster Randomized Trial [NCT01021696] | Phase 2/Phase 3 | 352 participants (Actual) | Interventional | 2009-11-30 | Completed |
A Multi Centre Open Label Single Therapy Dose Ranging Study to Characterise the Pharmacokinetics & Tolerability of BTDS 5-20 ug/h in Children Who Require Opioid Analgesia for Moderate to Severe Mouth Pain Secondary to Chemotherapy Induced Mucositis. [NCT00947466] | Phase 1/Phase 2 | 25 participants (Actual) | Interventional | 2010-02-28 | Terminated(stopped due to 25 patients have been recruited and it was considered that further recruitment would add no extra PK information) |
A Randomised Open Label Parallel Group Study Comparing Norspan Patch and Oral Tramadol [NCT01019265] | Phase 4 | 170 participants (Actual) | Interventional | 2008-03-31 | Completed |
Norspan Versus Oxycontin as Postoperative Painkiller to Proximal Extracapsular Fractures of the Femur [NCT00964808] | Phase 4 | 76 participants (Actual) | Interventional | 2009-09-30 | Completed |
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study to Evaluate the Analgesic Efficacy of BTDS on Postoperative Pain During Rehabilitation Following Total Knee Arthroplasty [NCT00403234] | Phase 2 | 10 participants (Actual) | Interventional | 2006-11-30 | Terminated(stopped due to due to administrative reasons not related to efficacy or safety.) |
Evaluation of Opioid Antagonist Activity in Humans [NCT00460239] | Phase 2 | 12 participants (Actual) | Interventional | 2007-01-31 | Completed |
A Phase 2 Multi-Center Open-label Study to Assess the Safety and Tolerability of a Buprenorphine/Naloxone Film Strip Administered by the Sublingual and Buccal Routes [NCT00640835] | Phase 2 | 382 participants (Actual) | Interventional | 2008-02-29 | Completed |
Comparative Effectiveness of Patient-Centered Strategies to Improve Pain Management and Opioid Safety for Veterans [NCT03026790] | Phase 2 | 820 participants (Actual) | Interventional | 2017-10-19 | Completed |
[NCT02360007] | Phase 1/Phase 2 | 70 participants (Actual) | Interventional | 2015-01-31 | Completed |
Rapid Initiation of Buprenorphine/Naloxone to Optimize MAT Utilization in Philadelphia [NCT03908437] | Phase 4 | 104 participants (Actual) | Interventional | 2019-07-15 | Completed |
Investigation of Analgesic and Anti-hyperalgesic Effect of Opioids in Experimental Pain [NCT00647127] | Phase 3 | 22 participants (Actual) | Interventional | 2008-02-29 | Completed |
Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals [NCT03711318] | Phase 3 | 8 participants (Actual) | Interventional | 2018-11-01 | Terminated(stopped due to continuing study was no longer feasible) |
A Phase 1 Study to Evaluate the Relative Exposures of Lofexidine and Its Major Metabolites in Subjects Seeking Buprenorphine Dose Reduction [NCT02801357] | Phase 1 | 10 participants (Actual) | Interventional | 2016-06-30 | Completed |
A Randomized Controlled Trial Comparing Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients [NCT00879996] | Phase 4 | 54 participants (Actual) | Interventional | 2009-04-30 | Completed |
A Randomized, Double-blind, Cross-over Trial Comparing the Analgesic Potency and Side Effects of Buprenorphine and Ultra-low-dose Naloxone to Buprenorphine Alone [NCT00679458] | | 12 participants (Anticipated) | Interventional | 2008-09-30 | Completed |
Phase 3 Study of the Effects of Buprenophine as Add-on Treatment to Antidepressants in Treating Acutely Suicidal Depressed Inpatients [NCT00863291] | Phase 3 | 40 participants (Anticipated) | Interventional | 2007-11-30 | Active, not recruiting |
A Single-Dose, 1-Period, 1-Treatment Pilot Study of an Investigational Capsule Formulation of 2 mg/.05 mg Buprenorphine/Naloxone Under Fasting Conditions [NCT00880841] | | 6 participants (Actual) | Observational | 2009-04-30 | Completed |
A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects [NCT00605033] | Phase 4 | 241 participants (Actual) | Interventional | 2008-03-31 | Completed |
Pharmacokinetic Interactions Between Buprenorphine/Naloxone and Tipranavir/Ritonavir in HIV-Negative Subjects Chronically Receiving Buprenorphine/Naloxone [NCT00486330] | | 12 participants (Actual) | Interventional | 2006-05-31 | Completed |
Efficacy of Computer Delivered CRA (Bup II) Grant No. R01DA012997-10 [NCT00929253] | | 170 participants (Actual) | Interventional | 2007-09-30 | Completed |
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of the Buprenorphine Transdermal Delivery System in Subjects With Moderate to Severe Osteoarthritic Pain of Hip or Knee [NCT00313846] | Phase 3 | 529 participants (Actual) | Interventional | 2003-04-30 | Completed |
An Open-label, Randomized, Single-dose, Parallel-group Study to Investigate the PK Profile of Single Dose Buprenorphine Transdermal Patch 20 mg Applied for 3 Days, 40 mg for 3 Days and 40 mg for 4 Days in Chinese Subjects With Chronic Pain [NCT03975010] | Phase 1 | 45 participants (Anticipated) | Interventional | 2019-05-13 | Recruiting |
Open Label Comparison of Injectable Buprenorphine ( Brixadi®) and Naltrexone (Vivitrol®) for Opioid Use Disorder [NCT05596955] | Phase 2 | 60 participants (Anticipated) | Interventional | 2023-01-12 | Recruiting |
Virginia Opioid Overdose Treatment InitiatVE [NCT03818399] | Phase 3 | 19 participants (Actual) | Interventional | 2019-01-04 | Terminated(stopped due to Due to a financial business decision by the company supporting the research study (Indivior). The decision was not due to adverse events, safety reasons, or scientific reasons, but was a business decision.) |
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study To Determine The Efficacy and Safety of Buprenorphine (as NTC-510 and NTC-510A) in Subjects With Pain Following Surgical Extraction of 1 or 2 Third Molars. [NCT02161354] | Phase 2 | 52 participants (Actual) | Interventional | 2014-06-30 | Terminated(stopped due to safety and efficacy after cohort 5 did not warrant further dose escalation) |
Emergency Department-Initiated Buprenorphine Validation Network Trial [NCT04225598] | Phase 2 | 2,000 participants (Anticipated) | Interventional | 2020-07-08 | Recruiting |
Long Acting Subcutaneous Compared to Short Acting Sublingual Buprenorphine Administration in Pregnant and Lactating Women [NCT04212065] | Phase 4 | 0 participants (Actual) | Interventional | 2020-02-21 | Withdrawn(stopped due to closed due to new safety concerns of subcutaneous buprenorphine in pregnant patients) |
Maternal Buprenorphine Administration and Fetal/Infant Neurobehavior [NCT00218621] | | 20 participants (Actual) | Observational | 2005-09-30 | Completed |
Chronic Administration of Opioids in Cancer Chronic Pain:an Open Prospective Study on Efficacy, Safety and Pharmacogenetic Factors Influence. [NCT00916890] | Phase 4 | 320 participants (Anticipated) | Interventional | 2009-02-28 | Suspended(stopped due to difficulties in patients enrolment) |
Relapse Prevention to Reduce HIV Among Women Prisoners [NCT00763958] | Phase 4 | 44 participants (Actual) | Interventional | 2008-05-31 | Completed |
Project BEST: Buprenorphine Entry Into Substance Abuse Treatment [NCT02583243] | | 209 participants (Actual) | Observational | 2005-05-31 | Completed |
Reinforcing Effects of Intravenous Buprenorphine Versus Buprenorphine/Naloxone in Buprenorphine-maintained Intravenous Drug Users (P05207) [NCT00710385] | Phase 3 | 19 participants (Actual) | Interventional | 2007-09-30 | Completed |
A Double-Blind Comparative Study of Buprenorphine Transdermal System (BTDS) and Hydrocodone/Acetaminophen Tablets in Patients With Chronic Back Pain [NCT00315887] | Phase 3 | 250 participants | Interventional | 1999-04-30 | Completed |
Effects of Low Dose Buprenorphine on Recovery After Hip or Knee Arthroplasty [NCT02575664] | Phase 4 | 160 participants (Actual) | Interventional | 2012-08-31 | Completed |
The Impact of Intravenous Heroin Use on Immune Activation in Treated HIV [NCT03976258] | | 190 participants (Actual) | Observational | 2017-07-14 | Completed |
Modulation of Opiate Reward by NK1 Antagonism: A Laboratory-Based Proof of Concept Study [NCT00726960] | Phase 1 | 60 participants (Anticipated) | Interventional | 2008-01-31 | Active, not recruiting |
CSP #2014 - Comparative Effectiveness of Two Formulations of Buprenorphine for Treating Opioid Use Disorder in Veterans (VA-BRAVE) [NCT04375033] | Phase 4 | 952 participants (Anticipated) | Interventional | 2020-11-03 | Recruiting |
Opiate Suicide Study in Patients With Major Depression [NCT04116528] | Phase 3 | 60 participants (Anticipated) | Interventional | 2020-08-01 | Recruiting |
A Randomized, Double-blind, Multicenter, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or OxyIR® Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain: A 52-Week Extension Phase [NCT01135524] | Phase 3 | 196 participants (Actual) | Interventional | 2004-04-30 | Terminated(stopped due to This study was terminated early for administrative reasons.) |
Bup/Nx - Facilitated Rehab for Opioid Dependent Adolescents [NCT00078130] | Phase 3 | 223 participants | Interventional | 2003-07-31 | Completed |
A Randomized, Double-blind, Placebo- & Positive-Controlled, Parallel Group, Dose Escalating Study to Evaluate the Effect of Buprenorphine Delivered by Buprenorphine Transdermal System at 10- and 40-mg Dose Levels on QT Intervals in Healthy Adult Volunteer [NCT01148537] | Phase 1 | 132 participants (Actual) | Interventional | 2004-07-31 | Completed |
Functional Brain Mechanisms Underlying the Anti-suicidal Effects of Buprenorphine in Opioid Use Disorder [NCT04234516] | Phase 4 | 0 participants (Actual) | Interventional | 2020-01-20 | Withdrawn(stopped due to PI leaving the institute) |
Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of the Efficacy and Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Mod to Sev OA Pain of Hip or Knee: A 6-Month Open-label Extension Phase [NCT01141283] | Phase 3 | 290 participants (Actual) | Interventional | 2003-04-30 | Completed |
A Multicenter, Randomized, Double-blind, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-Release Vs Buprenorphine Transdermal System (BTDS) 5 in Subjects With Moderate to Severe Low Back Pain: A 52-Week Open- [NCT01125917] | Phase 3 | 354 participants (Actual) | Interventional | 2004-06-30 | Terminated(stopped due to Terminated early due to administrative reasons.) |
A Phase 1 Study to Evaluate the Pharmacodynamics of RDC-0313 Coadministered With Buprenorphine to Opioid-Experienced Healthy Adults [NCT01046539] | Phase 1 | 12 participants (Anticipated) | Interventional | 2010-01-31 | Completed |
A Multicentre, Randomised, Open-label, Active-controlled Trial of the Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France [NCT00955162] | Phase 4 | 270 participants (Actual) | Interventional | 2009-08-31 | Completed |
Neurocomputational Mechanisms of Mood Improvement [NCT04276259] | Phase 4 | 120 participants (Anticipated) | Interventional | 2020-10-19 | Recruiting |
An Open Multi-center Trial of Suboxone® (Buprenorphine/Naloxone) Treatment Among Opiate-Dependent Subjects [NCT00901875] | Phase 4 | 127 participants (Actual) | Interventional | 2009-03-31 | Completed |
A Study to Evaluate the Efficacy and Safety of Buprenorphine Transdermal Patch Compared to Morphine Sulfate Sustained-release Tablet in Opioid Pre-treated Chinese Subjects With Moderate to Severe Chronic Cancer Pain [NCT03967327] | Phase 3 | 194 participants (Anticipated) | Interventional | 2019-04-22 | Recruiting |
A Double-Blind, Double-Dummy, Placebo- and Active Controlled Evaluation of the Efficacy, Safety and Tolerability of Buprenorphine HCl Buccal Film in the Treatment of Pain Associated With Third Molar Extraction [NCT00941304] | Phase 2 | 153 participants (Actual) | Interventional | 2009-08-31 | Completed |
Comparing Rapid Micro-Induction and Standard Induction of Buprenorphine/Naloxone for Treatment of Opioid Use Disorder: A Randomized Controlled Trial [NCT04234191] | Phase 2 | 50 participants (Anticipated) | Interventional | 2021-08-18 | Recruiting |
Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients: A Pilot Study [NCT04752384] | Phase 2 | 20 participants (Anticipated) | Interventional | 2021-07-08 | Recruiting |
A Comparative Study of Buprenorphine TDS, Oxycodone/ Acetaminophen Tablets Qid and Placebo in Patients With Chronic Back Pain [NCT00315445] | Phase 3 | 134 participants (Actual) | Interventional | 1997-12-31 | Completed |
Assessing the Safety of Buprenorphine in People With Sickle Cell Disease [NCT03492099] | Phase 2 | 47 participants (Actual) | Interventional | 2018-08-01 | Completed |
Effects of Buprenorphine on Ulnar Nerve Motor Block [NCT00949299] | Phase 4 | 20 participants (Anticipated) | Interventional | 2010-01-31 | Terminated(stopped due to Not enough could be recruted) |
A Phase1, Open-Label, Drug-Drug Interaction Study Between Methadone and Daclatasvir/Asunaprevir/BMS-791325 3 DAA FDC + 75mg BMS-791325 and Between Buprenorphine/Naloxone and Daclatasvir/Asunaprevir/BMS-791325 3 DAA FDC +75mg BMS-791325 [NCT02045693] | Phase 1 | 32 participants (Actual) | Interventional | 2014-02-28 | Completed |
Single Dose Bioequivalence Trial Comparing a New Analgesic Transdermal Patch Formulation to an Analgesic Reference Patch [NCT00388219] | Phase 1 | 24 participants | Interventional | 2006-10-31 | Terminated |
Buprenorphine Maintenance Protocol [NCT00000205] | Phase 3 | 0 participants | Interventional | 1990-10-31 | Completed |
IV Cocaine Abuse: A Laboratory Model [NCT00000214] | Phase 2 | 0 participants | Interventional | 1992-01-31 | Completed |
A Prospective, Randomized Trial of the Effect of Standard of Care Reduced Dose Versus Full Dose Buprenorphine/Naloxone in the Perioperative Period on Pain Control and Post-Operative Opioid Use Disorder Symptoms [NCT04091009] | Phase 4 | 76 participants (Anticipated) | Interventional | 2020-01-31 | Not yet recruiting |
Buprenorphine Maintenance for Cocaine Abusing Opioid Addicts [NCT00000216] | Phase 3 | 0 participants | Interventional | | Completed |
CS1008A Efficacy/Safety Trial of Buprenorphine/Naloxone [NCT00015028] | Phase 2 | 0 participants | Interventional | 1996-11-30 | Completed |
Buprenorphine/Nx Treatment of Heroin Dependence-A Compassionate Use Study [NCT00015340] | Phase 4 | 582 participants (Actual) | Interventional | 1999-08-31 | Completed |
[NCT01723527] | Phase 1 | 1 participants (Actual) | Interventional | 2012-12-31 | Completed |
Bariatric Surgery and Pharmacokinetics Buprenorphine: BAR-MEDS Buprenorphine [NCT03460314] | | 12 participants (Anticipated) | Observational | 2016-11-02 | Recruiting |
Explorative, Double-blind Study on Dose Effectiveness of DUROGESIC D-Trans 12 Mcg/h and 25mcg/h Compared to Transtec and Placebo in Acute Pain Models in Healthy Volunteers. [NCT00886002] | Phase 1 | 20 participants (Actual) | Interventional | 2004-11-30 | Completed |
A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users [NCT00604188] | Phase 4 | 188 participants (Actual) | Interventional | 2008-02-22 | Completed |
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of Buprenorphine HCl (Sublingual) 8 mg Tablets With a Naltrexone Block Under Fasting Conditions [NCT00992095] | | 48 participants (Actual) | Interventional | 2006-08-31 | Completed |
An Open-label Run-in, Followed by a Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Show the Effectiveness of Buprenorphine Transdermal System in Management of Patients With Chronic Nonmalignant Pain Syndromes [NCT00312195] | Phase 3 | 267 participants (Actual) | Interventional | 2001-03-31 | Completed |
A Multicenter, Inpatient, Open-label Study to Characterize the Pharmacokinetics, Safety, and Efficacy of Intravenous Dosing of Buprenorphine in Pediatric Patients Aged From Birth to 6 Years of Age (Inclusive) Who Require Opioid Analgesia for Acute Moderat [NCT01324544] | Phase 3 | 0 participants (Actual) | Interventional | 2011-11-30 | Withdrawn(stopped due to Due to change in development plan.) |
Evaluation of Preference Between Two Buprenorphine Sublingual Formulations, After a Switch From the Marketed Tablet (Subutex®) to the New Fast Dissolving Tablet (FDT), in Opioid-dependent Patients With Buprenorphine Maintenance Therapy [NCT01075971] | Phase 2 | 52 participants (Actual) | Interventional | 2005-09-30 | Completed |
Randomized, Double-blind, Placebo-controlled With Open-label Run-in Assessing Efficacy, Tolerability,Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects w/Moderate to Severe, Chronic Pain Due to OA of Knee [NCT00531427] | Phase 3 | 567 participants (Actual) | Interventional | 2007-09-30 | Completed |
Multi-center, Randomized, Double-blind, Placebo-controlled With Open Label run-in Study Assessing Efficacy, Tolerability, Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects With Moderate to Severe, Chronic Low Back Pain [NCT00490919] | Phase 3 | 539 participants (Actual) | Interventional | 2007-06-30 | Completed |
An Open, Randomised, Multicentre Study to Compare Buprenorphine Transdermal Delivery System (BTDS) With Standard Treatment in Elderly Subjects With OA of the Hip and/or Knee [NCT00324038] | Phase 4 | 219 participants (Actual) | Interventional | 2006-03-31 | Completed |
A Multicenter, Randomized, Double-blind, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-release Versus BTDS 5 in Subjects With Moderate to Severe Low Back Pain [NCT00313014] | Phase 3 | 660 participants (Actual) | Interventional | 2004-02-29 | Terminated(stopped due to Terminated early due to administrative reasons unrelated to efficacy or safety.) |
Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Determine Efficacy and Safety of Buprenorphine Transdermal System in Subjects With Moderate To Severe Osteoarthritis Pain Requiring Daily Treatment With Opioids [NCT00315458] | Phase 3 | 107 participants (Actual) | Interventional | 2003-12-31 | Terminated(stopped due to Administrative reasons.) |
A Randomized, Double-Blind Study Evaluating the Dose Conversion From Vicodin® to Buprenorphine Transdermal System (BTDS) in Subjects With Osteoarthritis (OA) Pain [NCT00312572] | Phase 3 | 204 participants (Actual) | Interventional | 2003-06-30 | Completed |
Kratom Use Disorder Management Using Clonidine and/or Buprenorphine [NCT05883358] | | 50 participants (Anticipated) | Observational | 2018-07-02 | Recruiting |
Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain [NCT01946555] | | 150 participants (Actual) | Observational | 2013-09-30 | Completed |
A Multiple Dose Opioid Challenge Study to Assess Blockade of Subjective Opioid Effects of CAM2038 q1w (Buprenorphine FluidCrystal® Subcutaneous Injection Depots) In Adults With Opioid Use Disorder [NCT02611752] | Phase 2 | 47 participants (Actual) | Interventional | 2015-10-31 | Completed |
Addition of Buprenorphine to Paracervical Block Prior to Osmotic Dilator Insertion for Dilation and Evacuation: A Randomized Controlled Trial [NCT04254081] | Phase 4 | 57 participants (Actual) | Interventional | 2020-05-28 | Completed |
A 52-Week, Open Label, Longterm Treatment Evaluation of the Safety and Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Pain [NCT01298765] | Phase 3 | 302 participants (Actual) | Interventional | 2011-03-31 | Completed |
A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Buprenorphine 8 mg Sublingual Tablets Under Fasting Conditions. [NCT01157169] | Phase 1 | 40 participants (Actual) | Interventional | 2007-08-31 | Completed |
Effective Use of Buprenorphine for Long-Acting Pain Relief in Combination With Short-Acting Full Agonist Opioids for Cancer Related Pain [NCT05910190] | Phase 4 | 50 participants (Anticipated) | Interventional | 2022-08-10 | Recruiting |
Effects of Mu-opiate Receptor Engagement on Microbial Translocation and Residual Immune Activation in HIV-infected, ART Suppressed Opioid Use Disorder Patients Initiating Medication-assisted Treatment [NCT04480554] | Phase 2 | 225 participants (Anticipated) | Interventional | 2023-01-30 | Recruiting |
Multiple Dose Bioequivalence Trial Comparing a New Analgesic Transdermal Patch Formulation to an Analgesic Reference Patch. [NCT00387777] | Phase 1 | 24 participants | Interventional | 2006-10-31 | Terminated |
A Multicenter Safety Trial of Buprenorphine/Naloxone for the Treatment of Opiate Dependence [NCT00007527] | Phase 4 | 600 participants | Interventional | 1999-08-31 | Completed |
Gradual Vs. Rapid Buprenorphine Detoxification [NCT00000220] | Phase 1 | 0 participants | Interventional | 1991-06-30 | Completed |
Oral Buprenorphine as a Novel Low-Dose Induction Strategy for Individuals With Opioid Use Disorder [NCT06086275] | Phase 1 | 22 participants (Anticipated) | Interventional | 2024-03-31 | Not yet recruiting |
A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals [NCT01136356] | Phase 1/Phase 2 | 12 participants (Actual) | Interventional | 2010-07-31 | Completed |
Safety and Effectiveness of Transdermal Buprenorphine in Cancer Pain: an Observational Study (SOOTHE) [NCT04315831] | | 83 participants (Actual) | Observational | 2018-01-31 | Completed |
A Brief Values Intervention to Support Veterans in Early Buprenorphine Treatment [NCT05189223] | | 50 participants (Anticipated) | Interventional | 2023-09-01 | Recruiting |
A Single Dose PK Study of BTDS 5, 10, and 20 in Chinese Osteoarthritis Patients [NCT01643759] | Phase 1 | 30 participants (Actual) | Interventional | 2009-07-31 | Completed |
Sublingual Buprenorphine for Chronic Pain in Patients at Risk for Drug Abuse [NCT00612287] | Phase 2 | 40 participants (Anticipated) | Interventional | 2009-04-30 | Not yet recruiting |
Attenuation of Opioid Effects of Three Different Doses of Sublingual Buprenorphine / Naloxone by Oral Naltrexone in Healthy Volunteers [NCT00733720] | Phase 1 | 8 participants (Anticipated) | Interventional | 2008-08-31 | Completed |
Inpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder: a Randomized Double-blind Trial [NCT06005662] | Phase 2 | 90 participants (Anticipated) | Interventional | 2023-12-31 | Recruiting |
A Parallel Open-Label Study to Examine Plasma Concentrations of Buprenorphine Following Reapplication of 10-mg Buprenorphine Transdermal System (BTDS) After Variable Application Site Rest Periods in Healthy Subjects [NCT01259102] | Phase 1 | 70 participants (Actual) | Interventional | 2000-11-30 | Completed |
A 12-Week, Placebo Controlled, Double Blind, Randomized Withdrawal Study to Evaluate the Efficacy and Safety of Buprenorphine HCl Buccal Film in Subjects With Moderate to Severe Chronic Low Back Pain [NCT01256450] | Phase 3 | 334 participants (Actual) | Interventional | 2010-11-30 | Completed |
Drug Counseling and Abstinent-Contingent Take-Home Buprenorphine in Malaysia [NCT00539123] | | 234 participants (Actual) | Interventional | 2007-09-30 | Completed |
Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia [NCT05988710] | Phase 4 | 72 participants (Anticipated) | Interventional | 2023-10-19 | Recruiting |
Optimal Timing of Endoscopic Intervention After Extracorporeal Shock-Wave Lithotripsy in the Treatment of Chronic Pancreatitis With Pancreatic Stones. [NCT05270434] | | 225 participants (Anticipated) | Interventional | 2022-03-01 | Not yet recruiting |
An Open Label, Longterm Treatment Evaluation of the Safety and Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Low Back Pain [NCT01431742] | Phase 3 | 0 participants (Actual) | Interventional | 2012-07-31 | Withdrawn |
Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals [NCT00134914] | | 10 participants (Actual) | Interventional | 1996-08-31 | Completed |
Models of Screening, Brief Intervention With a Facilitated Referral to Treatment (SBIRT) for Opioid Patients in the Emergency Department [NCT00913770] | | 329 participants (Actual) | Interventional | 2008-09-30 | Completed |
Optimal Treatment of Veterans With PTSD and Comorbid Opiate Use Disorder (OUD) [NCT03605342] | Phase 2 | 37 participants (Actual) | Interventional | 2018-10-01 | Terminated(stopped due to Early termination) |
Effects of Rifampicin on the Pharmacokinetics and Pharmacodynamics of Sublingual and Intravenous Buprenorphine: A Four-phase Cross-over Study in Healthy Subjects. [NCT01854489] | Phase 4 | 12 participants (Actual) | Interventional | 2013-04-30 | Completed |
Evaluating Microdosing in Emergency Departments: A Randomized Controlled Trial Comparing the Effectiveness of Buprenorphine/Naloxone Microdosing vs. Standard Dosing (EMED Study) [NCT04893525] | Phase 2/Phase 3 | 658 participants (Anticipated) | Interventional | 2021-07-23 | Recruiting |
Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals [NCT01262092] | Phase 2 | 30 participants (Actual) | Interventional | 2010-10-31 | Completed |
Clinical Study on the Effect of Tizanidine on the Function and Pain of Patients After Shoulder Arthroscopy [NCT05852093] | Early Phase 1 | 100 participants (Anticipated) | Interventional | 2023-06-01 | Not yet recruiting |
Buprenorphine Maintenance for Opioid Addicts [NCT00000204] | Phase 2 | 0 participants | Interventional | 1988-08-31 | Completed |
Treatment Efficacy for Drug Abuse and AIDS Prevention [NCT00000210] | Phase 2 | 0 participants | Interventional | 1989-09-30 | Completed |
Alternate Day Buprenorphine Administration, Phase XI [NCT00000234] | Phase 2 | 0 participants | Interventional | | Completed |
Combined Buprenorphine and Behavioral Treatment Without Contingent Reinforcement [NCT00000240] | Phase 2 | 0 participants | Interventional | 1999-04-30 | Completed |
Buprenorphine Maintenance Dose Schedule and Treatment Setting: Pilot [NCT00000318] | Phase 2 | 202 participants (Actual) | Interventional | 1994-12-31 | Completed |
NORSPAN Transdermal Patches Phase III Study In Non-Cancer Pain [NCT01476774] | Phase 3 | 280 participants (Actual) | Interventional | 2009-08-31 | Completed |
A Randomised Double-blind Multicentre Equivalence Study With Active Parallel Comparator Group to Evaluate the Efficacy and Safety of Norspan® Patches Versus Tramadol in Subjects With Chronic, Moderate to Severe Osteoarthritis Pain in the Hip, Knee &/or Lu [NCT00426647] | Phase 4 | 120 participants (Anticipated) | Interventional | 2007-02-28 | Completed |
Multiple Dose Bioequivalence Trial Comparing a Down-Scaled New Analgesic Transdermal Patch Formulation to an Analgesic Reference Patch (Protocol ID: 855509) [NCT00469053] | Phase 1 | 36 participants (Anticipated) | Interventional | 2007-05-31 | Terminated(stopped due to The trail end was achived according to the definition in the trial protocol) |
Single Dose Bioequivalence Trial Comparing a Down-Scaled New Analgesic Transdermal Patch Formulation to an Analgesic Reference Patch. [NCT00469404] | Phase 1 | 24 participants (Anticipated) | Interventional | 2007-05-31 | Terminated(stopped due to The trial end was achieved according to the definition in the trial protocol) |
Buprenorphine for Treatment of Opioid Dependence in Primary Care [NCT00471042] | | 30 participants (Actual) | Observational | 2006-06-30 | Completed |
An Open-label, Multicenter Study of the Safety, Pharmacokinetics, and Efficacy of Buprenorphine Transdermal System (BTDS) in Children From 7 to 16 Years of Age, Inclusive, Who Require Continuous Opioid Analgesia for Moderate to Severe Pain [NCT01324570] | Phase 3 | 41 participants (Actual) | Interventional | 2011-07-31 | Completed |
A Strategy to Improve Success of Treatment Discontinuation in Buprenorphine Responders [NCT03232346] | Phase 3 | 11 participants (Actual) | Interventional | 2017-08-01 | Completed |
Randomized Controlled Pilot Trial of Extended-released Buprenorphine vs. Sublingual Buprenorphine-naloxone in Rural Settings [NCT06023459] | Phase 3 | 144 participants (Anticipated) | Interventional | 2024-01-01 | Not yet recruiting |
Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy [NCT05942313] | | 100 participants (Anticipated) | Observational | 2023-08-28 | Recruiting |
An Open-Label, Multi-Center Extension Study Of Probuphine in Patients With Opioid Dependence [NCT00630201] | Phase 3 | 62 participants (Actual) | Interventional | 2007-10-31 | Completed |
Clinical Trial of Integrated Treatment for Pain and Opioid Dependence [NCT00634803] | Phase 1/Phase 2 | 90 participants (Actual) | Interventional | 2009-09-30 | Completed |
Analgesic Effects and Abuse Liability of Intravenous Hydromorphone and Buprenorphine in Pain-free Opioid Dependent Participants [NCT01642030] | Phase 1 | 132 participants (Actual) | Interventional | 2013-08-31 | Completed |
Alternate-Day Buprenorphine Administration. Phase II [NCT00000222] | Phase 1 | 0 participants | Interventional | 1992-07-31 | Completed |
Buprenorphine Detox With Two Types of Treatment. BBD I [NCT00000228] | Phase 2 | 0 participants | Interventional | 1994-08-31 | Completed |
Buprenorphine Maintenance for Opioid-Addicted Persons in Jail and Post-Release [NCT00367302] | Phase 1/Phase 2 | 116 participants (Actual) | Interventional | 2006-08-31 | Completed |
HCV Treatment of IDUs After Buprenorphine Stabilization [NCT00249574] | | 10 participants (Anticipated) | Interventional | 2003-06-30 | Completed |
Integrating Buprenorphine Into the SFGH AIDS Program (Patient Evaluation Study) [NCT00263458] | Phase 4 | 37 participants (Actual) | Interventional | 2005-12-31 | Completed |
Randomized, Controlled Study of Buprenorphine and Methadone in Hepatitis C Patients in Need of Treatment [NCT00279565] | Phase 4 | 128 participants | Interventional | 2005-08-31 | Terminated(stopped due to The trial was terminated because of deviations from the protocol.) |
Induction, STabilization, Adherence, and Retention Trial (ISTART) - A Randomized, Non-inferiority, Multicenter Study to Assess Early Treatment Efficacy of OX219 Versus SUBOXONE Film and to Explore Switching Between Treatments [NCT01908842] | Phase 3 | 759 participants (Actual) | Interventional | 2013-08-31 | Completed |
Maternal Buprenorphine-naloxone Treatment During the Perinatal Period: Fetal and Infant Effects [NCT03291847] | Phase 2 | 42 participants (Actual) | Interventional | 2018-06-01 | Active, not recruiting |
A Single Dose, Randomized, Double-Blind, Parallel Group Study of the Safety and Pharmacokinetics of Buprenorphine TDS (12.5, 25, 50 Mcg/Hour) Vs. Placebo in Patients With Moderate to Severe Pain Following Orthopedic Surgery [NCT00315835] | Phase 2 | 100 participants | Interventional | 1996-10-31 | Completed |
Safety and Efficacy of Buprenorphine TDS (Transdermal Delivery System) 5, 10 and 20 Applied Every 7 Days for Sixty Days vs. 5 mg Oxycodone/325 mg Acetaminophen Tablets q6h Prn vs. Placebo in Patients With Chronic Low Back Pain [NCT00315874] | Phase 3 | 225 participants | Interventional | 1997-04-30 | Completed |
Assessing Optimal XR-Buprenorphine Initiation Points in Jail [NCT05481112] | Phase 4 | 200 participants (Anticipated) | Interventional | 2023-11-01 | Not yet recruiting |
[NCT00344812] | Phase 2 | 220 participants | Interventional | 1996-01-31 | Completed |
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Determine the Efficacy and Safety of BTDS Compared to Placebo in Subjects With Moderate to Severe Osteoarthritic Pain of the Hip or Knee [NCT00345787] | Phase 3 | 262 participants (Actual) | Interventional | 2006-05-31 | Completed |
Buprenorphine Dose Alteration Study [NCT00000219] | Phase 1 | 0 participants | Interventional | 1991-12-31 | Completed |
Starting Treatment With Agonist Replacement Therapies (START) [NCT00315341] | Phase 4 | 1,269 participants (Actual) | Interventional | 2006-04-30 | Completed |
Pharmacokinetics and Pharmacodynamics of Buprenorphine After Intravenous Administration in Healthy Volunteers [NCT00347815] | Phase 1 | 24 participants | Interventional | 2006-06-30 | Recruiting |
A Pragmatic, Multi-centre, Open-label, Randomized, 12-month, Parallel Group, Superiority Study to Compare the Effectiveness of Subcutaneous Buprenorphine Depot (Sublocade®) vs Daily Sublingual Buprenorphine With Naloxone (Suboxone®) for the Treatment of O [NCT05594121] | Phase 4 | 90 participants (Anticipated) | Interventional | 2022-12-31 | Not yet recruiting |
Effects of Buprenorphine on Mood in Adults With a Range of Depressive Symptomatology [NCT02659787] | | 38 participants (Actual) | Interventional | 2016-06-30 | Completed |
The Acute and Protracted Blockade Efficacy of Buprenorphine/Naloxone [NCT00134888] | | 8 participants (Actual) | Interventional | 2000-12-31 | Completed |
Extended-release Pharmacotherapy for Opioid Use Disorder (EXPO): Protocol for an Open-label Randomised Controlled Trial of Injectable Maintenance Buprenorphine With Personalised Psychosocial Intervention. [NCT05164549] | Phase 3 | 342 participants (Actual) | Interventional | 2019-08-06 | Completed |
Optimizing Patient Centered-Care: A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse (OPTIMA Trial) [NCT03033732] | Phase 4 | 272 participants (Actual) | Interventional | 2017-10-02 | Completed |
Biobehavioral Studies of Opioid Seeking: Effects of Buprenorphine/Naloxone Dose on Experimental Stress Reactivity and Opioid Abstinence [NCT03015246] | Phase 1/Phase 2 | 26 participants (Actual) | Interventional | 2016-12-31 | Completed |
A Single Ascending Dose, Open-Label Study Evaluating the Safety, Tolerability, And Pharmacokinetics of ALA-1000 in Opioid-Dependent Individuals [NCT04122755] | Phase 1 | 59 participants (Actual) | Interventional | 2019-09-16 | Completed |
Exemplar Hospital Initiation Trial to Enhance Treatment Engagement - Comparative Effectiveness Trial of Extended Release Buprenorphine Versus Treatment as Usual for Hospitalized Patients With Opioid Use Disorder [NCT04345718] | Phase 2/Phase 3 | 342 participants (Anticipated) | Interventional | 2021-08-09 | Recruiting |
A Single-Dose Study to Evaluate the Relative Bioavailability, Safety, and Tolerability of SUBLOCADE at Alternative Injection Locations in Adults [NCT05704543] | Phase 4 | 88 participants (Actual) | Interventional | 2023-03-01 | Completed |
A Randomised, Double-Blind Study Comparing 2 Maintenance Dosing Regimens of Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in Treatment-Seeking Adult Participants With Opioid Use Disorder and High-risk Opioid Use [NCT04995029] | Phase 4 | 489 participants (Anticipated) | Interventional | 2021-10-26 | Active, not recruiting |
Buprenorphine for the Treatment of Neonatal Abstinence Syndrome [NCT00521248] | Phase 1 | 60 participants (Anticipated) | Interventional | 2004-04-30 | Completed |
Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections [NCT04677114] | Phase 2 | 90 participants (Anticipated) | Interventional | 2021-03-16 | Recruiting |
An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Treatment in HIV Primary Care Settings [NCT00124358] | Phase 4 | 1,350 participants | Interventional | 2005-08-31 | Recruiting |
A Prospective, Randomized Trial of the Effect of Buprenorphine Continuation Versus Dose Reduction on Pain Control and Post-Operative Opioid Use [NCT04981678] | Phase 4 | 12 participants (Actual) | Interventional | 2022-01-01 | Terminated(stopped due to This study was halted prior to accumulating the full number of participants due to difficulty in recruiting study subjects.) |
Assessing Optimal Extended-Release Buprenorphine (XRB) Initiation Points in Jail [NCT06051890] | Phase 4 | 200 participants (Anticipated) | Interventional | 2024-01-05 | Not yet recruiting |
Alternate-Day Buprenorphine. Phase V [NCT00000224] | Phase 1 | 0 participants | Interventional | 1993-02-28 | Completed |
[NCT01546701] | Phase 4 | 80 participants (Actual) | Interventional | 2011-03-31 | Completed |
Buprenorphine Detox With Two Types of Treatment. BBD II [NCT00000229] | Phase 2 | 0 participants | Interventional | 1995-10-31 | Completed |
Buprenorphine Pharmacology Related to Addiction Treatment [NCT00000239] | Phase 2 | 0 participants | Interventional | | Completed |
Rapid Opiate Detoxification & Naltrexone Induction Using Bup. [NCT00000299] | Phase 2 | 12 participants (Actual) | Interventional | 2008-10-31 | Completed |
Alternate-Day Buprenorphine Administration. Phase I [NCT00000221] | Phase 1 | 0 participants | Interventional | 1992-04-30 | Completed |
Buprenorphine/Naloxone Versus Clonidine For Out-patient Opiate Detoxification [NCT00032968] | Phase 3 | 341 participants | Interventional | 2001-01-31 | Completed |
CS1008 A&B Eff/Safety Trial of BUP/NX for the Treatment of Opiate Dependence [NCT00015171] | Phase 3 | 0 participants | Interventional | 1996-04-30 | Completed |
PK0496 Pharmacokinetics of Buprenorphine [NCT00015288] | Phase 1 | 0 participants | Interventional | 1996-11-30 | Completed |
HIV Risk Reduction and Drug Abuse Treatment in Iran [NCT00398008] | Phase 2 | 0 participants (Actual) | Interventional | 2004-10-31 | Withdrawn(stopped due to Study was never able to start in IRAN) |
PK 0396 - Buprenorphine Dose Escalation Trial [NCT00015041] | Phase 1 | 0 participants | Interventional | 1996-11-30 | Completed |
Counseling Conditions for Thrice Weekly Buprenorphine in a Primary Care Clinic [NCT00023283] | Phase 2 | 0 participants | Interventional | 2000-08-31 | Completed |
Buprenorphine/Naloxone Versus Clonidine for Inpatient Opiate Detoxification [NCT00032955] | Phase 3 | 163 participants | Interventional | 2001-02-28 | Completed |
Dose Reduction Strategies in Oral Opioid Dependence Subsequent to Pain Management: An Exploratory Study [NCT00218101] | Phase 2 | 10 participants | Interventional | 2004-05-31 | Completed |
Suboxone: (Buprenorphine/Naloxone) Comparison of Two Taper Schedules [NCT00078117] | Phase 3 | 516 participants | Interventional | 2003-06-30 | Completed |
Buprenorphine Effectiveness Evaluation in HIV Enhancement (BEEHIVE): A Randomized Trial of HIV Clinic-based Buprenorphine/Naloxone vs. Case Management and Referral in Opioid-dependent Individuals [NCT00130819] | Phase 2 | 120 participants (Anticipated) | Interventional | 2005-11-30 | Completed |
Abuse Potential of Parenteral Buprenorphine/Naloxone in Non-Dependent Opioid Abusers [NCT00134875] | | 9 participants (Actual) | Interventional | 2000-12-31 | Terminated |
Abuse Potential of Buprenorphine/Naloxone as a Function of Maintenance Dose of Buprenorphine/Naloxone [NCT00149539] | Phase 2 | 12 participants (Actual) | Interventional | 2004-06-30 | Terminated(stopped due to Funding ended for the study) |
Effects of Buprenorphine/Naloxone in Non-Dependent Opioid Abusers [NCT00158236] | | 7 participants | Interventional | 1997-01-31 | Completed |
Science-Based Treatment for Opioid-Dependent Adolescents [NCT00182572] | Phase 2 | 80 participants (Anticipated) | Interventional | 2005-07-31 | Recruiting |
Pilot for Improved Office Based Treatment of Opioid-Dependence [NCT03586466] | | 80 participants (Anticipated) | Interventional | 2018-12-01 | Recruiting |
Integrating Long-Acting Injectable Treatment to Improve Medication Adherence Among Persons Living With HIV and Opioid Use Disorder [NCT05991622] | Early Phase 1 | 40 participants (Anticipated) | Interventional | 2022-04-01 | Recruiting |
A Randomized, Open Label Clinical Trial of Buprenorphine in the Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines or Are Breastfeeding [NCT01671410] | Phase 1 | 11 participants (Actual) | Interventional | 2012-08-31 | Completed |
Prospective Randomized Blinded Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS) [NCT04455802] | Phase 3 | 0 participants (Actual) | Interventional | 2020-10-01 | Withdrawn(stopped due to termination of funding) |
Pharmacokinetic Interactions Between Buprenorphine and Kaletra (Lopinavir/Ritonavir) [NCT00571961] | | 12 participants (Actual) | Interventional | 2007-01-31 | Completed |
A Multi-center, Open-Label, 24-Week, Follow-Up Study to Assess Safety, Efficacy, and Treatment Adherence For Maintenance Treatment of Opioid Dependence With OX219 [NCT01903005] | Phase 4 | 668 participants (Actual) | Interventional | 2013-07-31 | Completed |
Buprenorphine for Prisoners [NCT00574067] | Phase 3 | 213 participants (Actual) | Interventional | 2008-09-30 | Completed |
Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone: An Outpatient Detoxification for Opioid Dependence. [NCT02294253] | Phase 2/Phase 3 | 30 participants (Actual) | Interventional | 2014-09-30 | Completed |
Multicentre Study To Evaluate Efficacy And Safety Of Buprenorphine Transdermal Patch (Norspan) In Chronic Non-Malignant Pain Of Moderate To Severe Intensity Due To Osteoarthritis, Rheumatoid Arthritis, Lower Back Pain And Joint / Muscle Pain, When Opioid [NCT01961271] | Phase 4 | 114 participants (Actual) | Interventional | 2013-06-30 | Completed |
An Open-label, Multicentre, Single-arm Trial of Monthly Injections of Depot Buprenorphine in People With Opioid Dependence [NCT03809143] | Phase 3 | 100 participants (Actual) | Interventional | 2019-05-22 | Active, not recruiting |
Post-marketing Surveillance Study (Paper-AWB) for GPs and Clinics: Treatment of Opioid-dependent Patients With SUBOXONE® 2 mg / 8 mg Sublingual Tablets - Acceptability and Safety Data From a Real Life Scenario. [NCT00723749] | | 384 participants (Actual) | Observational | 2008-03-31 | Completed |
A Phase 1, Open-Label, Single-Sequence Study to Examine the Effect of Telaprevir on the Pharmacokinetics of Buprenorphine in Subjects on Stable Buprenorphine/Naloxone Maintenance Therapy [NCT01275599] | Phase 1 | 16 participants (Anticipated) | Interventional | 2011-01-31 | Completed |
Multicentre Study for Evaluation of the Efficacy and Safety of Buprenorphine Transdermal Patch (SOVENOR®) 5mg and 10mg in Patients With Non-malignant Pain of Moderate Intensity Due to Osteoarthritis, Rheumatoid Arthritis, Lower Back Pain and Joint/Muscle [NCT02519387] | Phase 4 | 78 participants (Actual) | Interventional | 2013-07-31 | Completed |
Novel Induction to Buprenorphine/Naloxone: A Quasi-Experimental Study With Comparison Group [NCT05644587] | Phase 4 | 170 participants (Anticipated) | Interventional | 2023-02-06 | Enrolling by invitation |
Neurocognitive Effects of Opiate Agonist Treatment [NCT01733693] | Phase 4 | 135 participants (Actual) | Interventional | 2013-01-31 | Completed |
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ASP8062 as an Add-on Therapy to Buprenorphine/Naloxone in Participants With Opioid Use Disorder [NCT05062577] | Phase 2 | 0 participants (Actual) | Interventional | 2021-11-08 | Withdrawn(stopped due to Due to corporate strategic considerations) |
A Randomized, Blinded, Active-controlled Non-inferiority Study of the Efficacy and Safety of OX219 for the Induction of Treatment of Opioid Dependence [NCT01848054] | Phase 3 | 313 participants (Actual) | Interventional | 2013-06-30 | Completed |
Buprenorphine for Probationers and Parolees: Bridging the Gap Into Treatment [NCT03616236] | Phase 3 | 320 participants (Anticipated) | Interventional | 2019-03-01 | Active, not recruiting |
Buprenorphine Detoxification With Two Types of Treatment. BBD IV [NCT00000231] | Phase 2 | 0 participants | Interventional | 1992-02-29 | Completed |
SPNS - An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Abuse Treatment in HIV Primary Care [NCT00227357] | | 101 participants (Actual) | Observational | 2005-07-31 | Completed |
A Double-Blind Placebo-Controlled Study of Buprenorphine Transdermal System (BTDS) in Patients With Osteoarthritis of the Hip or Knee [NCT00314652] | Phase 3 | 260 participants | Interventional | 1999-06-30 | Completed |
A Randomized, Double Blind, Pilot Evaluation of the Effectiveness of BTDS Versus Placebo on Health Outcomes Associated With Analgesic Management of Elderly Residents in Supervised Living Environments [NCT00313833] | Phase 3 | 100 participants | Interventional | 2000-12-31 | Completed |
Assessing the Acceptability, Feasibility, Effectiveness and Cost-effectiveness of Long-acting Depot Buprenorphine (LADB) for the Treatment of Opioid Dependence in Low- and Middle-income Countries (LMIC): a Multicentre International Study [NCT06129916] | | 1,050 participants (Anticipated) | Observational | 2024-04-01 | Not yet recruiting |
Buprenorphine for Late-Life Treatment Resistant Depression [NCT01071538] | Phase 2 | 15 participants (Actual) | Interventional | 2010-05-31 | Completed |
Graded Strategy for Pharmacological Treatment of Heroin Dependence [NCT00310934] | Phase 4 | 96 participants | Interventional | 2005-08-31 | Completed |
A Multi-Center, Randomized, Double-Blind, Parallel Group Study of the Safety and Efficacy of Buprenorphine Transdermal Delivery System Vs. Oxycodone/Acetaminophen Tablets Vs. Placebo in Patients With Chronic Pain Due to Osteoarthritis [NCT00315848] | Phase 3 | 225 participants | Interventional | 1996-11-30 | Completed |
A Phase I Double-Blind, Placebo-Controlled Randomized Study to Assess Repeated Doses of INDV-2000 (C4X_3256) up to 28 Days in Healthy Volunteers, and an Open-Label Study of INDV-2000 up to 11 Days in Treatment Seeking Individuals With Opioid Use Disorder [NCT04976855] | Phase 1 | 64 participants (Actual) | Interventional | 2022-08-17 | Completed |
Randomized, Placebo-Controlled Trial of Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2) [NCT05262270] | Phase 2 | 426 participants (Anticipated) | Interventional | 2023-04-18 | Recruiting |
A Randomized Comparison of Sublingual Buprenorphine to Morphine Sulfate in the Treatment of Neonatal Abstinence Syndrome (NAS) [NCT01708707] | Phase 2 | 29 participants (Actual) | Interventional | 2012-12-31 | Completed |
Evaluation of BEMA® Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects [NCT01713803] | Phase 3 | 0 participants (Actual) | Interventional | | Withdrawn(stopped due to FDA did not require a clinical trial for indication.) |
Optimal Prevention of Overdose Deaths and Opioid Relapse Following Discharge: A Multi-Center RCT of Naltrexone Versus Buprenorphine in Norway [NCT01717963] | Phase 3 | 166 participants (Actual) | Interventional | 2012-10-31 | Completed |
Development of a Community-based Buprenorphine Treatment Intervention [NCT01761110] | | 77 participants (Actual) | Interventional | 2012-12-31 | Completed |
Randomized, Double-blind, Placebo-controlled Trial of Monthly Injectable Buprenorphine (BUP) for Methamphetamine (MA) Use Disorder [NCT05283304] | Phase 2 | 18 participants (Actual) | Interventional | 2023-03-24 | Active, not recruiting |
Maternal Brain Imaging in Opioid Use Disorder [NCT06008990] | | 40 participants (Anticipated) | Observational | 2023-08-01 | Recruiting |
The Effects of Buprenorphine on Responses to Verbal Tasks [NCT01860287] | Early Phase 1 | 48 participants (Actual) | Interventional | 2013-09-30 | Completed |
Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence [NCT00555425] | Phase 4 | 113 participants (Actual) | Interventional | 2008-07-31 | Completed |
Relationship Between Buprenorphine Dose Adjustments and Gestational Age in the Treatment of Opioid-Maintained Pregnant Women [NCT03028883] | | 40 participants (Actual) | Observational | 2016-12-02 | Completed |
A Comparative Effectiveness Trial of Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail [NCT04408313] | Phase 2/Phase 3 | 240 participants (Anticipated) | Interventional | 2020-10-28 | Recruiting |
A Randomized Pilot Study of Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films [NCT03744663] | Phase 2 | 0 participants (Actual) | Interventional | 2022-06-30 | Withdrawn(stopped due to Funding for uninsured subjects could not be realized and staffing after COVID hit was also a problem.) |
CTN-0051: Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment [NCT02032433] | Phase 4 | 570 participants (Actual) | Interventional | 2014-01-29 | Completed |
A Phase 3, Open-label, Long-term Study to Evaluate the Safety, Tolerability, and Analgesic Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Pain Requiring Continuous Around-the-Clock Opioid Analgesia for an Extended Period of Ti [NCT01755546] | Phase 3 | 304 participants (Actual) | Interventional | 2012-12-31 | Completed |
A Randomized Controlled Trial Testing Buprenorphine as a Treatment in Opiate Dependent Pain Patients [NCT00552578] | Phase 4 | 12 participants (Actual) | Interventional | 2007-10-31 | Terminated(stopped due to "Tapering doses protocol arm was not effective for treatment retention outcome.") |
Buprenorphine Tx:A Safe Alternative for Opioid Dependent Pain Patients [NCT01841931] | | 4 participants (Actual) | Interventional | 2013-02-28 | Terminated(stopped due to Principal Investigator is no longer at this site) |
Multicenter Clinical Trial of Buprenorphine [NCT00000207] | Phase 3 | 0 participants | Interventional | 1992-05-31 | Completed |
Alternate-Day Buprenorphine Administration. Phase VI [NCT00000225] | Phase 2 | 0 participants | Interventional | 1992-12-31 | Completed |
Buprenorphine Detoxification - BBDVI [NCT00000237] | Phase 2 | 0 participants | Interventional | 1997-05-31 | Completed |
Transitioning Patients From Methadone to Buprenorphine/Naloxone for Treating Opioid Dependence [NCT00000243] | | 16 participants | Interventional | 2002-09-30 | Terminated |
A Laboratory Model for Heroin Abuse Medications [NCT00000273] | Phase 2 | 8 participants (Actual) | Interventional | 1995-08-31 | Completed |
Buprenorphine Maintenance for Opiate Dependence [NCT00000357] | Phase 2 | 0 participants | Interventional | 1992-06-30 | Completed |
Medications Development for Drug Abuse Disorders [NCT01188421] | Phase 1/Phase 2 | 106 participants (Actual) | Interventional | 2010-10-31 | Completed |
Buprenorphine Maintenance for Opioid Addicts [NCT00000202] | Phase 2 | 0 participants | Interventional | 1988-08-31 | Completed |
Methadone/Buprenorphine Cross-Over Study [NCT00000208] | Phase 2 | 0 participants | Interventional | 1992-02-29 | Completed |
Alternate-Day Buprenorphine Administration. Phase VII [NCT00000226] | Phase 2 | 0 participants | Interventional | 1994-11-30 | Completed |
Alternate Day Buprenorphine Administration, Phase IX [NCT00000232] | Phase 2 | 0 participants | Interventional | 1992-03-31 | Completed |
Temporal Discounting Delayed Outcomes on Opioid-Dependent Outpatients [NCT00000238] | Phase 2 | 0 participants | Interventional | 1997-08-31 | Completed |
Buprenorphine Combination Tablet Feasibility [NCT00000298] | Phase 2 | 0 participants | Interventional | 1995-08-31 | Completed |
Pharmacological Comparison of Buprenorphine and Methadone [NCT00000334] | Phase 2 | 0 participants | Interventional | 2002-12-01 | Completed |
Project STRIDE2 - Seek/Test/Retain: PLWHA and Opioid Users in Washington, DC [NCT03583138] | | 159 participants (Actual) | Observational | 2014-06-23 | Completed |
Duration of Analgesic Effect for Ultrasound Guided Supraclavicular Blocks With the Addition of Buprenorphine to Local Anesthetic Solution [NCT01583179] | | 26 participants (Actual) | Interventional | 2012-04-30 | Terminated(stopped due to The study was closed prematurely due to low enrollment and anticipation of future barriers in enrollment) |
Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone [NCT00637000] | Phase 2 | 38 participants (Actual) | Interventional | 2008-03-31 | Completed |
Etude Observationnelle Prospective de l'Utilisation en Situation Reelle; Prospective Real Situation Observational Study of Subutex® or Its Buprenorphine High Dose Generic (BHD) in the Replacement Treatment of Major Opiate Dependence: Following Parameters [NCT00723697] | | 1,307 participants (Actual) | Observational | 2007-05-31 | Completed |
Evaluation of Preference for a Buprenorphine-based Maintenance Therapy, After a Switch From Buprenorphine Alone (Subutex®) to the Buprenorphine/Naloxone Combination (Suboxone®), in Opioid-dependent Patients With Buprenorphine Maintenance Therapy [NCT00684073] | Phase 4 | 60 participants (Actual) | Interventional | 2007-07-31 | Completed |
Incomplete Response in Late-Life Depression: Getting to Remission With Buprenorphine [NCT02181231] | Phase 1/Phase 2 | 18 participants (Actual) | Interventional | 2016-06-01 | Completed |
"Bupe by the Book: Developing and Testing a Tele-Buprenorphine Intervention in Public Libraries With Unstably Housed Persons With Opioid Use Disorder" [NCT05872386] | | 60 participants (Anticipated) | Interventional | 2023-05-31 | Not yet recruiting |
A Multicenter, Open-Label, Single Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Depot Buprenorphine (RBP-6000) in Opioid-Dependent Subjects [NCT03002961] | Phase 1 | 48 participants (Actual) | Interventional | 2012-07-31 | Completed |
Phase 3, Double-Blind, Placebo-Controlled Study to Evaluate the Analgesic Efficacy, Safety, and Tolerability of Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects With Chronic Lower Back Pain Requiring Opioid Analgesia [NCT01675167] | Phase 3 | 815 participants (Actual) | Interventional | 2012-09-30 | Completed |
Maternal Opioid Treatment: Human Experimental Research [NCT00271219] | Phase 3 | 175 participants (Actual) | Interventional | 2005-07-31 | Completed |
Pharmacokinetics of Buprenorphine and Naloxone in Subjects With Mild to Severe Hepatic Impairment (Child-Pugh Classes, A, B, and C), in HCV-Seropositive Subjects, and in Healthy Volunteers [NCT01846455] | Phase 4 | 43 participants (Actual) | Interventional | 2012-09-30 | Completed |
Comparing Medication Maintenance in Comprehensive Community and Pharmacy Settings to Enhance Engagement [NCT04139213] | Phase 2/Phase 3 | 250 participants (Anticipated) | Interventional | 2019-07-25 | Active, not recruiting |
A Pilot Study Comparing a Low-dose Versus a High-dose Sublingual Buprenorphine Induction Dosing Scheme in Fentanyl Using Patients With Opioid Use Disorder (OUD) [NCT05944952] | Phase 4 | 40 participants (Anticipated) | Interventional | 2023-10-01 | Not yet recruiting |
Randomized Controlled Trial of Extended-Release Buprenorphine vs. Sublingual Buprenorphine for the Treatment of Opioid Use Disorder Patients Using Fentanyl [NCT04352166] | Phase 2 | 40 participants (Anticipated) | Interventional | 2020-12-15 | Suspended(stopped due to U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023. This study will resume recruitment after OHRP has approved the resumption of research.) |
Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: Clinical Trials Network 0075 [NCT03248947] | Early Phase 1 | 71 participants (Actual) | Interventional | 2018-03-28 | Completed |
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Determine the Efficacy and Safety of BTDS Compared to Placebo in Subjects With Moderate to Severe Low Back Pain [NCT00346047] | Phase 3 | 238 participants (Actual) | Interventional | 2006-05-31 | Completed |
Fetal and Infant Effects of Maternal Buprenorphine Treatment [NCT01561079] | Phase 2/Phase 3 | 127 participants (Actual) | Interventional | 2012-02-29 | Completed |
An Evaluation of the Tolerability of Switching Subjects on Chronic Around-the-Clock (ATC) Opioid Therapy to Buprenorphine HCl Buccal Film [NCT01871285] | Phase 2 | 39 participants (Actual) | Interventional | 2013-06-30 | Completed |
Clinical Rescue Protocol [NCT00000206] | Phase 2 | 0 participants | Interventional | 1991-04-30 | Completed |
Buprenorphine Detoxification With Two Types of Treatment. BBD III [NCT00000230] | Phase 2 | 0 participants | Interventional | 1995-01-31 | Completed |
Buprenorphine Pharmacology Related to Addiction Treatment [NCT00000236] | Phase 2 | 0 participants | Interventional | | Completed |
Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution [NCT00000320] | Phase 1/Phase 2 | 120 participants (Actual) | Interventional | 1997-10-31 | Completed |
Trial of Buprenorphine/Naloxone for Treatment of Opiate Dependence [NCT00000344] | Phase 2 | 40 participants | Interventional | | Completed |
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Assess the Efficacy, Safety, and Tolerability of Multiple Subcutaneous Injections of Depot Buprenorphine (RBP-6000 [100 mg and 300 mg]) Over 24 Weeks in Treatment-Seeking Subjects With O [NCT02357901] | Phase 3 | 665 participants (Actual) | Interventional | 2015-01-28 | Completed |
Treatment Efficacy for Drug Abuse and AIDS Prevention [NCT00000211] | Phase 2 | 0 participants | Interventional | 1989-09-30 | Completed |
Alternate-Day Buprenorphine Administration. Phase IV [NCT00000223] | Phase 2 | 0 participants | Interventional | 1993-06-30 | Completed |
Alternate Day Buprenorphine Administration, Phase XII [NCT00000235] | Phase 2 | 0 participants | Interventional | | Completed |
Buprenorphine Maintenance Dose Schedule and Treatment Setting [NCT00000319] | Phase 2 | 0 participants | Interventional | 1996-06-30 | Completed |
Effects of Buprenophine and Naloxone in Opiate Addicts [NCT00000355] | Phase 1 | 0 participants | Interventional | 1994-11-30 | Completed |
Suboxone User Perioperative Early Referral and Enhanced Recovery After Surgery- Orthopaedic Trauma Surgery Population [NCT04464512] | Phase 4 | 0 participants (Actual) | Interventional | 2020-01-10 | Withdrawn(stopped due to No qualified enrollments; study cancelled due to pandemic) |
A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-4 Study) [NCT02158533] | Phase 3 | 385 participants (Actual) | Interventional | 2014-05-31 | Completed |
A Multicenter, Phase IV, Interventional Study to Assess the Efficacy and Safety of NORSPAN® (Buprenorphine) in Korean Patients With Spinal Disorders (NOBLE) [NCT01818700] | Phase 4 | 245 participants (Actual) | Interventional | 2012-09-30 | Completed |
Buprenorphine Maintenance for Opioid Addicts [NCT00000203] | Phase 2 | 0 participants | Interventional | 1988-08-31 | Completed |
Buprenorphine Dosing Interval [NCT00000209] | Phase 2 | 0 participants | Interventional | 1992-11-30 | Completed |
Alternate-Day Buprenorphine Administration. Phase VIII [NCT00000227] | Phase 2 | 0 participants | Interventional | 1994-08-31 | Completed |
Alternate Day Buprenorphine Administration, Phase X [NCT00000233] | Phase 2 | 0 participants | Interventional | 1993-05-31 | Completed |
Combining Behavioral Treatment With Agonist Maintenance [NCT00000311] | Phase 3 | 168 participants (Actual) | Interventional | 1995-02-28 | Completed |
Pharmacokinetics and Bioavailability of Liquid vs Tablet Buprenorphine [NCT00000341] | Phase 2 | 1 participants | Interventional | 1996-08-31 | Completed |
Efficacy/Safety Trial of Buprenorphine/Nx for Opiate Dependence [NCT00000353] | Phase 2 | 0 participants | Interventional | 1996-10-31 | Completed |
A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Placebo-Controlled Study of Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain [NCT02310581] | Phase 3 | 40 participants (Actual) | Interventional | 2015-02-24 | Terminated(stopped due to Business decision) |
HIV Risk Reduction and Drug Abuse Treatment in Malaysia [NCT00383045] | Phase 2 | 180 participants | Interventional | 2003-04-30 | Completed |
A Multicenter, Phase IV, Interventional Study to Compare the Efficacy and Safety of NORSPAN to Tramadol/Acetaminophen in Patients With Prolonged Postoperative Pain After Spinal Surgery (PASSION) [NCT01983111] | Phase 4 | 136 participants (Actual) | Interventional | 2013-10-31 | Completed |
Neuroimaging Study on the Effect of Transdermal Buprenorphine in Complex Regional Pain Syndrome(CRPS) Patients With Chronic Lower Back Pain: A Pilot Study [NCT03977012] | | 20 participants (Anticipated) | Observational | 2019-06-11 | Recruiting |
An Open-Label Multicenter Study Assessing the Long-Term Safety of a Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injection Depot of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder [NCT02672111] | Phase 3 | 228 participants (Actual) | Interventional | 2015-11-30 | Completed |
Prescription Opioid Abuse Among Pain Patients: Predictors of Relapse [NCT01967641] | Phase 2 | 51 participants (Actual) | Interventional | 2005-11-30 | Completed |
Is Serratus Anterior Plane Block (SAPB) With Adjuvant Medications Better at Managing Post-operative Pain Than Serratus Anterior Plane Block With Bupivacaine Alone in Patients Undergoing Video-assisted Thoracoscopy? [NCT05090761] | | 120 participants (Anticipated) | Interventional | 2021-10-12 | Recruiting |
Transdermal Buprenorphine Patch for Postoperative Pain Control in Laparoscopic Cholecystectomy: a Prospective Randomized, Placebo-controlled, Study [NCT05871424] | | 66 participants (Anticipated) | Interventional | 2023-06-12 | Recruiting |
Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder [NCT05011266] | Phase 2/Phase 3 | 180 participants (Anticipated) | Interventional | 2022-08-01 | Recruiting |
NIDA-CTN-0100: Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD) [NCT04464980] | Phase 2 | 2,190 participants (Anticipated) | Interventional | 2021-06-08 | Recruiting |
True Functional Restoration and Analgesia in Non-Radicular Low Back Pain: a Prospective, Double Blind, Placebo-controlled Study of Buccal Buprenorphine [NCT05419297] | Phase 4 | 40 participants (Anticipated) | Interventional | 2022-08-03 | Recruiting |
Phase 3, Double-Blind, Placebo-Controlled, Study to Evaluate the Analgesic Efficacy, Safety, and Tolerability of Buprenorphine HCl Buccal Film in Opioid-Naive Subjects With Chronic Lower Back Pain Requiring Opioid Analgesia [NCT01633944] | Phase 3 | 752 participants (Actual) | Interventional | 2012-08-31 | Completed |
Treatment of Polydrug-Using Opiate Dependents During Withdrawal [NCT00367874] | Phase 4 | 12 participants | Interventional | 2003-02-28 | Completed |
A Phase II, Open-label, Partially Randomized, 3 Treatment Groups, Multi-Site Study Assessing Pharmacokinetics After Administration of the Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injectable Depot of Buprenorphine (CAM2038) at Different Injec [NCT02710526] | Phase 2 | 66 participants (Actual) | Interventional | 2015-02-28 | Completed |
A Prospective Triple-masked Randomized Controlled Trial Measuring Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block [NCT03117140] | Phase 4 | 160 participants (Actual) | Interventional | 2013-12-31 | Completed |
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Enriched-Enrollment Withdrawal, Multicenter Study to Evaluate the Efficacy and Safety of a Long-Acting Subcutaneous Injectable Depot of Buprenorphine (CAM2038) in Subjects With Moderate to Severe [NCT02946073] | Phase 3 | 1,053 participants (Actual) | Interventional | 2016-09-30 | Completed |
An Open-Label Pilot Study of Sublocade as Treatment for Opiate Use Disorder [NCT03861338] | Phase 1/Phase 2 | 11 participants (Actual) | Interventional | 2019-03-01 | Completed |
Prisma Health Clemson University [NCT06102200] | | 90 participants (Anticipated) | Interventional | 2023-10-03 | Recruiting |
A Pivotal, Phase 1, Open-Label, Randomized, Crossover, Single-Dose, Comparative Bioavailability Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers [NCT02477267] | Phase 1 | 47 participants (Actual) | Interventional | 2015-06-30 | Completed |
Intravenous Buprenorphine Versus Morphine for Severe Pain in the Emergency Department [NCT03256487] | Phase 2 | 122 participants (Anticipated) | Interventional | 2017-09-26 | Recruiting |
An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects (BNX-201) [NCT01666119] | Phase 2 | 249 participants (Actual) | Interventional | 2012-08-31 | Completed |
Expanded Steady-State Pharmacokinetic Study, Comparing Liquid and Tablet Buprenorphine Formulations [NCT00000302] | Phase 3 | 0 participants | Interventional | | Completed |
Analgesic Effects and Abuse Liability of Intravenous Hydromorphone and Buprenorphine in Opioid Dependent Participants With Chronic Musculoskeletal Pain [NCT02372591] | Phase 1 | 14 participants (Actual) | Interventional | 2015-08-31 | Completed |
Buprenorphine in the Emergency Department: Buprenorphine Versus Clonidine for Opioid Withdrawal [NCT03174067] | Phase 4 | 26 participants (Actual) | Interventional | 2013-03-31 | Completed |
A Randomized, Triple-blind, Placebo- and Positive-Controlled, Parallel Group Study of the Effect of Buprenorphine Delivered by the Buprenorphine Transdermal System (BTDS) at Doses up to 80 mcg/Hour and Naltrexone on ECG Intervals in Healthy Adult Subjects [NCT01999114] | Phase 1 | 328 participants (Actual) | Interventional | 2012-03-31 | Completed |
Add-on Buprenorphine at Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode [NCT03646058] | Phase 3 | 180 participants (Anticipated) | Interventional | 2021-10-10 | Recruiting |
Are Superficial Parasternal Intercostal Plane (SPIP) Blocks With Local Anesthetic Alone and Local Anesthetic With Adjuvants Helpful in Managing Post-operative Pain in Coronary Artery Bypass Grafting (CABG)? [NCT05003765] | | 200 participants (Anticipated) | Interventional | 2020-08-06 | Recruiting |
Are Adductor Canal Blocks With Bupivacaine and Added Magnesium Better at Managing Post-operative Pain Than Adductor Canal Blocks With Bupivacaine and Added Buprenorphine in Patients Undergoing Same-day Discharge Total Knee Arthroplasty? [NCT05091138] | | 100 participants (Anticipated) | Interventional | 2021-10-12 | Recruiting |
Buprenorphine For Treatment Resistant Depression [NCT01407575] | Phase 3 | 13 participants (Actual) | Interventional | 2011-09-30 | Completed |
Kappa Opioid Receptor Antagonism for the Treatment of Alcohol Use Disorder (AUD) and Comorbid Post-Traumatic Stress Disorder (PTSD) [NCT03852628] | Phase 2 | 69 participants (Actual) | Interventional | 2019-05-20 | Terminated(stopped due to Futility analysis) |
Health Promotion and Public Safety: Community-based Collaborative Services to Addicted Offenders [NCT01843751] | Phase 3 | 24 participants (Actual) | Interventional | 2013-03-31 | Completed |
Open-Label, Multicenter, Multiple Dose Study of Safety, Tolerability, Pharmacokinetics, Efficacy Markers, and Opioid Receptor Availability of Subcutaneous Injections of Depot Buprenorphine in Treatment Seeking Opioid-Dependent Subjects [NCT01738503] | Phase 2 | 124 participants (Actual) | Interventional | 2012-10-31 | Completed |
Buprenorphine vs. Opioid Dose Escalation Among Patients With Chronic Pain [NCT01875848] | Phase 4 | 7 participants (Actual) | Interventional | 2013-12-31 | Terminated(stopped due to Data safety monitoring board recommended due to low recruitment yield.) |
Influence of CYP3A Modulation on Buprenorphine Disposition and Clinical Effects [NCT01576575] | | 21 participants (Actual) | Interventional | 2010-06-30 | Completed |
Improving Treatment Outcomes for Prescription Opioid Dependence [NCT02543944] | Phase 2/Phase 3 | 117 participants (Actual) | Interventional | 2016-02-29 | Completed |
Randomized Trial of Buprenorphine Microdose Initiation for Ambulatory Settings [NCT05450718] | Phase 4 | 70 participants (Anticipated) | Interventional | 2024-01-31 | Not yet recruiting |
A Randomized, Active-Control, Double-Blind, Double-Dummy Clinical Trial Comparing Sublingual Buprenorphine And Morphine Solution For The Treatment Of Neonatal Opioid Abstinence Syndrome [NCT01452789] | Phase 3 | 63 participants (Actual) | Interventional | 2011-11-30 | Completed |
An Open-Label, One-Period Study in Patients Receiving Methadone or Buprenorphine/Naloxone Maintenance Therapy to Evaluate the Effect of SCH 503034 (Boceprevir) on Either Methadone or Buprenorphine/Naloxone Plasma Concentrations (Protocol No. P08123) [NCT01396005] | Phase 1 | 21 participants (Actual) | Interventional | 2011-09-30 | Completed |
Low-dose Buprenorphine as a Modulator of Social Motivation in Schizophrenia [NCT05778591] | Phase 2 | 40 participants (Anticipated) | Interventional | 2023-12-01 | Not yet recruiting |
Sublingual Buprenorphine Treatment for Neonatal Abstinence Syndrome - Pilot Study [NCT02249026] | Phase 1/Phase 2 | 40 participants (Anticipated) | Interventional | 2014-10-31 | Recruiting |
A Randomized, Double-Blind, Double-Dummy, Active-Controlled Multicenter Study of Adult Outpatients With Opioid Dependence Transitioned From a Daily Maintenance Dose of 8 mg or Less of Sublingual Buprenorphine or Buprenorphine/Naloxone to Four Probuphine® [NCT02180659] | Phase 3 | 177 participants (Actual) | Interventional | 2014-07-31 | Completed |
The Effects of Opioid Taper on Opioid-Induced Hyperalgesia [NCT03063905] | | 15 participants (Actual) | Observational | 2017-01-31 | Terminated(stopped due to funding expired) |
A Pilot Randomized Comparative Effectiveness Clinical Trial of Buprenorphine vs. Methadone for the Treatment of Opioid Dependence in Pregnancy. [NCT03098407] | | 55 participants (Actual) | Interventional | 2017-04-20 | Completed |
A Randomized Controlled Trial Comparing Buprenorphine and Methadone for Treatment in Opioid Dependent Chronic Back Pain Patients [NCT01559454] | Phase 4 | 19 participants (Actual) | Interventional | 2012-02-29 | Completed |
HIV, Buprenorphine, and the Criminal Justice System [NCT01550341] | | 50 participants (Actual) | Interventional | 2012-02-23 | Completed |
Buprenorphine Maintenance Treatment of Opioid Dependence in Primary Care: A Randomized Clinical Trial of At-Home Versus In-Office Buprenorphine Induction [NCT00684554] | Phase 2/Phase 3 | 20 participants (Actual) | Interventional | 2007-12-31 | Completed |
Duration of Analgesia After Popliteal Fossa Nerve Blockade: Effects of Dexamethasone and Buprenorphine [NCT01277159] | | 108 participants (Actual) | Interventional | 2010-10-31 | Completed |
Modeled Dose Exposure of Sublingual Buprenorphine in the Neonatal Opioid Abstinence Syndrome [NCT03608696] | Phase 1/Phase 2 | 10 participants (Actual) | Interventional | 2018-08-29 | Completed |
Cocaine Use Reduction With Buprenorphine (CURB) [NCT01402492] | Phase 2/Phase 3 | 302 participants (Actual) | Interventional | 2011-09-30 | Completed |
A Randomized, Double-blind, Active Control Evaluation of the Safety of BioErodible MucoAdhesive (BEMA®) Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects [NCT02516436] | Phase 3 | 0 participants (Actual) | Interventional | | Withdrawn(stopped due to FDA did not require a clinical trial for indication.) |
An Open Label, Flexible Dose Study of Very Low Doses of Naltrexone-Buprenorphine Transfer to Extend-Release Naltrexone (VIVITROL®) in Opioid Addiction [NCT01690546] | Phase 2 | 38 participants (Actual) | Interventional | 2012-09-30 | Completed |
RCT Comparing the Analgesic Efficacy of 4 Therapeutic Strategies Based on 4 Different Major Opioids (Fentanyl, Oxycodone, Buprenorphine vs Morphine) in Cancer Patients With Moderate/Severe Pain, at the Moment of Starting 3rd Step of WHO Analgesic Ladder. [NCT01809106] | Phase 4 | 518 participants (Actual) | Interventional | 2011-04-30 | Completed |
Efficacy of Buprenorphine on Postoperative Endodontic Analgesia [NCT03268278] | Phase 1 | 10 participants (Actual) | Interventional | 2017-04-01 | Terminated(stopped due to Loss of interest) |
The Use of Buprenorphine Transdermal Patches Improves Post-Operative Pain Management in Arthroscopic Rotator Cuff Repair? [NCT03380533] | Phase 2/Phase 3 | 50 participants (Actual) | Interventional | 2016-09-22 | Completed |
High Dosage Buprenorphine as a Drug Strategy Withdrawal Assistance of Analgesics Opioid After Failure of an Opioid Tapering-off Strategy. [NCT03156907] | Phase 2 | 60 participants (Anticipated) | Interventional | 2017-09-15 | Active, not recruiting |
Efficacy of Pain Treatment on Depression in Patients With Dementia. A Randomized Clinical Trial. [NCT02267057] | Phase 4 | 163 participants (Actual) | Interventional | 2014-08-31 | Completed |
A Phase 3, Six-Month, Open-Label, Re-Treatment Study of Probuphine in Opioid Addiction [NCT01262261] | Phase 3 | 85 participants (Actual) | Interventional | 2010-11-30 | Completed |
Buprenorphine Group Medical Visits for Drug Users at Risk for HIV [NCT02526212] | Phase 3 | 18 participants (Actual) | Interventional | 2017-01-01 | Completed |
The Utilization of Buprenorphine in the Emergency Room to Treat Clinical Opioid Withdrawal [NCT03489161] | Early Phase 1 | 3 participants (Actual) | Interventional | 2018-08-01 | Completed |
Assess the Efficacy of Buprenorphine/Naloxone Micro-Dosing for Postoperative Pain Management in Opioid-Tolerant Patients [NCT04771689] | Phase 4 | 60 participants (Anticipated) | Interventional | 2022-07-01 | Not yet recruiting |
Interim Buprenorphine Treatment to Bridge Waitlist Delays: Stage II Evaluation [NCT03420313] | Phase 2 | 100 participants (Anticipated) | Interventional | 2018-03-01 | Recruiting |
Buprenorphine to Improve HIV Care Engagement and Outcomes: A Randomized Trial (BRAVO) [NCT01936857] | Phase 4 | 281 participants (Actual) | Interventional | 2015-07-31 | Completed |
A Randomized, Controlled Trial of Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual in the Treatment of Opioid Use Disorder [NCT05339256] | Phase 2 | 50 participants (Anticipated) | Interventional | 2024-01-01 | Not yet recruiting |
Effects of Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes [NCT03923374] | | 300 participants (Anticipated) | Observational [Patient Registry] | 2018-09-15 | Recruiting |
NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations: Conceptual Model Assessments (CMA) Sub-study [NCT03911466] | Phase 3 | 97 participants (Actual) | Interventional | 2020-07-21 | Active, not recruiting |
A Multiple-Dose Study of Blockade of Subjective Opioid Effects, Plasma Levels, and Safety of Subcutaneous Injections of Depot Buprenorphine (RBP-6000) in Subjects With Opioid Use Disorder [NCT02044094] | Phase 2 | 39 participants (Actual) | Interventional | 2013-11-30 | Completed |
A Single Center, Randomized, 2 Way Cross-Over, Phase 4 Study Comparing Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 Including Ease of Use, Taste Preference, Dissolution Time, Desire to Abuse, and Overall Acceptance In Bu [NCT02038790] | Phase 4 | 33 participants (Actual) | Interventional | 2013-11-30 | Completed |
Health Services Research: Extended Release Naltrexone for Opioid-Dependent Youth [NCT01843023] | Phase 4 | 288 participants (Actual) | Interventional | 2013-06-30 | Completed |
Psychopharmacological Treatment of Emotional Distress: A Randomized Controlled Trial [NCT06133114] | Phase 4 | 80 participants (Anticipated) | Interventional | 2023-12-31 | Not yet recruiting |
Interest of Concentrations in Meconium of Drugs Used for Treatment of Pregnant Opioid-dependent Woman as a Prognostic Factor of Time, Severity and Duration of Neonatal Abstinence Syndrome [NCT03334981] | | 92 participants (Actual) | Observational | 2012-07-31 | Completed |
Effects of a Triple Adjuvant Combination of Buprenorphine, Clonidine, and Dexamethasone on Duration of Brachial Plexus Blocks for Upper Extremity Surgery, a Prospective, Randomized Clinical Trial [NCT05824832] | Phase 4 | 120 participants (Anticipated) | Interventional | 2023-02-28 | Recruiting |
Brain Mechanisms of Cognitive Response to Pharmacotherapy in Opioid Use Disorder [NCT04454411] | Phase 2 | 200 participants (Anticipated) | Interventional | 2025-02-01 | Not yet recruiting |
A Phase III, Randomized, Double-Blind, Active-Controlled, Parallel Group, Multi-center Trial Assessing the Efficacy and Safety of a Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injectable Depot of Buprenorphine (CAM2038) in Treatment of Adult Ou [NCT02651584] | Phase 3 | 428 participants (Actual) | Interventional | 2015-12-31 | Completed |
Prolonged Popliteal Fossa Nerve Blockade [NCT02198235] | Phase 1 | 90 participants (Actual) | Interventional | 2012-10-31 | Completed |
Incomplete Response in Late-Life Depression: Getting to Remission With Buprenorphine [NCT02176291] | Phase 2 | 31 participants (Actual) | Interventional | 2014-08-31 | Completed |
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial | Outcome |
NCT00270257 (7) [back to overview] | Evidence of HIV-1 Infection or Death for Visits up to 104 Weeks |
NCT00270257 (7) [back to overview] | Incident Hepatitis B Infections |
NCT00270257 (7) [back to overview] | Incident Hepatitis C Infections for Thailand and China |
NCT00270257 (7) [back to overview] | Number of Participants Reported Using Injection Equipment (Needles, Syringes, Cookers, Cottons, and Rinse Water) in the Prior 6 Months |
NCT00270257 (7) [back to overview] | Number of Participants With Urinalysis Results Positive for Opiates |
NCT00270257 (7) [back to overview] | Self-report of Continued Injection Opiate Use in the Last 30 Days |
NCT00270257 (7) [back to overview] | Self-reported Number of Injections in the Last Month |
NCT00271219 (9) [back to overview] | Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS |
NCT00271219 (9) [back to overview] | Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS) |
NCT00271219 (9) [back to overview] | Mother's Self-report of Drug Use (Measured Monthly by Time Line Follow Back) |
NCT00271219 (9) [back to overview] | Mother's Psychosocial Functioning at Delivery as Measured by the Addiction Severity Index Psychosocial Index Score |
NCT00271219 (9) [back to overview] | Mother's Measures of Dose Adequacy and Acceptance Over Time (Measured Weekly by Dose Adequacy Measure) |
NCT00271219 (9) [back to overview] | Mother's HIV Risk Behaviors (Measured Monthly by Risk Behavior Assessment) |
NCT00271219 (9) [back to overview] | Child's Peak Daily Total NAS Score |
NCT00271219 (9) [back to overview] | Child's Length of Hospital Stay |
NCT00271219 (9) [back to overview] | Child's Head Circumference Measurement (Measured at Birth) |
NCT00312195 (4) [back to overview] | The Number of Subjects Who Had Ineffective Treatment or Who Discontinued Due to Reasons Other Than Ineffective Treatment in the Double-blind Phase |
NCT00312195 (4) [back to overview] | Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment |
NCT00312195 (4) [back to overview] | The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets). |
NCT00312195 (4) [back to overview] | The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase. |
NCT00312221 (4) [back to overview] | "Average Pain Over the Last 24 Hours Scores at Weeks 4, 8, and 12 of the Double-blind Phase." |
NCT00312221 (4) [back to overview] | The Mean Daily Number of Supplemental Analgesic Medication Tablets |
NCT00312221 (4) [back to overview] | The Physical Function Subscale of The Western Ontario and McMaster's Universities Osteoarthritis (WOMAC OA) Index at Weeks 4, 8, and 12 of the Double Blind Phase |
NCT00312221 (4) [back to overview] | The Sleep Disturbance Subscale in The Medical Outcomes (MOS)-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase |
NCT00312572 (1) [back to overview] | The Percentage of Subjects Who Completed the 14-day Double-blind Phase. |
NCT00313014 (4) [back to overview] | The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12. |
NCT00313014 (4) [back to overview] | Oswestry Disability Index (ODI) Score (V 2.0) |
NCT00313014 (4) [back to overview] | Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12. |
NCT00313014 (4) [back to overview] | Mean Daily Number of Supplemental Analgesic Tablets |
NCT00313846 (2) [back to overview] | The Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site. |
NCT00313846 (2) [back to overview] | "Daily Maximum Pain Right Now Score for the Primary Osteoarthritis (OA) Pain Site" |
NCT00315341 (1) [back to overview] | Hepatic Safety |
NCT00315445 (22) [back to overview] | Time to Stable Pain Management |
NCT00315445 (22) [back to overview] | "Bodily Pain (MOS SF-36): Mean Percent at Day 84 (LOCF)" |
NCT00315445 (22) [back to overview] | "Emotional Role (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)" |
NCT00315445 (22) [back to overview] | "General Health (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)" |
NCT00315445 (22) [back to overview] | "Mental Health (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF)" |
NCT00315445 (22) [back to overview] | "Physical Functioning Scale of the Medical Outcomes Survey (MOS) 36 Item Short-Form Health Survey (SF-36): Mean Percent ± Standard Error of the Mean (SEM) at Day 84 (LOCF)" |
NCT00315445 (22) [back to overview] | "Physical Role Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF)" |
NCT00315445 (22) [back to overview] | "Sensitivity Analysis: Pain on the Average Change From Baseline in the Maintenance Period (Days 21 - 84) Baseline Observation Carried Forward (BOCF)" |
NCT00315445 (22) [back to overview] | "Sensitivity Analysis: Pain on the Average Change From Baseline to End of Treatment (Day 84) (Hybrid BOCF/LOCF)" |
NCT00315445 (22) [back to overview] | "Sensitivity Analysis: Pain Right Now Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF)" |
NCT00315445 (22) [back to overview] | "Sensitivity Analysis: Pain Right Now Change From Baseline in the Maintenance Period (Days 21-84), BOCF" |
NCT00315445 (22) [back to overview] | Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF) |
NCT00315445 (22) [back to overview] | Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF) |
NCT00315445 (22) [back to overview] | Pain Right Now, Mean Change From Baseline, Days 21-84 (LOCF) |
NCT00315445 (22) [back to overview] | Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF]) |
NCT00315445 (22) [back to overview] | "Vitality (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)" |
NCT00315445 (22) [back to overview] | "Sensitivity Analysis Pain on the Average Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF)" |
NCT00315445 (22) [back to overview] | The Time to Discontinuation Due to Lack of Efficacy |
NCT00315445 (22) [back to overview] | "Social Functioning (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)" |
NCT00315445 (22) [back to overview] | Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF) |
NCT00315445 (22) [back to overview] | Subject Satisfaction: Mean ± SEM (Day 84)(LOCF) |
NCT00315445 (22) [back to overview] | "Sensitivity Analysis: Pain Right Now Change From Baseline to End of Treatment (Day 84) (Hybrid BOCF/LOCF)" |
NCT00315458 (1) [back to overview] | Number of Participants With Adverse Events (AEs) as a Measure of Safety |
NCT00320801 (1) [back to overview] | The Number of Participants With Adverse Events (AEs) as a Measure of Safety. |
NCT00324038 (1) [back to overview] | Average Daily Pain Scores - BS11 Pain Scores. |
NCT00403234 (1) [back to overview] | Number of Participants With Adverse Events (AEs) as a Measure of Safety |
NCT00460239 (8) [back to overview] | Physiologic Effects as Assessed by Oxygen Saturation |
NCT00460239 (8) [back to overview] | Physiologic Effects as Assessed by Heart Rate |
NCT00460239 (8) [back to overview] | Physiologic Effects as Assessed by Body Temperature |
NCT00460239 (8) [back to overview] | Peak Change From Baseline in Drug Effect Assessed by Visual Analog Scale (VAS) |
NCT00460239 (8) [back to overview] | Physiologic Effects as Assessed by Blood Pressure |
NCT00460239 (8) [back to overview] | Psychomotor/Cognitive Performance Effects Assessed by Trails B |
NCT00460239 (8) [back to overview] | Psychomotor/Cognitive Performance Effects Assessed by Digit Symbol Substitution Test (DSST) |
NCT00460239 (8) [back to overview] | Physiologic Effects as Assessed by Pupil Diameter |
NCT00486330 (1) [back to overview] | Area Under the Curve of BUP/NLX With TPV/r (h*ng/mL) |
NCT00490919 (3) [back to overview] | Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase. |
NCT00490919 (3) [back to overview] | The Sleep Disturbance Subscale in the Medical Outcome Study (MOS) Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase |
NCT00490919 (3) [back to overview] | The Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Medications Taken During Weeks 2 Through 12 of the Double-blind Phase |
NCT00531427 (3) [back to overview] | Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Used From Week 2 to 12 of the Double-blind Phase. |
NCT00531427 (3) [back to overview] | "Average Pain Over the Last 24 Hours Score of the Study Knee at Week 12 of the Double Blind Phase." |
NCT00531427 (3) [back to overview] | Sleep Disturbance Subscale of the MOS-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase. |
NCT00552578 (3) [back to overview] | Number of Participants With Better Overall Quality of Life at Six Months as Compared to Baseline. |
NCT00552578 (3) [back to overview] | Relapse to Substance Abuse |
NCT00552578 (3) [back to overview] | Treatment Retention. |
NCT00555425 (7) [back to overview] | Proportion of Patients Protectively Transferred |
NCT00555425 (7) [back to overview] | Illicit Opioid Use |
NCT00555425 (7) [back to overview] | Reduction in Cocaine Use |
NCT00555425 (7) [back to overview] | Patient Satisfaction |
NCT00555425 (7) [back to overview] | Retention in Treatment |
NCT00555425 (7) [back to overview] | Changes in HIV Risk |
NCT00555425 (7) [back to overview] | Health Status |
NCT00571961 (1) [back to overview] | Buprenorphine Area Under the Curve With LPV/r (ng/mL*hr) |
NCT00574067 (7) [back to overview] | Number of Days of Heroin Use |
NCT00574067 (7) [back to overview] | Number of Days of Cocaine Use |
NCT00574067 (7) [back to overview] | Drug Abuse Treatment Entry and Retention in the Community |
NCT00574067 (7) [back to overview] | Criminal Activity |
NCT00574067 (7) [back to overview] | Employment Status |
NCT00574067 (7) [back to overview] | HIV Risk Behavior |
NCT00574067 (7) [back to overview] | HIV Risk Behavior Needle Sharing |
NCT00604188 (8) [back to overview] | Self-reported Opioid Withdrawal Symptoms (SOWS) |
NCT00604188 (8) [back to overview] | Addiction-related Severity Index (ASI-Lite): A Composite Score to Evaluate Seven Potential Problem Areas: Medical, Employment/Support Status, Alcohol, Drug, Legal, Family/Social, and Psychiatric |
NCT00604188 (8) [back to overview] | Responders at Day 3 |
NCT00604188 (8) [back to overview] | Responders at Day 28 |
NCT00604188 (8) [back to overview] | Observer-rated Opioid Withdrawal Symptoms (OOWS) |
NCT00604188 (8) [back to overview] | Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS) |
NCT00604188 (8) [back to overview] | Illicit Opioid and Non-opioid Drug Use: Substance Use Inventory (SUI) |
NCT00604188 (8) [back to overview] | Compliance Rate |
NCT00605033 (1) [back to overview] | Response Rate |
NCT00634803 (3) [back to overview] | Pain Intensity |
NCT00634803 (3) [back to overview] | Pain Interference |
NCT00634803 (3) [back to overview] | Number of Opioid-negative Urine Toxicology Tests |
NCT00637000 (18) [back to overview] | "Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: Does the Drug Have Any Bad Effects?" |
NCT00637000 (18) [back to overview] | Pupil Diameter Measurements At End of Induction (End of Day 2) and the Minimum Pupil Diameter During the Post Induction Period (Days 3-5) |
NCT00637000 (18) [back to overview] | "Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: Does the Drug Have Any Good Effects?" |
NCT00637000 (18) [back to overview] | "Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: Do You Like the Drug?" |
NCT00637000 (18) [back to overview] | Pupil Diameter Measurements at Baseline and the Minimum Pupil Diameter up to 23.5 Hours After the First Administration |
NCT00637000 (18) [back to overview] | "Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: Does the Drug Make You Sick?" |
NCT00637000 (18) [back to overview] | "CVisual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: Do You Like the Drug?" |
NCT00637000 (18) [back to overview] | "Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: Does the Drug Have Any Bad Effects?" |
NCT00637000 (18) [back to overview] | "Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: Does the Drug Make You Sick?" |
NCT00637000 (18) [back to overview] | "Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: How High Are You?" |
NCT00637000 (18) [back to overview] | "Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: Do You Feel Any Drug Effect?" |
NCT00637000 (18) [back to overview] | "Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: Do You Feel Any Good Effects?" |
NCT00637000 (18) [back to overview] | "Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: Do You Feel Any Drug Effect?" |
NCT00637000 (18) [back to overview] | Severity of Withdrawal Symptoms Measured Using the Clinical Opiate Withdrawal Scale (COWS) at the End of Induction and the Peak COWS Post Induction |
NCT00637000 (18) [back to overview] | "Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: How High Are You?" |
NCT00637000 (18) [back to overview] | Pupil Diameter Measurements at Baseline and the Maximum Pupil Diameter up to 23.5 Hours After the First Administration |
NCT00637000 (18) [back to overview] | Severity of Withdrawal Symptoms Measured Using the Clinical Opiate Withdrawal Scale (COWS) at Baseline and the Peak COWS up to 23.5 Hours After the First Administration |
NCT00637000 (18) [back to overview] | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) |
NCT00640835 (2) [back to overview] | Number of Subjects With Mild, Moderate or Severe Treatment-emergent Adverse Events Associated With the Oral Cavity |
NCT00640835 (2) [back to overview] | Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity. |
NCT00684073 (1) [back to overview] | Subject's Self Assessment Using 10 cm Visual Analogue Scale (VAS) of Overall Preference for One of the Two Buprenorphine-based Maintenance Therapies (Suboxone® or Subutex®). |
NCT00684554 (2) [back to overview] | The Primary Outcome Will Include a Comparison of the Proportion of Patients Successfully Inducted One Week After the Initial Primary Care Visit. |
NCT00684554 (2) [back to overview] | Prolonged Withdrawal |
NCT00710385 (2) [back to overview] | Drug's Breakpoint |
NCT00710385 (2) [back to overview] | "Drug Liking" |
NCT00723697 (3) [back to overview] | Number of Patients Reporting Clinical Consequences of Engaging in Misuse |
NCT00723697 (3) [back to overview] | Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) |
NCT00723697 (3) [back to overview] | Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. |
NCT00723749 (4) [back to overview] | Take Home Prescriptions of SUBOXONE® |
NCT00723749 (4) [back to overview] | Drug Craving (Subjective Effects of Therapy) |
NCT00723749 (4) [back to overview] | Dosage of SUBOXONE® |
NCT00723749 (4) [back to overview] | Retention Rate After 12 Months of Treatment With Suboxone |
NCT00725608 (3) [back to overview] | Dosing of Suboxone (Buprenorphine Plus Naloxone) |
NCT00725608 (3) [back to overview] | Retention Rate |
NCT00725608 (3) [back to overview] | Dispensing of Suboxone (Buprenorphine Plus Naloxone) |
NCT00763958 (3) [back to overview] | Opiate Positive Urines With Missing Urines Coded as Positive at Week 24. |
NCT00763958 (3) [back to overview] | Opiate Positive Urines With Missing Urines Coded as Positive at Week 12. |
NCT00763958 (3) [back to overview] | Number of Participants Who Enroll in the Study. |
NCT00879996 (4) [back to overview] | Self-reported Illicit Opioid Use |
NCT00879996 (4) [back to overview] | Numerical Rating Score for Pain |
NCT00879996 (4) [back to overview] | Numerical Rating Score for Functioning |
NCT00879996 (4) [back to overview] | Number of Participants Retained in Treatment |
NCT00913770 (2) [back to overview] | Days of Self-reported Illicit Opioid Use in the Past 7 Days |
NCT00913770 (2) [back to overview] | Self-reported Engagement in Formal Substance Abuse Treatment at 30 Days (Verified by Contact With the Treatment Program) |
NCT00929253 (1) [back to overview] | Abstinence |
NCT00941304 (11) [back to overview] | Peak Pain Relief |
NCT00941304 (11) [back to overview] | Sum of Pain Intensity Difference From Baseline to 8 Hours |
NCT00941304 (11) [back to overview] | Sum of Pain Relief and Intensity Differences Over 2 Hours |
NCT00941304 (11) [back to overview] | Sum of Pain Relief and Intensity Differences Over 8 Hours |
NCT00941304 (11) [back to overview] | Total Pain Relief Over 8 Hours |
NCT00941304 (11) [back to overview] | Change From Baseline in Cognitive Assessment Using CNS-VS |
NCT00941304 (11) [back to overview] | "Percentage of Participants Reporting a Global Rating of Study Drug as Excellent" |
NCT00941304 (11) [back to overview] | "Percentage of Participants With Excellent Investigator Global Rating of Study Drug" |
NCT00941304 (11) [back to overview] | Duration of Analgesia |
NCT00941304 (11) [back to overview] | Onset of Analgesia |
NCT00941304 (11) [back to overview] | Peak Pain Intensity Difference |
NCT01071538 (7) [back to overview] | Positive and Negative Affect Scale |
NCT01071538 (7) [back to overview] | Blood Pressure |
NCT01071538 (7) [back to overview] | UKU Side Effect Rating Scale |
NCT01071538 (7) [back to overview] | Pain Numeric Rating Scale (20 Item) |
NCT01071538 (7) [back to overview] | Montgomery Asberg Depression Rating Scale |
NCT01071538 (7) [back to overview] | Heart Rate |
NCT01071538 (7) [back to overview] | Brief Symptom Inventory -- Anxiety Subscale |
NCT01075971 (1) [back to overview] | The Overall Preference Between Two Buprenorphine Sublingual Formulations, After a Switch From the Marketed Tablet (Subutex®) to the New Fast Dissolving Tablet (FDT), in Opioid-dependent Patients With Buprenorphine 8 mg or 16 mg Daily Maintenance Therapy. |
NCT01125917 (1) [back to overview] | Number of Participants With Adverse Events (AEs) as a Measure of Safety |
NCT01135524 (1) [back to overview] | The Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
NCT01136356 (3) [back to overview] | Mean Peak Sleep Assessed by Pittsburgh Sleep Quality Index (PSQI) |
NCT01136356 (3) [back to overview] | Mean Daily Peak Pain Ratings Assessed by the Visual Analog Scale (VAS) |
NCT01136356 (3) [back to overview] | Mean Peak Opioid Withdrawal Assessed by the Clinical Opiate Withdrawal Scale (COWS) |
NCT01141283 (1) [back to overview] | The Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
NCT01148537 (8) [back to overview] | The Average Differences From Baseline Between BTDS and Placebo by Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13 |
NCT01148537 (8) [back to overview] | The Average Differences Between Moxifloxacin vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6 |
NCT01148537 (8) [back to overview] | The Average Differences From Baseline Between BTDS and Placebo by Fridericia's Corrected Interval (QTcF) on Day 6 and Day 13 |
NCT01148537 (8) [back to overview] | The Average Differences From Baseline Between Moxifloxacin and Placebo of Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13 |
NCT01148537 (8) [back to overview] | The Average Differences From Baseline Between Moxifloxacin and Placebo by Fridericia's Corrected Interval (QTcF) on Day 6 and Day 13 |
NCT01148537 (8) [back to overview] | The Average Differences Between BTDS vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6 |
NCT01148537 (8) [back to overview] | The Comparison of BTDS to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Corrected From Within-subject Data (QTci) on Day 13 |
NCT01148537 (8) [back to overview] | The Comparison of Moxifloxacin to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Interval Corrected From Within-subject Data (QTci) on Day 13 |
NCT01151098 (1) [back to overview] | Number of Participants With Adverse Events (AEs) as a Measure of Safety. |
NCT01157169 (6) [back to overview] | AUC0-inf for Norbuprenorphine. |
NCT01157169 (6) [back to overview] | AUC0-t for Buprenorphine. |
NCT01157169 (6) [back to overview] | AUC0-t for Norbuprenorphine. |
NCT01157169 (6) [back to overview] | Cmax for Norbuprenorphine. |
NCT01157169 (6) [back to overview] | AUC0-inf for Buprenorphine. |
NCT01157169 (6) [back to overview] | Cmax of Buprenorphine. |
NCT01188421 (1) [back to overview] | Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period. |
NCT01256450 (10) [back to overview] | Change From Baseline to Week 12 in Roland Morris Disability Questionnaire |
NCT01256450 (10) [back to overview] | Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks) |
NCT01256450 (10) [back to overview] | Use of Rescue Medication |
NCT01256450 (10) [back to overview] | Number of Participants With Response to Treatment as Assessed by an NRS Scale |
NCT01256450 (10) [back to overview] | Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM |
NCT01256450 (10) [back to overview] | Change From Baseline in Pain Intensity Over Time Using NRS Scale |
NCT01256450 (10) [back to overview] | Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale |
NCT01256450 (10) [back to overview] | Change in Pain Intensity From Baseline to Week 12 |
NCT01256450 (10) [back to overview] | Change From Baseline to Week 12 in Subject's Overall Satisfaction With Study Drug |
NCT01256450 (10) [back to overview] | Change From Baseline to Week 12 in Investigator's Overall Satisfaction With Study Drug |
NCT01259102 (10) [back to overview] | Period 2: Tmax0-7d. |
NCT01259102 (10) [back to overview] | Period 2: Cmax0-3d |
NCT01259102 (10) [back to overview] | Period 2: AUC0-7d |
NCT01259102 (10) [back to overview] | Period 2: AUC0-3d. |
NCT01259102 (10) [back to overview] | Period 1: AUC0-3d |
NCT01259102 (10) [back to overview] | Period 1: Tmax0-7d. |
NCT01259102 (10) [back to overview] | Period 1: Cmax0-7 |
NCT01259102 (10) [back to overview] | Period 1: Cmax0-3d |
NCT01259102 (10) [back to overview] | Period 1: AUC0-7d. |
NCT01259102 (10) [back to overview] | Period 2: Cmax0-7d |
NCT01259115 (13) [back to overview] | AUCinf of Nor-buprenorphine Glucuronide With and Without Ketoconazole |
NCT01259115 (13) [back to overview] | AUCinf of Nor-buprenorphine With and Without Ketoconazole |
NCT01259115 (13) [back to overview] | AUCt of Buprenorphine With and Without Ketoconazole. |
NCT01259115 (13) [back to overview] | AUCt of Buprenorphine-3-glucuronide With and Without Ketoconazole |
NCT01259115 (13) [back to overview] | AUCt of Nor-buprenorphine With and Without Ketoconazole |
NCT01259115 (13) [back to overview] | Cmax of Buprenorphine With and Without Ketoconazole. |
NCT01259115 (13) [back to overview] | Cmax of Buprenorphine-3-glucuronide With and Without Ketoconazole |
NCT01259115 (13) [back to overview] | Cmax of Nor-buprenorphine Glucuronide With and Without Ketoconazole |
NCT01259115 (13) [back to overview] | Cmax of Nor-buprenorphine With and Without Ketoconazole |
NCT01259115 (13) [back to overview] | CYP3A4 Inhibition by Observation of Plasma Nor-buprenorphine Production Assessed by the Erythromycin Breath Test. |
NCT01259115 (13) [back to overview] | The Number of Participants With Adverse Events (AEs) as a Measure of Safety. |
NCT01259115 (13) [back to overview] | AUCt of Nor-buprenorphine Glucuronide With and Without Ketoconazole |
NCT01259115 (13) [back to overview] | AUCinf of Buprenorphine With and Without Ketoconazole. |
NCT01262092 (1) [back to overview] | Illicit Opioid Use as Determine by Urine Dipsticks |
NCT01277159 (1) [back to overview] | Time it Takes for Nerve Block to Wear Off |
NCT01298765 (5) [back to overview] | Change From Baseline in NRS Pain Intensity |
NCT01298765 (5) [back to overview] | Subjects Overall Satisfaction With Study Drug |
NCT01298765 (5) [back to overview] | Treatment Satisfaction Questionnaire for Medication/Global Satisfaction |
NCT01298765 (5) [back to overview] | Patient Global Impression of Change in Pain Intensity |
NCT01298765 (5) [back to overview] | Investigator's Overall Satisfaction With Study Drug |
NCT01324570 (6) [back to overview] | Pain Right Now Assessment by Patients Aged 12 to 16 Years, Inclusive |
NCT01324570 (6) [back to overview] | Parent/Caregiver-assessed Global Impression of Change (PGIC) |
NCT01324570 (6) [back to overview] | The Number of Participants With Adverse Events as a Measure of Safety |
NCT01324570 (6) [back to overview] | Pharmacokinetics (PK) of Buprenorphine Following Transdermal Administration: Apparent Clearance (CL/F) |
NCT01324570 (6) [back to overview] | Pharmacokinetics (PK) of Buprenorphine Following Transdermal Administration: Apparent Volume of Distribution (Vc/F) |
NCT01324570 (6) [back to overview] | Pain Right Now Assessment by Patients Aged 7 to 11 Years, Inclusive |
NCT01396005 (6) [back to overview] | Area Under the Concentration Versus Time Curve (AUC) at Steady State of Methadone Enantiomers When Administered With or Without Boceprevir |
NCT01396005 (6) [back to overview] | Maximum Concentration (Cmax) at Steady State of Methadone Enantiomers When Administered With or Without Boceprevir |
NCT01396005 (6) [back to overview] | Cmax of Naloxone (Administered in Combination With Buprenorphine) at Steady State With or Without Boceprevir |
NCT01396005 (6) [back to overview] | Cmax of Buprenorphine (Administered in Combination With Naloxone) at Steady State With or Without Boceprevir |
NCT01396005 (6) [back to overview] | AUC of Naloxone (Administered in Combination With Buprenorphine) at Steady State With or Without Boceprevir |
NCT01396005 (6) [back to overview] | AUC of Buprenorphine (Administered in Combination With Naloxone) at Steady State With or Without Boceprevir |
NCT01402492 (1) [back to overview] | Cocaine Use Days as Measured by Self-report, Corroborated by Thrice-weekly Urine Drug Screens |
NCT01407575 (7) [back to overview] | Positive and Negative Affect Scale |
NCT01407575 (7) [back to overview] | Weight |
NCT01407575 (7) [back to overview] | Brief Symptom Inventory -- Anxiety Subscale |
NCT01407575 (7) [back to overview] | Heart Rate |
NCT01407575 (7) [back to overview] | Montgomery Asberg Depression Rating Scale |
NCT01407575 (7) [back to overview] | UKU Side Effect Rating Scale |
NCT01407575 (7) [back to overview] | Blood Pressure |
NCT01452789 (4) [back to overview] | Number of Patients Requiring Supplemental Phenobarbital Treatment. |
NCT01452789 (4) [back to overview] | Length of Treatment |
NCT01452789 (4) [back to overview] | Length of Hospitalization |
NCT01452789 (4) [back to overview] | Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
NCT01550341 (12) [back to overview] | Log Viral Load |
NCT01550341 (12) [back to overview] | CD4 Percent |
NCT01550341 (12) [back to overview] | CD4 Percent |
NCT01550341 (12) [back to overview] | Viral Load |
NCT01550341 (12) [back to overview] | Viral Load |
NCT01550341 (12) [back to overview] | Log Viral Load |
NCT01550341 (12) [back to overview] | Viral Load |
NCT01550341 (12) [back to overview] | Log Viral Load |
NCT01550341 (12) [back to overview] | CD4 Percent |
NCT01550341 (12) [back to overview] | CD4 Count Absolute |
NCT01550341 (12) [back to overview] | CD4 Count Absolute |
NCT01550341 (12) [back to overview] | CD4 Count Absolute |
NCT01559454 (6) [back to overview] | Depression |
NCT01559454 (6) [back to overview] | Cravings |
NCT01559454 (6) [back to overview] | Analgesia |
NCT01559454 (6) [back to overview] | Functioning |
NCT01559454 (6) [back to overview] | Treatment Retention |
NCT01559454 (6) [back to overview] | Illicit Drug Use |
NCT01561079 (5) [back to overview] | Fetal Movement |
NCT01561079 (5) [back to overview] | Fetal Heart Rate |
NCT01561079 (5) [back to overview] | Accelerations of Fetal Heart Rate |
NCT01561079 (5) [back to overview] | Fetal Heart Rate Variability |
NCT01561079 (5) [back to overview] | Fetal Movement - Fetal Heart Rate Coupling |
NCT01583179 (2) [back to overview] | Time Until First Pain Medication Post-operatively |
NCT01583179 (2) [back to overview] | Pain Score on Post Operative Day 1 |
NCT01633944 (8) [back to overview] | Number of Participants With Response to Treatment (Responder) Using NRS Scale |
NCT01633944 (8) [back to overview] | Patient Global Impression of Change |
NCT01633944 (8) [back to overview] | Time to Optimal Dose of Open-label Study Medication |
NCT01633944 (8) [back to overview] | Change From Baseline to Week 12 in Medical Outcomes Score Sleep Subscale |
NCT01633944 (8) [back to overview] | Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks) |
NCT01633944 (8) [back to overview] | Number of Subjects With Rescue Medication Use |
NCT01633944 (8) [back to overview] | Change From Baseline to Week 12 in Average Daily Pain Intensity Scores |
NCT01633944 (8) [back to overview] | Change From Baseline to Week 12 in Roland Morris Disability Questionnaire |
NCT01666119 (2) [back to overview] | Adverse Events |
NCT01666119 (2) [back to overview] | Urine Drug Screen |
NCT01675167 (9) [back to overview] | Change From Baseline to Week 12 in Average Daily Pain Intensity Scores |
NCT01675167 (9) [back to overview] | Change From Baseline to Week 12 in Roland Morris Disability Questionnaire |
NCT01675167 (9) [back to overview] | Time to Optimal Dose of Open-label Study Medication |
NCT01675167 (9) [back to overview] | Number of Participants With Response to Treatment (Responder) Using NRS Scale |
NCT01675167 (9) [back to overview] | Medical Outcomes Score Sleep Subscale - Quantity of Sleep/Optimal Sleep |
NCT01675167 (9) [back to overview] | Number of Subjects With Opioid Rescue Medication Use |
NCT01675167 (9) [back to overview] | Change From Baseline to Week 12 in Medical Outcome Score Sleep Subscale |
NCT01675167 (9) [back to overview] | Patient Global Impression of Change |
NCT01675167 (9) [back to overview] | Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks) |
NCT01690546 (10) [back to overview] | Percentage of Participants Who Adhered to Study Visits. |
NCT01690546 (10) [back to overview] | Craving |
NCT01690546 (10) [back to overview] | Number of Participants That Self Reported Illicit Drug Use |
NCT01690546 (10) [back to overview] | Illicit Drug Use, Measured by Urine Drug Testing |
NCT01690546 (10) [back to overview] | Withdrawal Intensity as Measured by the Subjective Opiate Withdrawal Scale (SOWS) |
NCT01690546 (10) [back to overview] | Satisfaction With Treatment, Measured by a Treatment Satisfaction Questionnaire |
NCT01690546 (10) [back to overview] | Withdrawal Intensity as Measured by the Clinical Opiate Withdrawal Scale (COWS) |
NCT01690546 (10) [back to overview] | Use of Ancillary Medications. |
NCT01690546 (10) [back to overview] | Retention in Treatment |
NCT01690546 (10) [back to overview] | Percentage of Participants With Adherence to Medication (Naltrexone) |
NCT01738503 (65) [back to overview] | Norbuprenorphine PK: Area Under Plasma Concentration Time Curves (AUC) |
NCT01738503 (65) [back to overview] | Norbuprenorphine PK: Area Under Plasma Concentration Time Curves (AUC) |
NCT01738503 (65) [back to overview] | Norbuprenorphine PK: Area Under Plasma Concentration Time Curves (AUC) |
NCT01738503 (65) [back to overview] | Norbuprenorphine PK: Area Under Plasma Concentration Time Curve From Time Zero Of Injection 4 and 6 (AUC0-∞) |
NCT01738503 (65) [back to overview] | Norbuprenorphine PK: Area Under Plasma Concentration Time Curve From Time Zero Of Injection 4 and 6 (AUC0-∞) |
NCT01738503 (65) [back to overview] | Norbuprenorphine PK: % Fluctuation |
NCT01738503 (65) [back to overview] | Norbuprenorphine PK: % Fluctuation |
NCT01738503 (65) [back to overview] | Norbuprenorphine PK: % Fluctuation |
NCT01738503 (65) [back to overview] | Columbia Suicide Severity Rating Scale (C-SSRS): Severity |
NCT01738503 (65) [back to overview] | Columbia Suicide Severity Rating Scale (C-SSRS): Severity |
NCT01738503 (65) [back to overview] | Columbia Suicide Severity Rating Scale (C-SSRS): Severity |
NCT01738503 (65) [back to overview] | Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) Prior to Injections 1, 2, 3, 4 and 6 |
NCT01738503 (65) [back to overview] | Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) Prior to Injections 1, 2, 3, 4 and 6 |
NCT01738503 (65) [back to overview] | Norbuprenorphine PK: Average Plasma Concentration (Cavg) |
NCT01738503 (65) [back to overview] | Norbuprenorphine PK: Average Plasma Concentration (Cavg) |
NCT01738503 (65) [back to overview] | Norbuprenorphine PK: Maximum Observed Plasma Concentration (Cmax) |
NCT01738503 (65) [back to overview] | Norbuprenorphine PK: Maximum Observed Plasma Concentration (Cmax) |
NCT01738503 (65) [back to overview] | Norbuprenorphine PK: Minimum Observed Plasma Concentration (Cmin) |
NCT01738503 (65) [back to overview] | Norbuprenorphine PK: Minimum Observed Plasma Concentration (Cmin) |
NCT01738503 (65) [back to overview] | Norbuprenorphine PK: Swing of Plasma Concentrations |
NCT01738503 (65) [back to overview] | Norbuprenorphine PK: Terminal Phase Half Life (t1/2) Calculated For Injection 4 |
NCT01738503 (65) [back to overview] | Norbuprenorphine PK: Average Plasma Concentration (Cavg) |
NCT01738503 (65) [back to overview] | Norbuprenorphine PK: Time to Maximum Buprenorphine Plasma Concentration (Tmax) |
NCT01738503 (65) [back to overview] | Norbuprenorphine PK: Time to Maximum Buprenorphine Plasma Concentration (Tmax) |
NCT01738503 (65) [back to overview] | Participants With Treatment-Emergent Adverse Events (TEAEs) |
NCT01738503 (65) [back to overview] | Norbuprenorphine PK: Swing of Plasma Concentrations |
NCT01738503 (65) [back to overview] | Columbia Suicide Severity Rating Scale (C-SSRS): Severity |
NCT01738503 (65) [back to overview] | Columbia Suicide Severity Rating Scale (C-SSRS): Severity |
NCT01738503 (65) [back to overview] | Norbuprenorphine PK: Accumulation Index in Terms of Maximum Observed Plasma Drug Concentration (Rac(Cmax)) |
NCT01738503 (65) [back to overview] | Buprenorphine PK: Accumulation Index in Terms of Area Under the Curve (Rac(AUC)) |
NCT01738503 (65) [back to overview] | Buprenorphine PK: Accumulation Index in Terms of Maximum Observed Plasma Drug Concentration (Rac(Cmax)) |
NCT01738503 (65) [back to overview] | Buprenorphine PK: Area Under Plasma Concentration Time Curve From Time Zero Of Injection 4 (AUC0-∞) |
NCT01738503 (65) [back to overview] | Buprenorphine PK: Terminal Phase Half Life (t1/2) Calculated For Injection 4 |
NCT01738503 (65) [back to overview] | Norbuprenorphine PK: Accumulation Index in Terms of Area Under the Curve (Rac(AUC)) |
NCT01738503 (65) [back to overview] | Percentage of Urine Drug Screen Samples Negative for Opioids |
NCT01738503 (65) [back to overview] | Buprenorphine PK: % Fluctuation |
NCT01738503 (65) [back to overview] | Buprenorphine PK: % Fluctuation |
NCT01738503 (65) [back to overview] | Buprenorphine PK: Swing of Plasma Concentrations |
NCT01738503 (65) [back to overview] | Norbuprenorphine PK: Terminal Phase Half Life (t1/2) Calculated For Injection 4 |
NCT01738503 (65) [back to overview] | Buprenorphine PK: % Fluctuation |
NCT01738503 (65) [back to overview] | Buprenorphine PK: Apparent Clearance at Steady-State (CLss/F) Following Injections 4 and 6 |
NCT01738503 (65) [back to overview] | Buprenorphine PK: Apparent Clearance at Steady-State (CLss/F) Following Injections 4 and 6 |
NCT01738503 (65) [back to overview] | Buprenorphine PK: Area Under Plasma Concentration Time Curves (AUC) |
NCT01738503 (65) [back to overview] | Buprenorphine PK: Area Under Plasma Concentration Time Curves (AUC) |
NCT01738503 (65) [back to overview] | Buprenorphine PK: Area Under Plasma Concentration Time Curves (AUC) |
NCT01738503 (65) [back to overview] | Buprenorphine PK: Average Plasma Concentration (Cavg) |
NCT01738503 (65) [back to overview] | Buprenorphine PK: Average Plasma Concentration (Cavg) |
NCT01738503 (65) [back to overview] | Buprenorphine PK: Average Plasma Concentration (Cavg) |
NCT01738503 (65) [back to overview] | Buprenorphine PK: Maximum Observed Plasma Concentration (Cmax) |
NCT01738503 (65) [back to overview] | Buprenorphine PK: Maximum Observed Plasma Concentration (Cmax) |
NCT01738503 (65) [back to overview] | Buprenorphine PK: Minimum Observed Plasma Concentration (Cmin) |
NCT01738503 (65) [back to overview] | Buprenorphine PK: Minimum Observed Plasma Concentration (Cmin) |
NCT01738503 (65) [back to overview] | Buprenorphine PK: Swing of Plasma Concentrations |
NCT01738503 (65) [back to overview] | Buprenorphine PK: Time to Maximum Buprenorphine Plasma Concentration (Tmax) |
NCT01738503 (65) [back to overview] | Buprenorphine PK: Time to Maximum Buprenorphine Plasma Concentration (Tmax) |
NCT01738503 (65) [back to overview] | Change From Baseline in the Clinical Global Impression Improvement (CGI-I) Scale on Days 7, 29, 57, 85 and 141 |
NCT01738503 (65) [back to overview] | Change From Baseline in the Clinical Global Impression Improvement (CGI-I) Scale on Days 7, 29, 57, 85 and 141 |
NCT01738503 (65) [back to overview] | Change From Baseline in the Clinical Global Impression Improvement (CGI-I) Scale on Days 7, 29, 57, 85 and 141 |
NCT01738503 (65) [back to overview] | Change From Baseline in the Clinical Global Impression Severity (CGI-S) Scale on Days 1, 7, 29, 57, 85 and 141 |
NCT01738503 (65) [back to overview] | Change From Baseline in the Clinical Global Impression Severity (CGI-S) Scale on Days 1, 7, 29, 57, 85 and 141 |
NCT01738503 (65) [back to overview] | Change From Baseline in the Clinical Global Impression Severity (CGI-S) Scale on Days 1, 7, 29, 57, 85 and 141 |
NCT01738503 (65) [back to overview] | Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) Prior to Injections 1, 2, 3, 4 and 6 |
NCT01738503 (65) [back to overview] | Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) Prior to Injections 1, 2, 3, 4 and 6 |
NCT01738503 (65) [back to overview] | Change From Baseline in the Clinical Opioid Craving Visual Analog Scale (VAS) Total Score Prior to Injections 1, 2, 3, 4 and 6 |
NCT01738503 (65) [back to overview] | Change From Baseline in the Clinical Opioid Craving Visual Analog Scale (VAS) Total Score Prior to Injections 1, 2, 3, 4 and 6 |
NCT01755546 (1) [back to overview] | Change From Baseline to Week 48 in Daily Average NRS Pain Intensity Score |
NCT01809106 (3) [back to overview] | Proportion of Full-responder |
NCT01809106 (3) [back to overview] | The Opioid Escalation Index |
NCT01809106 (3) [back to overview] | Proportion of Non-Responder (NR) Participants |
NCT01818700 (6) [back to overview] | Change of Pain Intensity* at Week 8 of Treatment With the Study Drug From Baseline |
NCT01818700 (6) [back to overview] | Change in Quality of Life at 8 Week of Treatment With Study Drug From Baseline |
NCT01818700 (6) [back to overview] | Clinician Global Impression of Change(CGIC) |
NCT01818700 (6) [back to overview] | Patients Global Impression og Change(PGIC) |
NCT01818700 (6) [back to overview] | Change of EQ-VAS at 8 Weeks of Treatment With Study Drug From Baseline. |
NCT01818700 (6) [back to overview] | Change of Pain Intensity at 4 Week of Treatment With Study Srug From Baseline. |
NCT01843023 (4) [back to overview] | Opioid Use at 6 Month Follow-up |
NCT01843023 (4) [back to overview] | Treatment Retention |
NCT01843023 (4) [back to overview] | Monetized Healthcare Utilization |
NCT01843023 (4) [back to overview] | HIV Sex Risk Behaviors |
NCT01843751 (5) [back to overview] | Number of Emergency Room Visits |
NCT01843751 (5) [back to overview] | Human Immunodeficiency Virus (HIV) Risk Behavior Assessment by Assessing Change in Risk Assessment Battery (RAB) Score |
NCT01843751 (5) [back to overview] | Initiation of Medication Assisted Treatment |
NCT01843751 (5) [back to overview] | Number of Days From Treatment Initiation to First Drug Use |
NCT01843751 (5) [back to overview] | Number of Participants With New Crime |
NCT01846455 (10) [back to overview] | Apparent Body Clearance (CL/F) of Buprenorphine and Naloxone |
NCT01846455 (10) [back to overview] | Apparent Volume of Distribution During Terminal Phase (Vz/F) of Buprenorphine and Naloxone |
NCT01846455 (10) [back to overview] | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide |
NCT01846455 (10) [back to overview] | Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide |
NCT01846455 (10) [back to overview] | Maximum Observed Plasma Concentration (Cmax) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide |
NCT01846455 (10) [back to overview] | Terminal Elimination Half-life (t1/2) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide |
NCT01846455 (10) [back to overview] | Terminal Phase Elimination Rate-Constant (λz) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide |
NCT01846455 (10) [back to overview] | Time of the Last Measureable Plasma Concentration (Tlast) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide |
NCT01846455 (10) [back to overview] | Percentage of Area Under the Concentration-time Curve From Time Zero to Infinity Due to Extrapolation (%AUCextrap) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide |
NCT01846455 (10) [back to overview] | Time to Reach the Maximum Plasma Concentration (Tmax) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide |
NCT01848054 (8) [back to overview] | Mean Change From Baseline in the VAS Score for Cravings After Day 3 (Maintenance Phase) |
NCT01848054 (8) [back to overview] | Area Under the Curve (AUC) in Clinical Opiate Withdrawal Scale (COWS) Total Score on Days 1 to 3 Inclusive |
NCT01848054 (8) [back to overview] | AUC in Subjective Opiate Withdrawal Scale (SOWS) Total Score on Days 1 to 3 Inclusive |
NCT01848054 (8) [back to overview] | AUC in Visual Analog Scale (VAS) Score for Craving on Days 1 to 3 Inclusive |
NCT01848054 (8) [back to overview] | Retention in Treatment in the Full Analysis Population |
NCT01848054 (8) [back to overview] | Retention in Treatment in the Per Protocol Population |
NCT01848054 (8) [back to overview] | Mean Change From Baseline in SOWS Total Score After Day 3 (Maintenance Phase) |
NCT01848054 (8) [back to overview] | Mean Change From Baseline in COWS Total Score After Day 3 (Maintenance Phase) |
NCT01860287 (1) [back to overview] | "Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire Subjective Responses to Stress With and Without Buprenorphine" |
NCT01871285 (5) [back to overview] | Change From Baseline in COWS Total Score Over Time |
NCT01871285 (5) [back to overview] | "Change From Baseline in Pain Now Over Time Using NRS" |
NCT01871285 (5) [back to overview] | Number of Responders |
NCT01871285 (5) [back to overview] | Maximum COWS Total Score |
NCT01871285 (5) [back to overview] | Change From Baseline in Maximum COWS Total Score |
NCT01875848 (2) [back to overview] | Change in Numeric Rating Scale of Pain Severity |
NCT01875848 (2) [back to overview] | Patient Global Impression of Change (PGIC) |
NCT01903005 (11) [back to overview] | Number of Patient Discontinuations Due to Treatment-Emergent Adverse Events |
NCT01903005 (11) [back to overview] | Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores |
NCT01903005 (11) [back to overview] | Number of Patients Reporting Treatment-Related, Treatment-Emergent Adverse Events |
NCT01903005 (11) [back to overview] | Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score |
NCT01903005 (11) [back to overview] | Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score |
NCT01903005 (11) [back to overview] | Number of Patients Reporting Treatment-Emergent Adverse Events |
NCT01903005 (11) [back to overview] | Number of Patients Reporting Treatment-Emergent Serious Adverse Events |
NCT01903005 (11) [back to overview] | Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 5-6 of the WPAI:SHP |
NCT01903005 (11) [back to overview] | Percent Change From Primary Study Baseline (OX219-006 or OX219-007) for Question 1 of the Work Productivity/Activity Impairment: 6-Question Specific Health Problem Questionnaire (WPAI:SHP) |
NCT01903005 (11) [back to overview] | Retention in Treatment in the Safety Population |
NCT01903005 (11) [back to overview] | Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHP |
NCT01908842 (7) [back to overview] | VAS Craving Scores: Stabilization/Maintenance |
NCT01908842 (7) [back to overview] | Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction |
NCT01908842 (7) [back to overview] | SOWS Total Scores: Stabilization/Maintenance |
NCT01908842 (7) [back to overview] | Clinical Opiate Withdrawal Scale (COWS) Scores: Induction |
NCT01908842 (7) [back to overview] | COWS Total Scores: Stabilization/Maintenance |
NCT01908842 (7) [back to overview] | Primary Endpoints of Retention in Treatment at Days 3 and 15 |
NCT01908842 (7) [back to overview] | Visual Analog Scale (VAS) Cravings: Induction |
NCT01936857 (5) [back to overview] | Number of Participants in Receipt of Antiretroviral Therapy (ART) |
NCT01936857 (5) [back to overview] | Number of Participants in Retention in HIV Care |
NCT01936857 (5) [back to overview] | Participants With Heroin Use (Self-report) |
NCT01936857 (5) [back to overview] | Participants With Heroin Use (Urine Drug Screen) |
NCT01936857 (5) [back to overview] | Number of Participants With HIV Viral Suppression |
NCT01961271 (6) [back to overview] | Secondary Efficacy Outcome on Physicians' and Patients' Treatment Satisfaction Assessed Using Physician's Global Impression of Change Scale and Patient's Global Impression of Change Scale Respectively |
NCT01961271 (6) [back to overview] | Efficacy According to BS-11 Pain Score Reduction |
NCT01961271 (6) [back to overview] | Treatment-emergent Adverse Events (TEAE's) as Measured by Number of Subjects With at Least 1 TEAE |
NCT01961271 (6) [back to overview] | Secondary Efficacy Outcome Determined by Change in Percentage of Subjects Who Met Criteria on EQ5D-3L Quality of Life Questionnaire From Pre- to Post-intervention |
NCT01961271 (6) [back to overview] | Secondary Efficacy Outcome -- Incidence of Early Treatment Discontinuation Due to Lack of Efficacy. |
NCT01961271 (6) [back to overview] | Secondary Efficacy Outcome as Measured by Number of Subjects Requiring at Least 1 Breakthrough (Rescue) Pain Medication |
NCT01967641 (3) [back to overview] | Pain Measurement |
NCT01967641 (3) [back to overview] | Number of Participants Retained in Study |
NCT01967641 (3) [back to overview] | Number of Participants Abstinent From Opioids |
NCT01983111 (6) [back to overview] | Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS) |
NCT01983111 (6) [back to overview] | Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to Week 2 of the Investigational Product Administration |
NCT01983111 (6) [back to overview] | Clinical Global Impression of Change(CGIC) |
NCT01983111 (6) [back to overview] | Change in the Quality of Life (EQ-5D) Score From Visit 1 (Baseline) to Week 6 Post-dose |
NCT01983111 (6) [back to overview] | Patient Global Impressions of Change(PGIC) |
NCT01983111 (6) [back to overview] | Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to 6weeks After Treatment. |
NCT01999114 (12) [back to overview] | The Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI) |
NCT01999114 (12) [back to overview] | ECG Morphology |
NCT01999114 (12) [back to overview] | ECG Morphology |
NCT01999114 (12) [back to overview] | ECG Morphology |
NCT01999114 (12) [back to overview] | Heart Rate (HR) |
NCT01999114 (12) [back to overview] | Heart Rate (HR) |
NCT01999114 (12) [back to overview] | Heart Rate (HR) |
NCT01999114 (12) [back to overview] | The Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI) |
NCT01999114 (12) [back to overview] | The Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI) |
NCT01999114 (12) [back to overview] | QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval |
NCT01999114 (12) [back to overview] | QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval |
NCT01999114 (12) [back to overview] | QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval |
NCT02032433 (58) [back to overview] | Cigarette Smoking, W24 11-20 |
NCT02032433 (58) [back to overview] | Cigarette Smoking, W24 21-30 |
NCT02032433 (58) [back to overview] | Cigarette Smoking, W24 31 or More |
NCT02032433 (58) [back to overview] | Number Successfully Inducted Onto Assigned Study Medication |
NCT02032433 (58) [back to overview] | Opioid Abstinence Over Time While on Study Medication (Objective) |
NCT02032433 (58) [back to overview] | Opioid Abstinence Over Time While on Study Medication (Subjective) |
NCT02032433 (58) [back to overview] | Opioid Craving Over Time W0 |
NCT02032433 (58) [back to overview] | Other Drug Use Over Time, Cannabis, W0 |
NCT02032433 (58) [back to overview] | Other Drug Use Over Time, Cannabis, W24 |
NCT02032433 (58) [back to overview] | Other Drug Use Over Time, Cocaine, W0 |
NCT02032433 (58) [back to overview] | Other Drug Use Over Time, Cocaine, W24 |
NCT02032433 (58) [back to overview] | Other Drug Use Over Time, Stimulant, W0 |
NCT02032433 (58) [back to overview] | Other Drug Use Over Time, Stimulant, W24 |
NCT02032433 (58) [back to overview] | Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale |
NCT02032433 (58) [back to overview] | Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale |
NCT02032433 (58) [back to overview] | Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS) |
NCT02032433 (58) [back to overview] | Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS) |
NCT02032433 (58) [back to overview] | Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale |
NCT02032433 (58) [back to overview] | Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale |
NCT02032433 (58) [back to overview] | Score of Family / Social Relationship Subscale Within Addiction Severity Index (ASI) Scale |
NCT02032433 (58) [back to overview] | Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale |
NCT02032433 (58) [back to overview] | Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale |
NCT02032433 (58) [back to overview] | Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale |
NCT02032433 (58) [back to overview] | Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale |
NCT02032433 (58) [back to overview] | Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale |
NCT02032433 (58) [back to overview] | Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale |
NCT02032433 (58) [back to overview] | Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS) |
NCT02032433 (58) [back to overview] | Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS) |
NCT02032433 (58) [back to overview] | Score of Social Relationship Subscale Within Addiction Severity Index (ASI) Scale |
NCT02032433 (58) [back to overview] | Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale |
NCT02032433 (58) [back to overview] | Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale |
NCT02032433 (58) [back to overview] | Score on Color Card of Stoop Test |
NCT02032433 (58) [back to overview] | Score on Color Card of Stoop Test |
NCT02032433 (58) [back to overview] | Score on Color Word Card of Stoop Test |
NCT02032433 (58) [back to overview] | Score on Color Word Card of Stoop Test |
NCT02032433 (58) [back to overview] | Score on EuroQOL EQ-5D Questionnaire |
NCT02032433 (58) [back to overview] | Score on EuroQOL EQ-5D Questionnaire |
NCT02032433 (58) [back to overview] | Score on Opioid Craving Scale (OCS) |
NCT02032433 (58) [back to overview] | Score on Subjective Opiate Withdrawal Scale (SOWS) |
NCT02032433 (58) [back to overview] | Score on Subjective Opiate Withdrawal Scale (SOWS) |
NCT02032433 (58) [back to overview] | Score on Trail Making Test Part A |
NCT02032433 (58) [back to overview] | Score on Trail Making Test Part A |
NCT02032433 (58) [back to overview] | Score on Trail Making Test Part B |
NCT02032433 (58) [back to overview] | Score on Trail Making Test Part B |
NCT02032433 (58) [back to overview] | Score on Word Card of Stoop Test |
NCT02032433 (58) [back to overview] | Score on Word Card of Stoop Test |
NCT02032433 (58) [back to overview] | Time to Relapse (Intent to Treat Population) |
NCT02032433 (58) [back to overview] | Time to Relapse (Per Protocol Population) |
NCT02032433 (58) [back to overview] | Adverse Events Related to Study Medications |
NCT02032433 (58) [back to overview] | Alcohol Use Over Time, Drinks Per Day |
NCT02032433 (58) [back to overview] | Alcohol Use Over Time, Drinks Per Day, Past 30 Days, W0 |
NCT02032433 (58) [back to overview] | Cigarette Smoking |
NCT02032433 (58) [back to overview] | Cigarette Smoking, W0 0 |
NCT02032433 (58) [back to overview] | Cigarette Smoking, W0 11-20 |
NCT02032433 (58) [back to overview] | Cigarette Smoking, W0 21-30 |
NCT02032433 (58) [back to overview] | Cigarette Smoking, W0 31 or More |
NCT02032433 (58) [back to overview] | Cigarette Smoking, W0, 10 or Less |
NCT02032433 (58) [back to overview] | Cigarette Smoking, W24 0 |
NCT02038790 (14) [back to overview] | Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Was it to Open the Package? |
NCT02038790 (14) [back to overview] | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters? |
NCT02038790 (14) [back to overview] | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging? |
NCT02038790 (14) [back to overview] | Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Were the Package Instructions to Follow? |
NCT02038790 (14) [back to overview] | Overall Intervention Preference As Assessed by Participants |
NCT02038790 (14) [back to overview] | Percentage of Participant Response to the Question: Compared to the Medication That You Are Currently Using for Treatment of Opioid Dependence, The Study Medication You Just Used Was..... |
NCT02038790 (14) [back to overview] | Participant Assessments With Regard to Ease of Dissolution of Interventions |
NCT02038790 (14) [back to overview] | Dissolution Time of Intervention as Recorded by a Trained Observer |
NCT02038790 (14) [back to overview] | Participant Preference With Regard to Overall Taste of Interventions |
NCT02038790 (14) [back to overview] | Percentage of Participant Favorable and Unfavorable Response to the Question: How Comfortable Did It Feel In Your Mouth? |
NCT02038790 (14) [back to overview] | Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication |
NCT02038790 (14) [back to overview] | Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High' |
NCT02038790 (14) [back to overview] | Percentage of Participant Response to the Question: If You Did Want to Abuse This Medication, Would You Prefer to...... |
NCT02038790 (14) [back to overview] | Percentage of Participant Favorable and Unfavorable Response to the Question: How Easily Did the Medication Dissolve in Your Mouth? |
NCT02044094 (20) [back to overview] | Participants With Treatment-Emergent Adverse Events (TEAE) |
NCT02044094 (20) [back to overview] | "VAS Score for Does the Drug Have Any Good Effects? by Study Week Analyzed by Mixed Model for Repeated Measures" |
NCT02044094 (20) [back to overview] | "VAS Score for How High Are You Right Now? by Study Week Analyzed by Mixed Model for Repeated Measures" |
NCT02044094 (20) [back to overview] | "Visual Analog Scale (VAS) Score for Do You Like the Drug? by Study Week Analyzed by Mixed Model for Repeated Measures" |
NCT02044094 (20) [back to overview] | Change From Placebo in Reinforcing Effects (Breakpoint) by Study Week and Simulated mu Opioid Receptor Occupancy (μORO) |
NCT02044094 (20) [back to overview] | Participants With Treatment-Emergent Adverse Events (TEAE) |
NCT02044094 (20) [back to overview] | Plasma Concentrations of Buprenorphine Summarized by Study Week |
NCT02044094 (20) [back to overview] | Predicted mu Opioid Receptor Occupancy (μORO) by Mean Buprenorphine Concentrations and Study Week |
NCT02044094 (20) [back to overview] | Reinforcing Effects (Breakpoint) by Study Week Analyzed by Mixed Model for Repeated Measures |
NCT02044094 (20) [back to overview] | Reinforcing Effects Of the Daily Randomized Hydromorphone Challenge as Measured by the Mean Hydromorphone Break Point Value at Weeks 1-12 |
NCT02044094 (20) [back to overview] | "Change From Placebo in VAS Score for How High Are You Right Now? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)" |
NCT02044094 (20) [back to overview] | "Opioid Blockade Following Administration of Hydromorphone Challenge As Measured Using the Subjective Opioid Effects Rating for the Question Do You Like the Drug? Visual Analog Scale (VAS) at Weeks 1-4 Analyzed by Mixed Model for Repeated Measures" |
NCT02044094 (20) [back to overview] | "VAS Score for Do You Feel Any Drug Effect? by Study Week Analyzed by Mixed Model for Repeated Measures" |
NCT02044094 (20) [back to overview] | "VAS Score for Do You Feel Sedated? by Study Week Analyzed by Mixed Model for Repeated Measures" |
NCT02044094 (20) [back to overview] | "VAS Score for Does the Drug Have Any Bad Effects? by Study Week Analyzed by Mixed Model for Repeated Measures" |
NCT02044094 (20) [back to overview] | "Change From Placebo in VAS Score for Do You Feel Sedated? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)" |
NCT02044094 (20) [back to overview] | "Change From Placebo in VAS Score for Does the Drug Have Any Good Effects? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)" |
NCT02044094 (20) [back to overview] | "Change From Placebo in VAS Score for Do You Feel Any Drug Effect? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)" |
NCT02044094 (20) [back to overview] | "Change From Placebo in VAS Score for Do You Like the Drug? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)" |
NCT02044094 (20) [back to overview] | "Change From Placebo in VAS Score for Does the Drug Have Any Bad Effects? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)" |
NCT02158533 (2) [back to overview] | Change From Baseline to Week 5 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score |
NCT02158533 (2) [back to overview] | Number of Subjects With Adverse Events (AEs) |
NCT02176291 (2) [back to overview] | Montgomery-Asberg Depression Rating Scale (MADRS) |
NCT02176291 (2) [back to overview] | Brief Symptom Inventory--Anxiety Subscale (BSI) |
NCT02180659 (7) [back to overview] | Measures of Withdrawal: Clinical Opiate Withdrawal Scale (COWS) |
NCT02180659 (7) [back to overview] | Measures of Craving: Desire to Use Visual Analogue Scale (VAS) |
NCT02180659 (7) [back to overview] | Percent of Subjects With no Urine Illicit Opioid Use by Month; |
NCT02180659 (7) [back to overview] | Percent of Subjects With no Self-reported Illicit Drug Use by Month |
NCT02180659 (7) [back to overview] | Number of Participants With Evidence of Urine Illicit Opioid Use by Month |
NCT02180659 (7) [back to overview] | Measures of Withdrawal: Subjective Opioid Withdrawal Scale (SOWS) (ITT Population) |
NCT02180659 (7) [back to overview] | Measures of Craving: Need to Use Visual Analogue Scale (VAS) |
NCT02181231 (6) [back to overview] | Numeric Scale of Pain (NRS-P) |
NCT02181231 (6) [back to overview] | Brief Symptom Inventory-Anxiety Subscale (BSI) |
NCT02181231 (6) [back to overview] | Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) |
NCT02181231 (6) [back to overview] | Montgomery-Asberg Depression Rating Scale (MADRS) |
NCT02181231 (6) [back to overview] | Antidepressant Side Effect Checklist (ASEC) |
NCT02181231 (6) [back to overview] | Suicide Ideation Scale (SIS) |
NCT02187198 (2) [back to overview] | Urine Toxicology for Opiate Use |
NCT02187198 (2) [back to overview] | Urine Toxicology |
NCT02198235 (4) [back to overview] | Numeric Rating Scale (NRS) Pain Score With Movement |
NCT02198235 (4) [back to overview] | Numeric Rating Scale (NRS) Pain Score at Rest |
NCT02198235 (4) [back to overview] | Block Duration |
NCT02198235 (4) [back to overview] | Median Time to Requiring Oral Opioids |
NCT02294253 (1) [back to overview] | Successful Induction Onto XR-NTX |
NCT02310581 (7) [back to overview] | NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours After Time 0 |
NCT02310581 (7) [back to overview] | NRS SPID Over 0 to 8 Hours After Time 0 (NRS SPID-8) |
NCT02310581 (7) [back to overview] | NRS SPID Over 0 to 24 Hours After Time 0 (NRS SPID-24) |
NCT02310581 (7) [back to overview] | NRS SPID Over 0 to 4 Hours After Time 0 (NRS SPID-4) |
NCT02310581 (7) [back to overview] | Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48) |
NCT02310581 (7) [back to overview] | Percentage of Participants Who Used Rescue Medication for Pain |
NCT02310581 (7) [back to overview] | NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0 |
NCT02357901 (15) [back to overview] | Change From Baseline in the Clinical Global Impression - Improvement Scale (CGI-I) Prior to Injections From Week 5 Through Week 24 Analyzed by Mixed Model for Repeated Measures |
NCT02357901 (15) [back to overview] | Cumulative Distribution Function (CDF) of the Percentage of Urine Samples Negative for Opioids Combined With Self-Reports Negative for Illicit Opioid Use Collected From Week 5 Through Week 24 |
NCT02357901 (15) [back to overview] | "Participants Who Complete the Week 24 Visit (Completers)" |
NCT02357901 (15) [back to overview] | Change From Baseline in the Clinical Global Impression - Severity Scale (CGI-S) Prior to Injections From Week 5 Through Week 24 Analyzed by Mixed Model for Repeated Measures |
NCT02357901 (15) [back to overview] | Participants Who Are Abstinent at Week 24 |
NCT02357901 (15) [back to overview] | Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) Through Week 24 Analyzed by Mixed Model for Repeated Measures |
NCT02357901 (15) [back to overview] | Change From Baseline in the Opioid Craving Visual Analog Scale (VAS) Prior to Injections From Week 5 Through Week 24 Analyzed by Mixed Model for Repeated Measures |
NCT02357901 (15) [back to overview] | Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) Through Week 24 Analyzed by Mixed Model for Repeated Measures |
NCT02357901 (15) [back to overview] | Percentage of Participants Considered A Treatment Success |
NCT02357901 (15) [back to overview] | Total Number of Weeks of Abstinence as Assessed From Urine Samples Negative for Opioids Combined With Self-Reports Negative for Illicit Opioid Use Collected From Week 5 Through Week 24 |
NCT02357901 (15) [back to overview] | Worst Injection Site Pain From Injections 1-6 as Measured by Participant-Reported Visual Analog Scale (VAS) |
NCT02357901 (15) [back to overview] | Cumulative Distribution Function (CDF) of the Percentage of Self-Reports Negative for Illicit Opioid Use From Week 5 Through Week 24 |
NCT02357901 (15) [back to overview] | Cumulative Distribution Function (CDF) of the Percentage of Urine Samples Negative for Opioids From Week 5 Through Week 24 |
NCT02357901 (15) [back to overview] | Participants With Adverse Events During the Treatment Period |
NCT02357901 (15) [back to overview] | Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) From Week 2 - 24 |
NCT02510014 (11) [back to overview] | Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) at End of Study (Weeks 25 and 49) |
NCT02510014 (11) [back to overview] | Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) at End of Study (Weeks 25 and 49) |
NCT02510014 (11) [back to overview] | Change From Baseline in the Opioid Craving Visual Analog Scale (VAS) at End of Study (Weeks 25 and 49) |
NCT02510014 (11) [back to overview] | Change From Baseline in the Opioid Craving Visual Analog Scale (VAS) at End of Study (Weeks 25 and 49) |
NCT02510014 (11) [back to overview] | Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) at End of Study (Weeks 25 and 49) |
NCT02510014 (11) [back to overview] | Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) at End of Study (Weeks 25 and 49) |
NCT02510014 (11) [back to overview] | Cumulative Distribution Function (CDF) of the Percentage Abstinence Collected From Week 1 Through End of Study (Weeks 25 and 49) |
NCT02510014 (11) [back to overview] | Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period |
NCT02510014 (11) [back to overview] | Percentage Change From Baseline to End of Study (Weeks 25 and 49) in Vital Signs |
NCT02510014 (11) [back to overview] | Worst Local Injection Site Pain From Injections as Measured by Participant-Reported Visual Analog Scale (VAS) |
NCT02510014 (11) [back to overview] | Worst Local Injection Site Pain From Injections as Measured by Participant-Reported Visual Analog Scale (VAS) |
NCT02519387 (5) [back to overview] | Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA) |
NCT02519387 (5) [back to overview] | Physicians' and Patients' Treatment Satisfaction of Buprenorphine Patch Usage Assessed Using Physician's Global Impression of Change Scale and Patient's Global Impression of Change Scale Respectively |
NCT02519387 (5) [back to overview] | Daily Use of Breakthrough Pain Medication as Measured by Number of Subjects With at Least 1 Day of Breakthrough (Rescue) Pain Medication Usage |
NCT02519387 (5) [back to overview] | Tolerability of Buprenorphine Patch Determined by Number of Patients Who Withdrew From the Study Due to Adverse Events |
NCT02519387 (5) [back to overview] | Change in Box Scale-11 (BS-11) Pain Score |
NCT02526212 (5) [back to overview] | Number of Participants With Opioid Abstinence at 8 Weeks |
NCT02526212 (5) [back to overview] | Number of Participants Who Reported Sharing Injection Equipment at 8 Weeks |
NCT02526212 (5) [back to overview] | Acceptability (Scale) |
NCT02526212 (5) [back to overview] | Feasibility (Percentage of Visits Attended) |
NCT02526212 (5) [back to overview] | Number of Participants Who Were Retained in Buprenorphine Treatment at 3 Months and 6 Months |
NCT02543944 (4) [back to overview] | Vivitrol Injection Receivers |
NCT02543944 (4) [back to overview] | NTX Transition Initiation |
NCT02543944 (4) [back to overview] | Detoxification Phase: Changes in Percent of Illicit Opioid-positive Urine Samples Over Time |
NCT02543944 (4) [back to overview] | Detox Phase Completers |
NCT02611752 (11) [back to overview] | Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 32 mg |
NCT02611752 (11) [back to overview] | Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) for Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 24 mg |
NCT02611752 (11) [back to overview] | Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) |
NCT02611752 (11) [back to overview] | Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) |
NCT02611752 (11) [back to overview] | Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) |
NCT02611752 (11) [back to overview] | Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) |
NCT02611752 (11) [back to overview] | Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 24 mg CAM2038 q1w Group (Completer Population) |
NCT02611752 (11) [back to overview] | Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 32 mg CAM2038 q1w Group (Completer Population) |
NCT02611752 (11) [back to overview] | Treatment Phase Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 32 mg |
NCT02611752 (11) [back to overview] | Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg |
NCT02611752 (11) [back to overview] | Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) |
NCT02634788 (15) [back to overview] | Total Pain Relief (TOTPAR) Over 4, 8, 24 and 48 Hours After Time 0 |
NCT02634788 (15) [back to overview] | Percentage of Participants With Scores in Each Pain Relief Category at 4, 8, 24 and 48 Hours After Time 0 |
NCT02634788 (15) [back to overview] | Percentage of Participants With Peak Scores in Each Pain Relief Category |
NCT02634788 (15) [back to overview] | Participant's Global Evaluation of Study Drug |
NCT02634788 (15) [back to overview] | NRS SPID Over 4 Hours (SPID-4), 8 Hours (SPID-8) and 24 Hours (SPID-24) After Time 0 |
NCT02634788 (15) [back to overview] | NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours After Time 0 |
NCT02634788 (15) [back to overview] | NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0 |
NCT02634788 (15) [back to overview] | Time to Peak Pain Relief |
NCT02634788 (15) [back to overview] | Time to Onset of Analgesia |
NCT02634788 (15) [back to overview] | Percentage of Participants Using Rescue Medication for Pain |
NCT02634788 (15) [back to overview] | Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48) |
NCT02634788 (15) [back to overview] | Time to Meaningful Pain Relief |
NCT02634788 (15) [back to overview] | Time to First Perceptible Pain Relief |
NCT02634788 (15) [back to overview] | Time to First Use of Rescue Medication for Pain |
NCT02634788 (15) [back to overview] | Total Use of Rescue Medication Over 0 to 24 Hours and 0 to 48 Hours |
NCT02651584 (3) [back to overview] | Number of Subjects Remaining in the Study (Retention Rate) |
NCT02651584 (3) [back to overview] | Cumulative Distribution Function (CDF) of Percentage of Urine Samples Negative for Illicit Opioids |
NCT02651584 (3) [back to overview] | Number of Subjects With Sustained Abstinence of Opioid Use |
NCT02659787 (1) [back to overview] | "Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire Subjective Response With and Without Buprenorphine" |
NCT02672111 (9) [back to overview] | Summary of Subjective Opiate Withdrawal Scale (SOWS) at Selected Time Points (Efficacy Population) |
NCT02672111 (9) [back to overview] | Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Full Exposure Safety Population |
NCT02672111 (9) [back to overview] | Summary of Need to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population) |
NCT02672111 (9) [back to overview] | Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population |
NCT02672111 (9) [back to overview] | Summary of Clinical Opiate Withdrawal Scale (COWS) at Selected Time Points (Efficacy Population) |
NCT02672111 (9) [back to overview] | Summary of Desire to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population) |
NCT02672111 (9) [back to overview] | Mean Percentage of Negative Urine Toxicology Results for Illicit Opioid Use Supported by Self Reported Illicit Opioid Use (Efficacy Population) |
NCT02672111 (9) [back to overview] | Mean Percentage of Self-reported No Illicit Opioid Use (Efficacy Population) |
NCT02672111 (9) [back to overview] | Summary of Retention in Treatment (Efficacy Population) |
NCT02696096 (3) [back to overview] | Working Memory - Between Groups at Baseline by Lapsed Category |
NCT02696096 (3) [back to overview] | Changes in Resting State Disorganization Between Baseline and One Week by Person by Lapsed Category |
NCT02696096 (3) [back to overview] | Changes in Working Memory - Within Groups During Satiation and Withdrawal |
NCT02696434 (7) [back to overview] | Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection on Day 8 |
NCT02696434 (7) [back to overview] | Proportion of Post-VIVITROL Days (Days 9-11) in Which Subjects in Each Group Demonstrate Mild Opioid Withdrawal |
NCT02696434 (7) [back to overview] | Mean Peak COWS Scores During the Treatment Period (Days 1/1a-7) |
NCT02696434 (7) [back to overview] | Incidence of Adverse Events (AEs) |
NCT02696434 (7) [back to overview] | Area Under the Curve (AUC) for COWS Scores During the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation Period |
NCT02696434 (7) [back to overview] | "Mean Score for Desire for Opioids Visual Analog Scale (VAS) During the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation Period" |
NCT02696434 (7) [back to overview] | Proportion of Days With COWS Peak Score =12 During the Treatment Period Prior to the VIVITROL Injection |
NCT02710526 (28) [back to overview] | Maximum Steady State Concentration-Norbuprenorphine |
NCT02710526 (28) [back to overview] | Norbuprenorphine/Buprenorphine Ratios at Maximum Concentration at Steady State |
NCT02710526 (28) [back to overview] | Norbuprenorphine/Buprenorphine Ratios for Area Under the Curve at Steady State |
NCT02710526 (28) [back to overview] | Time to Maximum Concentration at Steady State-Buprenorphine |
NCT02710526 (28) [back to overview] | Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site |
NCT02710526 (28) [back to overview] | Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site |
NCT02710526 (28) [back to overview] | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 |
NCT02710526 (28) [back to overview] | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests |
NCT02710526 (28) [back to overview] | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests |
NCT02710526 (28) [back to overview] | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests |
NCT02710526 (28) [back to overview] | Subject-rated Worst Daily Pain |
NCT02710526 (28) [back to overview] | Subject-rated Worst Daily Pain |
NCT02710526 (28) [back to overview] | Subject-rated Worst Daily Pain |
NCT02710526 (28) [back to overview] | Summary of Average Daily Pain by Week (ITT Population) |
NCT02710526 (28) [back to overview] | Summary of Average Daily Pain by Week (ITT Population) |
NCT02710526 (28) [back to overview] | Summary of Average Daily Pain by Week (ITT Population) |
NCT02710526 (28) [back to overview] | Time to Maximum Concentration at Steady State-Norbuprenorphine |
NCT02710526 (28) [back to overview] | Area Under the Curve at Steady State (AUC During a 28-day Dosing Interval at Steady State)-Buprenorphine |
NCT02710526 (28) [back to overview] | Area Under the Curve at Steady State (AUC During a 28-day Dosing Interval at Steady State)-Norepinephrine |
NCT02710526 (28) [back to overview] | AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm for the Evaluable Pharmacokinetic (PKEVAL) Population |
NCT02710526 (28) [back to overview] | AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm. |
NCT02710526 (28) [back to overview] | Average Steady State Concentration-Buprenorphine |
NCT02710526 (28) [back to overview] | Average Steady State Concentration-Norbuprenorphine |
NCT02710526 (28) [back to overview] | Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site |
NCT02710526 (28) [back to overview] | Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site for the Evaluable Pharmacokinetic (PKEVAL) Population |
NCT02710526 (28) [back to overview] | Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site. |
NCT02710526 (28) [back to overview] | Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site. |
NCT02710526 (28) [back to overview] | Maximum Steady State Concentration-Buprenorphine |
NCT02737826 (13) [back to overview] | Number of Participants Who Achieve Opioid Cessation |
NCT02737826 (13) [back to overview] | Number of Participants Who Achieved Opioid Cessation Post-taper - 3 Months |
NCT02737826 (13) [back to overview] | Number of Participants Who Achieved Opioid Cessation Post-taper - 6 Months |
NCT02737826 (13) [back to overview] | Number of Participants Who Achieved Opioid Cessation Post-taper - 12 Months |
NCT02737826 (13) [back to overview] | Percentage of Patients Who Tolerate Buprenorphine Initiation |
NCT02737826 (13) [back to overview] | Pain Self-report: Pain Catastrophizing Scale - Baseline |
NCT02737826 (13) [back to overview] | Mean Score Pittsburgh Sleep Quality Index |
NCT02737826 (13) [back to overview] | Number of Participants Who Achieve Opioid Cessation Post-taper: 1 Month |
NCT02737826 (13) [back to overview] | Pain Laboratory Testing: Mechanical - Baseline |
NCT02737826 (13) [back to overview] | Pain Laboratory Measures - Descending Noxious Inhibitory Control (DNIC) - Average, Baseline |
NCT02737826 (13) [back to overview] | Mean Score of Subjective Opioid Withdrawal Scale (SOWS) |
NCT02737826 (13) [back to overview] | Mean Score of Current Opioid Measure (COMM) |
NCT02737826 (13) [back to overview] | Mean Score of PROMIS Physical Function Short Form (PROMIS SF 10) - RAW SCORE PH |
NCT02891798 (8) [back to overview] | Short-Form McGill Pain Questionnaire (Version 2) Total Score Difference From Baseline |
NCT02891798 (8) [back to overview] | Quality of Recovery 15 Item Scale (QoR-15) Total Score |
NCT02891798 (8) [back to overview] | Quality of Recovery 15 Item Scale (QoR-15) Total Score |
NCT02891798 (8) [back to overview] | Performed-based Physical Function is Assessed Using the Standing Balance Test. |
NCT02891798 (8) [back to overview] | Performed-based Physical Function is Assessed Using the Self-Selected Gait Speed Test. |
NCT02891798 (8) [back to overview] | Performed-based Physical Function is Assessed Using the Repeated Chair Stand Test. |
NCT02891798 (8) [back to overview] | SF-MPQ2 Intermittent Pain Subscore Difference From Baseline |
NCT02891798 (8) [back to overview] | SF-MPQ2 Continuous Pain Subscore Difference From Baseline |
NCT02896296 (3) [back to overview] | Percentage Change From Baseline to Week 25 in Vital Signs |
NCT02896296 (3) [back to overview] | Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period |
NCT02896296 (3) [back to overview] | Participants With Treatment-emergent Adverse Events (TEAEs) Pertaining to Laboratory Test Values |
NCT02946073 (17) [back to overview] | Summary of Change From Baseline in EuroQoL Group EQ-5D-5L Scores Over Time-Open Label Phase |
NCT02946073 (17) [back to overview] | Summary of Rescue Medication Usage-Open Label Phase |
NCT02946073 (17) [back to overview] | Number of Subjects Discontinued Due to Loss of Efficacy |
NCT02946073 (17) [back to overview] | Subject Discontinued Due to Loss of Efficacy, Defined as Discontinuation of Study Drug for Lack of Efficacy. |
NCT02946073 (17) [back to overview] | Change From Baseline in the Weekly Average of (Daily) Worst Pain Intensity Scores at Week 12 of the Double-Blind Phase Based on 11-Point Numerical Rating Scale With 10 Being the Worst Pain. |
NCT02946073 (17) [back to overview] | Change From Baseline to Week 12 of the Double-Blind Phase in Patient Global Impression of Improvement (PGI-I) Scale |
NCT02946073 (17) [back to overview] | Change From Baseline to Week 12 of the Double-Blind Phase in Work Productivity and Activity Impairment Score |
NCT02946073 (17) [back to overview] | Change From Open Label Titration Baseline to Week 12 of the Double-Blind Phase in EuroQol Group 5-dimension 5-level Self-report Questionnaire Score. |
NCT02946073 (17) [back to overview] | Number of Subjects Discontinued Due to Loss of Efficacy |
NCT02946073 (17) [back to overview] | Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) and the Primary Timepoint Will be Week 12 of the Double-Blind Phase. |
NCT02946073 (17) [back to overview] | Summary of Rescue Medication Usage- Double-Blind Phase. |
NCT02946073 (17) [back to overview] | Summary of Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Open Label Phase |
NCT02946073 (17) [back to overview] | Summary of Change From Baseline in Patient Global Impression of Improvement (PGI-I) Scale |
NCT02946073 (17) [back to overview] | Summary of Change From Baseline in Clinical Global Impression of Improvement (CGI-I) Scale-Open Label |
NCT02946073 (17) [back to overview] | Number of Subjects With a 30% and 50% Reduction in WAAPI From Baseline to Week 12 of the Double-Blind Phase. |
NCT02946073 (17) [back to overview] | Change From Baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) of the Open Label Phase. |
NCT02946073 (17) [back to overview] | Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase. |
NCT03026790 (14) [back to overview] | GAD-7 |
NCT03026790 (14) [back to overview] | PROMIS Sleep Disturbance |
NCT03026790 (14) [back to overview] | Symptom Checklist |
NCT03026790 (14) [back to overview] | VR-12 Mental Component Score |
NCT03026790 (14) [back to overview] | VR-12 Physical Component Score |
NCT03026790 (14) [back to overview] | PODS Concerns |
NCT03026790 (14) [back to overview] | Brief Pain Inventory (BPI) Total Score |
NCT03026790 (14) [back to overview] | 50% Reduction in Opioid Daily Dose |
NCT03026790 (14) [back to overview] | Composite Response |
NCT03026790 (14) [back to overview] | Headache Impact Test |
NCT03026790 (14) [back to overview] | Pain Response |
NCT03026790 (14) [back to overview] | PHQ-8 |
NCT03026790 (14) [back to overview] | PODS Problems |
NCT03026790 (14) [back to overview] | PROMIS Fatigue |
NCT03113409 (1) [back to overview] | Percentage of Patients Who Receive the Second Injection of XR-NTX. |
NCT03117140 (15) [back to overview] | Number of Patients Reporting Nausea in the PACU |
NCT03117140 (15) [back to overview] | Number of Patients Vomiting in the PACU (Post-Anesthesia Care Unit) |
NCT03117140 (15) [back to overview] | Number of Patients With Blood Pressure (BP) Changes in the PACU |
NCT03117140 (15) [back to overview] | Pain Score Reported by Patients at First Phone Call |
NCT03117140 (15) [back to overview] | Patient Reporting Vomiting at Home |
NCT03117140 (15) [back to overview] | Surgical Length |
NCT03117140 (15) [back to overview] | Surgical Position |
NCT03117140 (15) [back to overview] | Sensory Duration of Block |
NCT03117140 (15) [back to overview] | Block Set up Time |
NCT03117140 (15) [back to overview] | Duration of Analgesia |
NCT03117140 (15) [back to overview] | Motor Duration of Block |
NCT03117140 (15) [back to overview] | Number of Patient With Blood Pressure Changes in the Second Stage Recovery Area |
NCT03117140 (15) [back to overview] | Number of Patients Reporting Itching at Home |
NCT03117140 (15) [back to overview] | Number of Patients Reporting Itching in the PACU |
NCT03117140 (15) [back to overview] | Number of Patients Reporting Nausea at Home |
NCT03188185 (1) [back to overview] | Change From Baseline to the End of Treatment (EOT) in the Montgomery Asberg Depression Rating Scale-10 (MADRS-10) Scores |
NCT03232346 (1) [back to overview] | Percent of Patients Successfully Transitioned Off Buprenorphine |
NCT03248947 (8) [back to overview] | Treatment Satisfaction |
NCT03248947 (8) [back to overview] | Recruitment Rate |
NCT03248947 (8) [back to overview] | Treatment Fidelity |
NCT03248947 (8) [back to overview] | Treatment Retention |
NCT03248947 (8) [back to overview] | Number of Participants With Opioid and Other Substance Use |
NCT03248947 (8) [back to overview] | Participant Safety |
NCT03248947 (8) [back to overview] | Number of Medication-Compliant Months Across All Participants |
NCT03248947 (8) [back to overview] | Pharmacists' Use of the Prescription Drug Monitoring Program (PDMP) |
NCT03254459 (7) [back to overview] | Percentage of Participants Provided Rescue Medication for Nausea |
NCT03254459 (7) [back to overview] | Time to First Use of Rescue Medication for Nausea Following Each Dose of the Investigational Product (IP) |
NCT03254459 (7) [back to overview] | Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
NCT03254459 (7) [back to overview] | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings at 90 Minutes,12, 24, 48 and 72 Hours |
NCT03254459 (7) [back to overview] | Number of Participants With Abnormal Oral Cavity Examinations |
NCT03254459 (7) [back to overview] | Pulse Oximetry Levels at 90 Minutes,12, 24, 48 and 72 Hours |
NCT03254459 (7) [back to overview] | Total Use of Rescue Medication for Nausea Over 0 to 24 Hours, Over 0 to 48 Hours, Over 0-72 Hours and 0-7 Days |
NCT03291847 (8) [back to overview] | Total Fetal Movement at 36 Weeks Gestation |
NCT03291847 (8) [back to overview] | Fetal Heart Rate at 24 Weeks |
NCT03291847 (8) [back to overview] | Fetal Heart Rate at 28 Weeks Gestation |
NCT03291847 (8) [back to overview] | Fetal Heart Rate at 32 Weeks Gestation |
NCT03291847 (8) [back to overview] | Fetal Heart Rate at 36 Weeks Gestation |
NCT03291847 (8) [back to overview] | Total Fetal Movement at 24 Weeks Gestation |
NCT03291847 (8) [back to overview] | Total Fetal Movement at 32 Weeks Gestation |
NCT03291847 (8) [back to overview] | Total Fetal Movement at 28 Weeks Gestation |
NCT03492099 (4) [back to overview] | Number of Subjects Who Require Hospitalization Within 72 Hours Post Conversion From Full Agonist Opioids to Buprenorphine-based Pain Treatment |
NCT03492099 (4) [back to overview] | Number of Participants Continuing Buprenorphine Therapy After 6 Months of Induction |
NCT03492099 (4) [back to overview] | Change in the Number of Acute Care Visits Per Subject in the 6 Months Prior to Buprenorphine (BUP) Induction and in the 6 Months Post to BUP Induction |
NCT03492099 (4) [back to overview] | Change in Severity of Opiate Withdrawal, Based on the Clinical Opiate Withdrawal Scale (COWS) Score |
NCT03604159 (8) [back to overview] | The # of Participants Who Received Their Randomly Assigned Study Medication Prior to Release From Jail as Scheduled |
NCT03604159 (8) [back to overview] | The # of Participants That Received Their Randomly Assigned Study Medication |
NCT03604159 (8) [back to overview] | the # of Participants Re-incarcerated |
NCT03604159 (8) [back to overview] | Mean # of Weeks (0-8) on Any Buprenorphine Treatment |
NCT03604159 (8) [back to overview] | # of Participants Retained on Any Form of Community Buprenorphine (Not Randomzied tx) at Week 8 |
NCT03604159 (8) [back to overview] | # of Participants Retained on Their Randomly Assigned Treatment at Week 8 |
NCT03604159 (8) [back to overview] | Urine Samples Opioid-negative |
NCT03604159 (8) [back to overview] | The Mean In-jail Medical Visits Per Day Following Randomization and Induction on Study Medication |
NCT03608696 (2) [back to overview] | Number of Participants With Treatment Related Adverse Events |
NCT03608696 (2) [back to overview] | Length of Treatment |
NCT03711318 (1) [back to overview] | Proportion of Heroin-dependent Patients Successfully Inducted Onto Vivitrol |
NCT03818399 (2) [back to overview] | Number of Repeat OD or Opioid-related Death |
NCT03818399 (2) [back to overview] | Treatment Engagement |
NCT03852628 (3) [back to overview] | Composite Outcome Measure for a Reduction in Both Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD) Symptoms |
NCT03852628 (3) [back to overview] | Number of Participants With a Reduction in Alcohol Use Disorder (AUD), With TLFB Tool |
NCT03852628 (3) [back to overview] | Number of Participants With a Reduction in CAPS-5 Total Symptom Severity Score (TSSS) of 10 or More Points |
NCT03861338 (1) [back to overview] | Sublocade Induction |
NCT03908437 (4) [back to overview] | Enrollment in Medication Assisted Treatment at 6-month Post-enrollment |
NCT03908437 (4) [back to overview] | Overdose During the 6-month Follow-up |
NCT03908437 (4) [back to overview] | Change in Opioid Use From Baseline to 6-month Follow-up |
NCT03908437 (4) [back to overview] | Enrollment in Medication Assisted Treatment at 1-month Post-enrollment |
NCT03993392 (7) [back to overview] | Total Score on Opioid Craving Visual Analogue Scale (OC-VAS) At Timepoints During the Treatment Period |
NCT03993392 (7) [back to overview] | COWS Total Score Normalized Area Under the Curve (AUC) Through Key Timepoints Post SUBLOCADE Injection |
NCT03993392 (7) [back to overview] | Participants Who Experienced Any Precipitated Withdrawal Within One Hour After SUBLOCADE Administration |
NCT03993392 (7) [back to overview] | Cumulative Number of Participants Who Experienced a >=6 Point Clinical Opiate Withdrawal Scale (COWS) Total Score Increase After SUBLOCADE Administration From the Pre-SUBLOCADE Value at Key Timepoints |
NCT03993392 (7) [back to overview] | Participants With Treatment-Emergent Adverse Events (TEAE) |
NCT03993392 (7) [back to overview] | Participants With Treatment-Emergent Adverse Events (TEAE) Within 48 Hours Post-SUBLOCADE Injection |
NCT03993392 (7) [back to overview] | Total Score on COWS At Timepoints During the Treatment Period |
NCT03996694 (4) [back to overview] | Adverse Event (AE) Reporting of Belbuca, Oxycodone Hydrochloride and Placebo for 6 Periods. |
NCT03996694 (4) [back to overview] | Respiratory Drive |
NCT03996694 (4) [back to overview] | Change in Ratio of Minute Ventilation |
NCT03996694 (4) [back to overview] | Pupil Diameter |
NCT04060654 (1) [back to overview] | Treatment Emergent Adverse Event (TEAE) Occurrence |
NCT04254081 (4) [back to overview] | Pain Score 1 Hour After Osmotic Dilator Insertion |
NCT04254081 (4) [back to overview] | Pain Score 2 Hours After Osmotic Dilator Insertion |
NCT04254081 (4) [back to overview] | Pain Score 6 Hours After Osmotic Dilator Insertion |
NCT04254081 (4) [back to overview] | Pain Score at the Time of Osmotic Dilator Insertion |
NCT04447287 (22) [back to overview] | Number of Participants With Suicidal Ideation and/or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) |
NCT04447287 (22) [back to overview] | Pharmacokinetics (PK) of ASP8062 in Plasma: Area Under the Concentration-time Curve From the Time of Dosing Extrapolated to Time Infinity (AUCinf) |
NCT04447287 (22) [back to overview] | Pharmacokinetics (PK) of ASP8062 in Plasma: Area Under the Concentration-time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) |
NCT04447287 (22) [back to overview] | Pharmacokinetics (PK) of ASP8062 in Plasma: Maximum Concentration (Cmax) |
NCT04447287 (22) [back to overview] | Pharmacokinetics (PK) of Buprenorphine in Plasma: Area Under the Concentration-time Curve From the Time of Dosing to 24 Hours (AUC24) |
NCT04447287 (22) [back to overview] | Pharmacokinetics (PK) of Buprenorphine in Plasma: Cmax |
NCT04447287 (22) [back to overview] | Pharmacokinetics (PK) of Naloxone in Plasma: AUC24 |
NCT04447287 (22) [back to overview] | Pharmacokinetics (PK) of Naloxone in Plasma: Cmax |
NCT04447287 (22) [back to overview] | Pharmacokinetics (PK) of Norbuprenorphine (Buprenorphine's Metabolite) in Plasma: AUC24 |
NCT04447287 (22) [back to overview] | Number of Participants With Adverse Events (AEs) |
NCT04447287 (22) [back to overview] | Pharmacokinetics (PK) of Norbuprenorphine (Buprenorphine's Metabolite) in Plasma: Cmax |
NCT04447287 (22) [back to overview] | Change From Baseline in End Tidal Carbon Dioxide (CO2) at 8 Hour Postdose |
NCT04447287 (22) [back to overview] | Change From Baseline in End Tidal Carbon Dioxide (CO2) at 4 Hour Postdose |
NCT04447287 (22) [back to overview] | Change From Baseline in End Tidal Carbon Dioxide (CO2) at 2 Hour Postdose |
NCT04447287 (22) [back to overview] | Change From Baseline in End Tidal Carbon Dioxide (CO2) at 1 Hour Postdose |
NCT04447287 (22) [back to overview] | Change From Baseline in Blood Oxygen Saturation (SpO2) at Predose |
NCT04447287 (22) [back to overview] | Change From Baseline in Blood Oxygen Saturation (SpO2) at 8 Hour Postdose |
NCT04447287 (22) [back to overview] | Change From Baseline in Blood Oxygen Saturation (SpO2) at 4 Hour Postdose |
NCT04447287 (22) [back to overview] | Change From Baseline in Blood Oxygen Saturation (SpO2) at 12 Hour Postdose |
NCT04447287 (22) [back to overview] | Change From Baseline in Blood Oxygen Saturation (SpO2) at 1 Hour Postdose |
NCT04447287 (22) [back to overview] | Change From Baseline in End Tidal Carbon Dioxide (CO2) at Predose |
NCT04447287 (22) [back to overview] | Change From Baseline in Blood Oxygen Saturation (SpO2) at 2 Hour Postdose |
Evidence of HIV-1 Infection or Death for Visits up to 104 Weeks
The primary endpoint for the study was cumulative HIV infection or death after a second year of follow-up (i.e. at week 104), one year after completion of the treatment phase, designed to test a durable intervention effect. (NCT00270257)
Timeframe: For visits up to week 104
Intervention | participants (Number) |
---|
| # of HIV infections | # of Deaths |
---|
Long Term Medication Assisted Treatment (LT-MAT) | 2 | 8 |
,Short Term Medication Assisted Treatment (ST-MAT) | 5 | 9 |
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Incident Hepatitis B Infections
Serum samples were tested at baseline and between 26-52 weeks later for Hepatitis B surface antigen (HBsAg) using a commercial enzyme immunoassay (EIA) (Abbott Murex HBsAg version 3.0). If the HBsAg test was initially non-reactive, then the participant was considered to be negative for HBsAg. If the HBsAg test was initially reactive, then it was repeated in duplicate. If at least two of 3 tests were reactive, then the participant was considered to be positive for HBsAg. (NCT00270257)
Timeframe: Measured through week 52
Intervention | participants with HBsAg (Number) |
---|
China | 9 |
Thailand | 0 |
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Incident Hepatitis C Infections for Thailand and China
"HCV antibody using two different HCV EIA assays (Ortho HCV antibody version 3.0 and Wantai HCV antibody assay) at baseline and between 26-156 weeks later.~If both HCV EIA antibody assays were nonreactive, then the participant was considered not to be HCV infected. If either assay was reactive, then the Ortho HCV assay was repeated in duplicate. If two of 3 Ortho HCV assays were reactive, then the participant was considered to be HCV infected. Samples that were repeatedly reactive for HCV antibody at a follow-up visit were tested for HCV RNA by the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV assay. Not all participants had follow-up testing performed in China due to early closure of the study by the Data Safety Monitoring Board on account of futility due to a low HIV incidence (the primary study endpoint).~Analysis was done separately for both countries" (NCT00270257)
Timeframe: Measured through week 156 in Thailand and 104 weeks in China
Intervention | participants with HCV antibody (Number) |
---|
China | 41 |
Thailand | 8 |
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Number of Participants Reported Using Injection Equipment (Needles, Syringes, Cookers, Cottons, and Rinse Water) in the Prior 6 Months
(NCT00270257)
Timeframe: Measured through Week 104
Intervention | participants (Number) |
---|
Long Term Medication Assisted Treatment (LT-MAT) | 23 |
Short Term Medication Assisted Treatment (ST-MAT) | 28 |
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Number of Participants With Urinalysis Results Positive for Opiates
Urine drug screen were assessed monthly and semiannually. (NCT00270257)
Timeframe: Measured through Week 104
Intervention | participants (Number) |
---|
Long Term Medication Assisted Treatment (LT-MAT) | 138 |
Short Term Medication Assisted Treatment (ST-MAT) | 141 |
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Self-report of Continued Injection Opiate Use in the Last 30 Days
All participants completed interviewer-administered assessments of injection and non-injection drug use at baseline and at semi-annual visits. (NCT00270257)
Timeframe: Measured through Week 104
Intervention | participants (Number) |
---|
Long Term Medication Assisted Treatment (LT-MAT) | 102 |
Short Term Medication Assisted Treatment (ST-MAT) | 107 |
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Self-reported Number of Injections in the Last Month
(NCT00270257)
Timeframe: Measured through Week 104
Intervention | injections (Median) |
---|
Long Term Medication Assisted Treatment (LT-MAT) | 30 |
Short Term Medication Assisted Treatment (ST-MAT) | 30 |
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Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS
Total amount in mg (NCT00271219)
Timeframe: Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days)
Intervention | mg (Mean) |
---|
A Methadone | 10.4 |
B Buprenorphine | 1.1 |
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Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS)
Neonatal abstinence syndrome (NAS) characterized by hyperirritability of the central nervous system and dysfunction in the autonomic nervous system, gastrointestinal tract, and respiratory system.11 When left untreated, NAS can result in serious illness (e.g., diarrhea, feeding difficulties, weight loss, and seizures) and death. (NCT00271219)
Timeframe: From birth until hospital discharge (min=4 days, max=10, depending on site)
Intervention | participants (Number) |
---|
A Methadone | 41 |
B Buprenorphine | 27 |
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Mother's Self-report of Drug Use (Measured Monthly by Time Line Follow Back)
(NCT00271219)
Timeframe: monthly from study entry until discontinuation or delivery (min=29 days, max=239 days)
Intervention | percentage of drug use (Number) |
---|
A Methadone | NA |
B Buprenorphine | NA |
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Mother's Psychosocial Functioning at Delivery as Measured by the Addiction Severity Index Psychosocial Index Score
The Addiction Severity Index is a structured clinical interview that assesses problem severity in 7 areas of functioning: alcohol use, drug use, medical, legal, employment, psychosocial, and psychiatric status. Each area of functioning yields a composite scale score between 0 and 1, with higher scores indicating greater problem severity in that area. Only the psychosocial index was examined in this study. (NCT00271219)
Timeframe: at delivery
Intervention | Score on the scale (Mean) |
---|
Methadone | .014 |
Buprenorphine | .088 |
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Mother's Measures of Dose Adequacy and Acceptance Over Time (Measured Weekly by Dose Adequacy Measure)
Pregnant women maintained on an opioid agonist medication may require upward adjustment to their medication during the course of pregnant. The Dose Adequacy Measure represented a recordation of dosing adjustments during the course of the study. (NCT00271219)
Timeframe: from study entry until discontinuation or delivery (min=29 days, max=239 days)
Intervention | dose increase per trimester (Number) |
---|
A Methadone | NA |
B Buprenorphine | NA |
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Mother's HIV Risk Behaviors (Measured Monthly by Risk Behavior Assessment)
(NCT00271219)
Timeframe: monthly from study entry until discontinuation or delivery (min=29 days, max=239 days)
Intervention | percentage of HIV risk behaviors (Number) |
---|
A Methadone | NA |
B Buprenorphine | NA |
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Child's Peak Daily Total NAS Score
NAS was measured with the MOTHER NAS scale, which includes 28 items, 19 of which are used for scoring and medication decisions. Scores can range from 0 to 42, with higher scores indicating more severe withdrawal. (NCT00271219)
Timeframe: minimum twice daily from birth until NAS no longer measured (min=10 days)
Intervention | Score on the scale (Mean) |
---|
A Methadone | 12.8 |
B Buprenorphine | 11.0 |
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Child's Length of Hospital Stay
(NCT00271219)
Timeframe: delivery until hospital discharge (min=2 days, max=79 days)
Intervention | days (Mean) |
---|
A Methadone | 17.5 |
B Buprenorphine | 10.0 |
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Child's Head Circumference Measurement (Measured at Birth)
(NCT00271219)
Timeframe: birth
Intervention | cm (Mean) |
---|
A Methadone | 33.0 |
B Buprenorphine | 33.8 |
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The Number of Subjects Who Had Ineffective Treatment or Who Discontinued Due to Reasons Other Than Ineffective Treatment in the Double-blind Phase
"Note: The total numbers of Subjects w/ineffective treatment or who discont'd for placebo and BTDS are 1 less because there were reasons other than lack of efficacy that made up this total: adverse event, death, lost to follow- up, protocol violation, and other. Example for placebo 89+5=94; however, 93 is indicated for the total because there is 1 subject in the placebo group who was counted under ineffective treatment and discontinued due to reasons other than lack of efficacy. The same is true for 1 subject in BTDS." (NCT00312195)
Timeframe: 14 days
Intervention | participants (Number) |
---|
| Subjects w/ineffective treatment or who discont'd | Ineffective Treatment | Discontinued due to other reasons |
---|
Double-blind BTDS | 71 | 66 | 6 |
,Double-blind Placebo Patch | 93 | 89 | 5 |
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Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment
"The time of ineffective treatment was calculated as the earliest of the following:~The date the subject first took >1 gram of acetaminophen,~The visit date when ineffective treatment was first determined, or~The date the last patch was removed." (NCT00312195)
Timeframe: 14 days
Intervention | Days (Mean) |
---|
Double-blind Placebo Patch | 5.6 |
Double-blind BTDS | 7.4 |
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The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets).
The average daily acetaminophen (Panadol) use (1 tablet = 500 mg) during the double-blind phase was compared between the treatment groups using ANCOVA methodology with terms for country and treatment. The average escape medication used in the last 4 days prior to randomization was included as a covariate. (NCT00312195)
Timeframe: 14 days
Intervention | Tablets (Least Squares Mean) |
---|
Double-blind Placebo Patch | 2.2 |
Double-blind BTDS | 1.8 |
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The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase.
"Ineffective treatment was defined as:~Subject took >1 gram of acetaminophen in a 24-hour period, or~Subject required a change in transdermal patch (TDS) dose, or~Subject had difficulty in keeping the TDS on, or~Subject discontinued due to ineffective treatment (but did not meet any of the above criteria).~Note: some subjects may have had multiple reasons for ineffective treatment and are counted under each category. Therefore the sum of subjects across all criteria for ineffective treatment is greater than the total number of subjects with ineffective treatment." (NCT00312195)
Timeframe: Double-blind phase (14 days)
Intervention | participants (Number) |
---|
| Subjects With Ineffective Treatment | Reason: took more than 1 gram of acetaminophen/day | Reason: required a change in TDS dose | Reason: difficulty keeping patch on | Reason: discontinued due to ineffective treatment |
---|
Double-blind BTDS | 66 | 59 | 25 | 1 | 3 |
,Double-blind Placebo Patch | 89 | 81 | 34 | 6 | 2 |
,Total | 155 | 140 | 59 | 7 | 5 |
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"Average Pain Over the Last 24 Hours Scores at Weeks 4, 8, and 12 of the Double-blind Phase."
"The average pain over the last 24 hours score was collected using an 11-point numerical scale ranging from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. This variable was obtained at each clinic visit during the double-blind phase of the study (postrandomization weeks 1, 2, 4, 8, and 12)." (NCT00312221)
Timeframe: Weeks 4, 8, and 12 of the double-blind phase
Intervention | Units on a scale (Mean) |
---|
| Screening | Prerandomization | Week 4 | Week 8 | Week 12 |
---|
Double-blind BTDS 20 | 6.58 | 3.02 | 3.57 | 3.37 | 3.56 |
,Double-blind BTDS 5 | 6.60 | 3.25 | 4.21 | 3.78 | 3.67 |
,Double-blind Oxycodone Immediate-Release | 6.44 | 3.03 | 3.45 | 3.59 | 3.37 |
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The Mean Daily Number of Supplemental Analgesic Medication Tablets
The mean daily number of supplemental analgesic medication tablets included sponsor-supplied ibuprofen, acetaminophen, or OxyIR®. (NCT00312221)
Timeframe: Double-blind phase (84 days)
Intervention | Tablets (Mean) |
---|
| Prerandomization | Double-blind |
---|
Double-blind BTDS 20 | 1.7 | 2.3 |
,Double-blind BTDS 5 | 2.0 | 3.3 |
,Double-blind Oxycodone Immediate-Release | 1.6 | 2.3 |
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The Physical Function Subscale of The Western Ontario and McMaster's Universities Osteoarthritis (WOMAC OA) Index at Weeks 4, 8, and 12 of the Double Blind Phase
"The WOMAC (Version LK 3.1) measures symptoms and physical functioning of patients with OA of the hip and knee. It contains 24 items (5 pain, 2 stiffness, 17 physical function) and takes less than 5 minutes to complete.~The WOMAC physical function subscale has 17 items coded as 0 to 4 (best to worst), which are summed, giving a range of 0 to 68 (best to worst)." (NCT00312221)
Timeframe: Weeks 4, 8 and 12 of the double-blind phase
Intervention | Units on a scale (Mean) |
---|
| Screening | Prerandomization | Week 4 | Week 8 | Week 12 |
---|
Double-blind BTDS 20 | 37.69 | 24.19 | 28.34 | 28.34 | 29.35 |
,Double-blind BTDS 5 | 36.88 | 25.96 | 30.60 | 28.70 | 29.68 |
,Double-blind Oxycodone Immediate-Release | 36.81 | 24.42 | 26.65 | 26.59 | 27.25 |
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The Sleep Disturbance Subscale in The Medical Outcomes (MOS)-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase
The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity of optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 and Questions 2 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance. (NCT00312221)
Timeframe: Weeks 4, 8, and 12 of the Double-blind Phase
Intervention | Units on a scale (Mean) |
---|
| Screening | Prerandomization | Week 4 | Week 8 | Week 12 |
---|
Double-blind BTDS 20 | 55.28 | 28.65 | 32.40 | 31.71 | 32.95 |
,Double-blind BTDS 5 | 51.91 | 34.64 | 39.23 | 35.95 | 39.13 |
,Double-blind Oxycodone Immediate-Release | 55.74 | 33.03 | 35.72 | 34.13 | 36.32 |
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The Percentage of Subjects Who Completed the 14-day Double-blind Phase.
The indicator variable was 1 = completion, and 0 = noncompletion. For the primary efficacy analysis, the percentage of subjects who completed the double-blind phase was computed with its 95% confidence interval (CI) for each treatment regimen (starting dose of BTDS 10 or BTDS 20) across and within baseline Vicodin® stratum (15 to 22.5mg/day vs >22.5 to 30 mg/day as determined by the daily average hydrocodone dose during the run-in period). (NCT00312572)
Timeframe: 14 days
Intervention | Percentage of Participants (Number) |
---|
| 15 - 22.5 mg HCD (Stratum 1) | more than 22.5 - 30 mg HCD (Stratum 2) | Overall |
---|
Combined Total | 85 | 82 | 84 |
,Double-blind BTDS 10/20 | 88 | 85 | 87 |
,Double-blind BTDS 20 | 83 | 79 | 82 |
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The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12.
"The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity/ optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath).~Question 1 is scored on a scale of 1 to 5 and Questions 3 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance." (NCT00313014)
Timeframe: Weeks 4, 8, 12 of the double-blind phase
Intervention | units on a scale (Mean) |
---|
| Week 4 | Week 8 | Week 12 |
---|
Double-blind BTDS 20 | 34.65 | 35.69 | 33.65 |
,Double-blind BTDS 5 | 40.67 | 42.28 | 40.85 |
,Double-blind Oxycodone Immediate-Release | 38.10 | 39.17 | 41.60 |
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Oswestry Disability Index (ODI) Score (V 2.0)
"The ODI (version 2) is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes.~The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0 = good to 5 = worse). (Note: A higher score represents greater disability.)" (NCT00313014)
Timeframe: Weeks 4, 8, 12
Intervention | units on a scale (Mean) |
---|
| Week 4 | Week 8 | Week 12 |
---|
Double-blind BTDS 20 | 33.04 | 34.27 | 33.06 |
,Double-blind BTDS 5 | 34.80 | 35.69 | 36.30 |
,Double-blind Oxycodone Immediate-Release | 30.79 | 31.64 | 32.96 |
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Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12.
"Subjects were evaluated during the double-blind phase for average pain over the last 24 hours prior to the study visits. Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)" (NCT00313014)
Timeframe: Last 24 hours score at weeks 4, 8, 12 of the double-blind phase
Intervention | units on a scale (Mean) |
---|
| Screening | Prerandomization | Week 4 | Week 8 | Week 12 |
---|
Double-blind BTDS 20 | 6.46 | 2.91 | 3.40 | 3.35 | 3.35 |
,Double-blind BTDS 5 | 6.36 | 2.84 | 3.79 | 3.83 | 4.02 |
,Double-blind Oxycodone Immediate-Release | 6.46 | 2.74 | 3.14 | 3.24 | 3.26 |
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Mean Daily Number of Supplemental Analgesic Tablets
The mean daily number of tablets of supplemental analgesic medications used during the double-blind phase (NCT00313014)
Timeframe: Double-blind phase (84 days)
Intervention | tablets (Mean) |
---|
Double-blind BTDS 5 | 3.8 |
Double-blind BTDS 20 | 3.3 |
Double-blind Oxycodone Immediate-Release | 3.5 |
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The Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site.
"Inadequate analgesia:~average pain over the last 24 hours score for pain at primary osteoarthritis (OA) site ≥ 5 on any 2 days of any 7-day dosing period, on a scale from 0 - 10 (0 = no pain to 10 = pain as bad as you can imagine)or;~>1000 mg/day acetaminophen for pain at primary OA site for ≥ 2 days in any 7-day dosing period, or;~ingested nonstudy opioid analgesic medication for pain at primary OA site. Score: lowest score = shortest time to inadequate analgesia; highest score = longest time to inadequate analgesia." (NCT00313846)
Timeframe: "Double-blind phase ( 28 days): reaching inadequate analgesia on any 2 days of the 7-day dosing periods"
Intervention | days (Mean) |
---|
Double-blind Placebo | 12.3 |
Double-blind BTDS | 17.2 |
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"Daily Maximum Pain Right Now Score for the Primary Osteoarthritis (OA) Pain Site"
"The daily maximum 'pain right now' score for the primary OA pain site was calculated over the last 7-day dosing period in the double-blind phase or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase. Collected prior to ingestion of acetaminophen. Pain right now scale score for primary OA site on a scale from 0-10 (where 0= no pain and 10= worst pain you can imagine)." (NCT00313846)
Timeframe: 7 days of the last dosing period of the double-blind phase, or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase.
Intervention | units on a scale (Mean) |
---|
Double-blind Placebo | 3.8 |
Double-blind BTDS | 3.2 |
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Hepatic Safety
"Participants were categorized according liver transaminase (ALT, AST) levels in blood comparing the baseline sample to any and all subsequent samples in the following manner:~A: both ALT and AST started at less than or equal to two times the ULN and remained at two times or less ULN throughout the study~B: either ALT or AST started at less than or equal to 2 x ULN and at any point in study exceeded 2 x ULN~C: Either ALT or AST started > 2 x ULN, decreased (both ALT and AST) to < 2 x ULN, and remained < 2 x ULN~D: Either ALT or AST started > 2 x ULN and remained above 2 x ULN throughout the study" (NCT00315341)
Timeframe: 24 Weeks
Intervention | participants (Number) |
---|
| ALT - A (low, stays low) | ALT - B (low, goes high) | ALT - C (high, goes low, stays low) | ALT - D (high, stays high) | AST - A (low, stay low) | AST - B (low, goes high) | AST - C (high, goes low, stays low) | AST - D (high, stays high) |
---|
Buprenorphine/Nx | 278 | 41 | 4 | 17 | 291 | 37 | 3 | 9 |
,Methadone | 318 | 62 | 1 | 10 | 328 | 54 | 1 | 8 |
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Time to Stable Pain Management
"For each subject, time to stable pain management is defined as the first (post-baseline) time during the titration period when his/her diary pain was 4 or less (or at least 2 points lower than baseline) for 3 consecutive daily records or the pain on the average (at the day 7 or day 21 visit) was 4 or less (or at least 2 points lower than baseline)." (NCT00315445)
Timeframe: Start of study to day 21.
Intervention | Days (Median) |
---|
Placebo | 14 |
OXY/APAP | 7 |
BTDS | 7 |
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"Bodily Pain (MOS SF-36): Mean Percent at Day 84 (LOCF)"
"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Bodily Pain is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed." (NCT00315445)
Timeframe: Day 84
Intervention | Units on a scale (Mean) |
---|
Placebo | 35.3 |
OXY/APAP | 39.0 |
BTDS | 41.9 |
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"Emotional Role (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"
"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Emotional Role is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic." (NCT00315445)
Timeframe: Day 84
Intervention | Units on a scale (Mean) |
---|
Placebo | 55.3 |
OXY/APAP | 56.3 |
BTDS | 63.0 |
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"General Health (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"
"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. General Health is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at clinic. The mean scores were analyzed." (NCT00315445)
Timeframe: Day 84
Intervention | Units on a scale (Mean) |
---|
Placebo | 52.4 |
OXY/APAP | 52.5 |
BTDS | 57.7 |
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"Mental Health (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF)"
"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Mental Health is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic." (NCT00315445)
Timeframe: Day 84
Intervention | Units on a scale (Mean) |
---|
Placebo | 67.4 |
OXY/APAP | 68.8 |
BTDS | 67.8 |
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"Physical Functioning Scale of the Medical Outcomes Survey (MOS) 36 Item Short-Form Health Survey (SF-36): Mean Percent ± Standard Error of the Mean (SEM) at Day 84 (LOCF)"
"The Medical Outcomes Survey (MOS) Short-Form-36 Health Survey (SF-36) assesses 8 categories of functionality through 36 individual questions. Physical Functioning is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed." (NCT00315445)
Timeframe: Day 84, or, if applicable, at early termination
Intervention | Units on a scale (Mean) |
---|
Placebo | 46.4 |
OXY/APAP | 44.5 |
BTDS | 46.5 |
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"Physical Role Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF)"
"The Medical Outcomes Survey Short-Form-36 health survey assesses 8 categories of functionality through 36 individual questions. Physical Role is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed." (NCT00315445)
Timeframe: Day 84
Intervention | Units on a scale (Mean) |
---|
Placebo | 18.9 |
OXY/APAP | 24.4 |
BTDS | 33.9 |
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"Sensitivity Analysis: Pain on the Average Change From Baseline in the Maintenance Period (Days 21 - 84) Baseline Observation Carried Forward (BOCF)"
"Subjects were asked, Please rate your pain by circling the one number (0-10) that best describes your pain on the average since your last visit. 0 = no pain and 10 = pain as bad as you can imagine it." (NCT00315445)
Timeframe: Baseline to days 21 - 84
Intervention | Units on a scale (Least Squares Mean) |
---|
Placebo | -0.77 |
OXY/APAP | -1.70 |
BTDS | -1.74 |
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"Sensitivity Analysis: Pain on the Average Change From Baseline to End of Treatment (Day 84) (Hybrid BOCF/LOCF)"
"Subjects were asked, Please rate your pain by circling the one number (0-10) that best describes your pain on the average since your last visit. 0 = no pain and 10 = pain as bad as you can imagine it.~This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd due to AE, the baseline observation was carried forward (ie, BOCF method of imputation). If subject D/C'd other than for an AE, the last missing data prior to D/C of study drug was carried forward (ie, LOCF method of imputation)." (NCT00315445)
Timeframe: Baseline to day 84
Intervention | Units on a scale (Least Squares Mean) |
---|
Placebo | -1.44 |
OXY/APAP | -1.47 |
BTDS | -1.70 |
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"Sensitivity Analysis: Pain Right Now Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF)"
"Subjects were asked, Please rate your pain by circling the one number (0-10) that tells how much pain you have right now. Subjects rated their answers on a 0-10 ordinal scale from 0 = No pain to 10 = Pain as bad as you can imagine it.~This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd from study due to AE, the baseline observation was carried forward (BOCF). If subject D/C'd from study other than for AE, the last missing data prior to D/C of study drug was carried forward (LOCF)." (NCT00315445)
Timeframe: Baseline to days 21-84
Intervention | Units on a scale (Least Squares Mean) |
---|
Placebo | -0.78 |
OXY/APAP | -1.60 |
BTDS | -1.59 |
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"Sensitivity Analysis: Pain Right Now Change From Baseline in the Maintenance Period (Days 21-84), BOCF"
"Subjects were asked, Please rate your pain by circling the one number (0-10) that tells how much pain you have right now. Subjects rated their answers on a 0-10 ordinal scale from 0 = No pain to 10 = Pain as bad as you can imagine it. Primary back pain was measured." (NCT00315445)
Timeframe: Baseline to days 21-84
Intervention | Units on a scale (Least Squares Mean) |
---|
Placebo | -0.53 |
OXY/APAP | -1.46 |
BTDS | -1.64 |
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Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF)
"The therapeutic response was rated by the subject. The assessment was completed by the subject using a 0-3 ordinal scale from 0 = No response to 3 = Marked response." (NCT00315445)
Timeframe: Day 84
Intervention | Units on a scale (Mean) |
---|
Placebo | 1.1 |
OXY/APAP | 2.1 |
BTDS | 2.0 |
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Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF)
"The therapeutic response was rated by the investigator. The assessment was completed by the investigator using a 0-3 ordinal scale from 0 = No response to 3 = Marked response." (NCT00315445)
Timeframe: Day 84
Intervention | Units on a scale (Mean) |
---|
Placebo | 1.1 |
OXY/APAP | 2.0 |
BTDS | 1.9 |
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Pain Right Now, Mean Change From Baseline, Days 21-84 (LOCF)
"Subjects were asked, Please rate your pain by circling the one number (0-10) that tells how much pain you have right now. Subjects rated their answers on a 0-10 ordinal scale from 0 = No pain to 10 = Pain as bad as you can imagine it. Pain right now is presented as the LSmean [change from baseline] (SE)." (NCT00315445)
Timeframe: Assessed at baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.
Intervention | Units on a scale (Least Squares Mean) |
---|
Placebo | -0.80 |
OXY/APAP | -1.53 |
BTDS | -1.66 |
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Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF])
"Subjects were asked, Please rate your pain by circling the one number (0-10) that best describes your pain on the average since your last visit. 0 = no pain and 10 = pain as bad as you can imagine it." (NCT00315445)
Timeframe: On baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.
Intervention | Units on a scale (Least Squares Mean) |
---|
Placebo | -1.01 |
OXY/APAP | -1.82 |
BTDS | -1.92 |
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"Vitality (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"
"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Vitality is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed." (NCT00315445)
Timeframe: Day 84
Intervention | Units on a scale (Mean) |
---|
Placebo | 39.0 |
OXY/APAP | 42.9 |
BTDS | 41.2 |
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"Sensitivity Analysis Pain on the Average Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF)"
"Subjects were asked, Please rate your pain by circling the one number (0-10) that best describes your pain on the average since your last visit. 0 = no pain and 10 = pain as bad as you can imagine it.~This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd due to AE, the baseline observation was carried forward (ie, BOCF method of imputation). If subject D/C'd other than for an AE, the last missing data prior to D/C of study drug was carried forward (ie, LOCF method of imputation)." (NCT00315445)
Timeframe: Baseline to days 21-84
Intervention | Units on a scale (Least Squares Mean) |
---|
Placebo | -0.91 |
OXY/APAP | -1.77 |
BTDS | -1.86 |
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The Time to Discontinuation Due to Lack of Efficacy
Dropouts due to various reasons were summarized by counts and percentage. Cox proportional hazards regression was used to assess the treatment differences in time to dropout due to lack of efficacy. Clinically important covariates (including gender, age, race, weight, baseline pain, and previous opioid use) were incorporated into the model when statistically significant at P< .10, using a backward elimination procedure. (NCT00315445)
Timeframe: Time after dosing to dropout due to lack of efficacy
Intervention | Days (Median) |
---|
Placebo | NA |
OXY/APAP | NA |
BTDS | NA |
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"Social Functioning (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"
"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Social Functioning is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic." (NCT00315445)
Timeframe: Day 84
Intervention | Units on a scale (Mean) |
---|
Placebo | 53.3 |
OXY/APAP | 59.5 |
BTDS | 65.2 |
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Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF)
"The subject compared study drug treatment to prestudy analgesic. The assessment was completed by the subject using a 0-2 ordinal scale from 0 = Worse than prestudy medicine to 2 = Better than prestudy medicine." (NCT00315445)
Timeframe: Day 84
Intervention | Units on a scale (Mean) |
---|
Placebo | 0.9 |
OXY/APAP | 1.4 |
BTDS | 1.4 |
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Subject Satisfaction: Mean ± SEM (Day 84)(LOCF)
"The subject assessed satisfaction with study drug. The assessment was completed by the subject using a 0-3 ordinal scale from 0 = No response to 3 = Marked response." (NCT00315445)
Timeframe: Day 84
Intervention | Units on a scale (Mean) |
---|
Placebo | 2.2 |
OXY/APAP | 1.8 |
BTDS | 1.7 |
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"Sensitivity Analysis: Pain Right Now Change From Baseline to End of Treatment (Day 84) (Hybrid BOCF/LOCF)"
"Subjects were asked, Please rate your pain by circling the one number (0-10) that tells how much pain you have right now. Subjects rated their answers on a 0-10 ordinal scale from 0 = No pain to 10 = Pain as bad as you can imagine it.~This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd from study due to AE, the baseline observation was carried forward (BOCF). If subject D/C'd from study other than for AE, the last missing data prior to D/C of study drug was carried forward (LOCF)." (NCT00315445)
Timeframe: Baseline to day 84
Intervention | Units on a scale (Least Squares Mean) |
---|
Placebo | -1.30 |
OXY/APAP | -1.56 |
BTDS | -1.50 |
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Number of Participants With Adverse Events (AEs) as a Measure of Safety
For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase. (NCT00315458)
Timeframe: 483 days
Intervention | participants (Number) |
---|
| Death | Serious adverse events | All Other Adverse Events in ≥ 4.5% of Subjects |
---|
Double-blind BTDS | 1 | 2 | 22 |
,Double-blind Placebo | 0 | 1 | 14 |
,Overall BTDS Exposure | 1 | 5 | 82 |
,Run-in Period | 0 | 1 | 60 |
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The Number of Participants With Adverse Events (AEs) as a Measure of Safety.
Safety assessments included monitoring and recording of all adverse events and serious adverse events (SAEs). (NCT00320801)
Timeframe: Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase)
Intervention | Participants (Number) |
---|
| Deaths | Serious adverse events | Other Adverse Events in ≥ 4.5% of subjects |
---|
Double-blind BTDS 20 | 0 | 1 | 22 |
,Double-blind BTDS 5 | 0 | 1 | 17 |
,Overall BTDS Exposure | 0 | 6 | 101 |
,Run-in Period | 0 | 2 | 52 |
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Average Daily Pain Scores - BS11 Pain Scores.
The primary efficacy variable was the average daily pain score recorded on a Box Scale-11 pain scale in the evening. 0 = no pain and 10 = most pain imaginable. Subjects ticked the box from 0 - 10 which best describes their level of pain. (NCT00324038)
Timeframe: every day over a 12 week study duration.
Intervention | Box Scale 11 boxes (Mean) |
---|
Buprenorphine Transdermal System | 3 |
Co-codamol Tablets | 3 |
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Number of Participants With Adverse Events (AEs) as a Measure of Safety
Adverse Events that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved. (NCT00403234)
Timeframe: From signed informed consent to 7 days after end of study (approx. 35 days)
Intervention | participants (Number) |
---|
| Deaths | Serious Adverse Events | All Other Adverse Events in ≥ 4.5% of subjects |
---|
BTDS 10 | 0 | 0 | 2 |
,BTDS 20 | 0 | 0 | 3 |
,BTDS 30 | 0 | 0 | 2 |
,Placebo | 0 | 0 | 2 |
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Physiologic Effects as Assessed by Oxygen Saturation
(NCT00460239)
Timeframe: Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)
Intervention | percentage of saturated hemoglobin (Mean) |
---|
Placebo 0 mg | 97.81 |
Morphine 15 mg | 97.57 |
Morphine 30 mg | 97.15 |
Buprenorphine 8 mg | 96.94 |
Buprenorphine 16 mg | 96.73 |
Buprenorphine 32 mg | 96.37 |
Buprenorphine 48 mg | 96.75 |
Buprenorphine 60 mg | 96.49 |
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Physiologic Effects as Assessed by Heart Rate
(NCT00460239)
Timeframe: Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)
Intervention | beats/min (Mean) |
---|
Placebo 0 mg | 70.44 |
Morphine 15 mg | 70.56 |
Morphine 30 mg | 69.80 |
Buprenorphine 8 mg | 71.22 |
Buprenorphine 16 mg | 69.41 |
Buprenorphine 32 mg | 66.44 |
Buprenorphine 48 mg | 69.06 |
Buprenorphine 60 mg | 67.51 |
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Physiologic Effects as Assessed by Body Temperature
(NCT00460239)
Timeframe: Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)
Intervention | Degrees Fahrenheit (Mean) |
---|
Placebo 0 mg | 85.99 |
Morphine 15 mg | 87.43 |
Morphine 30 mg | 89.20 |
Buprenorphine 8 mg | 89.76 |
Buprenorphine 16 mg | 90.33 |
Buprenorphine 32 mg | 89.11 |
Buprenorphine 48 mg | 90.22 |
Buprenorphine 60 mg | 90.62 |
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Peak Change From Baseline in Drug Effect Assessed by Visual Analog Scale (VAS)
Opioid agonist effects measured by peak change from baseline drug effect visual analog scale. Scores range from 0 (not all all) to 100 (extremely); higher scores indicate a stronger drug effect. (NCT00460239)
Timeframe: Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)
Intervention | units on a scale (Mean) |
---|
Placebo 0 mg | 17.75 |
Morphine 15 mg | 27.25 |
Morphine 30 mg | 29.63 |
Buprenorphine 8 mg | 58.25 |
Buprenorphine 16 mg | 48.50 |
Buprenorphine 32 mg | 40.25 |
Buprenorphine 48 mg | 57.63 |
Buprenorphine 60 mg | 41.63 |
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Physiologic Effects as Assessed by Blood Pressure
(NCT00460239)
Timeframe: Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)
Intervention | mmHg (Mean) |
---|
| Systolic Blood Pressure | Diastolic Blood Pressure |
---|
Buprenorphine 16 mg | 111.42 | 61.82 |
,Buprenorphine 32 mg | 114.11 | 62.60 |
,Buprenorphine 48 mg | 119.18 | 65.73 |
,Buprenorphine 60 mg | 116.77 | 64.39 |
,Buprenorphine 8 mg | 118.59 | 67.35 |
,Morphine 15 mg | 114.71 | 64.92 |
,Morphine 30 mg | 119.21 | 66.72 |
,Placebo 0 mg | 114.11 | 63.85 |
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Physiologic Effects as Assessed by Pupil Diameter
(NCT00460239)
Timeframe: Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)
Intervention | millimeters (Mean) |
---|
Placebo 0 mg | 4.00 |
Morphine 15 mg | 3.33 |
Morphine 30 mg | 2.74 |
Buprenorphine 8 mg | 2.87 |
Buprenorphine 16 mg | 2.73 |
Buprenorphine 32 mg | 2.63 |
Buprenorphine 48 mg | 2.61 |
Buprenorphine 60 mg | 2.64 |
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Area Under the Curve of BUP/NLX With TPV/r (h*ng/mL)
Non-compartmental methods were used for pharmacokinetic analysis. The area under the plasma drug concentration-time curve was estimated by linear-log trapezoidal rule at 24-hrs. (NCT00486330)
Timeframe: 10 days
Intervention | h*ng/mL (Geometric Mean) |
---|
Tipranavir/Ritonavir (500mg/200mg) | 43.7 |
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Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase.
Pain was assessed on an 11-point numerical scale ranging from 0 = no pain to 10 = pain as bad as you can imagine. (NCT00490919)
Timeframe: Prerandomization phase consisted of a 6-10 day screening period and a <27 day open-label run-in period; and a 12-week double-blind phase.
Intervention | Units on a scale (Mean) |
---|
| Screening | Prerandomization | Week 12 - Primary outcome |
---|
Double-blind BTDS | 7.24 | 2.57 | 3.83 |
,Double-blind Placebo TDS | 7.17 | 2.56 | 4.38 |
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The Sleep Disturbance Subscale in the Medical Outcome Study (MOS) Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase
The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 and Questions 2 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance. (NCT00490919)
Timeframe: Weeks 4, 8, 12 of double-blind phase
Intervention | Units on a scale (Mean) |
---|
| Week 4 | Week 8 | Week 12 |
---|
Double-blind BTDS | 32.84 | 35.63 | 34.97 |
,Double-blind Placebo TDS | 41.20 | 39.87 | 40.42 |
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The Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Medications Taken During Weeks 2 Through 12 of the Double-blind Phase
Nonopioid supplemental analgesic tablets were sponsor-supplied acetaminophen or ibuprofen. (NCT00490919)
Timeframe: weeks 2-12
Intervention | tablets (Mean) |
---|
Double-blind BTDS | 0.620 |
Double-blind Placebo TDS | 0.743 |
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Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Used From Week 2 to 12 of the Double-blind Phase.
Subjects were permitted to take sponsor-provided supplemental analgesic medication after week 1 of the double-blind treatment (acetaminophen or ibuprofen). (NCT00531427)
Timeframe: 10 weeks
Intervention | tablets (Mean) |
---|
Double-blind BTDS 10 or 20 | 0.701 |
Double-blind Placebo | 0.740 |
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"Average Pain Over the Last 24 Hours Score of the Study Knee at Week 12 of the Double Blind Phase."
"Average pain over the last 24 hours scores of the study knee at week 12 was evaluated on an 11-point scale: 0 = no pain, 10 = worst pain imaginable, recorded daily." (NCT00531427)
Timeframe: 24 hours (week 12)
Intervention | units on a scale (Mean) |
---|
| Screening (Visit 2) | Prerandomization (Visit 3) | Double-blind Week 12 (Visit 8) |
---|
Double-blind BTDS 10 or 20 | 7.16 | 2.63 | 3.82 |
,Double-blind Placebo | 7.06 | 2.74 | 4.22 |
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Sleep Disturbance Subscale of the MOS-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase.
The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 ( 1 = 0-15 min to more than 60 min) and Questions 2 to 12 are scored on a scale of 1 to 6 (1 = all of the time to 6 = none of the time. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7, and 8 and ranges from 0 to 100, where higher scores indicate greater sleep disturbance. (NCT00531427)
Timeframe: Weeks 4, 8, and 12 of the double-bind phase
Intervention | units on a scale (Mean) |
---|
| Screening | Prerandomization | Week 4 | Week 8 | Week 12 |
---|
Double-blind BTDS 10 or 20 | 49.51 | 23.23 | 27.22 | 27.46 | 29.60 |
,Double-blind Placebo | 51.23 | 26.04 | 35.08 | 34.78 | 33.63 |
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Number of Participants With Better Overall Quality of Life at Six Months as Compared to Baseline.
Qualitative measure (better/no change/worse) of participant's perception of overall quality of life related to assigned study protocol arm. (NCT00552578)
Timeframe: Baseline and six months
Intervention | Participants (Number) |
---|
Tapering Doses of Buprenorphine | 4 |
Steady Dose of Buprenorphine | 4 |
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Relapse to Substance Abuse
Relapse to substance abuse (yes/no) was determined by participant self-report or by a positive urine toxicology. (NCT00552578)
Timeframe: Six months
Intervention | participants (Number) |
---|
Tapering Doses of Buprenorphine | 2 |
Steady Dose of Buprenorphine | 4 |
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Treatment Retention.
"Treatment retention was defined as the completion of the buprenorphine dosing protocol (i.e., tapering doses vs. steady doses)." (NCT00552578)
Timeframe: Six months
Intervention | Participants (Number) |
---|
Tapering Doses of Buprenorphine | 0 |
Steady Dose of Buprenorphine | 5 |
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Proportion of Patients Protectively Transferred
>= 2 consecutive weeks of daily illicit opioid use and opioid positive urine samples after completion of the first 6 weeks of the study (NCT00555425)
Timeframe: 18 weeks
Intervention | participants (Number) |
---|
Taper Condition | 16 |
Maintenance Condition | 3 |
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Illicit Opioid Use
Urinalysis based on scheduled weekly urine screenings during treatment period (NCT00555425)
Timeframe: 18 weeks
Intervention | percent of opioid negative urine samples (Mean) |
---|
Taper Condition | 35.2 |
Maintenance Condition | 53.2 |
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Reduction in Cocaine Use
As measured by the percent of provided urines positive for cocaine (NCT00555425)
Timeframe: 18 weeks
Intervention | percent of cocaine positive urines (Mean) |
---|
Taper Condition | 11.5 |
Maintenance Condition | 11.1 |
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Patient Satisfaction
Patient satisfaction as measured by survey. Primary Care Buprenorphine Satisfaction Scale (PCBSS). Comprises of 19 items evaluating satisfaction with staff expertise, concern, and responsiveness. Range of scores from 15-95. I higher score indicates greater satisfaction. (NCT00555425)
Timeframe: 18 weeks
Intervention | units on a scale (Mean) |
---|
Taper Condition | 78.7 |
Maintenance Condition | 79.9 |
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Retention in Treatment
Mean number of days from randomization to last clinical contact (NCT00555425)
Timeframe: 18 weeks
Intervention | number of days (Mean) |
---|
Taper Condition | 57.5 |
Maintenance Condition | 98.7 |
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Changes in HIV Risk
"As measured by the AIDS Risk Inventory. The AIDS Risk Inventory (ARI) is a 166 item structured interview that assesses the number and frequency of drug-related and sexual risk behaviors in the preceding 3 months. Calculation of the ARI total score is based on the frequency of occurrence of a given behavior and on the recency of this behavior, with recency being weighted more than a life-time occurrence of the same behavior. Higher values are associated with greater risk of HIV transmission (worse).~There are 10 subscales comprised of between 8 and 24 items. Subscales scores are based on the sum of the individual items and the overall ARI total score is the sum of the subscales.~Scores can range from 0 to 350, although among opioid dependent patients most values are below 100 with means between 50 and 60 depending on characteristics of the patients and treatment status." (NCT00555425)
Timeframe: Baseline and 18 weeks
Intervention | units on a scale (Mean) |
---|
| Baseline | 18 weeks |
---|
Maintenance Condition | 67.6 | 74.4 |
,Taper Condition | 66.7 | 74.5 |
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Health Status
Measured by the SF-36 overall transformed measure. In the SF-36 all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. (NCT00555425)
Timeframe: 18 weeks
Intervention | units on a scale (Mean) |
---|
| Baseline | In-Treatment |
---|
Maintenance Condition | 67.6 | 66.6 |
,Taper Condition | 67.2 | 68.7 |
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Buprenorphine Area Under the Curve With LPV/r (ng/mL*hr)
Pharmacokinetic parameters were determined by use of non compartmental methods. The area under the plasma concentration versus time curve was determined by use of the trapezoidal rule and measured over a 24-hr time period. (NCT00571961)
Timeframe: 15 days
Intervention | (ng/mL)*hr (Mean) |
---|
Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg | 46.2 |
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Number of Days of Heroin Use
mean days used heroin during the past 30 days (NCT00574067)
Timeframe: 1 year
Intervention | days (Mean) |
---|
Bup+OTP | 6.0 |
Bup+CHC | 6.4 |
Counseling+OTP | 6.5 |
Counseling+CHC | 4.0 |
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Number of Days of Cocaine Use
Number of days used cocaine during the past 30 days. (NCT00574067)
Timeframe: 1 year
Intervention | days (Mean) |
---|
Bup+OTP | 1.1 |
Bup+CHC | 4.1 |
Counseling+OTP | 4.7 |
Counseling+CHC | 2.7 |
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Drug Abuse Treatment Entry and Retention in the Community
entered community treatment within 10 days of release from prison (yes vs. no) (NCT00574067)
Timeframe: 1 year
Intervention | participants (Number) |
---|
B+OTP | 22 |
B+CHC | 26 |
C+OTP | 23 |
C+CHC | 11 |
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Criminal Activity
Days of crime during the past 30 days (NCT00574067)
Timeframe: 1 year
Intervention | days (Mean) |
---|
Bup+OTP | 3.4 |
Bup+CHC | 5.4 |
Counseling+OTP | 3.3 |
Counseling+CHC | 3.2 |
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Employment Status
Number of days employed during the past year (NCT00574067)
Timeframe: 1 year
Intervention | days (Mean) |
---|
B+OTP | 30.0 |
B+CHC | 29.6 |
C+OTP | 22.3 |
C+CHC | 31.4 |
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HIV Risk Behavior
Number of times had sex without using a condom during the past year (NCT00574067)
Timeframe: 1 year
Intervention | times (Mean) |
---|
B+OTP | 59.7 |
B+CHC | 36.1 |
C+OTP | 33.3 |
C+CHC | 50.4 |
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HIV Risk Behavior Needle Sharing
Number of times shared a needle during the past year (NCT00574067)
Timeframe: 1 year
Intervention | times (Mean) |
---|
B+OTP | 2.9 |
B+CHC | .1 |
C+OTP | 2.1 |
C+CHC | .1 |
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Self-reported Opioid Withdrawal Symptoms (SOWS)
SOWS were 16 items whose intensity was scored on a scale from 0 (not at all) to 4 (extremely) for a maximum possible score of 64. A total score of 0 represented the best outcome and a score of 64 represented the worst outcome. Participants were scored for SOWS at baseline (prior to randomization) and on Day 28. Reported are the scores for Day 28, and the change in scores from baseline to Day 28. (NCT00604188)
Timeframe: Baseline and 28 days
Intervention | Score on a scale (Mean) |
---|
| Score on Day 28 | Change from Baseline to Day 28 |
---|
Direct Suboxone Induction | 3.8 | -23.3 |
,Subutex-to-Suboxone Induction | 3.4 | -21.9 |
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Responders at Day 3
"Responders included the number of participants who received the scheduled dose of Suboxone at the Day 3 study visit. Participants who discontinued the study at Day 3 were considered non-responders.~All participants that continued the study received Suboxone tablets on Day 3." (NCT00604188)
Timeframe: 3 days
Intervention | Participants (Number) |
---|
| Responders | Non responders |
---|
Direct Suboxone Induction | 85 | 8 |
,Subutex-to-Suboxone Induction | 85 | 9 |
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Responders at Day 28
Responders were the number of participants in each group who received the scheduled 8- to 24-mg dose of Suboxone at study visit day. A participant who discontinued from the study was treated as a non-responder at the timepoint after the participant discontinued. (NCT00604188)
Timeframe: 28 days
Intervention | Participants (Number) |
---|
| Responder | Non-responder |
---|
Direct Suboxone Induction | 46 | 47 |
,Subutex-to-Suboxone Induction | 55 | 39 |
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Observer-rated Opioid Withdrawal Symptoms (OOWS)
The OOWS were 13 physically observable signs that were present (scored 1) or absent (scored 0). A total score of 0 represented the best outcome and a total score of 13 represented the worst outcome. Participants were scored for OOWS at baseline (prior to randomization) and on Day 28. Reported are the total score for Day 28, and the change in scores from baseline to Day 28. (NCT00604188)
Timeframe: Baseline and 28 days
Intervention | Score on a scale (Mean) |
---|
| OOWS Score on Day 28 | Change from Baseline |
---|
Direct Suboxone Induction | 0.6 | -5.9 |
,Subutex-to-Suboxone Induction | 0.5 | -5.9 |
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Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS)
Number of participants who tested negative on UDS during open-label phase on Day 28. The drugs screened on Day 28 included amphetamines, methamphetamines, cocaine, morphine, methadone, benzodiazepines, and tetrahydrocannabinol. Buprenorphine was only tested at screening and randomization according to protocol, therefore no values for buprenorphine are available for Day 28. (NCT00604188)
Timeframe: 28 days
Intervention | Participants (Number) |
---|
| Tetrahydrocannabinol | Cocaine | Amphetamines | Benzodiazepines | Methamphetamines | Morphine | Methadone | Buprenorphine |
---|
Direct Suboxone Induction | 65 | 70 | 77 | 59 | 79 | 66 | 76 | NA |
,Subutex-to-Suboxone Induction | 59 | 69 | 81 | 64 | 80 | 67 | 81 | NA |
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Illicit Opioid and Non-opioid Drug Use: Substance Use Inventory (SUI)
Number of participants with intravenous use of drug as measured by self-reported SUI from Days 3-28. The SUI form consisted of questions addressing the number of days and times a drug was used, and the route of drug use. For suboxone the use of scheduled study medication was not considered illicit use. (NCT00604188)
Timeframe: Days 3 to 28
Intervention | Participants (Number) |
---|
| Subutex - Non prescription source | Suboxone - Non prescription source | Suboxone - Illicit use from study supplies | Heroin | Other opioids | Methadone | Methamphetamine | Cocaine | Benzodiazepines/Tranquilizers |
---|
Direct Suboxone Induction | 0 | 0 | 0 | 12 | 0 | 0 | 0 | 2 | 0 |
,Subutex-to-Suboxone Induction | 0 | 0 | 0 | 14 | 0 | 0 | 0 | 4 | 0 |
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Compliance Rate
Compliance rate was calculated as the number of days study medication was taken divided by the number of days study medication should have been taken X 100. The number of days study medication should have been taken was equal to the duration of treatment. (NCT00604188)
Timeframe: 28 days
Intervention | Percentage of days (Mean) |
---|
Direct Suboxone Induction | 98.7 |
Subutex-to-Suboxone Induction | 98.4 |
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Response Rate
Response rate was defined as the percentage of participants who did not receive a dose increase from the dose given at the first dosing date by Day 7 of a one-week, randomized, double-blind, double-dummy treatment transfer phase. (NCT00605033)
Timeframe: Assessed by Day 7 of double-blind, double-dummy treatment period.
Intervention | Percentage of participants (Number) |
---|
Suboxone | 83.2 |
Subutex | 88.7 |
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Pain Intensity
Pain intensity comprises the average of 4 items related to current pain and past-week average pain, pain at its worst, and pain at its least. Pain intensity is scored on 0-10 scale (average score ranges from 0-10), where higher scores indicate higher pain intensity.Originally labeled as Pain Reduction at 16 weeks- 3 months was the correct timeframe. (NCT00634803)
Timeframe: 3 months
Intervention | units on a scale (Mean) |
---|
| Intake/Induction | Month 1 | Month 2 | Month 3 |
---|
CBT for POD | 5.43 | 4.75 | 4.79 | 4.41 |
,Educational Counseling for POD | 5.92 | 5.02 | 4.98 | 4.62 |
,Physician Management | 5.28 | 4.53 | 4.72 | 4.84 |
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Pain Interference
Pain interference comprises the average of 7 items related to past-week pain-related interference in general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. Each item is scored on a 0-10 scale (averaged 0-10), where higher scores indicate higher pain interference. (NCT00634803)
Timeframe: 3 Months
Intervention | units on a scale (Mean) |
---|
| Intake/Induction | Month 1 | Month 2 | Month 3 |
---|
CBT for POD | 5.75 | 4.15 | 4.08 | 3.22 |
,Educational Counseling for POD | 5.48 | 3.74 | 3.61 | 3.23 |
,Physician Management | 5.01 | 3.32 | 3.45 | 3.87 |
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Number of Opioid-negative Urine Toxicology Tests
"Reduced illicit opioid use is defined as the number of documented opioid negative urine tests in each of the time periods.This measures the reduction in illicit opioid use - more opioid-negative tests means greater reductions in illicit opioid use. The highest possible score is 4- which would indicate 4 negative urine tests during the assessment period. Originally titled Reduced illicit opioid use and the timeframe was listed as 16 weeks." (NCT00634803)
Timeframe: 3 Months
Intervention | opioid negative urine tests (Mean) |
---|
| Intake/Induction | Month 1 | Month 2 | Month 3 |
---|
CBT for POD | 0.67 | 2.67 | 2.96 | 2.80 |
,Educational Counseling for POD | 0.67 | 2.80 | 3.30 | 3.25 |
,Physician Management | 0.55 | 2.48 | 2.56 | 2.04 |
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"Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: Does the Drug Have Any Bad Effects?"
"A visual analog scale (VAS) was used by participants to answer the subjective question, Does the drug have any bad effects?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no bad effects and 100=maximum bad effects." (NCT00637000)
Timeframe: End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5
Intervention | units on a scale (Mean) |
---|
| End of Induction | Peak Post Induction |
---|
Sublingual Buprenorphine Soluble Film | 0.0 | 0.4 |
,Sublingual Buprenorphine/Naloxone Soluble Film | 0.3 | 0.4 |
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Pupil Diameter Measurements At End of Induction (End of Day 2) and the Minimum Pupil Diameter During the Post Induction Period (Days 3-5)
Pupil diameter was measured at the end of induction (47.5 hours after the first administration of study intervention) and at intervals during the post-induction period (Days 3-5). Peak post induction measurement is the minimum pupil diameter recorded during days 3-5. (NCT00637000)
Timeframe: End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5
Intervention | mm (Mean) |
---|
| End of Induction | Peak Post Induction |
---|
Sublingual Buprenorphine Soluble Film | 5.3 | 4.1 |
,Sublingual Buprenorphine/Naloxone Soluble Film | 5.1 | 3.6 |
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"Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: Does the Drug Have Any Good Effects?"
"A visual analog scale (VAS) was used by participants to answer the subjective question, Do you feel any good effects?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no good effects and 100=maximum good effects." (NCT00637000)
Timeframe: Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1
Intervention | units on a scale (Mean) |
---|
| Baseline | Peak |
---|
Sublingual Buprenorphine Soluble Film | 0.0 | 62.3 |
,Sublingual Buprenorphine/Naloxone Soluble Film | 0.0 | 57.6 |
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"Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: Do You Like the Drug?"
"A visual analog scale (VAS) was used by participants to answer the subjective question, Do you like the drug?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no liking and 100=maximum liking." (NCT00637000)
Timeframe: End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5
Intervention | units on a scale (Mean) |
---|
| End of Induction | Peak Post Induction |
---|
Sublingual Buprenorphine Soluble Film | 14.9 | 61.7 |
,Sublingual Buprenorphine/Naloxone Soluble Film | 24.3 | 55.4 |
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Pupil Diameter Measurements at Baseline and the Minimum Pupil Diameter up to 23.5 Hours After the First Administration
Pupil diameter was measured at baseline and at intervals post drug administration on Day 1. Peak measurement is the minimum pupil diameter recorded from 15 minutes to 23.5 hours post administration of study intervention. (NCT00637000)
Timeframe: Baseline: 15 minutes prior to first administration on Day 1. Peak: 15 minutes - 23.5 hours post administration on Day 1
Intervention | mm (Mean) |
---|
| Baseline | Peak |
---|
Sublingual Buprenorphine Soluble Film | 6.24 | 4.39 |
,Sublingual Buprenorphine/Naloxone Soluble Film | 6.11 | 4.32 |
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"Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: Does the Drug Make You Sick?"
"A visual analog scale (VAS) was used by participants to answer the subjective question, Does the drug make you sick?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no effect and 100=maximum effect." (NCT00637000)
Timeframe: End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5
Intervention | units on a scale (Mean) |
---|
| End of Induction | Peak Post Induction |
---|
Sublingual Buprenorphine Soluble Film | 0 | 0 |
,Sublingual Buprenorphine/Naloxone Soluble Film | 0.3 | 0.7 |
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"CVisual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: Do You Like the Drug?"
"A visual analog scale (VAS) was used by participants to answer the subjective question, Do you like the drug?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no liking and 100=maximum liking." (NCT00637000)
Timeframe: Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1
Intervention | units on a scale (Mean) |
---|
| Baseline | Peak |
---|
Sublingual Buprenorphine Soluble Film | 0.0 | 61.2 |
,Sublingual Buprenorphine/Naloxone Soluble Film | 0.0 | 59.4 |
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"Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: Does the Drug Have Any Bad Effects?"
"A visual analog scale (VAS) was used by participants to answer the subjective question, Does the drug have any bad effects?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no bad effects and 100=maximum bad effects." (NCT00637000)
Timeframe: Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1
Intervention | units on a scale (Mean) |
---|
| Baseline | Peak |
---|
Sublingual Buprenorphine Soluble Film | 0.0 | 4.4 |
,Sublingual Buprenorphine/Naloxone Soluble Film | 12.5 | 6.1 |
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"Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: Does the Drug Make You Sick?"
"A visual analog scale (VAS) was used by participants to answer the subjective question, Does the drug make you sick?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no effect and 100=maximum effect." (NCT00637000)
Timeframe: Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1
Intervention | units on a scale (Mean) |
---|
| Baseline | Peak |
---|
Sublingual Buprenorphine Soluble Film | 0.0 | 2.1 |
,Sublingual Buprenorphine/Naloxone Soluble Film | 12.5 | 4.5 |
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"Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: How High Are You?"
"A visual analog scale (VAS) was used by participants to answer the subjective question, How high are you?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=not high and 100=extremely high.~The baseline VAS was the score obtained 30 minutes prior to administration of soluble films on Day 1. Peak VAS was the highest VAS score obtained between 1-23.5 hours post administration on Day 1." (NCT00637000)
Timeframe: Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1
Intervention | units on a scale (Mean) |
---|
| Baseline | Peak |
---|
Sublingual Buprenorphine Soluble Film | 0.0 | 5.8 |
,Sublingual Buprenorphine/Naloxone Soluble Film | 0.0 | 13.7 |
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"Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: Do You Feel Any Drug Effect?"
"A visual analog scale (VAS) was used by participants to answer the subjective question, Do you feel any drug effect?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no effect and 100=maximum effect." (NCT00637000)
Timeframe: End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5
Intervention | units on a scale (Mean) |
---|
| End of Induction | Peak Post Induction |
---|
Sublingual Buprenorphine Soluble Film | 7.9 | 53.2 |
,Sublingual Buprenorphine/Naloxone Soluble Film | 15.9 | 47.4 |
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"Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: Do You Feel Any Good Effects?"
"A visual analog scale (VAS) was used by participants to answer the subjective question, Do you feel any good effects?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no good effects and 100=maximum good effects." (NCT00637000)
Timeframe: End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5
Intervention | units on a scale (Mean) |
---|
| End of Induction | Peak Post Induction |
---|
Sublingual Buprenorphine Soluble Film | 11.0 | 61.7 |
,Sublingual Buprenorphine/Naloxone Soluble Film | 20.2 | 52.9 |
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"Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: Do You Feel Any Drug Effect?"
"A visual analog scale (VAS) was used by participants to answer the subjective question, Do you feel any drug effect?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no effect and 100=maximum effect." (NCT00637000)
Timeframe: Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1
Intervention | units on a scale (Mean) |
---|
| Baseline | Peak |
---|
Sublingual Buprenorphine Soluble Film | 0.0 | 44.3 |
,Sublingual Buprenorphine/Naloxone Soluble Film | 0.0 | 50.4 |
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Severity of Withdrawal Symptoms Measured Using the Clinical Opiate Withdrawal Scale (COWS) at the End of Induction and the Peak COWS Post Induction
"The COWS is an 11-item instrument used to assess symptoms of opioid withdrawal (Wesson et al., 1999). The score is the sum of the response to each of the 11 items and cover a range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderate/severe withdrawal, and 37-48 severe withdrawal.~The end of induction COWS was the score obtained 47.5 hours after first administration of soluble films on Day 1. Peak post induction COWS was the highest COWS score obtained on Days 2-5." (NCT00637000)
Timeframe: End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5
Intervention | units on a scale (Mean) |
---|
| End of Induction | Peak Post Induction |
---|
Sublingual Buprenorphine Soluble Film | 0.6 | 1.0 |
,Sublingual Buprenorphine/Naloxone Soluble Film | 1.0 | 2.6 |
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"Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: How High Are You?"
"A visual analog scale (VAS) was used by participants to answer the subjective question, How high are you?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=not high and 100=extremely high." (NCT00637000)
Timeframe: End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5
Intervention | units on a scale (Mean) |
---|
| End of Induction | Peak Post Induction |
---|
Sublingual Buprenorphine Soluble Film | 0.0 | 8.2 |
,Sublingual Buprenorphine/Naloxone Soluble Film | 6.3 | 12.9 |
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Pupil Diameter Measurements at Baseline and the Maximum Pupil Diameter up to 23.5 Hours After the First Administration
Pupil diameter was measured at baseline and at intervals post drug administration on Day 1. Peak measurement is the maximum pupil diameter recorded from 15 minutes to 23.5 hours post administration of study intervention. (NCT00637000)
Timeframe: Baseline: 15 minutes prior to first administration on Day 1. Peak: 15 minutes - 23.5 hours post administration on Day 1
Intervention | mm (Mean) |
---|
| Baseline | Peak |
---|
Sublingual Buprenorphine Soluble Film | 6.24 | 4.39 |
,Sublingual Buprenorphine/Naloxone Soluble Film | 6.11 | 5.99 |
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Severity of Withdrawal Symptoms Measured Using the Clinical Opiate Withdrawal Scale (COWS) at Baseline and the Peak COWS up to 23.5 Hours After the First Administration
"The COWS is an 11-item instrument used to assess symptoms of opioid withdrawal (Wesson et al., 1999). The score is the sum of the response to each of the 11 items and cover a range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderate/severe withdrawal, and 37-48 severe withdrawal.~The baseline COWS was the score obtained 30 minutes prior to administration of soluble films on Day 1. Peak COWS was the highest COWS score obtained between 1-23.5 hours post administration on Day 1." (NCT00637000)
Timeframe: Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1
Intervention | units on a scale (Mean) |
---|
| Baseline | Peak |
---|
Sublingual Buprenorphine Soluble Film | 9.1 | 4.2 |
,Sublingual Buprenorphine/Naloxone Soluble Film | 10.1 | 5.7 |
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Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)
"Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.~Severity was graded by the investigator as mild (grade 1), moderate (grade 2) and severe (grade 3)." (NCT00637000)
Timeframe: Day 1-6
Intervention | participants (Number) |
---|
| With any TEAE | With grade 1 TEAE | With grade 2 TEAE | With grade 3 TEAE |
---|
Sublingual Buprenorphine Soluble Film | 20 | 15 | 19 | 0 |
,Sublingual Buprenorphine/Naloxone Soluble Film | 18 | 16 | 16 | 0 |
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Number of Subjects With Mild, Moderate or Severe Treatment-emergent Adverse Events Associated With the Oral Cavity
Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment. (NCT00640835)
Timeframe: 12 weeks
Intervention | Participants (Number) |
---|
| Mild | Moderate | Severe |
---|
Buprenorphine/Naloxone Film Strip Administered Buccally | 12 | 3 | 1 |
,Buprenorphine/Naloxone Film Strip Administered Sublingually | 9 | 2 | 0 |
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Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity.
"Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment. Oral mucosa was graded as follows:~Grade 0: Normal mucosa Grade 1: Localized mucosal erythema and/or irritation without ulceration Grade 2: Erythema and/or irritation and induration without ulceration Grade 3: Ulceration, with or without any other combination of signs" (NCT00640835)
Timeframe: 12 weeks
Intervention | Participants (Number) |
---|
Buprenorphine/Naloxone Film Strip Administered Sublingually | 11 |
Buprenorphine/Naloxone Film Strip Administered Buccally | 16 |
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Subject's Self Assessment Using 10 cm Visual Analogue Scale (VAS) of Overall Preference for One of the Two Buprenorphine-based Maintenance Therapies (Suboxone® or Subutex®).
"Score of 0 = Not satisfied at all; Score of 10 = Totally satisfied" (NCT00684073)
Timeframe: Each treatment Day (post-dose on days 1-5)
Intervention | centimeters (Mean) |
---|
Day 1 (Subutex®) | 7.04 |
Day 2 (Subutex®) | 6.83 |
Day 3 (Suboxone®) | 7.38 |
Day 4 (Suboxone®) | 6.89 |
Day 5 (Suboxone®) | 7.12 |
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The Primary Outcome Will Include a Comparison of the Proportion of Patients Successfully Inducted One Week After the Initial Primary Care Visit.
The primary outcome will include a comparison of the proportion of patients successfully inducted one week after the initial primary care visit. Defined as in treatment, on Buprenorphine and withdrawal free. (NCT00684554)
Timeframe: one week after initial primary care visit
Intervention | participants (Number) |
---|
Unobserved-at Home | 6 |
Observed | 6 |
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Prolonged Withdrawal
participants experiencing prolonged withdrawal beyond two days after buprenorphine induction (NCT00684554)
Timeframe: a) 2 days
Intervention | participants (Number) |
---|
Unobserved-at Home | 3 |
Observed | 3 |
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Drug's Breakpoint
"Measure of a drug's reinforcing effects. The Breakpoint is the point at which the participant stop performing an operant task (clicks on a mouse) in order to received the drug. Therefore, the reported breakpoint is the total amount of work the participant was willing to perform to receive the dose being tested" (NCT00710385)
Timeframe: Single measurement taken following each of the 7 IV experimental doses
Intervention | number of clicks on a mouse (Mean) |
---|
Heroin | 1200 |
Naloxone | 10 |
Low Bup Dose | 1100 |
High Bup Dose | 1200 |
Lower Bup/Nal Dose | 300 |
High Bup/Nal Dose | 750 |
Placebo | 0 |
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"Drug Liking"
"Participant's subjective ratings of how much they Like the dose they just received on a scale of 0 -100." (NCT00710385)
Timeframe: Peak (highest) rating obtained following drug administration throughout the entire 3 hr session
Intervention | units on a scale (Mean) |
---|
Heroin | 41.5 |
Naloxone | 3 |
Low Bup Dose | 29.8 |
High Bup Dose | 42.5 |
Lower Bup/Nal Dose | 10.5 |
High Bup/Nal Dose | 27 |
Placebo | 1 |
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Number of Patients Reporting Clinical Consequences of Engaging in Misuse
Number of patients with clinical consequences (development or progression of: abscess, nutritional deficiency, dental problems, psychiatric problems including depression, sleep problems, schizophrenia, anxiety, phobias, hallucinations, delirium, withdrawal symptoms, inhibition, suicide attempts and other problems) at first, 6 month, and/or 12 month visit. (NCT00723697)
Timeframe: first visit, 6 months, and 12 months
Intervention | participants (Number) |
---|
| abscesses (n=1288/1134/1022) | nutritional deficiency (n=1288/1134/1022) | dental problems (n=1287/1133/1022) | psychiatric problems (n=1288/1133/1022) | depression (n=502/359/325) | schizophrenia (n=499/356/326) | sleep disturbances (n=500/360/327) | anxiety (n=500/360/326) | delirium/hallucinations (n=499/358/327) | autistic withdrawal, inhibition (n=500/357/326) | suicide attempts (n=499/357/326) | other psychiatric problems (n=487/355/326) |
---|
Patients at 12 Month Visit | 31 | 63 | 244 | 329 | 157 | 15 | 200 | 200 | 17 | 43 | 12 | 18 |
,Patients at 6 Month Visit | 29 | 65 | 293 | 364 | 174 | 15 | 228 | 222 | 21 | 50 | 14 | 14 |
,Patients at First Visit | 41 | 99 | 459 | 504 | 230 | 18 | 336 | 335 | 26 | 89 | 42 | 28 |
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Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents)
Number of patients who indicate misuse behaviours on self-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits. (NCT00723697)
Timeframe: first visit, 6 months, and 12 months
Intervention | participants (Number) |
---|
| Proper usage at all visits (no misuse) | Misuse at M12 only | Misuse at M6 only | Misuse at D1 only | Misuse at M6 and M12 only | Misuse at D1 and M12 only | Misuse at D1 and M6 only | Misuse at all visits | Missing Data |
---|
Patients | 131 | 20 | 15 | 38 | 19 | 24 | 34 | 151 | 448 |
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Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician.
Number of patients with misuse behaviours on physician-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits. (NCT00723697)
Timeframe: first visit, 6 months, and 12 months
Intervention | participants (Number) |
---|
| Proper usage at all visits (no misuse) | Misuse at M12 only | Misuse at M6 only | Misuse at D1 only | Misuse at M6 and M12 only | Misuse at D1 and M12 only | Misuse at D1 and M6 only | Misuse at all visits | Missing Data |
---|
Patients | 206 | 37 | 37 | 134 | 52 | 49 | 72 | 407 | 295 |
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Take Home Prescriptions of SUBOXONE®
"Circumstances of switching to SUBOXONE®: Analyze if the number of take home prescriptions of SUBOXONE®, reported by the treating physician, increase between day 1 and the final assessment.~Take Home prescription is defined as a prescription of up to 7 daily dosages SUBOXONE® from the treating physician which allows the patients to receive the prescribed amount of daily dosages SUBOXONE® from a pharmacy to take home and dispense the medication on his own on a daily basis.~A patient can receive only one take home prescription for up to 7 days at the time." (NCT00723749)
Timeframe: Day 1 and Final Assessment (month 12 or time of dropout)
Intervention | participants with take home prescription (Number) |
---|
| Frequency: Day 1 | Frequency: Final Assessment |
---|
Suboxone | 28 | 82 |
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Drug Craving (Subjective Effects of Therapy)
Circumstances of switching to SUBOXONE®: Analyse change of drug craving for opiates by using a 100mm visual analog scale (minimum: 0 = no craving; maximum: 100 = high craving) (NCT00723749)
Timeframe: Baseline and Final Assessment (month 12 or time of dropout)
Intervention | Units on a scale (Mean) |
---|
| Craving: Baseline | Craving: Final Assessment |
---|
Suboxone | 32.3 | 7.1 |
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Dosage of SUBOXONE®
Circumstances of switching to SUBOXONE®: Analyse induction and maintenance dose of SUBOXONE®. (NCT00723749)
Timeframe: Day 1 and Final Assessment (month 12 or time of dropout)
Intervention | mg daily dosage of Suboxone (Mean) |
---|
| Dosage: Day 1 | Dosage: Final Assessment |
---|
Suboxone | 9.2 | 7.7 |
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Retention Rate After 12 Months of Treatment With Suboxone
The primary aim of the SUBOXONE® NIS was to document the 12-month retention rate for at least N = 300 subjects with opioid dependence in a real-life scenario in at least N = 70 sites throughout Germany. (NCT00723749)
Timeframe: 12 months
Intervention | % of participants (Number) |
---|
Suboxone | 59.9 |
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Dosing of Suboxone (Buprenorphine Plus Naloxone)
One of the secondary objectives was to evaluate the effect of the switch to buprenorphine/naloxone on medication dispensing measured by dose. (NCT00725608)
Timeframe: day 1, month 6, month 12
Intervention | Dose of Suboxone® in mg (Mean) |
---|
| Suboxone® dose day 1 (mg) | Suboxone® dose month 6 (mg) | Suboxone® dose month 12 (mg) |
---|
Opioid Dependent Patients | 7.7 | 9.1 | 8.5 |
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Retention Rate
The primary objective of this study was to determine the retention rate of patients after 6 and 12 months of treatment with buprenorphine/naloxone measured by the percentage of patients remaining in the study (NCT00725608)
Timeframe: month 6, month 12
Intervention | percentage of patients (Number) |
---|
| Retention rate after 6 months of treatment | Retention rate after 12 months of treatment |
---|
Opioid Dependent Patients | 57.3 | 45.6 |
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Dispensing of Suboxone (Buprenorphine Plus Naloxone)
Another of the secondary objectives was to evaluate the effect of the switch to Suboxone (buprenorphine plus naloxone) on medication dispensing measured by frequency of visits to the treating physician or pharmacy to receive the medication (daily, biweekly, once weekly, monthly, other) (NCT00725608)
Timeframe: month 6, month 12
Intervention | Participants (Number) |
---|
| N patients with dispensing data at month 6 | 6 month: Daily | Month 6: Biweekly | Month 6: Once weekly | Month 6: Monthly | Month 6: Other | N patients with dispensing data at month 12 | Month 12: Daily | Month 12: Biweekly | Month 12: Once weekly | Month 12: Monthly | Month 12: Other |
---|
Opioid Dependent Patients | 183 | 96 | 1 | 79 | 2 | 5 | 142 | 68 | 1 | 63 | 1 | 9 |
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Opiate Positive Urines With Missing Urines Coded as Positive at Week 24.
Number of participants with positive opiate urine sample at the 24 week follow-up. (NCT00763958)
Timeframe: 24 weeks
Intervention | participants (Number) |
---|
Buprenorphine | 4 |
Placebo | 4 |
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Opiate Positive Urines With Missing Urines Coded as Positive at Week 12.
Number of participants with positive opiate urine samples at 12 weeks of treatment. (NCT00763958)
Timeframe: 12 weeks
Intervention | participants (Number) |
---|
Buprenorphine | 14 |
Placebo | 5 |
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Number of Participants Who Enroll in the Study.
To determine the number of participants who enroll in the study during the time of recruitment. (NCT00763958)
Timeframe: up to 24 months
Intervention | participants (Number) |
---|
Buprenorphine | 28 |
Placebo | 16 |
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Self-reported Illicit Opioid Use
(NCT00879996)
Timeframe: 6 months
Intervention | number of participants (Number) |
---|
Methadone | 0 |
Buprenorphine/Naloxone | 5 |
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Numerical Rating Score for Pain
Pain was measured using a 0-10 point numerical rating scale (NRS) with 0 representing no pain and 10 representing worst pain possible. (NCT00879996)
Timeframe: 6 months
Intervention | units on a 0-10 NRS scale (Mean) |
---|
Methadone | 5.4 |
Buprenorphine/Naloxone | 5.6 |
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Numerical Rating Score for Functioning
We assessed functioning measured on a 0-10 point numerical rating scale (NRS)with 0 being the least amount of functioning and 10 the best amount of functioning. (NCT00879996)
Timeframe: 6 months
Intervention | units on a 0-10 point NRS scale (Mean) |
---|
Methadone | 5.0 |
Buprenorphine/Naloxone | 5.3 |
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Number of Participants Retained in Treatment
This outcome assesses the number of participants who completed the treatment after 6 months. (NCT00879996)
Timeframe: 6 months
Intervention | participants (Number) |
---|
Methadone | 13 |
Buprenorphine/Naloxone | 13 |
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Days of Self-reported Illicit Opioid Use in the Past 7 Days
(NCT00913770)
Timeframe: 30 days post randomization
Intervention | Mean Number of Days (Mean) |
---|
Standard Care | 2.3 |
SBIRT | 2.4 |
SBI+Bup | 0.9 |
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Abstinence
Abstinence defined as the longest documented period of continuous abstinence from opioids and cocaine (NCT00929253)
Timeframe: 12 weeks
Intervention | days (Mean) |
---|
Computer Delivered CRA + CM + Suboxone | 55.0 |
CM + Suboxone | 49.5 |
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Peak Pain Relief
"Maximum pain relief (PAR) at any time following dosing, recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to How much relief have you had from your starting pain?" (NCT00941304)
Timeframe: 24 hours
Intervention | units on a scale (Mean) |
---|
0.25-mg Buprenorphine HCl Buccal Film, M2 | 1.5 |
0.5-mg Buprenorphine HCl Buccal Film, M2 | 1.8 |
0.5-mg Buprenorphine HCl Buccal Film, M1 | 1.9 |
Placebo | 1.1 |
Oxycodone 5 mg | 1.3 |
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Sum of Pain Intensity Difference From Baseline to 8 Hours
"Time-weighted sum of pain intensity difference from baseline to 8 hours (SPID-8) where total score ranges from -80 (worst) to 80 (best) and a higher value indicates greater pain relief. Pain intensity was recorded using an 11-point numeric rating scale (NRS), where 0=none and 10=worst pain imaginable, in response to What is your pain level at this time?" (NCT00941304)
Timeframe: Baseline, 8 hours
Intervention | units on a scale (Mean) |
---|
0.25-mg Buprenorphine HCl Buccal Film, M2 | 6.016 |
0.5-mg Buprenorphine HCl Buccal Film, M2 | 11.867 |
0.5-mg Buprenorphine HCl Buccal Film, M1 | 11.282 |
Placebo | 5.283 |
Oxycodone 5 mg | 4.290 |
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Sum of Pain Relief and Intensity Differences Over 2 Hours
"Time-weighted sum of PAR and PID over 2 hours (SPRID-2) where total score ranges from 0 (worst) to 8 (best) and higher values indicate greater pain relief. PAR was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to How much relief have you had from your starting pain? PID determined as the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to What is your pain level at this time?" (NCT00941304)
Timeframe: 2 hours
Intervention | units on a scale (Mean) |
---|
0.25-mg Buprenorphine HCl Buccal Film, M2 | 0.339 |
0.5-mg Buprenorphine HCl Buccal Film, M2 | 1.533 |
0.5-mg Buprenorphine HCl Buccal Film, M1 | 1.056 |
Placebo | 0.850 |
Oxycodone 5 mg | 1.484 |
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Sum of Pain Relief and Intensity Differences Over 8 Hours
"Time-weighted sum of PAR and pain intensity difference (PID) over 8 hours (SPRID-8) where total score ranges from -80 (worst) to 112 (best) and higher values indicate greater pain relief. PAR was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to How much relief have you had from your starting pain? PID determined as the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to What is your pain level at this time?" (NCT00941304)
Timeframe: 8 hours
Intervention | units on a scale (Mean) |
---|
0.25-mg Buprenorphine HCl Buccal Film, M2 | 13.290 |
0.5-mg Buprenorphine HCl Buccal Film, M2 | 21.725 |
0.5-mg Buprenorphine HCl Buccal Film, M1 | 21.782 |
Placebo | 11.675 |
Oxycodone 5 mg | 10.532 |
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Total Pain Relief Over 8 Hours
"Time-weighted sum of total pain relief over 8 hours (TOPAR-8) where total score ranges from 0 (worst) to 32 (best) and higher values indicate greater pain relief. Pain relief (PAR) was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to How much relief have you had from your starting pain?" (NCT00941304)
Timeframe: 8 hours
Intervention | units on a scale (Mean) |
---|
0.25-mg Buprenorphine HCl Buccal Film, M2 | 7.274 |
0.5-mg Buprenorphine HCl Buccal Film, M2 | 9.858 |
0.5-mg Buprenorphine HCl Buccal Film, M1 | 10.500 |
Placebo | 6.392 |
Oxycodone 5 mg | 6.242 |
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Change From Baseline in Cognitive Assessment Using CNS-VS
"Cognition assessed using computer-based CNS Vital Signs® neurocognitive function test (CNS-VS), including symbol digit coding, Stroop test, and shifting attention test to measure cognitive flexibility, executive functioning, processing speed, and reaction time(*). Scores are computed from raw score calculations using the data values of individual subtests. An asterisk denotes that lower score is better, otherwise higher scores are better." (NCT00941304)
Timeframe: Baseline (screening), 2 hours 15 minutes postdose
Intervention | Score (Mean) |
---|
| Cognitive flexibility | Executive functioning | Processing speed | Reaction time |
---|
0.25-mg Buprenorphine HCl Buccal Film, M2 | 5.9 | 5.7 | -0.8 | 26.9 |
,0.5-mg Buprenorphine HCl Buccal Film, M1 | -3.2 | -3.0 | -9.1 | 29.7 |
,0.5-mg Buprenorphine HCl Buccal Film, M2 | 4.0 | 4.1 | 0.8 | -19.5 |
,Oxycodone 5 mg | 2.1 | 2.2 | 1.5 | -8.9 |
,Placebo | 7.3 | 7.2 | 2.8 | -3.5 |
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"Percentage of Participants Reporting a Global Rating of Study Drug as Excellent"
"Subjects rated the global effectiveness of study drug as poor, fair, good, or excellent, in response to Overall, how would you rate the study medication you received for pain?" (NCT00941304)
Timeframe: 8 hours and 24 hours
Intervention | percentage of participants (Number) |
---|
| Excellent at 8 hours | Excellent at 24 hours |
---|
0.25-mg Buprenorphine HCl Buccal Film, M2 | 3.2 | 9.7 |
,0.5-mg Buprenorphine HCl Buccal Film, M1 | 9.7 | 12.9 |
,0.5-mg Buprenorphine HCl Buccal Film, M2 | 6.7 | 13.3 |
,Oxycodone 5 mg | 3.2 | 0 |
,Placebo | 6.7 | 3.3 |
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"Percentage of Participants With Excellent Investigator Global Rating of Study Drug"
"Investigators rated the global effectiveness of study drug as poor, fair, good, or excellent, in response to Overall, how would you rate the study medication for this subject?" (NCT00941304)
Timeframe: 24 hours
Intervention | percentage of participants (Number) |
---|
0.25-mg Buprenorphine HCl Buccal Film, M2 | 6.5 |
0.5-mg Buprenorphine HCl Buccal Film, M2 | 13.3 |
0.5-mg Buprenorphine HCl Buccal Film, M1 | 12.9 |
Placebo | 3.3 |
Oxycodone 5 mg | 0 |
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Duration of Analgesia
Duration of analgesia was the median time to use of rescue medication; earliest concomitant medication start time for medications identified as rescue medications from time of study drug administration. (NCT00941304)
Timeframe: 24 hours
Intervention | hours (Median) |
---|
0.25-mg Buprenorphine HCl Buccal Film, M2 | 1.75 |
0.5-mg Buprenorphine HCl Buccal Film, M2 | 2.62 |
0.5-mg Buprenorphine HCl Buccal Film, M1 | 4.12 |
Placebo | 1.69 |
Oxycodone 5 mg | 2.17 |
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Onset of Analgesia
Time to onset of analgesia defined as median time to perceptible pain relief if confirmed by experiencing meaningful pain relief from time of study drug administration. (NCT00941304)
Timeframe: 8 hours
Intervention | hours (Median) |
---|
0.25-mg Buprenorphine HCl Buccal Film, M2 | NA |
0.5-mg Buprenorphine HCl Buccal Film, M2 | 2.43 |
0.5-mg Buprenorphine HCl Buccal Film, M1 | NA |
Placebo | NA |
Oxycodone 5 mg | NA |
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Peak Pain Intensity Difference
"The maximum PID at any time following dosing determined from the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to What is your pain level at this time?" (NCT00941304)
Timeframe: 24 hours
Intervention | units on a scale (Mean) |
---|
0.25-mg Buprenorphine HCl Buccal Film, M2 | 2.2 |
0.5-mg Buprenorphine HCl Buccal Film, M2 | 2.9 |
0.5-mg Buprenorphine HCl Buccal Film, M1 | 2.8 |
Placebo | 1.5 |
Oxycodone 5 mg | 1.9 |
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Positive and Negative Affect Scale
"Positive Affect Score: Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.~Negative Affect Score: Scores can range from 10 - 50, with lower scores representing lower levels of negative affect." (NCT01071538)
Timeframe: 8 weeks
Intervention | units on a scale (Mean) |
---|
| Positive affect subscale | Negative affect subscale |
---|
Buprenorphine | 29.4 | 15.5 |
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Blood Pressure
Blood Pressure- systolic and diastolic 140/90 or lower is considered normal and indicates a better outcome. (NCT01071538)
Timeframe: 8 weeks
Intervention | mm Hg (Mean) |
---|
| systolic blood pressure | diastolic blood pressure |
---|
Buprenorphine | 122.5 | 70.5 |
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UKU Side Effect Rating Scale
measure of side effects 46 items with scores of 0,1,2,3 possible. Theoretical range 0-138 Lower scores indicate fewer side effects (NCT01071538)
Timeframe: 8 weeks
Intervention | units on a scale (Mean) |
---|
Buprenorphine | 6.2 |
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Pain Numeric Rating Scale (20 Item)
measure of average physical pain score range 0-20 Higher scores indicate worse outcome (NCT01071538)
Timeframe: 8 weeks
Intervention | units on a scale (Mean) |
---|
Buprenorphine | 4.6 |
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Montgomery Asberg Depression Rating Scale
measure of depression severity theoretical scale range 0-60 Lower values represent better outcome (NCT01071538)
Timeframe: 8 weeks
Intervention | units on a scale (Mean) |
---|
Buprenorphine | 9.5 |
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Heart Rate
Heart Rate (Beats per minute) 60-100 beats per minute is considered normal lower heart rate represent healthier outcome (NCT01071538)
Timeframe: 8 weeks
Intervention | beats per minute (Mean) |
---|
Buprenorphine | 72.7 |
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Brief Symptom Inventory -- Anxiety Subscale
measure of anxiety Lower numbers indicate better outcome Theoretical Range 0-2.4 (NCT01071538)
Timeframe: 8 weeks
Intervention | units on a scale (Mean) |
---|
Buprenorphine | 0.6 |
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The Overall Preference Between Two Buprenorphine Sublingual Formulations, After a Switch From the Marketed Tablet (Subutex®) to the New Fast Dissolving Tablet (FDT), in Opioid-dependent Patients With Buprenorphine 8 mg or 16 mg Daily Maintenance Therapy.
"Patient's overall satisfaction on Day 1 to Day 5 postdose. Marketed sublingual tablet (Marketed SL): Days 1 and 2; Fast dissolving tablet (FTD): Days 3, 4, and 5. Within 1 hour after complete dissolution of the tablet(s), overall satisfaction towards the study treatment was to be scored by the patient himself / herself using a 10-cm visual analogic scale (VAS) ranging from Not at all satisfied (score = 0) to Totally satisfied (score = 10)." (NCT01075971)
Timeframe: Daily, Day 1 to Day 5
Intervention | Score on a scale (Mean) |
---|
| Day 1 Marketed SL | Day 2 Marketed SL | Day 3 FTD | Day 4 FTD | Day 5 FTD | Overall SL formulation | Overall FTD formulation |
---|
Buprenorphine Hydrochloride | 6.01 | 5.91 | 7.73 | 7.75 | 7.72 | 5.96 | 7.73 |
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Number of Participants With Adverse Events (AEs) as a Measure of Safety
The purpose of the extension phase was to evaluate the long-term safety and tolerability of BTDS in subjects who had participated in the core study (BUP3015). (NCT01125917)
Timeframe: 52-week extension phase
Intervention | participants (Number) |
---|
| Death | Serious adverse events | All other adverse events in ≥ 4.5% of subjects |
---|
Total BTDS 5, 10, 20 | 1 | 20 | 153 |
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The Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements. (NCT01135524)
Timeframe: 52 weeks
Intervention | participants (Number) |
---|
| Deaths | Serious Adverse Events | Other Adverse Events in ≥ 4.5% of subjects |
---|
Extension Phase | 1 | 14 | 93 |
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Mean Peak Sleep Assessed by Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality, total scores range from 0 (better) to 21(worse). The data that has been reported reflects the peak scores on the PSQI during the withdrawal period from both morphine and buprenorphine. (NCT01136356)
Timeframe: Average mean peak sleep assessed once a week for up to 8 weeks
Intervention | units on a scale (Mean) |
---|
| Week 2 Withdrawal | Week 3 Withdrawal |
---|
Buprenorphine | 5.5 | 6.9 |
,Morphine | 10.3 | 11.3 |
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Mean Daily Peak Pain Ratings Assessed by the Visual Analog Scale (VAS)
"Visual Analog Scale (VAS) measures subjective ratings on pain. The scale on this measurement ranges from 0 being None to 100 being Extremely. The results below reflect the subjective measurements of pain taken from day 0 to day 18 of withdrawal from both morphine and buprenorphine." (NCT01136356)
Timeframe: Average mean daily peak pain ratings assessed from day 0 to day 18 during the 18 day withdrawal period
Intervention | units on a scale (Mean) |
---|
| Day 0 Withdrawal | Day 1 Withdrawal | Day 2 Withdrawal | Day 3 Withdrawal | Day 4 Withdrawal | Day 5 Withdrawal | Day 6 Withdrawal | Day 7 Withdrawal | Day 8 Withdrawal | Day 9 Withdrawal | Day 10 Withdrawal | Day 11 Withdrawal | Day 12 Withdrawal | Day 13 Withdrawal | Day 14 Withdrawal | Day 15 Withdrawal | Day 16 Withdrawal | Day 17 Withdrawal | Day 18 Withdrawal |
---|
Buprenorphine | 2 | 6.3 | 13.3 | 9.4 | 8.6 | 11.4 | 8.6 | 8.6 | 13.6 | 8.6 | 6.3 | 8.3 | 9.1 | 12.7 | 7.9 | 12.9 | 11.6 | 6.7 | 9.4 |
,Morphine | 6.1 | 29.3 | 51.6 | 33.1 | 29.9 | 20.1 | 20.3 | 11.9 | 6.7 | 17.0 | 13.4 | 4.1 | 11.7 | 7.4 | 6.9 | 15.6 | 3.1 | 7.7 | 5.9 |
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Mean Peak Opioid Withdrawal Assessed by the Clinical Opiate Withdrawal Scale (COWS)
Clinical Opiate Withdrawal Scale (COWS) is an observer-rated tool for quantifying opioid withdrawal. The scale ranges from 0 to 48: Scores 5 to 12 are mild, 13 to 24 are moderate, 25 to 36 are moderately severe, and over 36 are severe withdrawal. The scores on this repeated measure were analyzed by a two-factor ANOVA for mean peak daily COWS ratings. (NCT01136356)
Timeframe: Average mean peak opioid withdrawal thirty minutes before and after injection assessed up to 59 days
Intervention | units on a scale (Mean) |
---|
Morphine | 12.6 |
Buprenorphine | 1.3 |
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The Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements. (NCT01141283)
Timeframe: 6 months.
Intervention | participants (Number) |
---|
| Deaths | Serious Adverse Events | Adverse Events 4.5% |
---|
Extension Phase (BTDS 5, 10, or 20) | 0 | 6 | 202 |
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The Average Differences From Baseline Between BTDS and Placebo by Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13
"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (QT interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Bazett's method (QTcB) msec." (NCT01148537)
Timeframe: Baseline to Day 6 and Day 13
Intervention | QTcB (msec) (Least Squares Mean) |
---|
| QTcB Day 6 | QTcB Day 13 |
---|
BTDS | -0.37 | 6.31 |
,Placebo | -0.24 | -0.86 |
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The Average Differences Between Moxifloxacin vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6
"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec." (NCT01148537)
Timeframe: Baseline to Day 6
Intervention | QTci (msec) (Least Squares Mean) |
---|
Moxifloxacin | 6.26 |
Placebo | -1.38 |
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The Average Differences From Baseline Between BTDS and Placebo by Fridericia's Corrected Interval (QTcF) on Day 6 and Day 13
"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Fridericia's method (QTcF) msec." (NCT01148537)
Timeframe: Baseline to Day 6 and Day 13
Intervention | QTcF (msec) (Least Squares Mean) |
---|
| QTcF Day 6 | QTcF Day 13 |
---|
BTDS | -1.04 | 4.13 |
,Placebo | -2.33 | -1.88 |
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The Average Differences From Baseline Between Moxifloxacin and Placebo of Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13
"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Bazett's method (QTcB) msec." (NCT01148537)
Timeframe: Baseline to Day 6 and Day 13
Intervention | QTcB (msec) (Least Squares Mean) |
---|
| QTcB Day 6 | QTcB Day 13 |
---|
Mofloxacin | 8.13 | 6.55 |
,Placebo | -0.09 | -0.84 |
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The Average Differences From Baseline Between Moxifloxacin and Placebo by Fridericia's Corrected Interval (QTcF) on Day 6 and Day 13
"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Fridericia's method (QTcF) msec." (NCT01148537)
Timeframe: Baseline to Day 6 and Day 13
Intervention | QTcF (msec) (Least Squares Mean) |
---|
| QTcF Day 6 | QTcF Day 13 |
---|
Moxifloxacin | 4.74 | 2.83 |
,Placebo | -2.12 | -1.85 |
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The Average Differences Between BTDS vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6
"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec." (NCT01148537)
Timeframe: Baseline to Day 6
Intervention | QTci (msec) (Least Squares Mean) |
---|
BTDS | -1.06 |
Placebo | -1.46 |
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The Comparison of BTDS to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Corrected From Within-subject Data (QTci) on Day 13
"Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec." (NCT01148537)
Timeframe: Baseline to Day 13
Intervention | QTci (msec) (Least Squares Mean) |
---|
BTDS | 4.20 |
Placebo | -1.71 |
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The Comparison of Moxifloxacin to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Interval Corrected From Within-subject Data (QTci) on Day 13
"Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec." (NCT01148537)
Timeframe: Baseline to Day 13
Intervention | QTci (msec) (Least Squares Mean) |
---|
Moxifloxacin | 4.17 |
Placebo | -1.69 |
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Number of Participants With Adverse Events (AEs) as a Measure of Safety.
Safety was assessed using reports of all new adverse events (AEs) that occurred after the first application of a patch during the extension phase were recorded. (NCT01151098)
Timeframe: 28 weeks
Intervention | participants (Number) |
---|
| Deaths | Serious Adverse Events | All Other Adverse Events in ≥ 4.5% of Subjects |
---|
Total Extension Phase | 1 | 16 | 143 |
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AUC0-inf for Norbuprenorphine.
Informational comparison of AUC0-inf (area under the concentration-time curve from time zero to infinity) values for the metabolite Norbuprenorphine. (NCT01157169)
Timeframe: Blood samples collected over a 144 hour period.
Intervention | ng*h/mL (Mean) |
---|
Buprenorphine (Test) | 50.77 |
Subutex® (Reference) | 51.04 |
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AUC0-t for Buprenorphine.
Bioequivalence based on Buprenorphine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration). (NCT01157169)
Timeframe: Blood samples collected over a 144 hour period.
Intervention | ng*h/mL (Mean) |
---|
Buprenorphine (Test) | 35.12 |
Subutex® (Reference) | 32.92 |
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AUC0-t for Norbuprenorphine.
Informational comparison of AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration) values for the metabolite Norbuprenorphine. (NCT01157169)
Timeframe: Blood samples collected over a 144 hour period.
Intervention | ng*h/mL (Mean) |
---|
Buprenorphine (Test) | 45.34 |
Subutex® (Reference) | 47.58 |
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Cmax for Norbuprenorphine.
Informational comparison of Cmax (maximum observed concentration of drug substance in plasma) values for the metabolite Norbuprenorphine. (NCT01157169)
Timeframe: Blood samples collected over a 144 hour period.
Intervention | ng/mL (Mean) |
---|
Buprenorphine (Test) | 1.58 |
Subutex® (Reference) | 1.64 |
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AUC0-inf for Buprenorphine.
Bioequivalence based on Buprenorphine AUC0-inf (area under the concentration-time curve from time zero to infinity). (NCT01157169)
Timeframe: Blood samples collected over a 144 hour period.
Intervention | ng*h/mL (Mean) |
---|
Buprenorphine (Test) | 37.19 |
Subutex® (Reference) | 35.73 |
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Cmax of Buprenorphine.
Bioequivalence based on Buprenorphine Cmax (maximum observed concentration of drug substance in plasma). (NCT01157169)
Timeframe: Blood samples collected over a 144 hour period.
Intervention | ng/mL (Mean) |
---|
Buprenorphine (Test) | 4.40 |
Subutex® (Reference) | 3.88 |
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Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period.
Outcomes represent mean peak withdrawal as rated on the Clinical Opiate Withdrawal Scale (COWS) total score. Withdrawal was collected 7 times daily and daily peak values were identified for each participant and averaged together as a function of group. Primary outcomes were mean peak results from the 7-day taper period and first 7 days post-taper. The COWS is an 11-item observer-rated measure of opioid withdrawal severity. Items are rated on individual Likert scales and the total score range is 0-47. Higher values indicate more severe withdrawal. (NCT01188421)
Timeframe: 14 days total
Intervention | units on a scale (Mean) |
---|
| Taper Day 1 | Taper Day 2 | Taper Day 3 | Taper Day 4 | Taper Day 5 | Taper Day 6 | Taper Day 7 | Post Taper Day 1 | Post Taper Day 2 | Post Taper Day 3 | Post Taper Day 4 | Post Taper Day 5 | Post Taper Day 6 | Post Taper Day 7 |
---|
Buprenorphine | 7.79 | 6.16 | 4.76 | 4.21 | 4.31 | 4.06 | 3.51 | 4.82 | 5.62 | 6.23 | 5.49 | 5.87 | 4.91 | 4.91 |
,Clonidine | 8.28 | 8.00 | 5.85 | 4.70 | 3.32 | 3.57 | 3.86 | 3.27 | 4.09 | 3.68 | 3.82 | 3.27 | 2.91 | 2.41 |
,Tramadol ER | 8.41 | 6.10 | 3.77 | 4.25 | 3.25 | 3.39 | 3.69 | 3.36 | 4.48 | 3.28 | 3.13 | 2.75 | 2.57 | 2.30 |
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Change From Baseline to Week 12 in Roland Morris Disability Questionnaire
Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability. (NCT01256450)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Mean) |
---|
DB Buprenorphine HCl Buccal Film | 0.09 |
DB Placebo Film | 1.00 |
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Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)
Treatment failure is defined as study discontinuation due to lack of efficacy or due to adverse event in the double-blind treatment phase. (NCT01256450)
Timeframe: Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
DB Buprenorphine HCl Buccal Film | 9.4 |
DB Placebo Film | 11.9 |
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Use of Rescue Medication
Calculated from the use of rescue medication recorded in subject diary as the sum of all rescue medication tablets used in the last 7 days previous to the derived visit, divided by the number of days in this duration where the amount was reported. (NCT01256450)
Timeframe: Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phase
Intervention | Tablets per day (Mean) |
---|
| Day 7 | Day 14 | Day 28 | Day 42 | Day 56 | Day 70 | Day 84 | Follow-up Day 91 |
---|
DB Buprenorphine HCl Buccal Film | 0.87 | 0.93 | 0.93 | 0.97 | 0.89 | 0.83 | 0.97 | 0.79 |
,DB Placebo Film | 0.82 | 1.03 | 1.02 | 1.04 | 0.99 | 0.98 | 0.91 | 1.07 |
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Number of Participants With Response to Treatment as Assessed by an NRS Scale
Responses are defined as the relative improvement in pain score at week 12 from baseline, calculated from ratings of average pain intensity over the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable). (NCT01256450)
Timeframe: Week 12
Intervention | participants (Number) |
---|
| ≥0% Response | ≥10% Response | ≥20% Response | ≥30% Response | ≥40% Response | ≥50% Response | ≥60% Response | ≥70% Response | ≥80% Response | ≥90% Response | ≥100% Response |
---|
DB Buprenorphine HCl Buccal Film | 117 | 48 | 37 | 28 | 19 | 13 | 11 | 8 | 5 | 5 | 3 |
,DB Placebo Film | 118 | 32 | 30 | 27 | 23 | 20 | 16 | 13 | 9 | 7 | 6 |
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Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM
The Treatment Satisfaction Questionnaire for Medication (TSQM) is a 14-item instrument used to assess the subject's satisfaction with the ability of the study medication to prevent or treat the condition of chronic low back pain (CLBP) for effectiveness, side effects, convenience, and global satisfaction. Scores range from 0 to 100, where a higher score indicates less dissatisfaction (ie, greater satisfaction). (NCT01256450)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Mean) |
---|
| Effectiveness | Side effects | Convenience | Global satisfaction |
---|
DB Buprenorphine HCl Buccal Film | -2.06 | 3.09 | -3.12 | -8.19 |
,DB Placebo Film | -9.03 | 10.88 | -0.00 | -11.73 |
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Change From Baseline in Pain Intensity Over Time Using NRS Scale
Change in pain intensity = average of daily pain scores from the last 7 days prior to each visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable). (NCT01256450)
Timeframe: Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84
Intervention | units on a scale (Mean) |
---|
| Day 14 | Day 28 | Day 42 | Day 56 | Day 70 | Day 84 |
---|
DB Buprenorphine HCl Buccal Film | 0.21 | 0.20 | 0.13 | 0.21 | 0.15 | 0.29 |
,DB Placebo Film | 0.25 | 0.29 | 0.25 | 0.23 | 0.35 | 0.38 |
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Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale
Subjects assessed changes in activity, limitations, symptoms, and overall quality of life related to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC), a balanced 7-point scale from 1 (no change or condition got worse) to 7 (a great deal better and considerable improvement that has made all the difference). (NCT01256450)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Mean) |
---|
DB Buprenorphine HCl Buccal Film | -0.32 |
DB Placebo Film | -0.92 |
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Change in Pain Intensity From Baseline to Week 12
Change in pain intensity = average of daily pain scores from the last 7 days prior to week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable). (NCT01256450)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Mean) |
---|
DB Buprenorphine HCl Buccal Film | 0.33 |
DB Placebo Film | 0.46 |
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Change From Baseline to Week 12 in Subject's Overall Satisfaction With Study Drug
Subjects were asked to rate their overall satisfaction with their study drug on a 5-point scale ranging from 1 (poor) to 5 (excellent). (NCT01256450)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Mean) |
---|
DB Buprenorphine HCl Buccal Film | -0.30 |
DB Placebo Film | -0.48 |
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Change From Baseline to Week 12 in Investigator's Overall Satisfaction With Study Drug
Investigators rated their overall satisfaction with the study drug administered to a given subject on a 5-point scale ranging from 1 (poor) to 5 (excellent). (NCT01256450)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Mean) |
---|
DB Buprenorphine HCl Buccal Film | -0.27 |
DB Placebo Film | -0.37 |
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Period 2: Tmax0-7d.
"Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by Tmax0-7d.~Tmax0-7d - The time from dosing to the maximum observed concentration was taken directly from the plasma concentration-time course profile. If the maximum plasma concentration was observed at 2 or more consecutive time points, the earliest time point was used for Tmax." (NCT01259102)
Timeframe: 0 to 7 days
Intervention | hour (Mean) |
---|
No Rest | 42 |
7-Day Rest | 38 |
14-Day Rest | 36 |
21-Day Rest | 46 |
28-Day Rest | 63 |
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Period 2: Cmax0-3d
"Period 2 was the second application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by Cmax0-3d.~Cmax0-3d (pg/mL) - The maximum observed concentration taken directly from the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours). This was considered an index of maximum (peak) exposure to the study drug." (NCT01259102)
Timeframe: 0 to 3 days
Intervention | pg/mL (Mean) |
---|
No Rest | 216 |
7-Day Rest | 300 |
14-Day Rest | 262 |
21-Day Rest | 278 |
28-Day Rest | 182 |
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Period 2: AUC0-7d
"Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by AUC0-7d.~AUC0-7d - The area under the plasma concentration-time course profile from time = 0 (dosing) to BTDS removal." (NCT01259102)
Timeframe: 0 to 7 days
Intervention | pg/mL*h (Mean) |
---|
No Rest | 25126 |
7-Day Rest | 27543 |
14-Day Rest | 26174 |
21-Day Rest | 27123 |
28-Day Rest | 21790 |
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Period 2: AUC0-3d.
"Period 2 was the second application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by AUC0-3d.~AUC0-3d - The area under the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours)." (NCT01259102)
Timeframe: 0 to 3 days
Intervention | pg/mL*h (Mean) |
---|
No Rest | 12316 |
7-Day Rest | 14733 |
14-Day Rest | 13571 |
21-Day Rest | 12931 |
28-Day Rest | 9056 |
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Period 1: AUC0-3d
Period 1 was the first application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by AUC0-3d [The area under the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours)]. (NCT01259102)
Timeframe: 0 to 3 days (72 hours)
Intervention | pg/mL*h (Mean) |
---|
No Rest | 8680 |
7-Day Rest | 7651 |
14-Day Rest | 6465 |
21-Day Rest | 12258 |
28-Day Rest | 8890 |
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Period 1: Tmax0-7d.
"Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by Tmax0-7d.~Tmax0-7d - The time from dosing to the maximum observed concentration was taken directly from the plasma concentration-time course profile. If the maximum plasma concentration was observed at 2 or more consecutive time points, the earliest time point was used for Tmax." (NCT01259102)
Timeframe: 0 to 7days
Intervention | hour (Mean) |
---|
No Rest | 74 |
7-Day Rest | 86 |
14-Day Rest | 78 |
21-Day Rest | 55 |
28-Day Rest | 76 |
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Period 1: Cmax0-7
"Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by Cmax0-7.~Cmax0-7d - The maximum observed concentration taken directly from the plasma concentration-time course profile." (NCT01259102)
Timeframe: 0 to 7 days
Intervention | pg/mL (Mean) |
---|
No Rest | 188 |
7-Day Rest | 206 |
14-Day Rest | 160 |
21-Day Rest | 245 |
28-Day Rest | 192 |
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Period 1: Cmax0-3d
"Period 1 was the first application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by Cmax0-3d.~Cmax0-3d - The maximum observed concentration taken directly from the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours). This was considered an index of maximum (peak) exposure to the study drug." (NCT01259102)
Timeframe: 0 to 3 days
Intervention | pg/mL (Mean) |
---|
No Rest | 183 |
7-Day Rest | 193 |
14-Day Rest | 151 |
21-Day Rest | 241 |
28-Day Rest | 185 |
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Period 1: AUC0-7d.
"Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by AUC0-7d.~AUC0-7d - The area under the plasma concentration-time course profile from time = 0 (dosing) to BTDS removal." (NCT01259102)
Timeframe: 0 to 7 days
Intervention | pg/mL*h (Mean) |
---|
No Rest | 21946 |
7-Day Rest | 20541 |
14-Day Rest | 14707 |
21-Day Rest | 27040 |
28-Day Rest | 22086 |
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Period 2: Cmax0-7d
"Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by Cmax0-7d.~Cmax0-7d - The maximum observed concentration taken directly from the plasma concentration-time course profile." (NCT01259102)
Timeframe: 0 to 7 days
Intervention | pg/mL (Mean) |
---|
No Rest | 216 |
7-Day Rest | 300 |
14-Day Rest | 262 |
21-Day Rest | 278 |
28-Day Rest | 202 |
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AUCinf of Nor-buprenorphine Glucuronide With and Without Ketoconazole
"For nor-buprenorphine glucuronide pharmacokinetic metrics, AUCinf (the area under the plasma-concentration time course profile from time 0 [dosing] to infinity) log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27." (NCT01259115)
Timeframe: BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25
Intervention | pg/mL*h (Mean) |
---|
BTDS 10 With Ketoconazole Placebo | 17318.9 |
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AUCinf of Nor-buprenorphine With and Without Ketoconazole
"For nor-buprenorphine pharmacokinetic metric, AUCinf (the area under the plasma-concentration time course profile from time 0 [dosing] to infinity).~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27." (NCT01259115)
Timeframe: BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25
Intervention | pg/mL*h (Mean) |
---|
BTDS 10 With Ketoconazole | 6767.9 |
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AUCt of Buprenorphine With and Without Ketoconazole.
"AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration) of buprenorphine transdermal patch 10 with and without ketoconazole 200 mg oral twice daily.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or Ketoconazole placebo (orally twice daily) between days 17 and 27." (NCT01259115)
Timeframe: BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25
Intervention | pg/mL*h (Mean) |
---|
BTDS 10 With Ketoconazole | 16354.8 |
BTDS 10 With Ketoconazole Placebo | 16627.9 |
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AUCt of Buprenorphine-3-glucuronide With and Without Ketoconazole
"For buprenorphine-3-glucuronide pharmacokinetic metric, AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration), log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27." (NCT01259115)
Timeframe: BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25
Intervention | pg/mL*h (Mean) |
---|
BTDS 10 With Ketoconazole | 342.4 |
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AUCt of Nor-buprenorphine With and Without Ketoconazole
"For nor-buprenorphine pharmacokinetic metric, AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration).~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27." (NCT01259115)
Timeframe: BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25
Intervention | pg/mL*h (Mean) |
---|
BTDS 10 With Ketoconazole | 5091.0 |
BTDS 10 With Ketoconazole Placebo | 3207.8 |
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Cmax of Buprenorphine With and Without Ketoconazole.
"Cmax (maximum observed plasma concentration) of buprenorphine transdermal patch 10 with and without ketoconazole 200 mg oral tablets twice daily,~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27." (NCT01259115)
Timeframe: BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25
Intervention | pg/mL (Mean) |
---|
BTDS 10 With Ketoconazole | 142.2 |
BTDS 10 With Ketoconazole Placebo | 145.5 |
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Cmax of Buprenorphine-3-glucuronide With and Without Ketoconazole
"For buprenorphine-3-glucuronide pharmacokinetic metric, Cmax (maximum observed plasma concentration), log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27." (NCT01259115)
Timeframe: BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25
Intervention | pg/mL (Mean) |
---|
BTDS 10 With Ketoconazole | 88.5 |
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Cmax of Nor-buprenorphine Glucuronide With and Without Ketoconazole
"For nor-buprenorphine glucuronide pharmacokinetic metric, Cmax (maximum observed plasma concentration), log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27." (NCT01259115)
Timeframe: BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25
Intervention | pg/mL (Mean) |
---|
BTDS 10 With Ketoconazole | 218.2 |
BTDS 10 With Ketoconazole Placebo | 141.9 |
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Cmax of Nor-buprenorphine With and Without Ketoconazole
"For nor-buprenorphine pharmacokinetic metric, Cmax (maximum observed plasma concentration), log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27." (NCT01259115)
Timeframe: BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25
Intervention | pg/mL (Mean) |
---|
BTDS 10 With Ketoconazole | 63.4 |
BTDS 10 With Ketoconazole Placebo | 44.6 |
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CYP3A4 Inhibition by Observation of Plasma Nor-buprenorphine Production Assessed by the Erythromycin Breath Test.
As part of subject screening, Erythromycin Breath Tests (EBT) were done on all potential subjects (enrolled population). CYP 3A4 inhibition was calculated by taking the difference of the baseline 14C erythromycin metabolism, subtracting the 14C erythromycin metabolism during ketoconazole treatment, dividing this difference by the baseline 14C erythromycin metabolism, and multiplying by 100 to express results in the form of percent inhibition. CYP3A4 inhibition was only done when subjects were on ketoconazole. (NCT01259115)
Timeframe: One time at screening and one time during ketoconazole treatment
Intervention | Percentage of participants (Mean) |
---|
| All subjects [N = 20] | Inhibition ≤ 50% [n = 4] | Inhibition >50% but ≤ 70% [n = 8] | Inhibition > 70% [n = 8] |
---|
All Subjects | 64.49 | 37.50 | 64.50 | 77.98 |
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The Number of Participants With Adverse Events (AEs) as a Measure of Safety.
Safety assessments consisted of monitoring and recording medical history, physical examinations, vital signs (including temperature, heart rate, blood pressure and respiratory rate), reports of adverse experiences, and laboratory abnormalities (including electrocardiogram [ECG]). (NCT01259115)
Timeframe: The first day of study drug administration to 30 days after the last dose of study drug.
Intervention | participants (Number) |
---|
| Deaths | Serious Adverse Events | Adverse Events in 4% or more of subjects |
---|
BTDS 10 With Ketoconazole | 0 | 0 | 19 |
,BTDS 10 With Ketoconazole Placebo | 0 | 0 | 16 |
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AUCt of Nor-buprenorphine Glucuronide With and Without Ketoconazole
"For nor-buprenorphine glucuronide pharmacokinetic metrics, AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration), log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27." (NCT01259115)
Timeframe: BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25
Intervention | pg/mL*h (Mean) |
---|
BTDS 10 With Ketoconazole | 21376.9 |
BTDS 10 With Ketoconazole Placebo | 15840.5 |
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AUCinf of Buprenorphine With and Without Ketoconazole.
"AUCinf (the area under the plasma-concentration time course profile from time 0 [dosing] to infinity) of buprenorphine transdermal patch 10 with and without ketoconazole 200 mg oral twice daily.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27." (NCT01259115)
Timeframe: BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25
Intervention | pg /mL•h (Mean) |
---|
BTDS 10 With Ketoconazole | 18238.5 |
BTDS 10 With Ketoconazole Placebo | 19012.5 |
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Illicit Opioid Use as Determine by Urine Dipsticks
urine data are from those obtained during the buprenorphine taper (NCT01262092)
Timeframe: 3x weekly during wks 3 and 4
Intervention | % of urines positive for opioids (Mean) |
---|
Gabapentin | 13.64 |
Placebo | 32.56 |
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Time it Takes for Nerve Block to Wear Off
Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block? (NCT01277159)
Timeframe: up to 72 hours
Intervention | hours (Mean) |
---|
Control Nerve Block. IV Dexamethasone (4 mg). | 30.4 |
Nerve Block With Dexamethasone (4 mg). IV Saline. | 45.1 |
Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp | 32.2 |
Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone ( | 45.6 |
Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine | 45.6 |
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Change From Baseline in NRS Pain Intensity
The NRS Pain intensity score is a segmented version of a visual analog scale used to measure pain. The scale is from 0 (no pain) to 10. Scores between greater than 0 and 3 are considered mild pain, scores from greater than 3 to 6 are moderate and greater than 6 to 10 are severe. The daily average is calculated and used to calculate the change from baseline at week 52. (NCT01298765)
Timeframe: Baseline up to approximately Week 52
Intervention | units on a scale (Mean) |
---|
BEMA Buproneorphine Overall | -0.24 |
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Subjects Overall Satisfaction With Study Drug
Subjects Overall Satisfaction with Study Drug as measured on a 5 point scale, with 1 being not satisfied and 5 being very satisified. (NCT01298765)
Timeframe: Baseline to Week 52
Intervention | units on a scale (Mean) |
---|
BEMA Buproneorphine Overall | 4.1 |
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Treatment Satisfaction Questionnaire for Medication/Global Satisfaction
Treatment Satisfaction Questionnaire for Medication/Global Satisfaction at Week 28. Patients complete a 14 item questionaire that measures 4 scales based on side effects, effectiveness, convenience and global satisfaction. All items have either five or seven responses (except item 4), scored from one (least satisfied) to five or seven (most satisfied). The 7-item scales have a non-neutral midpoint, such that there are more positive response options than negative response options. Item scores are summed to give four domain scores, which are in turn transformed to a scale of 0-100. Item 4 was not included for scoring. If an item score is missing and half of the items in the domain are complete, domain scores may be imputed from the person-specific mean score of completed items (NCT01298765)
Timeframe: Baseline to Week 28
Intervention | units on a scale (Mean) |
---|
BEMA Buproneorphine Overall | 76.6 |
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Patient Global Impression of Change in Pain Intensity
Patient Global Impression of Change in Pain Intensity at Week 28 as measured by a 7 point scale. Patients measure their improvement from 7='very much improved', 6='much improved', 5='minimally improved', 4='no change', 3='minimally worse', 2='much worse', 1='very much worse'. (NCT01298765)
Timeframe: Baseline to Week 28
Intervention | units on a scale (Mean) |
---|
BEMA Buproneorphine Overall | 5.5 |
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Investigator's Overall Satisfaction With Study Drug
Investigator's Overall Satisfaction with Study Drug measured on a 5-point scale, with 1 being not satisfied and 5 being very satisfied. (NCT01298765)
Timeframe: Baseline to Week 52
Intervention | units on a scale (Mean) |
---|
BEMA Buproneorphine Overall | 4.2 |
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Pain Right Now Assessment by Patients Aged 12 to 16 Years, Inclusive
"Pain right now was assessed using a 100-mm visual analogue scale (VAS). The 100-mm VAS is a 100-mm line with 1 end marked as no pain and the other marked as pain as bad as it could be. The patient was asked to make a mark on that line indicating his or her level of pain. Pain right now score was defined as the distance (in mm) from the no pain end to the patient's mark; 0=no pain and bigger numbers indicate more pain. For screening to week 4, pain right now was assessed 30 minutes before initial BTDS application on day 1; one hour after initial BTDS application on day 1; thereafter, once daily at approximately 8 PM for the first 4 weeks. Baseline was the last assessment prior to the first dose. For weeks 1-4, weekly averages of the pain right now scores were calculated using the sum of all available pain right now scores recorded daily during a given week divided by the number of available scores.~For weeks 6-24, pain right now was measured once a week at approximately 8 PM." (NCT01324570)
Timeframe: Up to 24 weeks
Intervention | units on a scale (Mean) |
---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 | Week 15 | Week 16 | Week 17 | Week 18 | Week 19 | Week 20 | Week 21 | Week 22 | Week 23 | Week 24 |
---|
12 to 16 Years | 46.6 | 43.1 | 41.6 | 36.0 | 34.7 | 30.3 | 28.0 | 29.1 | 34.3 | 27.3 | 36.7 | 35.7 | 42.5 | 36.0 | 38.2 | 30.5 | 38.7 | 30.9 | 37.7 | 37.4 | 35.6 | 32.4 | 38.1 | 38.7 | 36.5 |
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Parent/Caregiver-assessed Global Impression of Change (PGIC)
The PGIC rating score variable was collected on a 7-point scale ranging from 1 to 7 (where 1 = very much improved; and 7 = very much worse). The PGIC is designed to assess overall satisfaction with the treatment. The PGIC score was summarized using the number and percent of patients in each of the 7 possible response categories overall and by age group. PGIC was assessed by the parent/caregiver at the end of treatment visit or early discontinuation visit. (NCT01324570)
Timeframe: End of treatment (week 24) or early discontinuation visit
Intervention | Participants (Count of Participants) |
---|
| Participants Represented | 1 = Very much improved | 2 = Much improved | 3 = Minimally improved | 4 = No change | 5 = Minimally worse | 6 = Much worse | 7 = Very much worse |
---|
12 to 16 Years | 34 | 6 | 12 | 8 | 5 | 2 | 1 | 0 |
,7 to 11 Years | 4 | 1 | 0 | 0 | 2 | 1 | 0 | 0 |
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The Number of Participants With Adverse Events as a Measure of Safety
Safety assessments consisted of reports of AEs, vital signs (blood pressure, pulse rate, respiratory rate, and temperature), weight, hemoglobin-oxygen saturation measured by pulse oximetry (SpO2), clinical laboratory tests, somnolence (assessed by the University of Michigan Sedation Scale [UMSS]), conventional 12-lead electrocardiograms (ECGs), and 24-hour digital 12-lead ECGs (Holter monitor). Safety variables were summarized descriptively within age group for the safety population. (NCT01324570)
Timeframe: Up to 28 weeks
Intervention | Participants (Count of Participants) |
---|
| Serious adverse events | All other adverse events in ≥ 5% of patients |
---|
12 to 16 Years | 5 | 20 |
,7 to 11 Years | 5 | 6 |
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Pharmacokinetics (PK) of Buprenorphine Following Transdermal Administration: Apparent Clearance (CL/F)
The population PK (PopPK) of BTDS buprenorphine in pediatric patients ages 7 to 16 years was described by a 2-compartment model with sequential zero- and first-order absorption from the patch. A fixed allometric relationship was used to describe the effects of changes in ideal body weight (IBW) across pediatric patients on all clearance and volume parameters. Given the sparse sample collections, small sample size, and complexity of the absorption process with the patch formulation, this PopPK model was fit to the pediatric data using nonlinear mixed effects modeling (NONMEM) Bayes method with selective use of priors from previous adult PopPK results. Estimates of fixed effects from the final model were used to calculate the CL/F after patch dosing given the covariate distribution in the PopPK dataset and the typical weights from children in the National Health and Nutrition Examination Survey (NHANES) dataset. (NCT01324570)
Timeframe: Day 1, end of week 1, days 9/10, end of week 2, and end of week 4 or at discontinuation prior to end of study visit
Intervention | Liters/hour (Mean) |
---|
Population PK Analysis Set | 293 |
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Pharmacokinetics (PK) of Buprenorphine Following Transdermal Administration: Apparent Volume of Distribution (Vc/F)
The population PK (PopPK) of BTDS buprenorphine in pediatric patients ages 7 to 16 years was described by a 2-compartment model with sequential zero- and first-order absorption from the patch. A fixed allometric relationship was used to describe the effects of changes in ideal body weight (IBW) across pediatric patients on all clearance and volume parameters. Given the sparse sample collections, small sample size, and complexity of the absorption process with the patch formulation, this PopPK model was fit to the pediatric data using nonlinear mixed effects modeling (NONMEM) Bayes method with selective use of priors from previous adult PopPK results. Estimates of fixed effects from the final model were used to calculate the Vc/F after patch dosing given the covariate distribution in the PopPK dataset and the typical weights from children in the National Health and Nutrition Examination Survey (NHANES) dataset. (NCT01324570)
Timeframe: Day 1, end of week 1, days 9/10, end of week 2, and end of week 4 or at discontinuation prior to end of study visit
Intervention | Liters (Mean) |
---|
Population PK Analysis Set | 2350 |
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Pain Right Now Assessment by Patients Aged 7 to 11 Years, Inclusive
"Pain right now was assessed using the Faces of Pain Scale-Revised (FPS-R). The FPS-R is a horizontal row of 6 faces representing pain intensity, with no hurt at the far left and hurts worst at the far right; the intensities are scored as 0, 2, 4, 6, 8, or 10. A score of 0=no pain, and 10=very much pain. For screening to week 4, pain right now was assessed at 30 minutes before initial BTDS application on day 1; one hour after initial BTDS application on day 1; thereafter, once daily at approximately 8 PM for the first 4 weeks. Baseline score was the last assessment prior to the first dose. For weeks 1-4, weekly averages of the pain right now scores were calculated using the sum of all available pain right now scores recorded daily during a given week divided by the number of available scores.~The study measured pain right now for weeks 6-24 once a week at approximately 8 PM while on treatment; however, no patients in this age group were treated beyond week 12." (NCT01324570)
Timeframe: Up to 24 weeks
Intervention | units on a scale (Mean) |
---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 |
---|
7 to 11 Years | 2.80 | 3.49 | 2.98 | 0.29 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
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Area Under the Concentration Versus Time Curve (AUC) at Steady State of Methadone Enantiomers When Administered With or Without Boceprevir
AUC is a measure of the amount of drug in the blood over time, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for methadone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for methadone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for methadone + boceprevir. (NCT01396005)
Timeframe: Methadone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and methadone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.
Intervention | (ng.hr/mL)/mg (Geometric Mean) |
---|
| R-methadone | S-methadone |
---|
Methadone + Boceprevir | 42.4 | 44.6 |
,Methadone Alone | 50.1 | 56.9 |
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Maximum Concentration (Cmax) at Steady State of Methadone Enantiomers When Administered With or Without Boceprevir
Cmax is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for methadone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for methadone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for methadone + boceprevir. (NCT01396005)
Timeframe: Methadone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and methadone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.
Intervention | (ng/mL)/mg (Geometric Mean) |
---|
| R-methadone | S-methadone |
---|
Methadone + Boceprevir | 2.63 | 3.07 |
,Methadone Alone | 2.94 | 3.69 |
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Cmax of Naloxone (Administered in Combination With Buprenorphine) at Steady State With or Without Boceprevir
Cmax is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir. (NCT01396005)
Timeframe: Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.
Intervention | (pg/mL)/mg (Geometric Mean) |
---|
Buprenorphine/Naloxone Alone | 58.5 |
Buprenorphine/Naloxone + Boceprevir | 65.2 |
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Cmax of Buprenorphine (Administered in Combination With Naloxone) at Steady State With or Without Boceprevir
Cmax is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir. (NCT01396005)
Timeframe: Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.
Intervention | (pg/mL)/mg (Geometric Mean) |
---|
Buprenorphine/Naloxone Alone | 440 |
Buprenorphine/Naloxone + Boceprevir | 545 |
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AUC of Naloxone (Administered in Combination With Buprenorphine) at Steady State With or Without Boceprevir
AUC is a measure of the amount of drug in the blood over time, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir. (NCT01396005)
Timeframe: Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.
Intervention | (pg.hr/mL)/mg (Geometric Mean) |
---|
Buprenorphine/Naloxone Alone | 157 |
Buprenorphine/Naloxone + Boceprevir | 224 |
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AUC of Buprenorphine (Administered in Combination With Naloxone) at Steady State With or Without Boceprevir
AUC is a measure of the amount of drug in the blood over time, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir. (NCT01396005)
Timeframe: Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.
Intervention | (pg.hr/mL)/mg (Geometric Mean) |
---|
Buprenorphine/Naloxone Alone | 3020 |
Buprenorphine/Naloxone + Boceprevir | 4040 |
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Cocaine Use Days as Measured by Self-report, Corroborated by Thrice-weekly Urine Drug Screens
Self-reported days of cocaine use corroborated with urine drug screens (UDS). (NCT01402492)
Timeframe: final 30 days of Treatment Phase, study days 25-54
Intervention | days of cocaine use (Mean) |
---|
BUP4+XR-NTX | 6.6 |
BUP16+XR-NTX | 7.2 |
PLB+XR-NTX | 7.7 |
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Positive and Negative Affect Scale
"Positive Affect Score: Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.~Negative Affect Score: Scores can range from 10 - 50, with lower scores representing lower levels of negative affect." (NCT01407575)
Timeframe: 6 weeks
Intervention | units on a scale (Mean) |
---|
| PANAS positive affect subscale | PANAS negative affect subscale |
---|
Buprenorphine | 13.75 | 22 |
,Placebo | 16.25 | 20.5 |
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Weight
Participant weight (NCT01407575)
Timeframe: 6 weeks
Intervention | lbs (Mean) |
---|
Buprenorphine | 191.7 |
Placebo | 203.7 |
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Brief Symptom Inventory -- Anxiety Subscale
measure of anxiety Lower numbers indicate better outcome Theoretical Range 0-2.4 (NCT01407575)
Timeframe: 6 weeks
Intervention | units on a scale (Mean) |
---|
Buprenorphine | 1.43 |
Placebo | 0.97 |
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Heart Rate
Heart Rate (Beats per minute) 60-100 beats per minute is considered normal lower heart rate represent healthier outcome (NCT01407575)
Timeframe: 6 weeks
Intervention | Beats per minute (Mean) |
---|
Buprenorphine | 87.25 |
Placebo | 72.6 |
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Montgomery Asberg Depression Rating Scale
measure of depression severity Theoretical Range 0-60 lower values represent better outcome (NCT01407575)
Timeframe: 6 weeks
Intervention | units on a scale (Mean) |
---|
Buprenorphine | 33.8 |
Placebo | 32.6 |
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UKU Side Effect Rating Scale
measure of side effects 46 items with scores of 0,1,2,3 possible. Theoretical range 0-138 Lower scores indicate fewer side effects (NCT01407575)
Timeframe: 6 weeks
Intervention | units on a scale (Mean) |
---|
Buprenorphine | 29.2 |
Placebo | 20.2 |
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Blood Pressure
Measure of systolic and diastolic blood pressure. 140/90 or lower is considered normal and indicates a better outcome. (NCT01407575)
Timeframe: 6 weeks
Intervention | mm Hg (Mean) |
---|
| Systolic Blood Pressure | Diastolic Blood Pressure |
---|
Buprenorphine | 138.4 | 91 |
,Placebo | 117.2 | 71 |
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Number of Patients Requiring Supplemental Phenobarbital Treatment.
This endpoint will compare requirement number of patients who require use of supplemental phenobarbital. (NCT01452789)
Timeframe: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks.
Intervention | participants (Number) |
---|
Sublingual Buprenorphine | 5 |
Oral Morphine | 7 |
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Length of Treatment
This endpoint will compare length of treatment (in days) using sublingual buprenorphine or oral morphine solution. (NCT01452789)
Timeframe: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks.
Intervention | days (Median) |
---|
Sublingual Buprenorphine | 15 |
Oral Morphine | 28 |
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Length of Hospitalization
This endpoint will compare length of stay in the hospital (in days) using sublingual buprenorphine or morphine solution. (NCT01452789)
Timeframe: Duration of hospital stay is an expected average of 5 weeks.
Intervention | days (Median) |
---|
Sublingual Buprenorphine | 21 |
Oral Morphine | 33 |
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Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Adverse events will be collected, graded by severity, and assessed for causality referent to study drug. (NCT01452789)
Timeframe: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks.
Intervention | Participants (Count of Participants) |
---|
Sublingual Buprenorphine | 7 |
Oral Morphine | 8 |
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Log Viral Load
Log Viral Load (NCT01550341)
Timeframe: 12 Months
Intervention | log(IU/mL) (Mean) |
---|
Buprenorphine | 2.40 |
Placebo | 1.84 |
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CD4 Percent
CD4 Percent (NCT01550341)
Timeframe: Baseline
Intervention | CD4 Percent (Mean) |
---|
Buprenorphine | 23.36 |
Placebo | 25.7 |
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CD4 Percent
CD4 Percent (NCT01550341)
Timeframe: 6 Months
Intervention | CD4 Percent (Mean) |
---|
Buprenorphine | 21.33 |
Placebo | 28.56 |
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Viral Load
Viral Load (NCT01550341)
Timeframe: Baseline
Intervention | IU/mL (Mean) |
---|
Buprenorphine | 1465.00 |
Placebo | 896.50 |
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Viral Load
Viral Load (NCT01550341)
Timeframe: 6 Months
Intervention | IU/mL (Mean) |
---|
Buprenorphine | 9269.04 |
Placebo | 7891.08 |
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Log Viral Load
Log Viral Load (NCT01550341)
Timeframe: Baseline
Intervention | log(IU/mL) (Mean) |
---|
Buprenorphine | 2.12 |
Placebo | 2.00 |
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Viral Load
Viral Load (NCT01550341)
Timeframe: 12 Months
Intervention | IU/mL (Mean) |
---|
Buprenorphine | 8122.10 |
Placebo | 19425.71 |
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Log Viral Load
Log Viral Load (NCT01550341)
Timeframe: 6 Months
Intervention | log(IU/mL) (Mean) |
---|
Buprenorphine | 2.22 |
Placebo | 1.79 |
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CD4 Percent
CD4 Percent (NCT01550341)
Timeframe: 12 Months
Intervention | CD4 Percent (Mean) |
---|
Buprenorphine | 22.14 |
Placebo | 27.95 |
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CD4 Count Absolute
CD4 Count Absolute (NCT01550341)
Timeframe: Baseline
Intervention | cells/uL (Mean) |
---|
Buprenorphine | 486.15 |
Placebo | 403.92 |
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CD4 Count Absolute
CD4 Count Absolute (NCT01550341)
Timeframe: 6 Months
Intervention | cells/uL (Mean) |
---|
Buprenorphine | 455.52 |
Placebo | 551.23 |
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CD4 Count Absolute
CD4 Count (NCT01550341)
Timeframe: 12 Months
Intervention | cells/uL (Mean) |
---|
Buprenorphine | 490.25 |
Placebo | 492.33 |
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Depression
"Depression will be assessed using the Beck Depression Inventory, a 63 point scale with 0 being none and 63 being severe." (NCT01559454)
Timeframe: at 6 months
Intervention | units on a BDI scale (Mean) |
---|
Methadone | 17.0 |
Buprenorphine/Naloxone | 15.3 |
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Cravings
Cravings will be assessed using the Visual Analogue Scale (VAS) with 0 being no cravings and 100 being worse possible cravings (NCT01559454)
Timeframe: at 6 months
Intervention | units on a VAS scale (Mean) |
---|
Methadone | 11.7 |
Buprenorphine/Naloxone | 27.2 |
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Analgesia
Pain severity will be measured using the Visual Analogue Scale (VAS) which has a range of 0-100 with 0 being no pain and 100 being worse possible pain. (NCT01559454)
Timeframe: 6 months
Intervention | units on a VAS scale (Mean) |
---|
Methadone | 36.3 |
Buprenorphine/Naloxone | 71.8 |
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Functioning
"Functioning will be assessed using the Visual Analogue Scale (VAS) with 0 being no limits and 100 being bedridden." (NCT01559454)
Timeframe: at 6 months
Intervention | units on a VAS scale (Mean) |
---|
Methadone | 31.7 |
Buprenorphine/Naloxone | 71.3 |
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Treatment Retention
Number of participants that completed the study protocol (NCT01559454)
Timeframe: 6 months
Intervention | participants (Number) |
---|
| completed | did not complete |
---|
Buprenorphine/Naloxone | 4 | 6 |
,Methadone | 6 | 3 |
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Illicit Drug Use
Illicit opioid use will be measured by self-report and confirmed with urine toxicology. (NCT01559454)
Timeframe: 6 months
Intervention | participants (Number) |
---|
| illicit drug use at 6 months | no illicit drug use at 6 months |
---|
Buprenorphine/Naloxone | 0 | 4 |
,Methadone | 0 | 6 |
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Fetal Movement
Fetal movement (number x duration of fetal movements) during the 60 minute recordings at times of trough and peak maternal buprenorphine levels (NCT01561079)
Timeframe: 24, 28, 32, 36 weeks of gestation
Intervention | seconds (Mean) |
---|
Fetal Movement 24 Trough | 1496.2 |
Fetal Movement 28 Trough | 1390.0 |
Fetal Movement 32 Trough | 1458.7 |
Fetal Movement 36 Trough | 1446.7 |
Fetal Movement 24 Peak | 1613.0 |
Fetal Movement 28 Peak | 1385.7 |
Fetal Movement 32 Peak | 1381.2 |
Fetal Movement 36 Peak | 1038.2 |
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Fetal Heart Rate
Fetal heart rate in beats per minute at time of trough and peak maternal buprenorphine levels (NCT01561079)
Timeframe: 24, 28, 32 and 36 weeks of gestation
Intervention | beats per minute (Mean) |
---|
FHR 24 Weeks Trough | 145.7 |
FHR 28 Weeks Trough | 143.3 |
FHR 32 Weeks Trough | 138.6 |
FHR 36 Weeks Trough | 136.3 |
FHR 24 Weeks Peak | 143.9 |
FHR 28 Weeks Peak | 141.0 |
FHR 32 Peak | 135.4 |
FHR 36 Peak | 131.3 |
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Accelerations of Fetal Heart Rate
Number of accelerations of fetal heart rate exhibited during the 60 minute recordings (NCT01561079)
Timeframe: 24, 28, 32 36 weeks of gestation
Intervention | accelerations (Mean) |
---|
Accelerations 24 Trough | 0.52 |
Accelerations 28 Trough | 1.59 |
Accelerations 32 Trough | 3.57 |
Accelerations 36 Trough | 5.28 |
Accelerations 24 Peak | 0.43 |
Accelerations 28 Peak | 2.12 |
Accelerations 32 Peak | 2.29 |
Accelerations36 Peak | 2.25 |
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Fetal Heart Rate Variability
Fetal heart rate variability at 24, 28, 32 and 36 weeks of gestation at times of trough and peak maternal buprenorphine levels (NCT01561079)
Timeframe: 24, 28, 32 and 36 weeks of gestation
Intervention | msec (Mean) |
---|
FHRV 24 Trough | 5.4 |
FHRV 28 Trough | 6.7 |
FHRV 32 Trough | 7.5 |
FHRV 36 Trough | 7.9 |
FHRV 24 Peak | 4.9 |
FHRV 28 Peak | 7.3 |
FHRV 32 Peak | 7.0 |
FHRV 36 Peak | 6.3 |
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Fetal Movement - Fetal Heart Rate Coupling
The integration between fetal movements and heart rate (FM-FHR coupling) was quantified as the proportion of time individual movements were associated with a change in FHR, using previously developed criteria. FM-FHR coupling reflects coactivation of the sympathetic and parasympathetic components of the autonomic nervous system. (NCT01561079)
Timeframe: 24, 28, 32, 36 weeks of gestation
Intervention | percentage of time FM assoc w FHR change (Mean) |
---|
FM-FHR 24 Trough | 0.13 |
FM-FHR 28 Trough | 0.21 |
FM-FHR 32 Trough | 0.23 |
FM-FHR 36 Trough | 0.25 |
FM-FHR 24 Peak | 0.09 |
FM-FHR 28 Peak | 0.20 |
FM-FHR 32 Peak | 0.21 |
FM-FHR 36 Peak | 0.20 |
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Time Until First Pain Medication Post-operatively
Time in minutes until first pain medication was take by participant post-operatively (NCT01583179)
Timeframe: 48 hrs
Intervention | Time in minutes (Mean) |
---|
Control Group | 965 |
Buprenorphine | 862 |
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Pain Score on Post Operative Day 1
pain score on post operative day 1 was measured on a scale 1-10. higher scores correlates with more severe pain. score range is from '0' (no pain) to 10 (pain as severe as it can be) (NCT01583179)
Timeframe: 1 day postoperative
Intervention | score on a scale (Median) |
---|
Control Group | 6.5 |
Buprenorphine | 4.5 |
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Number of Participants With Response to Treatment (Responder) Using NRS Scale
Responders are subjects who achieve a relative reduction in pain intensity from the start of open-label titration to Week 12 in double-blind treatment. Average pain intensity over the last 24 hours was rated on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain imaginable). (NCT01633944)
Timeframe: Prior to open-label titration to Week 12 in double-blind treatment
Intervention | participants (Number) |
---|
| Responders with ≥30% pain reduction | Responders with ≥50% pain reduction |
---|
DB Buprenorphine HCl Buccal Film | 131 | 86 |
,DB Placebo Film | 99 | 69 |
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Patient Global Impression of Change
Subjects assessed their change in activity limitations as they relate to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC) questionnaire, a 7-point scale ranging from 1 (no change [or condition has got worse]) to 7 (a great deal better, and a considerable improvement that made all the difference) (NCT01633944)
Timeframe: Week 12
Intervention | units on a scale (Mean) |
---|
DB Buprenorphine HCl Buccal Film | 4.5 |
DB Placebo Film | 3.9 |
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Time to Optimal Dose of Open-label Study Medication
"Overall time to reach the optimal dose of study medication required to progress to double-blind treatment." (NCT01633944)
Timeframe: Up to 8 weeks in open-label titration
Intervention | days (Mean) |
---|
OL Buprenorphine HCl Buccal Film | 17.1 |
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Change From Baseline to Week 12 in Medical Outcomes Score Sleep Subscale
Medical Outcomes Score (MOS) Sleep Scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The scores of the dimensions (except quantity of sleep/optimal sleep) and of the sleep problem index range on a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (eg, greater sleep disturbance, greater adequacy of sleep). (NCT01633944)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Mean) |
---|
| Sleep problems index | Sleep disturbance | Somnolence | Sleep adequacy |
---|
DB Buprenorphine HCl Buccal Film | -0.23 | -1.43 | 0.90 | 1.71 |
,DB Placebo Film | 0.10 | -1.68 | 0.14 | 6.19 |
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Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)
Treatment failure is defined as study discontinuation due to lack of efficacy or discontinuation due to adverse events in the double-blind treatment phase. (NCT01633944)
Timeframe: Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
DB Buprenorphine HCl Buccal Film | 9.6 |
DB Placebo Film | 14.2 |
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Number of Subjects With Rescue Medication Use
Use of analgesic rescue medication recorded in subject diary. (NCT01633944)
Timeframe: Week 1 to Week 12 in double-blind treatment
Intervention | participants (Number) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 |
---|
DB Buprenorphine HCl Buccal Film | 123 | 112 | 85 | 81 | 76 | 74 | 73 | 64 | 67 | 60 | 62 | 56 |
,DB Placebo Film | 140 | 132 | 107 | 98 | 92 | 94 | 85 | 85 | 82 | 81 | 72 | 72 |
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Change From Baseline to Week 12 in Average Daily Pain Intensity Scores
Change in pain intensity = average of daily pain scores from the last 7 days prior to Week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable). (NCT01633944)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Mean) |
---|
DB Buprenorphine HCl Buccal Film | 0.94 |
DB Placebo Film | 1.59 |
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Change From Baseline to Week 12 in Roland Morris Disability Questionnaire
Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability. (NCT01633944)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Mean) |
---|
DB Buprenorphine HCl Buccal Film | 0.6 |
DB Placebo Film | 1.2 |
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Adverse Events
Adverse events that occur in more than 2 subjects. Among the adverse events that occurred in > 2 subjects, the total number of unique events that were experienced are reported. (NCT01666119)
Timeframe: 12 weeks
Intervention | adverse events (Number) |
---|
BEMA Buprenorphine/NX Films | 36 |
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Urine Drug Screen
Urine samples collected at screening and baseline to test for the presence of non-prescribed opioids. (NCT01666119)
Timeframe: 12 weeks
Intervention | participants (Number) |
---|
| Subjects with +-result for non-prescribed opiod | Number with single positive result | Number with 2 positive results | Number with > 2 positive results |
---|
BEMA Buprenorphine/NX Films | 19 | 11 | 4 | 4 |
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Change From Baseline to Week 12 in Average Daily Pain Intensity Scores
Change in pain intensity = average of daily pain scores from the last 7 days prior to week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable). (NCT01675167)
Timeframe: Baseline, week 12
Intervention | units on a scale (Mean) |
---|
DB Buprenorphine HCl Buccal Film | 0.88 |
DB Placebo Film | 1.92 |
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Change From Baseline to Week 12 in Roland Morris Disability Questionnaire
Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability. (NCT01675167)
Timeframe: Baseline, week 12
Intervention | units on a scale (Mean) |
---|
DB Buprenorphine HCl Buccal Film | 0.5 |
DB Placebo Film | 1.6 |
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Time to Optimal Dose of Open-label Study Medication
"Overall time to reach the optimum dose of study medication required to progress to double-blind treatment" (NCT01675167)
Timeframe: Up to 8 weeks in open-label titration
Intervention | days (Mean) |
---|
OL Buprenorphine HCl Buccal Film | 24.5 |
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Number of Participants With Response to Treatment (Responder) Using NRS Scale
Responders are subjects who achieve a relative reduction in pain intensity from the start of open-label titration to week 12 in double-blind treatment. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable). (NCT01675167)
Timeframe: Prior to open-label titration to week 12 in double-blind treatment
Intervention | participants (Number) |
---|
| Responders with ≥30% pain reduction | Responders with ≥50% pain reduction |
---|
DB Buprenorphine HCl Buccal Film | 156 | 96 |
,DB Placebo Film | 76 | 42 |
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Medical Outcomes Score Sleep Subscale - Quantity of Sleep/Optimal Sleep
Medical Outcomes Score (MOS) Sleep scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The quantity of sleep dimension is the average number of hours of sleep per night reported and optimal sleep is when the number of hours of sleep is ≥7. (NCT01675167)
Timeframe: Week 12
Intervention | participants (Number) |
---|
| Quantity of Sleep/Optimal Sleep ≥7 | Quantity of Sleep/Optimal Sleep <7 |
---|
DB Buprenorphine HCl Buccal Film | 75 | 156 |
,DB Placebo Film | 81 | 149 |
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Number of Subjects With Opioid Rescue Medication Use
Use of analgesic rescue medication recorded in subject diary (NCT01675167)
Timeframe: Week 1 to Week 12
Intervention | participants (Number) |
---|
| Week 1 (n=242, 246) | Week 2 (n=234, 204) | Week 3 (n=229, 189) | Week 4 (n=229, 179) | Week 5 (n=222, 162) | Week 6 (n=219, 161) | Week 7 (n=213, 154) | Week 8 (n=210, 152) | Week 9 (n=207, 146) | Week 10 (n=205, 145) | Week 11 (n=203, 144) | Week 12 (n=201, 141) |
---|
DB Buprenorphine HCl Buccal Film | 215 | 202 | 197 | 191 | 186 | 185 | 178 | 177 | 173 | 172 | 172 | 166 |
,DB Placebo Film | 228 | 185 | 172 | 164 | 147 | 146 | 140 | 137 | 129 | 130 | 130 | 128 |
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Change From Baseline to Week 12 in Medical Outcome Score Sleep Subscale
Medical Outcomes Score (MOS) Sleep Scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The scores of the dimensions (except quantity of sleep/optimal sleep) and of the sleep problem index range on a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (eg, greater sleep disturbance, greater adequacy of sleep). (NCT01675167)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Mean) |
---|
| Sleep problems index | Sleep disturbance | Somnolence | Sleep adequacy | Snoring | Awaken short of breath or headache |
---|
DB Buprenorphine HCl Buccal Film | -0.36 | -0.93 | 0.20 | 0.13 | 0.87 | 0.52 |
,DB Placebo Film | -1.37 | -3.54 | -0.38 | 3.61 | -2.78 | -4.26 |
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Patient Global Impression of Change
Subjects assessed their change in activity limitations as they relate to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC) questionnaire, a 7-point scale ranging from 1 (no change [or condition has got worse]) to 7 (a great deal better, and a considerable improvement that made all the difference) (NCT01675167)
Timeframe: Week 12
Intervention | units on a scale (Mean) |
---|
DB Buprenorphine HCl Buccal Film | 4.5 |
DB Placebo Film | 3.2 |
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Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)
Treatment failure is defined as study discontinuation due to lack of efficacy or discontinuation due to adverse events in the double-blind treatment phase. (NCT01675167)
Timeframe: Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
DB Buprenorphine HCl Buccal Film | 9.9 |
DB Placebo Film | 29.4 |
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Percentage of Participants Who Adhered to Study Visits.
(NCT01690546)
Timeframe: baseline to end of study (approximately 40 days)
Intervention | percentage of participants (Number) |
---|
BUP/VLNXT to VIVITROL | 74 |
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Craving
Craving, assessed with a 100-point Visual Analog Scale (VAS), ranging from 'not at all' (0) to 'more than ever' (100). The higher the score the higher the craving. (NCT01690546)
Timeframe: 4 weeks
Intervention | units on a scale (Mean) |
---|
BUP/VLNXT to VIVITROL | 5.12 |
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Number of Participants That Self Reported Illicit Drug Use
Participants reported on any illicit drug use to include Cocaine marijuana opiates (NCT01690546)
Timeframe: 4 weeks
Intervention | participants (Number) |
---|
| Marijuana | Cocaine | Opiates |
---|
BUP/VLNXT to VIVITROL | 10 | 3 | 4 |
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Illicit Drug Use, Measured by Urine Drug Testing
number of participants that tested positive for marijuana, cocaine, and opiates. (NCT01690546)
Timeframe: 4 weeks
Intervention | participants (Number) |
---|
| Marijuana | Cocaine | Opiates |
---|
BUP/VLNXT to VIVITROL | 11 | 3 | 4 |
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Withdrawal Intensity as Measured by the Subjective Opiate Withdrawal Scale (SOWS)
"After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks and record the total time they remained in treatment.~SOWS contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). Total score range is 0 - 64; the higher the score the more withdrawal symptoms." (NCT01690546)
Timeframe: 4 weeks
Intervention | units on a scale (Mean) |
---|
BUP/VLNXT to VIVITROL | 1.52 |
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Satisfaction With Treatment, Measured by a Treatment Satisfaction Questionnaire
"Questionnaire consisted of 3 questions.~Were you satisfied with the treatment (range 1-5): Completely satisfied (1) to completely dissatisfied (5).~Were you satisfied with withdrawal treatment (range 1-5): Minimal withdrawal (1) to worse than ever (5).~Did the medication help (range 1-5): Helped a lot (1) to No it did not help (5).~Lower scores represent greater satisfaction." (NCT01690546)
Timeframe: Day 9
Intervention | units on a scale (Mean) |
---|
| Were you satisfied with the treatment | Were you satisfied with withdrawal treatment | Did the medication help |
---|
BUP/VLNXT to VIVITROL | 1.31 | 2.04 | 1.69 |
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Withdrawal Intensity as Measured by the Clinical Opiate Withdrawal Scale (COWS)
"After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks and record the total time they remained in treatment.~COWS rates eleven common opiate withdrawal signs or symptoms. The summed scores ranged from 0-48, with 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal." (NCT01690546)
Timeframe: 4 weeks
Intervention | units on a scale (Mean) |
---|
BUP/VLNXT to VIVITROL | 0.64 |
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Use of Ancillary Medications.
Number of participants that took ancillary medication (NCT01690546)
Timeframe: baseline to week 1
Intervention | participants (Number) |
---|
BUP/VLNXT to VIVITROL | 35 |
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Retention in Treatment
After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks. (NCT01690546)
Timeframe: 4 weeks
Intervention | participants (Number) |
---|
BUP/VLNXT to VIVITROL | 26 |
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Percentage of Participants With Adherence to Medication (Naltrexone)
Participant who took Naltrexone as prescribed. (NCT01690546)
Timeframe: Day 1 to Day 8 (+/- 2 days)
Intervention | percentage of participants (Number) |
---|
BUP/VLNXT to VIVITROL | 100 |
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Norbuprenorphine PK: Area Under Plasma Concentration Time Curves (AUC)
"AUC calculated using the linear trapezoidal rule and requiring a minimum of 5 data points for each time range.~Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | hr*ng/mL (Mean) |
---|
| Sublingual Period (0-24 hours) | Initial Burst: Injection 1 (0-48 hours) | Initial Burst: Injection 4 (0-48 hours) | Plateau: Injection 1 (2-28 days) | Plateau: Injection 4 (2-28 days) | Overall: Injection 1 (0-24 hours) | Overall: Injection 1 (0-28 days) | Overall: Injection 4 (0-24 hours) | Overall: Injection 4 (0-28 days) |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 42.536 | 60.834 | 15.435 | 122.265 | 166.360 | 32.465 | 181.912 | 6.274 | 182.405 |
,Group 2 (12 mg) RBP-6000: 100 mg | 72.339 | 98.705 | 29.401 | 209.679 | 523.076 | 52.878 | 343.357 | 15.199 | 557.707 |
,Group 3 (24 mg) RBP-6000: 200 mg | 134.739 | 180.685 | 50.185 | 384.101 | 519.103 | 99.040 | 541.539 | 22.870 | 570.958 |
,Group 4 (8 mg) RBP-6000: 100 mg | 49.312 | 69.878 | 30.755 | 197.483 | 410.621 | 37.446 | 261.745 | 13.807 | 452.892 |
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Norbuprenorphine PK: Area Under Plasma Concentration Time Curves (AUC)
"AUC calculated using the linear trapezoidal rule and requiring a minimum of 5 data points for each time range.~Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | hr*ng/mL (Mean) |
---|
| Sublingual Period (0-24 hours) | Initial Burst: Injection 1 (0-48 hours) | Initial Burst: Injection 4 (0-48 hours) | Initial Burst: Injection 6 (0-48 hours) | Plateau: Injection 1 (2-28 days) | Plateau: Injection 4 (2-28 days) | Plateau: Injection 6 (2-28 days) | Overall: Injection 1 (0-24 hours) | Overall: Injection 1 (0-28 days) | Overall: Injection 4 (0-24 hours) | Overall: Injection 4 (0-28 days) | Overall: Injection 6 (0-28 days) |
---|
Group 5 (14 mg) RBP-6000: 200 mg | 65.558 | 131.277 | 45.941 | 59.352 | 295.342 | 550.225 | 537.212 | 68.660 | 426.283 | 16.301 | 673.245 | 814.570 |
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Norbuprenorphine PK: Area Under Plasma Concentration Time Curves (AUC)
"AUC calculated using the linear trapezoidal rule and requiring a minimum of 5 data points for each time range.~Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | hr*ng/mL (Mean) |
---|
| Sublingual Period (0-24 hours) | Initial Burst: Injection 1 (0-48 hours) | Initial Burst: Injection 4 (0-48 hours) | Initial Burst: Injection 6 (0-48 hours) | Plateau: Injection 1 (2-28 days) | Plateau: Injection 4 (2-28 days) | Plateau: Injection 6 (2-28 days) | Overall: Injection 1 (0-24 hours) | Overall: Injection 1 (0-28 days) | Overall: Injection 4 (0-24 hours) | Overall: Injection 4 (0-28 days) | Overall: Injection 6 (0-24 hours) |
---|
Group 6 (8-24 mg) RBP-6000: 300 mg | 98.407 | 148.016 | 101.888 | 90.719 | 513.577 | 1208.505 | 592.199 | 80.525 | 688.487 | 43.722 | 658.609 | 37.093 |
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Norbuprenorphine PK: Area Under Plasma Concentration Time Curve From Time Zero Of Injection 4 and 6 (AUC0-∞)
"Area under plasma concentration time curve from time zero of Injection 4 extrapolated to infinity; calculated for Injection 4 and 6 (last injection) in subjects not participating in PET imaging sub-study only as:~(AUC0-∞ was reported if the coefficient of determination R2 was at least 0.8 and the extrapolated area is less than 25%). A minimum of 5 data points was required. AUC up to the last measurable concentration (AUClast) was calculated by using the linear trapezoidal rule." (NCT01738503)
Timeframe: Days 85-113, 141-197
Intervention | hr*ng/mL (Mean) |
---|
| Overall: Injection 6 (0-28 days) |
---|
Group 6 (8-24 mg) RBP-6000: 300 mg | 737.097 |
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Norbuprenorphine PK: Area Under Plasma Concentration Time Curve From Time Zero Of Injection 4 and 6 (AUC0-∞)
"Area under plasma concentration time curve from time zero of Injection 4 extrapolated to infinity; calculated for Injection 4 and 6 (last injection) in subjects not participating in PET imaging sub-study only as:~(AUC0-∞ was reported if the coefficient of determination R2 was at least 0.8 and the extrapolated area is less than 25%). A minimum of 5 data points was required. AUC up to the last measurable concentration (AUClast) was calculated by using the linear trapezoidal rule." (NCT01738503)
Timeframe: Days 85-113, 141-197
Intervention | hr*ng/mL (Mean) |
---|
| Overall: Injection 4 (0-28 days) |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 499.733 |
,Group 2 (12 mg) RBP-6000: 100 mg | 1583.219 |
,Group 3 (24 mg) RBP-6000: 200 mg | 639.892 |
,Group 5 (14 mg) RBP-6000: 200 mg | 1472.769 |
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Norbuprenorphine PK: % Fluctuation
"% Fluctuation was defined as the degree of fluctuation of norbuprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cavg*100, expressed as a percentage. Cmax=maximum plasma concentration Cmin=minimum plasma concentration Cavg = average plasma concentration~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | % of average concentration (Mean) |
---|
| Sublingual Period | Plateau: Injection 1 | Plateau: Injection 4 | Plateau: Injection 6 | Overall: Injection 1 | Overall: Injection 4 | Overall: Injection 6 |
---|
Group 5 (14 mg) RBP-6000: 200 mg | 89.832 | 407.217 | 101.898 | 91.763 | 609.481 | 131.650 | 94.048 |
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Norbuprenorphine PK: % Fluctuation
"% Fluctuation was defined as the degree of fluctuation of norbuprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cavg*100, expressed as a percentage. Cmax=maximum plasma concentration Cmin=minimum plasma concentration Cavg = average plasma concentration~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | % of average concentration (Mean) |
---|
| Sublingual Period | Plateau: Injection 1 | Plateau: Injection 4 | Plateau: Injection 6 | Overall: Injection 1 | Overall: Injection 4 |
---|
Group 6 (8-24 mg) RBP-6000: 300 mg | 71.213 | 354.764 | 83.579 | 242.246 | 468.074 | 102.192 |
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Norbuprenorphine PK: % Fluctuation
"% Fluctuation was defined as the degree of fluctuation of norbuprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cavg*100, expressed as a percentage. Cmax=maximum plasma concentration Cmin=minimum plasma concentration Cavg = average plasma concentration~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | % of average concentration (Mean) |
---|
| Sublingual Period | Plateau: Injection 1 | Plateau: Injection 4 | Overall: Injection 1 | Overall: Injection 4 |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 69.798 | 577.952 | 114.801 | 612.998 | 128.273 |
,Group 2 (12 mg) RBP-6000: 100 mg | 94.132 | 475.800 | 127.106 | 502.856 | 131.080 |
,Group 3 (24 mg) RBP-6000: 200 mg | 79.225 | 504.540 | 110.567 | 685.962 | 127.005 |
,Group 4 (8 mg) RBP-6000: 100 mg | 82.834 | 403.009 | 77.455 | 497.361 | 95.960 |
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Columbia Suicide Severity Rating Scale (C-SSRS): Severity
The scale used in the C-SSRS is a continuous variable ranging from 0 (no suicidal ideation present) to 5 (active ideation with specific plan and intent). Only participants with suicidal ideation (scale of 1-5) are reported. 1=desire to be dead to 5=active ideation with specific plan and intent. (NCT01738503)
Timeframe: Screening (summary of lifetime), Screening (last 6 months), Day 65, Day 113, End of Study (up to day 365)
Intervention | units on a scale (Mean) |
---|
| Screening (summary of lifetime) | Screening (last 6 months) | Day 65 |
---|
Group 6 (8-24 mg) RBP-6000: 300 mg | 1.3 | 1.0 | 1.0 |
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Columbia Suicide Severity Rating Scale (C-SSRS): Severity
The scale used in the C-SSRS is a continuous variable ranging from 0 (no suicidal ideation present) to 5 (active ideation with specific plan and intent). Only participants with suicidal ideation (scale of 1-5) are reported. 1=desire to be dead to 5=active ideation with specific plan and intent. (NCT01738503)
Timeframe: Screening (summary of lifetime), Screening (last 6 months), Day 65, Day 113, End of Study (up to day 365)
Intervention | units on a scale (Mean) |
---|
| Screening (summary of lifetime) | End of study |
---|
Group 3 (24 mg) RBP-6000: 200 mg | 1.8 | 5.0 |
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Columbia Suicide Severity Rating Scale (C-SSRS): Severity
The scale used in the C-SSRS is a continuous variable ranging from 0 (no suicidal ideation present) to 5 (active ideation with specific plan and intent). Only participants with suicidal ideation (scale of 1-5) are reported. 1=desire to be dead to 5=active ideation with specific plan and intent. (NCT01738503)
Timeframe: Screening (summary of lifetime), Screening (last 6 months), Day 65, Day 113, End of Study (up to day 365)
Intervention | units on a scale (Mean) |
---|
| Screening (summary of lifetime) | Day 65 |
---|
Group 5 (14 mg) RBP-6000: 200 mg | 1.0 | 1.0 |
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Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) Prior to Injections 1, 2, 3, 4 and 6
"The Subjective Opiate Withdrawal Scale (SOWS) contains 16 symptoms whose intensity the participant rates on a scale of 0 (not at all) to 4 (extremely) for a full scale of 0 (no withdrawal symptoms) to 64 (extreme withdrawal symptoms).~Baseline was defined as the peak (maximum) value from screening to study Day -13 pre-SUBUTEX dose. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing and reported as change from baseline values.~Negative change from baseline values indicate a lessening of withdrawal symptoms." (NCT01738503)
Timeframe: Baseline (screening to Day -13), Days -1, 1, 29, 57, 85 141
Intervention | units on a scale (Mean) |
---|
| Baseline (observed values) | Day -1 | Day 1 | Day 29 | Day 57 | Day 85 |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 40.2 | -38.07 | -38.73 | -38.20 | -39.50 | -38.36 |
,Group 2 (12 mg) RBP-6000: 100 mg | 47.8 | -45.20 | -45.60 | -45.64 | -46.07 | -45.58 |
,Group 3 (24 mg) RBP-6000: 200 mg | 45.1 | -43.40 | -43.47 | -44.15 | -43.09 | -43.82 |
,Group 4 (8 mg) RBP-6000: 100 mg | 42.7 | -40.67 | -40.80 | -40.62 | -39.50 | -41.60 |
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Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) Prior to Injections 1, 2, 3, 4 and 6
"The Subjective Opiate Withdrawal Scale (SOWS) contains 16 symptoms whose intensity the participant rates on a scale of 0 (not at all) to 4 (extremely) for a full scale of 0 (no withdrawal symptoms) to 64 (extreme withdrawal symptoms).~Baseline was defined as the peak (maximum) value from screening to study Day -13 pre-SUBUTEX dose. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing and reported as change from baseline values.~Negative change from baseline values indicate a lessening of withdrawal symptoms." (NCT01738503)
Timeframe: Baseline (screening to Day -13), Days -1, 1, 29, 57, 85 141
Intervention | units on a scale (Mean) |
---|
| Baseline (observed values) | Day -1 | Day 1 | Day 29 | Day 57 | Day 85 | Day 141 |
---|
Group 5 (14 mg) RBP-6000: 200 mg | 42.1 | -39.47 | -39.67 | -39.64 | -38.85 | -41.27 | -45.67 |
,Group 6 (8-24 mg) RBP-6000: 300 mg | 43.9 | -42.71 | -42.57 | -46.00 | -49.20 | -51.71 | -59.50 |
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Norbuprenorphine PK: Average Plasma Concentration (Cavg)
"Cavg was defined as the AUC (timeframe)/timeframe. For example, the sublingual steady-state Cavg reading on Day -1 = AUC0-24/ 24 hours~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | ng/mL (Mean) |
---|
| Sublingual Period | Plateau: Injection 1 | Plateau: Injection 4 | Plateau: Injection 6 | Overall: Injection 1 | Overall: Injection 4 |
---|
Group 6 (8-24 mg) RBP-6000: 300 mg | 4.100 | 0.823 | 1.937 | 0.949 | 1.025 | 0.980 |
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Norbuprenorphine PK: Average Plasma Concentration (Cavg)
"Cavg was defined as the AUC (timeframe)/timeframe. For example, the sublingual steady-state Cavg reading on Day -1 = AUC0-24/ 24 hours~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | ng/mL (Mean) |
---|
| Sublingual Period | Plateau: Injection 1 | Plateau: Injection 4 | Plateau: Injection 6 | Overall: Injection 1 | Overall: Injection 4 | Overall: Injection 6 |
---|
Group 5 (14 mg) RBP-6000: 200 mg | 2.732 | 0.473 | 0.882 | 0.861 | 0.634 | 1.002 | 1.212 |
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Norbuprenorphine PK: Maximum Observed Plasma Concentration (Cmax)
"Maximum observed plasma concentration, determined directly from individual concentration time data.~Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | ng/mL (Mean) |
---|
| Sublingual Period (0-24 hours) | Initial Burst: Injection 1 (0-48 hours) | Initial Burst: Injection 4 (0-48 hours) | Initial Burst: Injection 6 (0-48 hours) | Plateau: Injection 1 (2-28 days) | Plateau: Injection 4 (2-28 days) | Plateau: Injection 6 (2-28 days) | Overall: Injection 1 | Overall: Injection 4 | Overall: Injection 6 |
---|
Group 5 (14 mg) RBP-6000: 200 mg | 5.268 | 3.878 | 1.305 | 1.885 | 2.203 | 1.420 | 1.885 | 3.989 | 1.539 | 1.885 |
,Group 6 (8-24 mg) RBP-6000: 300 mg | 5.820 | 4.496 | 2.769 | 2.620 | 3.212 | 2.710 | 2.620 | 4.555 | 2.769 | 2.620 |
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Norbuprenorphine PK: Maximum Observed Plasma Concentration (Cmax)
"Maximum observed plasma concentration, determined directly from individual concentration time data.~Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | ng/mL (Mean) |
---|
| Sublingual Period (0-24 hours) | Initial Burst: Injection 1 (0-48 hours) | Initial Burst: Injection 4 (0-48 hours) | Plateau: Injection 1 (2-28 days) | Plateau: Injection 4 (2-28 days) | Overall: Injection 1 | Overall: Injection 4 |
---|
Group 3 (24 mg) RBP-6000: 200 mg | 8.515 | 5.335 | 1.343 | 3.201 | 1.387 | 5,572 | 1.456 |
,Group 4 (8 mg) RBP-6000: 100 mg | 3.268 | 1.965 | 0.799 | 1.320 | 0.926 | 1.977 | 0.929 |
,Group 1 (8 mg) RBP-6000: 50 mg | 2.559 | 1.674 | 0.462 | 1.165 | 0.464 | 1.698 | 0.474 |
,Group 2 (12 mg) RBP-6000: 100 mg | 4.941 | 2.704 | 0.966 | 1.904 | 1.423 | 2.753 | 1.431 |
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Norbuprenorphine PK: Minimum Observed Plasma Concentration (Cmin)
"Minimum observed plasma concentration, determined directly from individual concentration time data.~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | ng/mL (Mean) |
---|
| Sublingual Period (0-24 hours) | Plateau: Injection 1 (2-28 days) | Plateau: Injection 4 (2-28 days) | Overall: Injection 1 | Overall: Injection 4 |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 1.361 | 0.057 | 0.165 | 0.057 | 0.125 |
,Group 2 (12 mg) RBP-6000: 100 mg | 2.342 | 0.099 | 0.432 | 0.098 | 0.327 |
,Group 3 (24 mg) RBP-6000: 200 mg | 4.287 | 0.162 | 0.548 | 0.162 | 0.461 |
,Group 4 (8 mg) RBP-6000: 100 mg | 1.582 | 0.119 | 0.439 | 0.152 | 0.349 |
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Norbuprenorphine PK: Minimum Observed Plasma Concentration (Cmin)
"Minimum observed plasma concentration, determined directly from individual concentration time data.~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | ng/mL (Mean) |
---|
| Sublingual Period (0-24 hours) | Plateau: Injection 1 (2-28 days) | Plateau: Injection 4 (2-28 days) | Plateau: Injection 6 (2-28 days) | Overall: Injection 1 | Overall: Injection 4 | Overall: Injection 6 |
---|
Group 5 (14 mg) RBP-6000: 200 mg | 2.482 | 0.177 | 0.587 | 0.895 | 0.177 | 0.459 | 0.728 |
,Group 6 (8-24 mg) RBP-6000: 300 mg | 2.923 | 0.258 | 1.234 | 0.321 | 0.301 | 0.982 | 0.281 |
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Norbuprenorphine PK: Swing of Plasma Concentrations
"The swing of norbuprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cmin within the dosing interval.~Cmax=maximum plasma concentration Cmin=minimum plasma concentration~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | percentage of Cmin (Mean) |
---|
| Sublingual Period | Plateau: Injection 1 | Plateau: Injection 4 | Overall: Injection 1 | Overall: Injection 4 |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 93.472 | 1993.328 | 180.340 | 2903.100 | 322.876 |
,Group 2 (12 mg) RBP-6000: 100 mg | 130.823 | 1871.238 | 289.316 | 2812.484 | 379.301 |
,Group 3 (24 mg) RBP-6000: 200 mg | 102.059 | 2531.386 | 171.673 | 4477.582 | 265.586 |
,Group 4 (8 mg) RBP-6000: 100 mg | 109.416 | 1188.490 | 121.682 | 1776.276 | 186.942 |
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Norbuprenorphine PK: Terminal Phase Half Life (t1/2) Calculated For Injection 4
The terminal phase half life calculated for Injection 4 in subjects not participating in PET imaging sub-study. The t1/2 was reported only if the coefficient of determination R2 was at least 0.8. (NCT01738503)
Timeframe: Days 85-113, 141-197
Intervention | hours (Mean) |
---|
| Overall: Injection 4 (0-28 days) |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 405.325 |
,Group 2 (12 mg) RBP-6000: 100 mg | 241.914 |
,Group 3 (24 mg) RBP-6000: 200 mg | 334.080 |
,Group 5 (14 mg) RBP-6000: 200 mg | 310.879 |
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Norbuprenorphine PK: Average Plasma Concentration (Cavg)
"Cavg was defined as the AUC (timeframe)/timeframe. For example, the sublingual steady-state Cavg reading on Day -1 = AUC0-24/ 24 hours~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | ng/mL (Mean) |
---|
| Sublingual Period | Plateau: Injection 1 | Plateau: Injection 4 | Overall: Injection 1 | Overall: Injection 4 |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 1.772 | 0.196 | 0.267 | 0.271 | 0.271 |
,Group 2 (12 mg) RBP-6000: 100 mg | 3.014 | 0.336 | 0.838 | 0.511 | 0.830 |
,Group 3 (24 mg) RBP-6000: 200 mg | 5.614 | 0.616 | 0.832 | 0.806 | 0.850 |
,Group 4 (8 mg) RBP-6000: 100 mg | 2.055 | 0.316 | 0.658 | 0.390 | 0.674 |
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Norbuprenorphine PK: Time to Maximum Buprenorphine Plasma Concentration (Tmax)
"Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | hours (Median) |
---|
| Sublingual Period (0-24 hours) | Initial Burst: Injection 1 (0-48 hours) | Initial Burst: Injection 4 (0-48 hours) | Initial Burst: Injection 6 (0-48 hours) | Plateau: Injection 1 (2-28 days) | Plateau: Injection 4 (2-28 days) | Plateau: Injection 6 (2-28 days) | Overall: Injection 1 (0-28 days) | Overall: Injection 4 (0-28 days) | Overall: Injection 6 (0-28 days) |
---|
Group 5 (14 mg) RBP-6000: 200 mg | 2.000 | 6.000 | 24.000 | 48.000 | 48.000 | 167.017 | 48.000 | 4.000 | 30.067 | 48.000 |
,Group 6 (8-24 mg) RBP-6000: 300 mg | 2.000 | 4.000 | 12.000 | 48.000 | 48.000 | 303.133 | 48.000 | 4.000 | 12.000 | 48.000 |
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Norbuprenorphine PK: Time to Maximum Buprenorphine Plasma Concentration (Tmax)
"Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | hours (Median) |
---|
| Sublingual Period (0-24 hours) | Initial Burst: Injection 1 (0-48 hours) | Initial Burst: Injection 4 (0-48 hours) | Plateau: Injection 1 (2-28 days) | Plateau: Injection 4 (2-28 days) | Overall: Injection 1 (0-28 days) | Overall: Injection 4 (0-28 days) |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 2.000 | 8.000 | 48.000 | 48.000 | 48.000 | 8.000 | 48.000 |
,Group 2 (12 mg) RBP-6000: 100 mg | 1.017 | 6.000 | 48.000 | 48.000 | 96.883 | 6.000 | 48.000 |
,Group 3 (24 mg) RBP-6000: 200 mg | 1.000 | 4.000 | 48.000 | 48.000 | 48.100 | 2.525 | 48.000 |
,Group 4 (8 mg) RBP-6000: 100 mg | 2.000 | 12.000 | 39.000 | 48.000 | 182.808 | 6.000 | 182.808 |
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Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent one of the outcomes listed in this definition. A serious AE (SAE) is defined as any AE occurring at any dose that results in any of the following outcomes: death; lifethreatening AE; hospitalization or prolongation of existing hospitalization; a persistent or significant disability/incapacit (NCT01738503)
Timeframe: Days -14 to -1 (Subutex treatment), Days 1-316 (RBP-6000 treatment)
Intervention | Participants (Count of Participants) |
---|
| >=1 TEAE | >=1 TEAE related to study drug | >=1 Severe TEAE | Deaths | >=1 SAE other than death | Withdrew from study due to a TEAE |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 15 | 0 | 0 | 0 | 0 | 1 |
,Group 2 (12 mg) RBP-6000: 100 mg | 15 | 0 | 0 | 0 | 2 | 0 |
,Group 3 (24 mg) RBP-6000: 200 mg | 15 | 0 | 0 | 0 | 1 | 1 |
,Group 4 (8 mg) RBP-6000: 100 mg | 15 | 0 | 0 | 0 | 1 | 2 |
,Group 5 (14 mg) RBP-6000: 200 mg | 15 | 0 | 1 | 0 | 2 | 2 |
,Group 6 (8-24 mg) RBP-6000: 300 mg | 14 | 0 | 0 | 0 | 0 | 2 |
,SUBUTEX Only | 24 | 0 | 1 | 0 | 0 | 0 |
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Norbuprenorphine PK: Swing of Plasma Concentrations
"The swing of norbuprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cmin within the dosing interval.~Cmax=maximum plasma concentration Cmin=minimum plasma concentration~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | percentage of Cmin (Mean) |
---|
| Sublingual Period | Plateau: Injection 1 | Plateau: Injection 4 | Plateau: Injection 6 | Overall: Injection 1 | Overall: Injection 4 | Overall: Injection 6 |
---|
Group 5 (14 mg) RBP-6000: 200 mg | 124.601 | 1210.967 | 151.990 | 112.503 | 2355.099 | 272.260 | 155.577 |
,Group 6 (8-24 mg) RBP-6000: 300 mg | 101.558 | 1250.370 | 118.215 | 716.199 | 2116.996 | 173.090 | 832.384 |
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Columbia Suicide Severity Rating Scale (C-SSRS): Severity
The scale used in the C-SSRS is a continuous variable ranging from 0 (no suicidal ideation present) to 5 (active ideation with specific plan and intent). Only participants with suicidal ideation (scale of 1-5) are reported. 1=desire to be dead to 5=active ideation with specific plan and intent. (NCT01738503)
Timeframe: Screening (summary of lifetime), Screening (last 6 months), Day 65, Day 113, End of Study (up to day 365)
Intervention | units on a scale (Mean) |
---|
| Day 113 |
---|
Group 2 (12 mg) RBP-6000: 100 mg | 1.0 |
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Columbia Suicide Severity Rating Scale (C-SSRS): Severity
The scale used in the C-SSRS is a continuous variable ranging from 0 (no suicidal ideation present) to 5 (active ideation with specific plan and intent). Only participants with suicidal ideation (scale of 1-5) are reported. 1=desire to be dead to 5=active ideation with specific plan and intent. (NCT01738503)
Timeframe: Screening (summary of lifetime), Screening (last 6 months), Day 65, Day 113, End of Study (up to day 365)
Intervention | units on a scale (Mean) |
---|
| Screening (summary of lifetime) |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 1.0 |
,Group 4 (8 mg) RBP-6000: 100 mg | 2.0 |
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Norbuprenorphine PK: Accumulation Index in Terms of Maximum Observed Plasma Drug Concentration (Rac(Cmax))
Accumulation index in terms of Cmax calculated as ratio of Cmax Injection 4/ Cmax Injection 1. (NCT01738503)
Timeframe: Days 1-28, 85-113
Intervention | ratio (Mean) |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 0.300 |
Group 2 (12 mg) RBP-6000: 100 mg | 0.697 |
Group 3 (24 mg) RBP-6000: 200 mg | 0.272 |
Group 4 (8 mg) RBP-6000: 100 mg | 0.548 |
Group 5 (14 mg) RBP-6000: 200 mg | 0.445 |
Group 6 (8-24 mg) RBP-6000: 300 mg | 0.730 |
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Buprenorphine PK: Accumulation Index in Terms of Area Under the Curve (Rac(AUC))
Accumulation index in terms of AUC calculated as ratio of AUCtau Injection 4/ AUCtau Injection 1. AUCtau = area under plasma concentration time curve over the dosing interval tau (for SC RBP-6000, tau=28 days). (NCT01738503)
Timeframe: Days 1-28, 85-113
Intervention | ratio (Mean) |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 2.580 |
Group 2 (12 mg) RBP-6000: 100 mg | 2.738 |
Group 3 (24 mg) RBP-6000: 200 mg | 3.456 |
Group 4 (8 mg) RBP-6000: 100 mg | 3.379 |
Group 5 (14 mg) RBP-6000: 200 mg | 2.837 |
Group 6 (8-24 mg) RBP-6000: 300 mg | 3.573 |
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Buprenorphine PK: Accumulation Index in Terms of Maximum Observed Plasma Drug Concentration (Rac(Cmax))
Accumulation index in terms of Cmax calculated as ratio of Cmax Injection 4/ Cmax Injection 1. (NCT01738503)
Timeframe: Days 1-28, 85-113
Intervention | ratio (Mean) |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 1.380 |
Group 2 (12 mg) RBP-6000: 100 mg | 1.560 |
Group 3 (24 mg) RBP-6000: 200 mg | 1.766 |
Group 4 (8 mg) RBP-6000: 100 mg | 1.729 |
Group 5 (14 mg) RBP-6000: 200 mg | 1.559 |
Group 6 (8-24 mg) RBP-6000: 300 mg | 1.908 |
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Buprenorphine PK: Area Under Plasma Concentration Time Curve From Time Zero Of Injection 4 (AUC0-∞)
"Area under plasma concentration time curve from time zero of Injection 4 extrapolated to infinity; calculated for Injection 4 (last injection) in subjects not participating in PET imaging sub-study only as:~(AUC0-∞ was reported if the coefficient of determination R2 was at least 0.8 and the extrapolated area is less than 25%). A minimum of 5 data points was required. AUC up to the last measurable concentration (AUClast) was calculated by using the linear trapezoidal rule." (NCT01738503)
Timeframe: Days 85-113
Intervention | hr*ng/mL (Mean) |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 2280.295 |
Group 2 (12 mg) RBP-6000: 100 mg | 3521.376 |
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Buprenorphine PK: Terminal Phase Half Life (t1/2) Calculated For Injection 4
The terminal phase half life calculated for Injection 4 in subjects not participating in PET imaging sub-study. The t1/2 was reported only if the coefficient of determination R2 was at least 0.8. (NCT01738503)
Timeframe: Days 85-113
Intervention | hours (Mean) |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 550.329 |
Group 2 (12 mg) RBP-6000: 100 mg | 138.238 |
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Norbuprenorphine PK: Accumulation Index in Terms of Area Under the Curve (Rac(AUC))
Accumulation index in terms of AUC calculated as ratio of AUCtau Injection 4/ AUCtau Injection 1. AUCtau = area under plasma concentration time curve over the dosing interval tau (for SC RBP-6000, tau=28 days). (NCT01738503)
Timeframe: Days 1-28, 85-113
Intervention | ratio (Mean) |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 1.071 |
Group 2 (12 mg) RBP-6000: 100 mg | 1.924 |
Group 3 (24 mg) RBP-6000: 200 mg | 1.147 |
Group 4 (8 mg) RBP-6000: 100 mg | 1.709 |
Group 5 (14 mg) RBP-6000: 200 mg | 1.711 |
Group 6 (8-24 mg) RBP-6000: 300 mg | 1.247 |
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Percentage of Urine Drug Screen Samples Negative for Opioids
"Urine samples were screened for the following drugs:~opiates~cocaine~amphetamines~methadone~cannabinoids~barbiturates~buprenorphine. Buprenorphine was only included in the urine drug screen at screening and Day -14 to determine if the subject had used any buprenorphine-containing products prior to the start of SUBUTEX SL tablet dosing.~benzodiazepines~methamphetamine~phencyclidine~Urine drug screens were run every day when the participant was an inpatient; every 2-3 days when the participant was an outpatient. Drug screens were run less often for those participants in the PET substudy." (NCT01738503)
Timeframe: Day 1 to End of Study (up to day 365)
Intervention | percentage of total urine drug samples (Mean) |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 41.2 |
Group 2 (12 mg) RBP-6000: 100 mg | 42.0 |
Group 3 (24 mg) RBP-6000: 200 mg | 54.6 |
Group 4 (8 mg) RBP-6000: 100 mg | 49.9 |
Group 5 (14 mg) RBP-6000: 200 mg | 41.6 |
Group 6 (8-24 mg) RBP-6000: 300 mg | 64.9 |
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Buprenorphine PK: % Fluctuation
"% Fluctuation was defined as the degree of fluctuation of buprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cavg*100, expressed as a percentage. Cmax=maximum plasma concentration Cmin=minimum plasma concentration Cavg = average plasma concentration~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | % of average concentration (Mean) |
---|
| Sublingual Period | Plateau: Injection 1 | Plateau: Injection 4 | Overall: Injection 1 | Overall: Injection 4 |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 256.993 | 213.664 | 68.333 | 315.777 | 152.755 |
,Group 2 (12 mg) RBP-6000: 100 mg | 272.702 | 175.068 | 63.611 | 234.098 | 95.140 |
,Group 3 (24 mg) RBP-6000: 200 mg | 233.978 | 168.963 | 42.699 | 234.598 | 75.633 |
,Group 4 (8 mg) RBP-6000: 100 mg | 268.690 | 140.924 | 41.275 | 213.254 | 77.067 |
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Buprenorphine PK: % Fluctuation
"% Fluctuation was defined as the degree of fluctuation of buprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cavg*100, expressed as a percentage. Cmax=maximum plasma concentration Cmin=minimum plasma concentration Cavg = average plasma concentration~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | % of average concentration (Mean) |
---|
| Sublingual Period | Plateau: Injection 1 | Plateau: Injection 4 | Plateau: Injection 6 | Overall: Injection 1 | Overall: Injection 4 |
---|
Group 6 (8-24 mg) RBP-6000: 300 mg | 245.513 | 107.909 | 53.383 | 31.376 | 220.854 | 83.695 |
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Buprenorphine PK: Swing of Plasma Concentrations
"The swing of buprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cmin within the dosing interval.~Cmax=maximum plasma concentration Cmin=minimum plasma concentration~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | percentage of Cmin (Mean) |
---|
| Sublingual Period | Plateau: Injection 1 | Plateau: Injection 4 | Plateau: Injection 6 | Overall: Injection 1 | Overall: Injection 4 | Overall: Injection 6 |
---|
Group 5 (14 mg) RBP-6000: 200 mg | 500.322 | 197.895 | 57.889 | 39.390 | 336.666 | 103.271 | 73.993 |
,Group 6 (8-24 mg) RBP-6000: 300 mg | 534.280 | 147.463 | 61.481 | 36.175 | 548.179 | 138.783 | 66.434 |
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Norbuprenorphine PK: Terminal Phase Half Life (t1/2) Calculated For Injection 4
The terminal phase half life calculated for Injection 4 in subjects not participating in PET imaging sub-study. The t1/2 was reported only if the coefficient of determination R2 was at least 0.8. (NCT01738503)
Timeframe: Days 85-113, 141-197
Intervention | hours (Mean) |
---|
| Overall: Injection 6 (0-28 days) |
---|
Group 6 (8-24 mg) RBP-6000: 300 mg | 158.840 |
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Buprenorphine PK: % Fluctuation
"% Fluctuation was defined as the degree of fluctuation of buprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cavg*100, expressed as a percentage. Cmax=maximum plasma concentration Cmin=minimum plasma concentration Cavg = average plasma concentration~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | % of average concentration (Mean) |
---|
| Sublingual Period | Plateau: Injection 1 | Plateau: Injection 4 | Plateau: Injection 6 | Overall: Injection 1 | Overall: Injection 4 | Overall: Injection 6 |
---|
Group 5 (14 mg) RBP-6000: 200 mg | 227.874 | 135.433 | 47.282 | 22.597 | 206.691 | 75.202 | 54.789 |
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Buprenorphine PK: Apparent Clearance at Steady-State (CLss/F) Following Injections 4 and 6
Apparent clearance at steady-state (CLss/F) = Dose / AUCtau (tau was 28 days). (NCT01738503)
Timeframe: Days 85-113, 141-169
Intervention | L/hour (Mean) |
---|
| Injection 4 |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 85.543 |
,Group 2 (12 mg) RBP-6000: 100 mg | 85.043 |
,Group 3 (24 mg) RBP-6000: 200 mg | 105.155 |
,Group 4 (8 mg) RBP-6000: 100 mg | 87.404 |
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Buprenorphine PK: Apparent Clearance at Steady-State (CLss/F) Following Injections 4 and 6
Apparent clearance at steady-state (CLss/F) = Dose / AUCtau (tau was 28 days). (NCT01738503)
Timeframe: Days 85-113, 141-169
Intervention | L/hour (Mean) |
---|
| Injection 4 | Injection 6 |
---|
Group 5 (14 mg) RBP-6000: 200 mg | 105.390 | 77.749 |
,Group 6 (8-24 mg) RBP-6000: 300 mg | 80.860 | 79.777 |
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Buprenorphine PK: Area Under Plasma Concentration Time Curves (AUC)
"AUC calculated using the linear trapezoidal rule and requiring a minimum of 5 data points for each time range.~Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | hr*ng/mL (Mean) |
---|
| Sublingual Period (0-24 hours) | Initial Burst: Injection 1 (0-48 hours) | Initial Burst: Injection 4 (0-48 hours) | Initial Burst: Injection 6 (0-48 hours) | Plateau: Injection 1 (2-28 days) | Plateau: Injection 4 (2-28 days) | Plateau: Injection 6 (2-28 days) | Overall: Injection 1 (0-24 hours) | Overall: Injection 1 (0-28 days) | Overall: Injection 4 (0-24 hours) | Overall: Injection 4 (0-28 days) | Overall: Injection 6 (0-24 hours) |
---|
Group 6 (8-24 mg) RBP-6000: 300 mg | 46.628 | 164.511 | 381.729 | 320.159 | 926.110 | 3426.313 | 3460.459 | 85.090 | 1268.012 | 178.109 | 3230.873 | 155.779 |
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Buprenorphine PK: Area Under Plasma Concentration Time Curves (AUC)
"AUC calculated using the linear trapezoidal rule and requiring a minimum of 5 data points for each time range.~Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | hr*ng/mL (Mean) |
---|
| Sublingual Period (0-24 hours) | Initial Burst: Injection 1 (0-48 hours) | Initial Burst: Injection 4 (0-48 hours) | Initial Burst: Injection 6 (0-48 hours) | Plateau: Injection 1 (2-28 days) | Plateau: Injection 4 (2-28 days) | Plateau: Injection 6 (2-28 days) | Overall: Injection 1 (0-24 hours) | Overall: Injection 1 (0-28 days) | Overall: Injection 4 (0-24 hours) | Overall: Injection 4 (0-28 days) | Overall: Injection 6 (0-28 days) |
---|
Group 5 (14 mg) RBP-6000: 200 mg | 46.681 | 104.868 | 172.421 | 216.540 | 648.344 | 1859.204 | 2209.11 | 50.034 | 756.053 | 81.417 | 2051.989 | 2585.976 |
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Buprenorphine PK: Area Under Plasma Concentration Time Curves (AUC)
"AUC calculated using the linear trapezoidal rule and requiring a minimum of 5 data points for each time range.~Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | hr*ng/mL (Mean) |
---|
| Sublingual Period (0-24 hours) | Initial Burst: Injection 1 (0-48 hours) | Initial Burst: Injection 4 (0-48 hours) | Plateau: Injection 1 (2-28 days) | Plateau: Injection 4 (2-28 days) | Overall: Injection 1 (0-24 hours) | Overall: Injection 1 (0-28 days) | Overall: Injection 4 (0-24 hours) | Overall: Injection 4 (0-28 days) |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 28.452 | 46.855 | 69.845 | 208.013 | 596.568 | 24.922 | 246.650 | 35.250 | 667.611 |
,Group 2 (12 mg) RBP-6000: 100 mg | 40.971 | 72.453 | 113.347 | 395.450 | 1142.046 | 36.981 | 461.366 | 56.231 | 1272.047 |
,Group 3 (24 mg) RBP-6000: 200 mg | 63.019 | 109.029 | 185.535 | 541.226 | 1807.403 | 55.291 | 642.010 | 91.197 | 1932.068 |
,Group 4 (8 mg) RBP-6000: 100 mg | 30.029 | 62.395 | 98.566 | 368.925 | 1073.201 | 31.747 | 413.438 | 47.633 | 1275.098 |
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Buprenorphine PK: Average Plasma Concentration (Cavg)
"Cavg was defined as the AUC (timeframe)/timeframe. For example, the sublingual steady-state Cavg reading on Day -1 = AUC0-24/ 24 hours~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | ng/mL (Mean) |
---|
| Sublingual Period | Plateau: Injection 1 | Plateau: Injection 4 | Overall: Injection 1 | Overall: Injection 4 |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 1.186 | 0.333 | 0.954 | 0.367 | 0.993 |
,Group 2 (12 mg) RBP-6000: 100 mg | 1.707 | 0.634 | 1.830 | 0.687 | 1.893 |
,Group 3 (24 mg) RBP-6000: 200 mg | 2.626 | 0.867 | 2.896 | 0.955 | 2.875 |
,Group 4 (8 mg) RBP-6000: 100 mg | 1.251 | 0.591 | 1.720 | 0.615 | 1.897 |
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Buprenorphine PK: Average Plasma Concentration (Cavg)
"Cavg was defined as the AUC (timeframe)/timeframe. For example, the sublingual steady-state Cavg reading on Day -1 = AUC0-24/ 24 hours~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | ng/mL (Mean) |
---|
| Sublingual Period | Plateau: Injection 1 | Plateau: Injection 4 | Plateau: Injection 6 | Overall: Injection 1 | Overall: Injection 4 |
---|
Group 6 (8-24 mg) RBP-6000: 300 mg | 1.943 | 1.484 | 5.491 | 5.546 | 1.887 | 4.808 |
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Buprenorphine PK: Average Plasma Concentration (Cavg)
"Cavg was defined as the AUC (timeframe)/timeframe. For example, the sublingual steady-state Cavg reading on Day -1 = AUC0-24/ 24 hours~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | ng/mL (Mean) |
---|
| Sublingual Period | Plateau: Injection 1 | Plateau: Injection 4 | Plateau: Injection 6 | Overall: Injection 1 | Overall: Injection 4 | Overall: Injection 6 |
---|
Group 5 (14 mg) RBP-6000: 200 mg | 1.945 | 1.039 | 2.979 | 3.540 | 1.125 | 3.054 | 3.848 |
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Buprenorphine PK: Maximum Observed Plasma Concentration (Cmax)
"Maximum observed plasma concentration, determined directly from individual concentration time data.~Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | ng/mL (Mean) |
---|
| Sublingual Period (0-24 hours) | Initial Burst: Injection 1 (0-48 hours) | Initial Burst: Injection 4 (0-48 hours) | Initial Burst: Injection 6 (0-48 hours) | Plateau: Injection 1 (2-28 days) | Plateau: Injection 4 (2-28 days) | Plateau: Injection 6 (2-28 days) | Overall: Injection 1 | Overall: Injection 4 | Overall: Injection 6 |
---|
Group 5 (14 mg) RBP-6000: 200 mg | 5.260 | 2.861 | 4.404 | 5.015 | 2.112 | 3.780 | 4.650 | 2.861 | 4.404 | 5.015 |
,Group 6 (8-24 mg) RBP-6000: 300 mg | 5.813 | 4.817 | 9.637 | 7.140 | 2.975 | 7.452 | 6.550 | 4.817 | 9.637 | 7.140 |
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Buprenorphine PK: Maximum Observed Plasma Concentration (Cmax)
"Maximum observed plasma concentration, determined directly from individual concentration time data.~Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | ng/mL (Mean) |
---|
| Sublingual Period (0-24 hours) | Initial Burst: Injection 1 (0-48 hours) | Initial Burst: Injection 4 (0-48 hours) | Plateau: Injection 1 (2-28 days) | Plateau: Injection 4 (2-28 days) | Overall: Injection 1 | Overall: Injection 4 |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 3.521 | 1.352 | 2.085 | 0.853 | 1.384 | 1.352 | 2.085 |
,Group 2 (12 mg) RBP-6000: 100 mg | 5.350 | 1.916 | 2.958 | 1.518 | 2.590 | 2.023 | 3.066 |
,Group 3 (24 mg) RBP-6000: 200 mg | 7.571 | 2.755 | 4.526 | 2.018 | 3.776 | 2.732 | 4.526 |
,Group 4 (8 mg) RBP-6000: 100 mg | 3.964 | 1.686 | 2.549 | 1.174 | 2.211 | 1.686 | 2.554 |
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Buprenorphine PK: Minimum Observed Plasma Concentration (Cmin)
"Minimum observed plasma concentration, determined directly from individual concentration time data.~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | ng/mL (Mean) |
---|
| Sublingual Period (0-24 hours) | Plateau: Injection 1 (2-28 days) | Plateau: Injection 4 (2-28 days) | Overall: Injection 1 | Overall: Injection 4 |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 0.524 | 0.206 | 0.791 | 0.206 | 0.557 |
,Group 2 (12 mg) RBP-6000: 100 mg | 0.806 | 0.388 | 1.434 | 0.375 | 1.263 |
,Group 3 (24 mg) RBP-6000: 200 mg | 1.385 | 0.600 | 2.575 | 0.589 | 2.121 |
,Group 4 (8 mg) RBP-6000: 100 mg | 0.568 | 0.388 | 1.552 | 0.410 | 1.180 |
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Buprenorphine PK: Minimum Observed Plasma Concentration (Cmin)
"Minimum observed plasma concentration, determined directly from individual concentration time data.~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | ng/mL (Mean) |
---|
| Sublingual Period (0-24 hours) | Plateau: Injection 1 (2-28 days) | Plateau: Injection 4 (2-28 days) | Plateau: Injection 6 (2-28 days) | Overall: Injection 1 | Overall: Injection 4 | Overall: Injection 6 |
---|
Group 5 (14 mg) RBP-6000: 200 mg | 0.920 | 0.714 | 2.498 | 3.325 | 0.700 | 2.256 | 2.910 |
,Group 6 (8-24 mg) RBP-6000: 300 mg | 0.927 | 1.244 | 4.600 | 4.810 | 0.836 | 4.043 | 4.290 |
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Buprenorphine PK: Swing of Plasma Concentrations
"The swing of buprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cmin within the dosing interval.~Cmax=maximum plasma concentration Cmin=minimum plasma concentration~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | percentage of Cmin (Mean) |
---|
| Sublingual Period | Plateau: Injection 1 | Plateau: Injection 4 | Overall: Injection 1 | Overall: Injection 4 |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 656.884 | 332.132 | 79.731 | 586.788 | 279.713 |
,Group 2 (12 mg) RBP-6000: 100 mg | 665.742 | 295.987 | 84.772 | 440.102 | 147.264 |
,Group 3 (24 mg) RBP-6000: 200 mg | 493.475 | 253.417 | 47.479 | 399.355 | 112.812 |
,Group 4 (8 mg) RBP-6000: 100 mg | 597.543 | 223.388 | 44.874 | 350.591 | 120.236 |
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Buprenorphine PK: Time to Maximum Buprenorphine Plasma Concentration (Tmax)
"Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | hours (Median) |
---|
| Sublingual Period (0-24 hours) | Initial Burst: Injection 1 (0-48 hours) | Initial Burst: Injection 4 (0-48 hours) | Initial Burst: Injection 6 (0-48 hours) | Plateau: Injection 1 (2-28 days) | Plateau: Injection 4 (2-28 days) | Plateau: Injection 6 (2-28 days) | Overall: Injection 1 (0-28 days) | Overall: Injection 4 (0-28 days) | Overall: Injection 6 (0-28 days) |
---|
Group 5 (14 mg) RBP-6000: 200 mg | 2.000 | 20.000 | 24.000 | 24.000 | 48.000 | 48.000 | 48.000 | 20.000 | 24.000 | 24.000 |
,Group 6 (8-24 mg) RBP-6000: 300 mg | 2.000 | 20.000 | 24.000 | 24.350 | 48.000 | 48.000 | 48.000 | 20.000 | 24.000 | 24.350 |
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Buprenorphine PK: Time to Maximum Buprenorphine Plasma Concentration (Tmax)
"Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6" (NCT01738503)
Timeframe: Day -1, Days 1-29, 85-113, 141-197
Intervention | hours (Median) |
---|
| Sublingual Period (0-24 hours) | Initial Burst: Injection 1 (0-48 hours) | Initial Burst: Injection 4 (0-48 hours) | Plateau: Injection 1 (2-28 days) | Plateau: Injection 4 (2-28 days) | Overall: Injection 1 (0-28 days) | Overall: Injection 4 (0-28 days) |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 2.000 | 20.000 | 20.000 | 48.000 | 48.000 | 20.000 | 20.000 |
,Group 2 (12 mg) RBP-6000: 100 mg | 1.017 | 20.000 | 20.000 | 48.000 | 48.000 | 20.000 | 20.000 |
,Group 3 (24 mg) RBP-6000: 200 mg | 1.117 | 20.000 | 20.083 | 48.000 | 48.000 | 20.000 | 20.083 |
,Group 4 (8 mg) RBP-6000: 100 mg | 2.000 | 20.000 | 24.000 | 48.000 | 48.000 | 20.000 | 24.000 |
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Change From Baseline in the Clinical Global Impression Improvement (CGI-I) Scale on Days 7, 29, 57, 85 and 141
"The CGI-I is a 7-item scale completed by the clinician used to rate their impression of how much the participant has improved over a baseline state. The total range is 1 (very much improved) to 7 (very much worse).~Baseline was defined as value from Day 1. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing (not applicable for Day 7) and reported as change from baseline values.~Negative change from baseline values indicate an improvement." (NCT01738503)
Timeframe: Baseline (Day 1), Days 7, 29, 57, 85, 141
Intervention | units on a scale (Mean) |
---|
| Baseline (observed values) | Day 29 | Day 57 | Day 85 |
---|
Group 4 (8 mg) RBP-6000: 100 mg | 4.0 | -1.69 | -2.17 | -2.60 |
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Change From Baseline in the Clinical Global Impression Improvement (CGI-I) Scale on Days 7, 29, 57, 85 and 141
"The CGI-I is a 7-item scale completed by the clinician used to rate their impression of how much the participant has improved over a baseline state. The total range is 1 (very much improved) to 7 (very much worse).~Baseline was defined as value from Day 1. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing (not applicable for Day 7) and reported as change from baseline values.~Negative change from baseline values indicate an improvement." (NCT01738503)
Timeframe: Baseline (Day 1), Days 7, 29, 57, 85, 141
Intervention | units on a scale (Mean) |
---|
| Baseline (observed values) | Day 29 | Day 57 | Day 85 | Day 141 |
---|
Group 5 (14 mg) RBP-6000: 200 mg | 4.0 | 02.07 | -2.15 | -2.73 | -2.67 |
,Group 6 (8-24 mg) RBP-6000: 300 mg | 4.0 | -2.27 | -2.40 | -2.57 | -2.50 |
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Change From Baseline in the Clinical Global Impression Improvement (CGI-I) Scale on Days 7, 29, 57, 85 and 141
"The CGI-I is a 7-item scale completed by the clinician used to rate their impression of how much the participant has improved over a baseline state. The total range is 1 (very much improved) to 7 (very much worse).~Baseline was defined as value from Day 1. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing (not applicable for Day 7) and reported as change from baseline values.~Negative change from baseline values indicate an improvement." (NCT01738503)
Timeframe: Baseline (Day 1), Days 7, 29, 57, 85, 141
Intervention | units on a scale (Mean) |
---|
| Baseline (observed values) | Day 7 | Day 29 | Day 57 | Day 85 |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 4.0 | -1.00 | -1.67 | -2.08 | -2.18 |
,Group 2 (12 mg) RBP-6000: 100 mg | 4.1 | -0.73 | -1.07 | -1.79 | -2.00 |
,Group 3 (24 mg) RBP-6000: 200 mg | 4.0 | -1.42 | -1.77 | -2.36 | -2.73 |
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Change From Baseline in the Clinical Global Impression Severity (CGI-S) Scale on Days 1, 7, 29, 57, 85 and 141
"The CGI-S is a 7-item scale completed by the clinician used to rate the severity of symptoms. The total range is 1 (normal, not at all ill) to 7 (most extremely ill).~Baseline was defined as value from screening (Day -13). The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing (not applicable for Day 7) and reported as change from baseline values.~Negative change from baseline values indicate a lessening of the severity of symptoms." (NCT01738503)
Timeframe: Baseline (screening Day -15), Days 1, 7, 29, 57, 85, 141
Intervention | units on a scale (Mean) |
---|
| Baseline (observed values) | Day 1 | Day 29 | Day 57 | Day 85 |
---|
Group 4 (8 mg) RBP-6000: 100 mg | 4.6 | 0.00 | -1.38 | -1.83 | -2.30 |
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Change From Baseline in the Clinical Global Impression Severity (CGI-S) Scale on Days 1, 7, 29, 57, 85 and 141
"The CGI-S is a 7-item scale completed by the clinician used to rate the severity of symptoms. The total range is 1 (normal, not at all ill) to 7 (most extremely ill).~Baseline was defined as value from screening (Day -13). The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing (not applicable for Day 7) and reported as change from baseline values.~Negative change from baseline values indicate a lessening of the severity of symptoms." (NCT01738503)
Timeframe: Baseline (screening Day -15), Days 1, 7, 29, 57, 85, 141
Intervention | units on a scale (Mean) |
---|
| Baseline (observed values) | Day 1 | Day 29 | Day 57 | Day 85 | Day 141 |
---|
Group 5 (14 mg) RBP-6000: 200 mg | 4.7 | 0.00 | -1.64 | -2.00 | -2.64 | -3.00 |
,Group 6 (8-24 mg) RBP-6000: 300 mg | 4.6 | 0.00 | -1.91 | -2.50 | -2.86 | -2.00 |
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Change From Baseline in the Clinical Global Impression Severity (CGI-S) Scale on Days 1, 7, 29, 57, 85 and 141
"The CGI-S is a 7-item scale completed by the clinician used to rate the severity of symptoms. The total range is 1 (normal, not at all ill) to 7 (most extremely ill).~Baseline was defined as value from screening (Day -13). The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing (not applicable for Day 7) and reported as change from baseline values.~Negative change from baseline values indicate a lessening of the severity of symptoms." (NCT01738503)
Timeframe: Baseline (screening Day -15), Days 1, 7, 29, 57, 85, 141
Intervention | units on a scale (Mean) |
---|
| Baseline (observed values) | Day 1 | Day 7 | Day 29 | Day 57 | Day 85 |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 4.3 | 0.00 | -1.00 | -1.40 | -1.75 | -1.82 |
,Group 2 (12 mg) RBP-6000: 100 mg | 4.3 | 0.00 | -0.50 | -1.00 | -1.29 | -1.83 |
,Group 3 (24 mg) RBP-6000: 200 mg | 4.4 | 0.13 | -1.25 | -1.23 | -1.91 | -2.18 |
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Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) Prior to Injections 1, 2, 3, 4 and 6
"COWS is an 11-item instrument used to assess symptoms of opioid withdrawal (Wesson et al., 1999). The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderate/severe withdrawal, and 37-48 severe withdrawal. Each participant was to be assessed by the same qualified and trained individuals throughout the course of the study as much as possible.~Baseline was defined as the peak (maximum) value from screening to study Day -13 pre-SUBUTEX dose. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing and reported as change from baseline values.~Negative change from baseline values indicate a lessening of withdrawal symptoms." (NCT01738503)
Timeframe: Baseline (screening to Day -13), Days -1, 1, 29, 57, 85 141
Intervention | units on a scale (Mean) |
---|
| Baseline (observed values) | Day -1 | Day 1 | Day 29 | Day 57 | Day 85 |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 17.6 | -16.53 | -16.67 | -16.80 | -17.75 | -18.09 |
,Group 2 (12 mg) RBP-6000: 100 mg | 17.7 | -16.33 | -16.73 | -16.79 | -16.62 | -17.08 |
,Group 3 (24 mg) RBP-6000: 200 mg | 20.4 | -19.33 | -19.27 | -19.92 | -18.91 | -19.55 |
,Group 4 (8 mg) RBP-6000: 100 mg | 16.2 | -15.50 | -15.60 | -15.77 | -16.08 | -16.10 |
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Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) Prior to Injections 1, 2, 3, 4 and 6
"COWS is an 11-item instrument used to assess symptoms of opioid withdrawal (Wesson et al., 1999). The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderate/severe withdrawal, and 37-48 severe withdrawal. Each participant was to be assessed by the same qualified and trained individuals throughout the course of the study as much as possible.~Baseline was defined as the peak (maximum) value from screening to study Day -13 pre-SUBUTEX dose. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing and reported as change from baseline values.~Negative change from baseline values indicate a lessening of withdrawal symptoms." (NCT01738503)
Timeframe: Baseline (screening to Day -13), Days -1, 1, 29, 57, 85 141
Intervention | units on a scale (Mean) |
---|
| Baseline (observed values) | Day -1 | Day 1 | Day 29 | Day 57 | Day 85 | Day 141 |
---|
Group 5 (14 mg) RBP-6000: 200 mg | 17.9 | -16.80 | -16.87 | -16.71 | -17.62 | -18.00 | -19.67 |
,Group 6 (8-24 mg) RBP-6000: 300 mg | 16.7 | -15.93 | -16.36 | -16.91 | -17.00 | -16.00 | -18.00 |
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Change From Baseline in the Clinical Opioid Craving Visual Analog Scale (VAS) Total Score Prior to Injections 1, 2, 3, 4 and 6
"The Total Score was the sum of 10 questions regarding cravings each ranging from 0 (no craving) - 10 (extreme craving) for a total range from 0 (no cravings) to 100 (most intense craving I have ever had).~Baseline was defined as the peak (maximum) value from screening to study Day -13 pre-SUBUTEX dose. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing and reported as change from baseline values.~Negative change from baseline values indicate a lessening of craving symptoms." (NCT01738503)
Timeframe: Baseline (screening to Day -13), Days -1, 1, 29, 57, 85 141
Intervention | units on a scale (Mean) |
---|
| Baseline (observed values) | Day -1 | Day 1 | Day 29 | Day 57 | Day 85 |
---|
Group 1 (8 mg) RBP-6000: 50 mg | 85.6 | -84.00 | -84.47 | -81.73 | -84.42 | -84.91 |
,Group 2 (12 mg) RBP-6000: 100 mg | 89.7 | -86.93 | -88.20 | -85.00 | -86.64 | -84.92 |
,Group 3 (24 mg) RBP-6000: 200 mg | 87.2 | -84.53 | -84.40 | -85.31 | -86.36 | -86.55 |
,Group 4 (8 mg) RBP-6000: 100 mg | 86.0 | -83.33 | -83.73 | -83.46 | -82.08 | -85.70 |
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Change From Baseline in the Clinical Opioid Craving Visual Analog Scale (VAS) Total Score Prior to Injections 1, 2, 3, 4 and 6
"The Total Score was the sum of 10 questions regarding cravings each ranging from 0 (no craving) - 10 (extreme craving) for a total range from 0 (no cravings) to 100 (most intense craving I have ever had).~Baseline was defined as the peak (maximum) value from screening to study Day -13 pre-SUBUTEX dose. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing and reported as change from baseline values.~Negative change from baseline values indicate a lessening of craving symptoms." (NCT01738503)
Timeframe: Baseline (screening to Day -13), Days -1, 1, 29, 57, 85 141
Intervention | units on a scale (Mean) |
---|
| Baseline (observed values) | Day -1 | Day 1 | Day 29 | Day 57 | Day 85 | Day 141 |
---|
Group 5 (14 mg) RBP-6000: 200 mg | 85.1 | -82.07 | -83.00 | -82.36 | -83.85 | -89.27 | -85.33 |
,Group 6 (8-24 mg) RBP-6000: 300 mg | 87.4 | -85.21 | -85.36 | -88.45 | -88.10 | -87.14 | -85.00 |
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Change From Baseline to Week 48 in Daily Average NRS Pain Intensity Score
The NRS Pain intensity score is a segmented version of a visual analog scale used to measure pain. The scale is from 0 (no pain) to 10. Scores between greater than 0 and 3 are considered mild pain, scores from greater than 3 to 6 are moderate and greater than 6 to 10 are severe. The daily average is calculated and the change from baseline at week 48 is presented. (NCT01755546)
Timeframe: 48 weeks
Intervention | units on a scale (Mean) |
---|
Overall | 0.2 |
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Proportion of Full-responder
Evaluation of the proportion of subjects who report full analgesia (full responders: FR). FR is operationally defined as a patient with a P.I.D. =/> 30% from visit 6 and visit 1 (NRS 0 to 10). (NCT01809106)
Timeframe: 28 days
Intervention | participants (Number) |
---|
Morphine | 89 |
Oxycodone | 90 |
Buprenorphine | 95 |
Fentanyl | 88 |
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The Opioid Escalation Index
The proportion of subjects with an increase of opioid daily dose > 5% compared with the basal dosage (OEI%). (NCT01809106)
Timeframe: 28 days
Intervention | participants (Number) |
---|
Morphine | 13 |
Oxycodone | 24 |
Buprenorphine | 18 |
Fentanyl | 45 |
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Proportion of Non-Responder (NR) Participants
"Evaluation of the proportion of Non-Responder (NR) participants. NR correspond to the subjects who do not report any analgesic effects, with a P.I.D. (pain intensity difference) from visit 6 and visit 1 =/< 0%, (using a 0-10 NRS ). It includes the situations of average pain intensity stable or worsened at day 28 compared with baseline values." (NCT01809106)
Timeframe: 28 days
Intervention | participants (Number) |
---|
Morphine | 14 |
Oxycodone | 18 |
Buprenorphine | 14 |
Fentanyl | 11 |
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Change of Pain Intensity* at Week 8 of Treatment With the Study Drug From Baseline
NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain). NRS-Pain scale: Change = mean score at Week 8/ET minus mean score at Baseline. (NCT01818700)
Timeframe: 8 weeks
Intervention | units on a scale (Mean) |
---|
Single Arm-Norspan Patch (Buprenorphine) | -1.65 |
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Change in Quality of Life at 8 Week of Treatment With Study Drug From Baseline
"The Euroqol Health Survey (EQ-5D, 3-level) was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1. A higher score indicates better quality of life.~EQ-5D score = 1 - 0.081 - (relevant score by level for the relevant item)-0.269 (only if there is at least one level 3).~Table of scores by level for EQ-5D items mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.236)." (NCT01818700)
Timeframe: 8 weeks
Intervention | units on a scale (Mean) |
---|
Single Arm - Norspan Patch (Buprenorphine) | 0.18 |
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Clinician Global Impression of Change(CGIC)
Number of clinician with categorical change in overall status. CGIC: a clinician-rated instrument assessing change in clinician's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse). (NCT01818700)
Timeframe: 8weeks
Intervention | participants (Number) |
---|
| Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse |
---|
Single Arm - Norspan Patch (Buprenorphine) | 16 | 63 | 55 | 68 | 8 | 0 | 0 |
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Patients Global Impression og Change(PGIC)
Number of clinician with categorical change in overall status. PGIC: a participant-rated instrument assessing change in patient's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse). (NCT01818700)
Timeframe: 8 week
Intervention | participants (Number) |
---|
| Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse |
---|
Single Arm - Norspan Patch (Buprenorphine) | 12 | 60 | 57 | 71 | 10 | 0 | 0 |
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Change of EQ-VAS at 8 Weeks of Treatment With Study Drug From Baseline.
EQ-5D Visual Analogue Scale (VAS) in rates the participant's overall health status using values from 0 (worst imaginable) to 100 (best imaginable). (NCT01818700)
Timeframe: 8 week
Intervention | units on a scale (Mean) |
---|
Single Arm - Norspan Patch (Buprenorphine) | 10.55 |
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Change of Pain Intensity at 4 Week of Treatment With Study Srug From Baseline.
NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain). NRS-Pain scale: Change = mean score at Week 4/ET minus mean score at Baseline. (NCT01818700)
Timeframe: 4 weeks
Intervention | units on a scale (Mean) |
---|
Single Arm-Norspan Patch (Buprenorphine) | -1.26 |
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Opioid Use at 6 Month Follow-up
To determine the relative effectiveness of XR-NTX compared to TAU for opioid-dependent youth in terms of opioid use at 6-months post-treatment entry. (NCT01843023)
Timeframe: 6 months
Intervention | days (Mean) |
---|
Extended Release Naltrexone | 19.63 |
Treatment as Usual | 18.42 |
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Treatment Retention
To determine the relative effectiveness of XR-NTX compared to TAU for opioid-dependent youth in terms of days in treatment. Treatment defined as medications for OUD received in past 30 days at 6-month follow-up. (NCT01843023)
Timeframe: 6 months
Intervention | days (Mean) |
---|
Extended Release Naltrexone | 5.53 |
Treatment as Usual | 4.69 |
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Monetized Healthcare Utilization
The cost-effectiveness will be assessed using the Economic Form 90 to collect data on economic outcomes of health utilization at 6 months. (NCT01843023)
Timeframe: 6 months
Intervention | dollars (Mean) |
---|
Extended Release Naltrexone | 8136 |
Treatment as Usual | 6629 |
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HIV Sex Risk Behaviors
To examine the impact of XR-NTX on HIV sex-risk behaviors at 6 months. Past 90 days self-reported HIV sex risk behaviors on the Risk Assessment Battery (RAB). Minimum value 0; maximum value 24. Higher scores reflect endorsement of more risk behaviors (worse outcome). (NCT01843023)
Timeframe: 6 months
Intervention | score on a scale (Mean) |
---|
Extended Release Naltrexone | 3.53 |
Treatment as Usual | 3.42 |
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Number of Emergency Room Visits
Number of emergency room visits over 6 months (NCT01843751)
Timeframe: 6 months
Intervention | visits (Mean) |
---|
Physician Office | 0 |
Specialist Center | 0.2 |
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Human Immunodeficiency Virus (HIV) Risk Behavior Assessment by Assessing Change in Risk Assessment Battery (RAB) Score
"The RAB is a self-administered, multiple choice questionnaire. It offers a quick and confidential assessment of both needle sharing practices and sexual activity associated with HIV transmission.~The RAB is composed of 45 simple questions which uses discrete response. The questions have different numbers of items, and scores for a single question can range from 0 to 7, with higher values reflecting more instances of risk behavior. The RAB is scored by adding the values that correspond to the responses selected by the subject for the items. This total score is then divided by 40, the highest possible score for the overall instrument, yielding a score from 0 to 1.~HIV risk behaviors will be assessed via score on the Risk Assessment Battery at baseline and month 6--difference between baseline and month 6." (NCT01843751)
Timeframe: baseline and 6 months
Intervention | score on a scale (Mean) |
---|
Physician Office | 0.01 |
Specialist Center | 0.12 |
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Initiation of Medication Assisted Treatment
Initiation of medication assisted treatment (yes/no) (NCT01843751)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
Physician Office | 11 |
Specialist Center | 10 |
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Number of Days From Treatment Initiation to First Drug Use
Number of days from treatment initiation to first drug use thereafter (NCT01843751)
Timeframe: 6 months
Intervention | days (Mean) |
---|
Physician Office | 24 |
Specialist Center | 15 |
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Number of Participants With New Crime
The primary outcome will be measured via the publicly available Wisconsin Circuit Court Consolidated Court Automation Program (CCAP) database. The Wisconsin Circuit Court Access website provides access to certain public records of the circuit courts of Wisconsin. The information displayed on the website is an exact copy of the case information entered into CCAP case management system by court staff in the counties where the case files are located. The court record summaries viewed are all public records under Wisconsin open records law and freely accessible to the public. The CCAP database will searched periodically for all enrolled study participants until data analysis has been complete. (NCT01843751)
Timeframe: 2 years
Intervention | Participants (Count of Participants) |
---|
Physician Office | 5 |
Specialist Center | 3 |
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Apparent Body Clearance (CL/F) of Buprenorphine and Naloxone
Apparent body clearance (only for buprenorphine and naloxone), calculated as Dose/AUC0-inf. (NCT01846455)
Timeframe: before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing
Intervention | L/hr (Geometric Mean) |
---|
| Buprenorphine (5,4,5,3,6) | Naloxone (5,6,5,4,7) |
---|
HCV Without Hepatic Impairment | 232 | 5874 |
,Hepatic Impairment: Child-Pugh A | 182 | 7448 |
,Hepatic Impairment: Child-Pugh B | 106 | 1824 |
,Hepatic Impairment: Child-Pugh C | 78.3 | 344 |
,No Hepatic Disease or Impairment | 193 | 5148 |
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Apparent Volume of Distribution During Terminal Phase (Vz/F) of Buprenorphine and Naloxone
Apparent volume of distribution during terminal phase (only for buprenorphine and naloxone), calculated as Dose/(λz • AUC0-inf). (NCT01846455)
Timeframe: before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing
Intervention | Liters (Geometric Mean) |
---|
| Buprenorphine (5,4,5,3,6) | Naloxone (5,6,5,4,7) |
---|
HCV Without Hepatic Impairment | 9580 | 15845 |
,Hepatic Impairment: Child-Pugh A | 7226 | 23150 |
,Hepatic Impairment: Child-Pugh B | 6959 | 14353 |
,Hepatic Impairment: Child-Pugh C | 6373 | 2272 |
,No Hepatic Disease or Impairment | 9176 | 15294 |
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Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
"The extrapolation to infinity was done using the terminal phase.~AUC0-inf = AUC0-last + Ct/λz~Where Ct was the last observed quantifiable concentration and λz was the apparent terminal phase elimination rate constant." (NCT01846455)
Timeframe: before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing
Intervention | ng*hr/mL (Geometric Mean) |
---|
| Buprenorphine (5,4,5,3,6) | Norbuprenorphine (3,3,1,3,3) | Naloxone (5,6,5,4,7) | Naloxone-3-β-D-Glucuronide (5,7,6,5,4) |
---|
HCV Without Hepatic Impairment | 8.61 | 13.9 | 0.0851 | 21.5 |
,Hepatic Impairment: Child-Pugh A | 11.0 | 25.4 | 0.0671 | 21.9 |
,Hepatic Impairment: Child-Pugh B | 18.9 | 17.1 | 0.274 | 28.9 |
,Hepatic Impairment: Child-Pugh C | 25.5 | 6.67 | 1.45 | 21.3 |
,No Hepatic Disease or Impairment | 10.3 | 16.0 | 0.0971 | 26.0 |
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Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
"AUC0-last was calculated for buprenorphine, norbuprenorphine, naloxone, and naloxone-3-β-D-glucuronide using non-compartmental analysis:~AUC0-last = AUC from time 0 to the time of the last measurable plasma concentration, calculated using the linear trapezoidal rule." (NCT01846455)
Timeframe: before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing
Intervention | ng*hr/mL (Geometric Mean) |
---|
| Buprenorphine | Norbuprenorphine | Naloxone | Naloxone-3-β-D-Glucuronide |
---|
HCV Without Hepatic Impairment | 7.02 | 9.91 | 0.0968 | 19.1 |
,Hepatic Impairment: Child-Pugh A | 8.89 | 12.5 | 0.0726 | 19.3 |
,Hepatic Impairment: Child-Pugh B | 14.7 | 9.51 | 0.291 | 27.9 |
,Hepatic Impairment: Child-Pugh C | 25.2 | 2.25 | 1.28 | 20.6 |
,No Hepatic Disease or Impairment | 8.95 | 15.0 | 0.0915 | 22.5 |
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Maximum Observed Plasma Concentration (Cmax) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
(NCT01846455)
Timeframe: before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing
Intervention | ng/mL (Geometric Mean) |
---|
| Buprenorphine | Norbuprenorphine | Naloxone | Naloxone-3-β-D-Glucuronide |
---|
HCV Without Hepatic Impairment | 0.933 | 0.203 | 0.0361 | 6.80 |
,Hepatic Impairment: Child-Pugh A | 1.10 | 0.358 | 0.0287 | 9.02 |
,Hepatic Impairment: Child-Pugh B | 1.04 | 0.180 | 0.0773 | 9.03 |
,Hepatic Impairment: Child-Pugh C | 1.40 | 0.128 | 0.323 | 6.75 |
,No Hepatic Disease or Impairment | 0.913 | 0.265 | 0.0286 | 8.12 |
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Terminal Elimination Half-life (t1/2) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Terminal elimination half-life, calculated as ln(2)/λz. The terminal phase elimination half-life was calculated over a period of at least 2 half-lives. (NCT01846455)
Timeframe: before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing
Intervention | hours (Geometric Mean) |
---|
| Buprenorphine (6,5,5,5,7) | Norbuprenorphine (4,6,5,4,4) | Naloxone (5,6,5,4,7) | Naloxone-3-β-D-Glucuronide (5,7,6,5,4) |
---|
HCV Without Hepatic Impairment | 35.2 | 51.2 | 1.87 | 10.9 |
,Hepatic Impairment: Child-Pugh A | 31.4 | 41.3 | 2.15 | 7.12 |
,Hepatic Impairment: Child-Pugh B | 48.7 | 52.9 | 5.45 | 5.91 |
,Hepatic Impairment: Child-Pugh C | 56.4 | 36.7 | 4.58 | 4.55 |
,No Hepatic Disease or Impairment | 36.0 | 41.4 | 2.06 | 7.40 |
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Terminal Phase Elimination Rate-Constant (λz) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
For the determination of λz, only those data points judged to describe the terminal log-linear decline resulting in an adjusted coefficient of determination value (R2) > 0.7 were used in the regression. A minimum of 3 data points were used in calculating λz. (NCT01846455)
Timeframe: before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing
Intervention | 1/hour (Geometric Mean) |
---|
| Buprenorphine (6,5,5,5,7) | Norbuprenorphine (4,6,5,4,4) | Naloxone (5,6,5,4,7) | Naloxone-3-β-D-Glucuronide (5,7,6,5,4) |
---|
HCV Without Hepatic Impairment | 0.0197 | 0.0135 | 0.371 | 0.0637 |
,Hepatic Impairment: Child-Pugh A | 0.0221 | 0.0168 | 0.322 | 0.0974 |
,Hepatic Impairment: Child-Pugh B | 0.0142 | 0.0131 | 0.127 | 0.117 |
,Hepatic Impairment: Child-Pugh C | 0.0123 | 0.0189 | 0.151 | 0.152 |
,No Hepatic Disease or Impairment | 0.0193 | 0.0167 | 0.337 | 0.0937 |
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Time of the Last Measureable Plasma Concentration (Tlast) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
(NCT01846455)
Timeframe: before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing
Intervention | hours (Median) |
---|
| Buprenorphine | Norbuprenorphine | Naloxone | Naloxone-3-β-D-Glucuronide |
---|
HCV Without Hepatic Impairment | 71.5 | 144 | 10.0 | 36.0 |
,Hepatic Impairment: Child-Pugh A | 72.0 | 144 | 10.0 | 24.0 |
,Hepatic Impairment: Child-Pugh B | 120 | 120 | 24.0 | 24.1 |
,Hepatic Impairment: Child-Pugh C | 168 | 48.0 | 24.0 | 24.0 |
,No Hepatic Disease or Impairment | 96.0 | 156 | 10.0 | 36.0 |
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Percentage of Area Under the Concentration-time Curve From Time Zero to Infinity Due to Extrapolation (%AUCextrap) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
"Calculated as:~(AUC0-inf - AUC0-last)/AUC0-inf * 100~AUC0-inf, apparent body clearance (CL/F), and apparent volume of distribution during terminal phase (Vz/F) would not have been reported if %AUCextrap was > 20%." (NCT01846455)
Timeframe: before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing
Intervention | percentage of AUC0-inf (Mean) |
---|
| Buprenorphine (6,5,5,5,7) | Norbuprenorphine (4,6,5,4,4) | Naloxone (5,6,5,4,7) | Naloxone-3-β-D-Glucuronide (5,7,6,5,4) |
---|
HCV Without Hepatic Impairment | 17.6 | 16.5 | 5.16 | 6.04 |
,Hepatic Impairment: Child-Pugh A | 17.2 | 10.2 | 6.59 | 4.98 |
,Hepatic Impairment: Child-Pugh B | 17.1 | 24.3 | 7.48 | 3.34 |
,Hepatic Impairment: Child-Pugh C | 14.2 | 36.1 | 1.30 | 3.50 |
,No Hepatic Disease or Impairment | 15.5 | 13.1 | 5.31 | 5.13 |
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Time to Reach the Maximum Plasma Concentration (Tmax) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
(NCT01846455)
Timeframe: before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing
Intervention | hours (Median) |
---|
| Buprenorphine | Norbuprenorphine | Naloxone | Naloxone-3-β-D-Glucuronide |
---|
HCV Without Hepatic Impairment | 1.38 | 1.00 | 1.00 | 0.750 |
,Hepatic Impairment: Child-Pugh A | 1.25 | 1.25 | 0.875 | 0.500 |
,Hepatic Impairment: Child-Pugh B | 1.50 | 1.25 | 0.750 | 0.750 |
,Hepatic Impairment: Child-Pugh C | 1.00 | 0.875 | 0.750 | 0.500 |
,No Hepatic Disease or Impairment | 1.75 | 1.00 | 1.13 | 0.500 |
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Mean Change From Baseline in the VAS Score for Cravings After Day 3 (Maintenance Phase)
"Mean change from baseline in VAS scores for cravings during the maintenance phase (Days 4, 8, 15, 22, and 29); the VAS craving scores range from 0 (no cravings) to 100 (most intense craving I have ever had)" (NCT01848054)
Timeframe: Pre-dose on Days 4, 8, 15, 22, and 29
Intervention | units on a scale (Mean) |
---|
| Day 4 | Day 8 | Day 15 | Day 22 | Day 29 |
---|
BNX Sublingual Tablets Induction | -40.1 | -46.1 | -48.5 | -53.3 | -52.7 |
,Buprenorphine Induction | -34.2 | -39.9 | -44.3 | -47.2 | -45.1 |
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Area Under the Curve (AUC) in Clinical Opiate Withdrawal Scale (COWS) Total Score on Days 1 to 3 Inclusive
Least squares mean AUC in COWS total score on Days 1 to 3; COWS scores range from 0-48, with a lower score being more favorable (NCT01848054)
Timeframe: Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1
Intervention | score x hour (Least Squares Mean) |
---|
BNX Sublingual Tablets Induction | 7.21 |
Buprenorphine Induction | 6.88 |
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AUC in Subjective Opiate Withdrawal Scale (SOWS) Total Score on Days 1 to 3 Inclusive
Least squares mean AUC day 1 pre-dose through Day 3 in SOWS; SOWS scores range from 0-64, with a lower score being more favorable (NCT01848054)
Timeframe: Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1
Intervention | score x hour (Least Squares Mean) |
---|
BNX Sublingual Tablets Induction | 17.7 |
Buprenorphine Induction | 17.4 |
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AUC in Visual Analog Scale (VAS) Score for Craving on Days 1 to 3 Inclusive
"Least squares mean AUC measurement in VAS score for cravings on Days 1 to 3; the VAS craving scores range from 0 (no cravings) to 100 (most intense craving I have ever had)" (NCT01848054)
Timeframe: Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1
Intervention | score x hour (Least Squares Mean) |
---|
BNX Sublingual Tablets Induction | 40.0 |
Buprenorphine Induction | 39.5 |
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Retention in Treatment in the Full Analysis Population
Retention in treatment at Day 3 in the full analysis population (N=310) was defined as the number of patients in each induction arm completing the induction phase and who received study medication on Day 3. Treatment with BNX sublingual tablets was considered non-inferior to generic buprenorphine if the lower limit of the 95% confidence interval for the difference between BNX and generic buprenorphine was ≥-10% in the number of patients retained in treatment on Day 3. (NCT01848054)
Timeframe: Day 3
Intervention | participants (Number) |
---|
BNX Sublingual Tablets Induction | 132 |
Buprenorphine Induction | 147 |
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Retention in Treatment in the Per Protocol Population
Retention in treatment at Day 3 in the per protocol population (n=256) was defined as the number of patients in each induction arm completing the induction phase and who received study medication on Day 3. Treatment with BNX sublingual tablets was considered non-inferior to generic buprenorphine if the lower limit of the 95% confidence interval for the difference between BNX and generic buprenorphine was ≥-10% in the number of patients retained in treatment on Day 3. (NCT01848054)
Timeframe: Day 3
Intervention | participants (Number) |
---|
BNX Sublingual Tablets Induction | 113 |
Buprenorphine Induction | 122 |
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Mean Change From Baseline in SOWS Total Score After Day 3 (Maintenance Phase)
Mean change from baseline in SOWS total scores during the maintenance phase (Days 4, 8, 15, 22, and 29); SOWS scores range from 0-64, with a lower score being more favorable (NCT01848054)
Timeframe: Pre-dose on Days 4, 8, 15, 22, and 29
Intervention | units on a scale (Mean) |
---|
| Day 4 | Day 8 | Day 15 | Day 22 | Day 29/premature discontinuation |
---|
BNX Induction | -24.7 | -27.0 | -29.2 | -30.8 | -30.4 |
,Buprenorphine Induction | -18.9 | -21.3 | -23.3 | -24.1 | -24.3 |
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Mean Change From Baseline in COWS Total Score After Day 3 (Maintenance Phase)
Mean change from baseline in COWS total scores during the maintenance phase (Days 4, 8, 15, 22, and 29); COWS scores range from 0-48, with a lower score being more favorable (NCT01848054)
Timeframe: Predose on Days 4, 8, 15, 22, and 29
Intervention | units on a scale (Mean) |
---|
| Day 4 | Day 8 | Day 15 | Day 22 | Day 29/premature discontinuation |
---|
BNX Sublingual Tablets Induction | -9.4 | -11.2 | -11.9 | -12.5 | -12.5 |
,Buprenorphine Induction | -8.5 | -10.1 | -11.1 | -11.6 | -11.4 |
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"Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire Subjective Responses to Stress With and Without Buprenorphine"
"The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: Feel Drug, Feel High, and Want More. The Feel Drug, Feel High, Like Drug, and Want More subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0 -100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome." (NCT01860287)
Timeframe: End of study - (Pre-administration of drug or placebo (Time 0), and approx 210 minutes after drug/placebo admin), End of study (210 min) shown
Intervention | units on a scale (Mean) |
---|
| Feel Drug | Like Drug | Feel High | Want More |
---|
0.2 Buprenorphine | 36.57 | 43.27 | 27.27 | 12.47 |
,0.4 mg Buprenorphine | 59.89 | 56.25 | 41.69 | 21.57 |
,Placebo Group | 13.57 | 9.4 | 6.0 | 4.27 |
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Change From Baseline in COWS Total Score Over Time
Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal. (NCT01871285)
Timeframe: Pre-dose (-0.5; baseline), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence
Intervention | score (Mean) |
---|
| Hour 0.5 | Hour 1 | Hour 1.5 | Hour 2 | Hour 2.5 | Hour 3 | Hour 3.5 | Hour 4 | Hour 6 | Hour 9 | Hour 12 | Hour 12.5 | Hour 13 | Hour 13.5 | Hour 14 | Hour 16 | Hour 24 |
---|
MSE Dose Group 1 - ATC Opioid | -0.3 | 0.0 | 0.2 | 0.2 | 0.3 | 0.2 | 0.3 | 0.4 | 0.6 | 1.4 | 1.5 | 0.5 | 0.5 | 0.4 | 0.2 | -0.1 | 0.7 |
,MSE Dose Group 1 - Buprenorphine | 0.1 | 0.3 | 0.4 | 0.3 | 0.6 | 0.6 | 0.9 | 0.8 | 0.6 | 0.9 | 2.1 | 1.0 | 0.9 | 1.0 | 0.7 | 0.5 | 1.8 |
,MSE Dose Group 2 - ATC Opioid | -1.3 | -1.0 | -1.0 | -1.0 | -1.0 | -1.0 | -0.8 | -1.0 | 0.0 | 1.0 | 0.3 | 1.3 | 0.0 | -0.3 | -0.3 | -0.3 | 2.8 |
,MSE Dose Group 2 - Buprenorphine | 0.0 | 0.8 | 0.5 | 1.8 | 1.3 | 0.3 | 1.5 | 1.0 | 1.0 | 1.3 | 3.3 | 3.0 | 3.3 | 1.8 | 3.3 | 1.8 | 2.0 |
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"Change From Baseline in Pain Now Over Time Using NRS"
Subject rating of pain intensity using 11-point numerical rating scale (NRS) where 0=no pain and 10=pain as bad as you can imagine. (NCT01871285)
Timeframe: Pre-dose (-0.5; baseline), 0.5, 1, 2, 4, 9, 12, 12.5, 13, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence
Intervention | units on a scale (Mean) |
---|
| Hour 0.5 | Hour 1 | Hour 2 | Hour 4 | Hour 9 | Hour 12 | Hour 12.5 | Hour 13 | Hour 14 | Hour 16 | Hour 24 |
---|
MSE Dose Group 1 - ATC Opioid | -0.6 | -1.1 | -1.2 | -1.0 | -0.1 | 0.3 | -0.4 | -0.7 | -1.2 | -1.4 | -0.2 |
,MSE Dose Group 1 - Buprenorphine | -0.3 | -0.5 | -0.7 | -0.9 | -0.5 | 0.5 | 0.0 | -0.4 | -0.7 | -0.9 | -0.2 |
,MSE Dose Group 2 - ATC Opioid | -1.3 | -1.5 | -1.3 | -1.8 | -0.8 | -0.3 | -0.3 | -0.8 | -1.0 | -1.3 | 0.0 |
,MSE Dose Group 2 - Buprenorphine | -0.5 | 0.3 | 0.8 | 0.5 | 1.0 | 1.5 | 1.0 | 0.8 | 1.0 | 0.3 | 0.8 |
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Number of Responders
A responder is defined as a subject whose maximum (across all time points) clinical opiate withdrawal scale (COWS) total score is ≥13. COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal. (NCT01871285)
Timeframe: Pre-dose (-0.5), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence
Intervention | participants (Number) |
---|
MSE Dose Group 1 - Buprenorphine | 1 |
MSE Dose Group 1 - ATC Opioid | 2 |
MSE Dose Group 2 - Buprenorphine | 0 |
MSE Dose Group 2 - ATC Opioid | 0 |
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Maximum COWS Total Score
Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal. The maximum COWs total score is defined as the maximum COWs total score across all time points during the corresponding treatment period after study drug administration for each subject. (NCT01871285)
Timeframe: Pre-dose (-0.5), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence
Intervention | score (Mean) |
---|
MSE Dose Group 1 - Buprenorphine | 4.6 |
MSE Dose Group 1 - ATC Opioid | 5.3 |
MSE Dose Group 2 - Buprenorphine | 5.5 |
MSE Dose Group 2 - ATC Opioid | 6.3 |
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Change From Baseline in Maximum COWS Total Score
Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal. The change from baseline in maximum COWS total score is determined as the difference between the maximum COWs total score and the baseline COWs total score. (NCT01871285)
Timeframe: Pre-dose (-0.5; baseline), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence
Intervention | score (Mean) |
---|
MSE Dose Group 1 - Buprenorphine | 4.0 |
MSE Dose Group 1 - ATC Opioid | 3.9 |
MSE Dose Group 2 - Buprenorphine | 4.5 |
MSE Dose Group 2 - ATC Opioid | 4.3 |
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Change in Numeric Rating Scale of Pain Severity
Validated 11 pt scale 0-10, to evaluate a patient's current severity of pain. A rating of 0 indicates no pain while 10 indicates the worst pain imaginable. A score of 4 or above is considered a clinically significant pain level according to VHA treatment guidelines. (NCT01875848)
Timeframe: Baseline and 12 wks
Intervention | units on a scale (Mean) |
---|
Buprenorphine/Naloxone | -2 |
Opioid Dose Escalation | 0.5 |
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Patient Global Impression of Change (PGIC)
"The Patient Global Impression of Change Scale (PGIC) is one question capturing the individual's overall perception of efficacy of treatment in a clinical trial. It uses verbal outcome categories on a 7-point scale with very much worse and very much better as anchors and no change in the middle. The verbal categories were coded on a scale with -3 very much worse,+3 very much better, and 0 same. To calculate the mean and standard deviation of each group (Bup/Opioid Increase) we took the sum of each participants final PGIC score and divided by the total number of participants." (NCT01875848)
Timeframe: 12 wks
Intervention | units on a scale (Mean) |
---|
Buprenorphine/Naloxone | 1 |
Opioid Dose Escalation | 1 |
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Number of Patient Discontinuations Due to Treatment-Emergent Adverse Events
Study discontinuations due to treatment-emergent adverse events that occurred during treatment with bioavailability BNX sublingual tablets (NCT01903005)
Timeframe: Day 1 through week 24
Intervention | participants (Number) |
---|
Safety Population | 14 |
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Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores
"Mean change from primary study baseline in VAS craving scores during the 24-week open-label, extension study; VAS craving scores range from 0 (no cravings) to 100 mm (most intense craving I have ever had); study endpoint was defined as the last post-baseline value recorded for VAS craving" (NCT01903005)
Timeframe: Prior to dosing on day 1, at weeks 4, 8, 12, 16, 20, and 24, and at study endpoint
Intervention | units on a scale (Mean) |
---|
| Day 1 (n=646) | Week 4 (n=563) | Week 8 (n=479) | Week 12 (n=426) | Week 16 (n=384) | Week 20 (n=338) | Week 24 (n=289) | Study Endpoint (n=598) |
---|
Safety Population | -52.8 | -56.6 | -59.4 | -59.4 | -61.5 | -61.4 | -60.5 | -57.3 |
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Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score
Mean change from primary study baseline in COWS total scores during the 24-week open-label, extension study; COWS scores range from 0 to 48, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for COWS (NCT01903005)
Timeframe: Prior to dosing on day 1, at weeks 4, 8,12,16, 20, 24, and at study endpoint
Intervention | units on a scale (Mean) |
---|
| Day 1 (n=658) | Week 4 (n=557) | Week 8 (n=477) | Week 12 (n=423) | Week 16 (n=384) | Week 20 (n=336) | Week 24 (completers only; n=288) | Study Endpoint (n=597) |
---|
Safety Population | -12.0 | -12.2 | -12.7 | -12.9 | -13.1 | -13.3 | -13.1 | -12.5 |
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Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score
Mean change from primary study baseline in SOWS total scores during the 24-week open-label, extension study; SOWS scores range from 0 to 64, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for SOWS (NCT01903005)
Timeframe: Prior to dosing on day 1, at weeks 4, 8,12,16, 20, and 24, and at study endpoint
Intervention | units on a scale (Mean) |
---|
| Day 1 (n=650) | Week 4 (n=550) | Week 8 (n=472) | Week 12 (n=418) | Week 16 (n=376) | Week 20 (n=331) | Week 24 (n=282) | Study Endpoint (n=588) |
---|
Safety Population | -26.8 | -27.4 | -28.0 | -27.7 | -28.7 | -28.9 | -27.7 | -27.3 |
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Number of Patients Reporting Treatment-Emergent Adverse Events
Number of patients reporting treatment-emergent adverse events during open-label, extension treatment with higher bioavailability BNX sublingual tablets (NCT01903005)
Timeframe: Day 1 through week 24
Intervention | participants (Number) |
---|
| Constipation | Headache |
---|
Safety Population | 20 | 21 |
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Number of Patients Reporting Treatment-Emergent Serious Adverse Events
Patients reporting treatment-emergent serious adverse events considered either related or not related to treatment with the higher bioavailability BNX sublingual tablets (NCT01903005)
Timeframe: Day 1 throught week 24
Intervention | participants (Number) |
---|
| Possibly treatment-related | Not treatment-related |
---|
Safety Population | 1 | 8 |
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Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 5-6 of the WPAI:SHP
Mean change from primary study baseline to week 24 of the open-label extension study for questions 5-6 of the WPAI:SHP; Question 5: During the past 7 days, how much did your opioid dependence affect your productivity while you were working?; Question 6: During the past 7 days, how much did your opioid dependence affect your ability to do regular daily activities, other than work at a job?; Questions 5 and 6 of the WPAI:SHP are scored on an 11-point scale (0 = problem had no effect; 10 = problem completely prevented me from doing my work/daily activities) (NCT01903005)
Timeframe: Week 24
Intervention | units on a scale (Mean) |
---|
| Problem affects work productivity (n=70) | Problem affects daily activities (n=283) |
---|
Safety Population | -3.9 | -4.3 |
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Percent Change From Primary Study Baseline (OX219-006 or OX219-007) for Question 1 of the Work Productivity/Activity Impairment: 6-Question Specific Health Problem Questionnaire (WPAI:SHP)
"Question 1 of the WPAI:SHP asks patients to provide a yes or no response to the question Are you employed?; The percentage of patients employed at the end of the 24-week open-label, extension study was calculated by subtracting the percentage of previously employed patients not employed at study end from the percentage of previously unemployed patients who were employed by study end" (NCT01903005)
Timeframe: Study Endpoint
Intervention | percentage of patients (Number) |
---|
| Unemployed at baseline; employed at study endpoint | Employed at baseline; unemployed at study endpoint | Increase in patients employed at study endpoint |
---|
Safety Population | 21.3 | 6.0 | 15.3 |
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Retention in Treatment in the Safety Population
Retention in treatment by visit in the safety population at weeks 4, 8, 12, 16, 20, and 24, defined as the number of patients receiving treatment on the day of the visit (± 5 days for each visit) (NCT01903005)
Timeframe: Treatment retention was assessed at weeks 4, 8, 12, 16, 20, and 24
Intervention | participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 |
---|
Safety Population | 563 | 483 | 425 | 383 | 333 | 292 |
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Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHP
Mean change from primary study baseline to week 24 of the open-label, extension study for questions 2-4 of the WPAI:SHP; Question 2: During the past 7 days, how many hours did you miss from work because of problems associated with your opioid dependence?; Question 3: During the past 7 days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study?; Question 4: During the past 7 days, how many hours did you actually work? (NCT01903005)
Timeframe: Week 24
Intervention | hours (Mean) |
---|
| Missed work hours due to opioid dependence (n=79) | Missed work hours due to other reason (n=79) | Number of hours actually worked (n=78) |
---|
Safety Population | -4.8 | -0.2 | 7.7 |
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VAS Craving Scores: Stabilization/Maintenance
"Absolute mean ± standard deviation values for VAS cravings scores on Days 3, 4, 8, 15, and 22; the VAS craving scores range from 0 (no cravings) to 100 (most intense craving I have ever had)" (NCT01908842)
Timeframe: Days 3 through 22
Intervention | units on a scale (Mean) |
---|
| Day 3 | Day 4 | Day 8 | Day 15 | Day 22: Film (col 1); Tablets (col 2) |
---|
BNX Tablets, Then OL BNX Tablets, Then BNX Film | 33.7 | 29.1 | 26.2 | 21.6 | 20.2 |
,Buprenorphine, Then OL BNX Film, Then BNX Tablets | 34.5 | 28.5 | 23.7 | 19.1 | 20.9 |
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Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction
Absolute ± mean standard deviation values for SOWS total scores at baseline, 0.5 h, 1.5 h, 3 h, and 6 h post dose on Day 1, and Day 2; SOWS score ranges from 0-64, with a lower score being more favorable (NCT01908842)
Timeframe: Days 1 and 2
Intervention | units on a scale (Mean) |
---|
| Baseline | Day 1 0.5 h post dose | Day 1 1.5 h post dose | Day 1 3 h post dose | Day 1 6 h post dose | Day 2 |
---|
BNX Tablets, Then OL BNX Tablets, Then BNX Film | 31.7 | 22.7 | 19.1 | 13.6 | 10.7 | 16.7 |
,Buprenorphine, Then OL BNX Film, Then BNX Tablets | 33.0 | 23.0 | 17.8 | 13.0 | 11.1 | 16.4 |
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SOWS Total Scores: Stabilization/Maintenance
Absolute ± mean standard deviation values for SOWS total scores on Days 2, 3, 4, 8, 15, and 22; SOWS scores ranged from 0-64, with a lower score being more favorable (NCT01908842)
Timeframe: Days 3 through 22
Intervention | units on a scale (Mean) |
---|
| Day 3 | Day 4 | Day 8 | Day 15 | Day 22: Film (col 1); Tablets (col 2) |
---|
BNX Tablets, Then OL BNX Tablets, Then BNX Film | 11.9 | 10.1 | 9.0 | 7.2 | 6.8 |
,Buprenorphine, Then OL BNX Film, Then BNX Tablets | 12.6 | 10.2 | 8.8 | 6.7 | 7.3 |
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Clinical Opiate Withdrawal Scale (COWS) Scores: Induction
Absolute ± mean standard deviation values for COWS total scores at baseline; 0.5 h, 1.5 h, 3 h, and 6 h post dose on Day 1, and Day 2; COWS scores range from 0-48, with a lower score being more favorable (NCT01908842)
Timeframe: Days 1 and 2
Intervention | units on a scale (Mean) |
---|
| Baseline | Day 1 0.5 h post dose | Day 1 1.5 h post dose | Day 1 3 h post dose | Day 1 6 h post dose | Day 2 |
---|
BNX Tablets, Then OL BNX Tablets, Then BNX Film | 15.0 | 10.5 | 8.8 | 6.6 | 5.3 | 8.0 |
,Buprenorphine, Then OL BNX Film, Then BNX Tablets | 14.9 | 10.3 | 8.3 | 6.1 | 5.4 | 7.6 |
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COWS Total Scores: Stabilization/Maintenance
Absolute ± mean standard deviation values for COWS total scores at Days 3, 4, 8, 15, and 22; COWS scores range from 0-48, with a lower score being more favorable (NCT01908842)
Timeframe: Days 3 through 22
Intervention | units on a scale (Mean) |
---|
| Day 3 | Day 4 | Day 8 | Day 15 | Day 22: Film (col 1); Tablets (col 2) |
---|
BNX Tablets, Then OL BNX Tablets, Then BNX Film | 6.0 | 5.2 | 4.8 | 4.1 | 3.4 |
,Buprenorphine, Then OL BNX Film, Then BNX Tablets | 5.9 | 5.1 | 4.6 | 3.7 | 3.3 |
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Primary Endpoints of Retention in Treatment at Days 3 and 15
Retention rates (number of patients retained) for the primary efficacy endpoints of retention in treatment at Days 3 and 15, which was defined as the number of patients who received treatment on Days 3 and 15. (NCT01908842)
Timeframe: Day 3 and Day 15
Intervention | participants (Number) |
---|
| Retention at Day 3 | Retention at Day 15 |
---|
BNX Tablets, Then OL BNX Tablets, Then BNX Film | 309 | 273 |
,Buprenorphine, Then OL BNX Film, Then BNX Tablets | 302 | 269 |
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Visual Analog Scale (VAS) Cravings: Induction
"Absolute mean ± standard deviation values for VAS cravings at baseline, 0.5 h, 1.5 h, 3 h, and 6 post dose on Day 1, and Day 2; the VAS craving scores range from 0 (no cravings) to 100 (most intense craving I have ever had)" (NCT01908842)
Timeframe: Days 1 and 2
Intervention | units on a scale (Mean) |
---|
| Baseline | Day 1 0.5 h post dose | Day 1 1.5 h post dose | Day 1 3 h post dose | Day 1 6 h post dose | Day 2 |
---|
BNX Tablets, Then OL BNX Tablets, Then BNX Film | 69.2 | 56.8 | 49.2 | 36.0 | 30.2 | 45.3 |
,Buprenorphine, Then OL BNX Film, Then BNX Tablets | 71.9 | 58.2 | 48.8 | 34.9 | 29.6 | 44.9 |
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Number of Participants in Receipt of Antiretroviral Therapy (ART)
Initiation of and retention on treatment with antiretroviral medications. (NCT01936857)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
Buprenorphine/Naloxone | 108 |
Methadone Maintenance Therapy | 116 |
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Number of Participants in Retention in HIV Care
HIV clinic visit in past 3 months (NCT01936857)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
Buprenorphine/Naloxone | 111 |
Methadone Maintenance Therapy | 118 |
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Participants With Heroin Use (Self-report)
(NCT01936857)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
Buprenorphine/Naloxone | 64 |
Methadone Maintenance Therapy | 67 |
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Participants With Heroin Use (Urine Drug Screen)
(NCT01936857)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
Buprenorphine/Naloxone | 66 |
Methadone Maintenance Therapy | 72 |
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Number of Participants With HIV Viral Suppression
HIV-1 RNA < 200 copies/mL (NCT01936857)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
| Viral suppression at baseline | Viral suppression at 12 months |
---|
Buprenorphine/Naloxone | 97 | 74 |
,Methadone Maintenance Therapy | 92 | 99 |
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Secondary Efficacy Outcome on Physicians' and Patients' Treatment Satisfaction Assessed Using Physician's Global Impression of Change Scale and Patient's Global Impression of Change Scale Respectively
"The overall assessment of the change in pain intensity from baseline is measured at Visit 6.~Physician's Global Impression of Change scale: Investigator's opinion on a scale of 1 to 7 where 1 is very much improved and 7 is very much worse Patient's Global Impression of Change scale: Subject's opinion on a scale of 1 to 7 where 1 is very much improved and 7 is very much worse" (NCT01961271)
Timeframe: At visit 6 (anywhere between Day 91 to 119 after enrolment depending on how long titration took)
Intervention | units on a scale (Mean) |
---|
| Physician Impression | Patient Impression |
---|
Buprenorphine Transdermal Patch | 2.62 | 2.66 |
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Efficacy According to BS-11 Pain Score Reduction
"The primary efficacy outcome analysis is the pre- and post-intervention change in BS-11 pain score. The reduction in scores were calculated by subtracting the post-intervention score from the baseline score.~BS-11 is known as Box scale-11; it is an 11-point scale measuring pain intensity. It ranges from 0 to 10, whereby 0 represents no pain and 10 represents the worst imaginable pain. Subjects selected a number based on the pain intensity they were feeling at that time." (NCT01961271)
Timeframe: Maximum 17 weeks starting from enrolment
Intervention | units on a scale (Mean) |
---|
Buprenorphine Transdermal Patch | 2.7 |
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Treatment-emergent Adverse Events (TEAE's) as Measured by Number of Subjects With at Least 1 TEAE
Side effects of the transdermal patch treatment will be analysed. (NCT01961271)
Timeframe: From time of enrolment up to 7 days after completion / discontinuation visit (up to 140 days)
Intervention | participants (Number) |
---|
Buprenorphine Transdermal Patch | 89 |
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Secondary Efficacy Outcome Determined by Change in Percentage of Subjects Who Met Criteria on EQ5D-3L Quality of Life Questionnaire From Pre- to Post-intervention
"Pre-intervention: Visit 1 Post-intervention: Visit 6~There are 5 dimensions in the EQ5D-3L questionnaire answered by the subjects, classified into 5 categories here:~Mobility -- change in % of subjects who have no problem in walking around Self-care -- change in % of subjects who have no problem in self-care Usual activities -- change in % of subjects who have no problem with performing their usual activities Pain/ discomfort -- change in % of subjects who do not experience pain or discomfort Anxiety/ depression -- change in % of subjects who do not feel anxious or depressed" (NCT01961271)
Timeframe: approximately 17 weeks starting from enrolment
Intervention | percentage of subjects (Number) |
---|
| Mobility | Self-care | Usual Activities | Pain/Discomfort | Anxiety/ Depression |
---|
Buprenorphine Transdermal Patch | 25.8 | 20.2 | 19.4 | 14.3 | 18 |
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Secondary Efficacy Outcome -- Incidence of Early Treatment Discontinuation Due to Lack of Efficacy.
(NCT01961271)
Timeframe: From time of enrolment to Visit 6 (ie. up to119 days from enrolment)
Intervention | participants (Number) |
---|
Buprenorphine Transdermal Patch | 3 |
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Secondary Efficacy Outcome as Measured by Number of Subjects Requiring at Least 1 Breakthrough (Rescue) Pain Medication
Daily use of breakthrough pain medication from visits 1-6, assessed from patient diaries. (NCT01961271)
Timeframe: Approximately 17 weeks starting from enrolment
Intervention | participants (Number) |
---|
Buprenorphine Transdermal Patch | 26 |
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Pain Measurement
The primary pain measure was the Pain Assessment and Documentation Tool (PADT). Total score ranging from 0-11 reported. Higher score considered indicative of more pain. Lower score is indicative of less pain. (NCT01967641)
Timeframe: assessed twice weekly during course of 19 weeks or length of participation, only screening and last assessment reported.
Intervention | units on a scale (Mean) |
---|
| screening | end of study |
---|
Buprenorphine/Naloxone Combination | 6.1 | 4.3 |
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Number of Participants Retained in Study
Retention was number of participants retained at study end (Week 19). (NCT01967641)
Timeframe: week 19
Intervention | participants (Number) |
---|
Buprenorphine/Naloxone Combination | 18 |
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Number of Participants Abstinent From Opioids
Relapse was number of participants with opioid-negative urine toxicology in last week of study participation. (NCT01967641)
Timeframe: at week 19 or length of study participation
Intervention | participants (Number) |
---|
Buprenorphine/Naloxone Combination | 17 |
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Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to Week 2 of the Investigational Product Administration
NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week 2/ET minus mean score at Baseline. (NCT01983111)
Timeframe: 2 weeks
Intervention | Scores on a scale (Mean) |
---|
Buprenorphine | -1.19 |
Tramadol/Acetaminophen | -1.70 |
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Clinical Global Impression of Change(CGIC)
The number of patients who choose the best opinion of overall satisfaction among Clinical Global Impression of Change Scale(CGIC) among 7 point scale. Missing data was imputed by LOCF. Scores measure from 1: Very much improved to 7:very much worse. (NCT01983111)
Timeframe: 6 weeks
Intervention | Scores on 1 to 7 point (Mean) |
---|
Buprenorphine | 2.28 |
Tramadol/Acetaminophen | 2.43 |
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Change in the Quality of Life (EQ-5D) Score From Visit 1 (Baseline) to Week 6 Post-dose
"EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions for 'Motor capability', 'Self-care', 'Daily activities', 'Pain/discomfort', 'Depression/anxiety' and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)).~*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)~EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by 1 means that the healthy condition and high quality of life." (NCT01983111)
Timeframe: Baseline and at 6 weeks
Intervention | EQ-5D Total score (Mean) |
---|
Buprenorphine | 0.09 |
Tramadol/Acetaminophen | 0.21 |
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Patient Global Impressions of Change(PGIC)
"In the PP set, Number of participants with categorical change in overall satisfaction.~PGIC: a participant-rated instrument assessing change in participant's overall satisfaction from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse)." (NCT01983111)
Timeframe: 6 weeks
Intervention | Scores on 1 to 7point (Mean) |
---|
Buprenorphine | 2.32 |
Tramadol/Acetaminophen | 2.45 |
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Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to 6weeks After Treatment.
NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week6/ET minus mean score at Baseline. (NCT01983111)
Timeframe: baseline and 6 weeks
Intervention | Scores on a scale (Mean) |
---|
Buprenorphine | -2.32 |
Tramadol/Acetaminophen | -2.75 |
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The Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI)
The effects of 80 mcg/hr buprenorphine (Day 17) delivered by BTDS alone, or by BTDS dosed with naltrexone, and naltrexone alone on cardiac repolarization, were assessed based on the corrected QT interval since HR inversely affects QT duration. The time-matched analysis was conducted as the primary endpoint as recommended by ICH E14, with the 2-sided 90% confidence interval for each treatment at each time point showing the placebo- and baseline-corrected (ΔΔ) analysis for QTcI. The effect of BTDS 80 on QT intervals was compared with the moxifloxacin-positive control after placebo and baseline correction. (NCT01999114)
Timeframe: Baseline to Day 17
Intervention | msec (Mean) |
---|
BTDS Only (Placebo-corrected ΔΔQTcI) | 11.46 |
BTDS With Naltrexone (Placebo-corrected ΔΔQTcI) | 4.47 |
Naltrexone Alone (Placebo-corrected ΔΔQTcI) | 1.50 |
Moxifloxacin (Placebo-corrected ΔΔQTcI) | 10.78 |
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ECG Morphology
"Morphological analyses were performed with regard to the digital ECG waveform interpretation as defined by a central ECG laboratory's cardiologist blinded to the study treatment. Changes from baseline to each day of treatment were evaluated separately. Any T-U wave complex that suggested an abnormal form compatible with an effect on cardiac repolarization was noted. New ECG morphological onset changes were presented as the percentage of subjects meeting the new criterion (new meant not present on any baseline ECG and became present on at least 1 on-treatment ECG) for the following variables:~Second degree heart block~Third degree heart block~Complete right bundle branch block (RBBB)~Complete left bundle branch block (LBBB)~ST segment changes (elevation and depression separately)~T-wave abnormalities (negative T waves only)~Myocardial infarction (MI) pattern~Any new abnormal U waves" (NCT01999114)
Timeframe: Baseline to Day 13
Intervention | Participants (Count of Participants) |
---|
| New abnormal U waves | New T wave (negative) inverted | New ST segment depression changes | New ST segment elevation changes | New complete RBBB & LBBB | New MI | New 2nd or 3rd degree heart block |
---|
BTDS Only | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
,BTDS With Naltrexone | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
,Moxifloxacin | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
,Naltrexone Alone | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
,Placebo | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
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ECG Morphology
"Morphological analyses were performed with regard to the digital ECG waveform interpretation as defined by a central ECG laboratory's cardiologist blinded to the study treatment. Changes from baseline to each day of treatment were evaluated separately. Any T-U wave complex that suggested an abnormal form compatible with an effect on cardiac repolarization was noted. New ECG morphological onset changes were presented as the percentage of subjects meeting the new criterion (new meant not present on any baseline ECG and became present on at least 1 on-treatment ECG) for the following variables:~Second degree heart block~Third degree heart block~Complete right bundle branch block (RBBB)~Complete left bundle branch block (LBBB)~ST segment changes (elevation and depression separately)~T-wave abnormalities (negative T waves only)~Myocardial infarction (MI) pattern~Any new abnormal U waves" (NCT01999114)
Timeframe: Baseline to Day 17
Intervention | Participants (Count of Participants) |
---|
| New abnormal U waves | New T wave (negative) inverted | New ST segment depression changes | New ST segment elevation changes | New complete RBBB & LBBB | New MI | New 2nd or 3rd degree heart block |
---|
BTDS Only | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
,BTDS With Naltrexone | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
,Moxifloxacin | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
,Naltrexone Alone | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Placebo | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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ECG Morphology
"Morphological analyses were performed with regard to the digital ECG waveform interpretation as defined by a central ECG laboratory's cardiologist blinded to the study treatment. Changes from baseline to each day of treatment were evaluated separately. Any T-U wave complex that suggested an abnormal form compatible with an effect on cardiac repolarization was noted. New ECG morphological onset changes were presented as the percentage of subjects meeting the new criterion (new meant not present on any baseline ECG and became present on at least 1 on-treatment ECG) for the following variables:~Second degree heart block~Third degree heart block~Complete right bundle branch block (RBBB)~Complete left bundle branch block (LBBB)~ST segment changes (elevation and depression separately)~T-wave abnormalities (negative T waves only)~Myocardial infarction (MI) pattern~Any new abnormal U waves" (NCT01999114)
Timeframe: Baseline to Day 6
Intervention | Participants (Count of Participants) |
---|
| New abnormal U waves | New T wave (negative) inverted | New ST segment depression changes | New ST segment elevation changes | New complete RBBB & LBBB | New MI | New 2nd or 3rd degree heart block |
---|
BTDS Only | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
,BTDS With Naltrexone | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Moxifloxacin | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
,Naltrexone Alone | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
,Placebo | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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Heart Rate (HR)
Mean change from baseline for the BTDS 10 mcg/hr dose on Day 6, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo. (NCT01999114)
Timeframe: Baseline to Day 6
Intervention | bpm (Mean) |
---|
BTDS Only | -0.1 |
BTDS With Naltrexone | -1.3 |
Naltrexone Alone | -0.5 |
Moxifloxacin | 2.0 |
Placebo | 1.3 |
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Heart Rate (HR)
Mean change from baseline for the BTDS 40 mcg/hr dose on Day 13, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo. (NCT01999114)
Timeframe: Baseline to Day 13
Intervention | bpm (Mean) |
---|
BTDS Only | 1.3 |
BTDS With Naltrexone | -1.9 |
Naltrexone Alone | -0.8 |
Moxifloxacin | 2.3 |
Placebo | 1.6 |
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Heart Rate (HR)
Mean change from baseline for the BTDS 80 mcg/hr dose on Day 17, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo. (NCT01999114)
Timeframe: Baseline to Day 17
Intervention | bpm (Mean) |
---|
BTDS Only | 1.3 |
BTDS With Naltrexone | -2.4 |
Naltrexone Alone | -0.8 |
Moxifloxacin | 2.5 |
Placebo | 1.5 |
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The Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI)
The effects of 10 mcg/hr buprenorphine (Day 6) delivered by BTDS alone, or by BTDS dosed with naltrexone, and naltrexone alone on cardiac repolarization, were assessed based on the corrected QT interval since HR inversely affects QT duration. The time-matched analysis was conducted as the primary endpoint as recommended by ICH E14, with the 2-sided 90% confidence interval for each treatment at each time point showing the placebo- and baseline-corrected (ΔΔ) analysis for QTcI. The effect of BTDS 10 on QT intervals was compared with the moxifloxacin-positive control after placebo and baseline correction. (NCT01999114)
Timeframe: Baseline to Day 6
Intervention | milliseconds (msec) (Mean) |
---|
BTDS Only (Placebo-corrected ΔΔQTcI) | 3.36 |
BTDS With Naltrexone (Placebo-corrected ΔΔQTcI) | 5.37 |
Naltrexone Alone (Placebo-corrected ΔΔQTcI) | 4.34 |
Moxifloxacin (Placebo-corrected ΔΔQTcI) | 11.90 |
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The Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI)
The effects of 40 mcg/hr buprenorphine (Day 13) delivered by BTDS alone, or by BTDS dosed with naltrexone, and naltrexone alone on cardiac repolarization, were assessed based on the corrected QT interval since HR inversely affects QT duration. The time-matched analysis was conducted as the primary endpoint as recommended by ICH E14, with the 2-sided 90% confidence interval for each treatment at each time point showing the placebo- and baseline-corrected (ΔΔ) analysis for QTcI. The effect of BTDS 40 on QT intervals was compared with the moxifloxacin-positive control after placebo and baseline correction. (NCT01999114)
Timeframe: Baseline to Day 13
Intervention | msec (Mean) |
---|
BTDS Only (Placebo-corrected ΔΔQTcI) | 9.16 |
BTDS With Naltrexone (Placebo-corrected ΔΔQTcI) | 5.12 |
Naltrexone Alone (Placebo-corrected ΔΔQTcI) | 1.81 |
Moxifloxacin (Placebo-corrected ΔΔQTcI) | 10.68 |
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QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval
Mean change from baseline for the BTDS 80 mcg/hr dose on Day 17, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo. (NCT01999114)
Timeframe: Baseline to Day 17
Intervention | msec (Mean) |
---|
| QTcF | QTcB | PR | QRS | QT |
---|
BTDS Only | 9.0 | 10.4 | 5.4 | 0.4 | 6.1 |
,BTDS With Naltrexone | 1.8 | -0.8 | 5.8 | 1.5 | 7.1 |
,Moxifloxacin | 6.7 | 9.3 | 3.8 | 0.2 | 1.4 |
,Naltrexone Alone | -0.8 | -1.7 | 4.3 | 1.3 | 0.8 |
,Placebo | -0.4 | 1.2 | 3.0 | 0.6 | -3.7 |
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QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval
Mean change from baseline for the BTDS 40 mcg/hr dose on Day 13, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo. (NCT01999114)
Timeframe: Baseline to Day 13
Intervention | msec (Mean) |
---|
| QTcF | QTcB | PR | QRS | QT |
---|
BTDS Only | 5.0 | 6.3 | 4.5 | 0.2 | 2.4 |
,BTDS With Naltrexone | 1.1 | -1.1 | 4.4 | 0.9 | 5.5 |
,Moxifloxacin | 5.6 | 8.0 | 1.3 | -0.2 | 0.9 |
,Naltrexone Alone | -1.3 | -2.2 | 3.2 | 1.3 | 0.4 |
,Placebo | -1.6 | 0.2 | 2.0 | 0.3 | -5.1 |
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QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval
Mean change from baseline for the BTDS 10 mcg/hr dose on Day 6, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo. (NCT01999114)
Timeframe: Baseline to Day 6
Intervention | msec (Mean) |
---|
| QTcF | QTcB | PR | QRS | QT |
---|
BTDS Only | -0.1 | -0.3 | 4.7 | 0.4 | 0.3 |
,BTDS With Naltrexone | 2.9 | 1.5 | 2.4 | 0.7 | 5.6 |
,Moxifloxacin | 6.9 | 9.1 | 0.3 | -0.2 | 2.6 |
,Naltrexone Alone | 1.5 | 0.9 | 2.1 | 0.6 | 2.6 |
,Placebo | -0.8 | 0.5 | 0.6 | 0.0 | -3.4 |
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Cigarette Smoking, W24 11-20
Participants average cigarettes/day, in past 4 weeks, at week 24, equals 11-20. (NCT02032433)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
Extended-Release Naltrexone | 57 |
Buprenorphine-Naloxone | 71 |
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Cigarette Smoking, W24 21-30
Participants average cigarettes/day, in past 4 weeks, at week 24, equals 21-30 (NCT02032433)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
Extended-Release Naltrexone | 2 |
Buprenorphine-Naloxone | 11 |
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Cigarette Smoking, W24 31 or More
Participants average cigarettes/day, in past 4 weeks, at week 24, equals 31 or more (NCT02032433)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
Extended-Release Naltrexone | 1 |
Buprenorphine-Naloxone | 5 |
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Number Successfully Inducted Onto Assigned Study Medication
Binary Y/N assessment of whether the participant was or was not able to initiate their assigned study medication. (NCT02032433)
Timeframe: Weeks 0-24
Intervention | participants (Number) |
---|
Extended-Release Naltrexone | 204 |
Buprenorphine-Naloxone | 270 |
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Opioid Abstinence Over Time While on Study Medication (Objective)
A urine sample was obtained and tested for opioids at each in person visit; screening, prior to induction onto study medication, weekly through week 24 and at each of the follow up visits. (NCT02032433)
Timeframe: Weeks 0-24
Intervention | Weeks (Median) |
---|
Extended-Release Naltrexone | 13 |
Buprenorphine-Naloxone | 11 |
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Opioid Abstinence Over Time While on Study Medication (Subjective)
Self report of opioid use by participants using the TLFB. At each visit, the TLFB was completed for dates going back to the last participant encounter. (NCT02032433)
Timeframe: Weeks 0-24
Intervention | days (Median) |
---|
Extended-Release Naltrexone | 123 |
Buprenorphine-Naloxone | 87 |
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Opioid Craving Over Time W0
Opioid craving over time via VAS at week 0 (NCT02032433)
Timeframe: Week 0
Intervention | score on a scale (Mean) |
---|
Extended-Release Naltrexone | 68.7 |
Buprenorphine-Naloxone | 68.8 |
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Other Drug Use Over Time, Cannabis, W0
Other drug use over time measuring cannabis at week 0 (NCT02032433)
Timeframe: week 0
Intervention | Participants (Count of Participants) |
---|
Extended-Release Naltrexone | 123 |
Buprenorphine-Naloxone | 135 |
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Other Drug Use Over Time, Cannabis, W24
Other drug use over time measuring cannabis at week 24 (NCT02032433)
Timeframe: week 24
Intervention | Participants (Count of Participants) |
---|
Extended-Release Naltrexone | 20 |
Buprenorphine-Naloxone | 20 |
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Other Drug Use Over Time, Cocaine, W0
Other drug use over time measuring cocaine at week 0 (NCT02032433)
Timeframe: week 0
Intervention | Participants (Count of Participants) |
---|
Extended-Release Naltrexone | 61 |
Buprenorphine-Naloxone | 80 |
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Other Drug Use Over Time, Cocaine, W24
Other drug use over time measuring cocaine at week 0 (NCT02032433)
Timeframe: week 24
Intervention | Participants (Count of Participants) |
---|
Extended-Release Naltrexone | 5 |
Buprenorphine-Naloxone | 2 |
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Other Drug Use Over Time, Stimulant, W0
Other drug use over time measuring stimulant (cocaine, crack and amphetamine) at week 0 (NCT02032433)
Timeframe: week 0
Intervention | Participants (Count of Participants) |
---|
Extended-Release Naltrexone | 132 |
Buprenorphine-Naloxone | 166 |
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Other Drug Use Over Time, Stimulant, W24
Other drug use over time measuring stimulant (cocaine, crack and amphetamine) at week 24 (NCT02032433)
Timeframe: week 24
Intervention | Participants (Count of Participants) |
---|
Extended-Release Naltrexone | 5 |
Buprenorphine-Naloxone | 3 |
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Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale
The Alcohol Subscale within ASI is one question that asks how bothered one has been by alcohol problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem. (NCT02032433)
Timeframe: Week 0
Intervention | score on a scale (Mean) |
---|
Extended-Release Naltrexone | .1 |
Buprenorphine-Naloxone | .1 |
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Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale
The Alcohol Subscale within ASI is one question that asks how bothered one has been by alcohol problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem. (NCT02032433)
Timeframe: Week 24
Intervention | score on a scale (Mean) |
---|
Extended-Release Naltrexone | .1 |
Buprenorphine-Naloxone | 0.0 |
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Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
The Sexual Behavior Subscale consists of 3 questions. Each question is scored from 0-5, for a total score range of 0-15. Higher scores indicate a greater degree of risk-taking behavior. (NCT02032433)
Timeframe: Week 0
Intervention | score on a scale (Mean) |
---|
Extended-Release Naltrexone | 3.6 |
Buprenorphine-Naloxone | 4.3 |
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Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
The Sexual Behavior Subscale consists of 3 questions. Each question is scored from 0-5, for a total score range of 0-15. Higher scores indicate a greater degree of risk-taking behavior. (NCT02032433)
Timeframe: Week 24
Intervention | score on a scale (Mean) |
---|
Extended-Release Naltrexone | 4.8 |
Buprenorphine-Naloxone | 4.3 |
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Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale
The Drug Use Subscale within ASI is one question that asks how bothered one has been by drug use problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem. (NCT02032433)
Timeframe: Week 0
Intervention | score on a scale (Mean) |
---|
Extended-Release Naltrexone | 0.3 |
Buprenorphine-Naloxone | .3 |
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Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale
The Drug Use Subscale within ASI is one question that asks how bothered one has been by drug use problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem. (NCT02032433)
Timeframe: Week 24
Intervention | score on a scale (Mean) |
---|
Extended-Release Naltrexone | .1 |
Buprenorphine-Naloxone | .1 |
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Score of Family / Social Relationship Subscale Within Addiction Severity Index (ASI) Scale
The Family / Social Relationship Subscale within ASI contains 2 questions that ask how bothered one has been by family or social problems. The total range of the subscale is 0-8. The higher the score, the bigger the problem. (NCT02032433)
Timeframe: Week 24
Intervention | score on a scale (Mean) |
---|
Extended-Release Naltrexone | .1 |
Buprenorphine-Naloxone | .1 |
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Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale
The Legal Status Subscale within ASI is one question that asks how bothered one has been by legal problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem. (NCT02032433)
Timeframe: Week 0
Intervention | score on a scale (Mean) |
---|
Extended-Release Naltrexone | .2 |
Buprenorphine-Naloxone | .2 |
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Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale
The Legal Status Subscale within ASI is one question that asks how bothered one has been by legal problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem. (NCT02032433)
Timeframe: Week 24
Intervention | score on a scale (Mean) |
---|
Extended-Release Naltrexone | .1 |
Buprenorphine-Naloxone | .1 |
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Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale
The Medical Status Subscale within ASI is one question that asks how bothered one has been by medical problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem. (NCT02032433)
Timeframe: Week 0
Intervention | score on a scale (Mean) |
---|
Extended-Release Naltrexone | .2 |
Buprenorphine-Naloxone | .2 |
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Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale
The Medical Status Subscale within ASI is one question that asks how bothered one has been by medical problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem. (NCT02032433)
Timeframe: Week 24
Intervention | score on a scale (Mean) |
---|
Extended-Release Naltrexone | .1 |
Buprenorphine-Naloxone | .2 |
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Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale
The Psychiatric Status Subscale within ASI is one question that asks how bothered one has been by psychiatric or emotional problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem. (NCT02032433)
Timeframe: Week 0
Intervention | score on a scale (Mean) |
---|
Extended-Release Naltrexone | .3 |
Buprenorphine-Naloxone | .3 |
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Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale
The Psychiatric Status Subscale within ASI is one question that asks how bothered one has been by psychiatric or emotional problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem. (NCT02032433)
Timeframe: Week 24
Intervention | score on a scale (Mean) |
---|
Extended-Release Naltrexone | .2 |
Buprenorphine-Naloxone | .2 |
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Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
The Sexual Behavior Subscale consists of 5 questions. Each question is scored from 0-5, for a total score range of 0-25. Higher scores indicate a greater degree of risk-taking behavior. (NCT02032433)
Timeframe: Week 0
Intervention | score on a scale (Mean) |
---|
Extended-Release Naltrexone | 5.5 |
Buprenorphine-Naloxone | 5.9 |
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Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
The Sexual Behavior Subscale consists of 5 questions. Each question is scored from 0-5, for a total score range of 0-25. Higher scores indicate a greater degree of risk-taking behavior. (NCT02032433)
Timeframe: Week 24
Intervention | score on a scale (Mean) |
---|
Extended-Release Naltrexone | 7.3 |
Buprenorphine-Naloxone | 6.0 |
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Score of Social Relationship Subscale Within Addiction Severity Index (ASI) Scale
The Social Relationship Subscale within ASI contains 2 questions that ask how bothered one has been by family or social problems. The total range of the subscale is 0-8. The higher the score, the bigger the problem. (NCT02032433)
Timeframe: Week 0
Intervention | score on a scale (Mean) |
---|
Extended-Release Naltrexone | .3 |
Buprenorphine-Naloxone | .3 |
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Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale
The Subacute Withdrawal Symptoms Subscale consists of 6 symptoms. Classification of symptoms can be scored as: 0 - absent, 1 - doubtful or trivial, 2 - present. The total range of scores is 0 - 12, and the higher the total score the more severe the depression. (NCT02032433)
Timeframe: Week 0
Intervention | score on a scale (Mean) |
---|
Extended-Release Naltrexone | 8.6 |
Buprenorphine-Naloxone | 9.3 |
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Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale
The Subacute Withdrawal Symptoms Subscale consists of 6 symptoms. Classification of symptoms can be scored as: 0 - absent, 1 - doubtful or trivial, 2 - present. The total range of scores is 0 - 12, and the higher the total score the more severe the depression. (NCT02032433)
Timeframe: Week 24
Intervention | score on a scale (Mean) |
---|
Extended-Release Naltrexone | 5.2 |
Buprenorphine-Naloxone | 4.8 |
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Score on Color Card of Stoop Test
"The color card contains 100 patches of between 3-5 different colors. The patient's task is to utter the names of the colored patches as rapidly as possible, scanning the rows from left to right. The score is the total time (in seconds) it takes to utter the 100 colors." (NCT02032433)
Timeframe: Week 0
Intervention | seconds (Mean) |
---|
Extended-Release Naltrexone | 69.3 |
Buprenorphine-Naloxone | 70.5 |
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Score on Color Card of Stoop Test
"The color card contains 100 patches of between 3-5 different colors. The patient's task is to utter the names of the colored patches as rapidly as possible, scanning the rows from left to right. The score is the total time (in seconds) it takes to utter the 100 colors." (NCT02032433)
Timeframe: Week 24
Intervention | seconds (Mean) |
---|
Extended-Release Naltrexone | 75.3 |
Buprenorphine-Naloxone | 76.1 |
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Score on Color Word Card of Stoop Test
"The color-word card contains the printed names of colors, but printed in an ink of a conflicting color (e.g. the word RED might be printed in green, yellow, or blue). The patient is required to name the colors of the inks while ignoring the conflicting printed color names. The basic score is the total time (in seconds) to utter the 100 colors." (NCT02032433)
Timeframe: Week 0
Intervention | seconds (Mean) |
---|
Extended-Release Naltrexone | 41.1 |
Buprenorphine-Naloxone | 42.2 |
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Score on Color Word Card of Stoop Test
"The color-word card contains the printed names of colors, but printed in an ink of a conflicting color (e.g. the word RED might be printed in green, yellow, or blue). The patient is required to name the colors of the inks while ignoring the conflicting printed color names. The basic score is the total time (in seconds) to utter the 100 colors." (NCT02032433)
Timeframe: Week 24
Intervention | seconds (Mean) |
---|
Extended-Release Naltrexone | 47.6 |
Buprenorphine-Naloxone | 48.8 |
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Score on EuroQOL EQ-5D Questionnaire
Problems related to drug abuse is assessed through this questionnaire, which consists of 5 conditions. Each condition is scored from 0-2 for a total score range of 0-10. The higher the score, the more problems. (NCT02032433)
Timeframe: Week 0
Intervention | score on a scale (Mean) |
---|
Extended-Release Naltrexone | 6.8 |
Buprenorphine-Naloxone | 6.8 |
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Score on EuroQOL EQ-5D Questionnaire
Problems related to drug abuse is assessed through this questionnaire, which consists of 5 conditions. Each condition is scored from 0-2 for a total score range of 0-10. The higher the score, the more problems. (NCT02032433)
Timeframe: Week 24
Intervention | score on a scale (Mean) |
---|
Extended-Release Naltrexone | 5.8 |
Buprenorphine-Naloxone | 6.1 |
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Score on Opioid Craving Scale (OCS)
OCS is a brief 3-item measure used to measure opioid craving. The scale consists of 3 items rated on a visual analogue scale (VAS) from 1-10. The total range of score is 0-30, and a higher score indicates a stronger craver / desire to use opiates. (NCT02032433)
Timeframe: Week 24
Intervention | score on a scale (Mean) |
---|
Extended-Release Naltrexone | 9.9 |
Buprenorphine-Naloxone | 9.4 |
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Score on Subjective Opiate Withdrawal Scale (SOWS)
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). The total range of scores is 0-64; the higher the score, the more intense the withdrawal. (NCT02032433)
Timeframe: Week 0
Intervention | score on a scale (Mean) |
---|
Extended-Release Naltrexone | 15.6 |
Buprenorphine-Naloxone | 15.6 |
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Score on Subjective Opiate Withdrawal Scale (SOWS)
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). The total range of scores is 0-64; the higher the score, the more intense the withdrawal. (NCT02032433)
Timeframe: Week 24
Intervention | score on a scale (Mean) |
---|
Extended-Release Naltrexone | 4.5 |
Buprenorphine-Naloxone | 5.3 |
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Score on Trail Making Test Part A
Trail Making Test Part A consists of 25 circles distributed over a sheet of paper. The circles are number 1-25, and the patient is asked to draw lines to connect the numbers in ascending order. The patient is instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Higher scores reveal greater impairment. (NCT02032433)
Timeframe: Week 0
Intervention | seconds (Mean) |
---|
Extended-Release Naltrexone | 26.8 |
Buprenorphine-Naloxone | 25.8 |
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Score on Trail Making Test Part A
Trail Making Test Part A consists of 25 circles distributed over a sheet of paper. The circles are number 1-25, and the patient is asked to draw lines to connect the numbers in ascending order. The patient is instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Higher scores reveal greater impairment. (NCT02032433)
Timeframe: Week 24
Intervention | seconds (Mean) |
---|
Extended-Release Naltrexone | 21.6 |
Buprenorphine-Naloxone | 20.3 |
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Score on Trail Making Test Part B
Part B consists of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern, by alternating between the numbers and letters. Results are reported as the number of seconds required to complete the task. (NCT02032433)
Timeframe: Week 0
Intervention | seconds (Mean) |
---|
Extended-Release Naltrexone | 79.1 |
Buprenorphine-Naloxone | 78.3 |
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Score on Trail Making Test Part B
Part B consists of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern, by alternating between the numbers and letters. Results are reported as the number of seconds required to complete the task. (NCT02032433)
Timeframe: Week 24
Intervention | seconds (Mean) |
---|
Extended-Release Naltrexone | 61.2 |
Buprenorphine-Naloxone | 58.1 |
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Score on Word Card of Stoop Test
"The word card of the Stoop Test has the names of colors printed in black and white (100 items to be named). The patient's basic score is the total time he/she takes to utter the 100 words on the card." (NCT02032433)
Timeframe: Week 0
Intervention | seconds (Mean) |
---|
Extended-Release Naltrexone | 95.8 |
Buprenorphine-Naloxone | 96.4 |
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Score on Word Card of Stoop Test
"The word card of the Stoop Test has the names of colors printed in black and white (100 items to be named). The patient's basic score is the total time he/she takes to utter the 100 words on the card." (NCT02032433)
Timeframe: Week 24
Intervention | seconds (Mean) |
---|
Extended-Release Naltrexone | 103.2 |
Buprenorphine-Naloxone | 102.9 |
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Time to Relapse (Intent to Treat Population)
Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week. (NCT02032433)
Timeframe: Weeks 3-24
Intervention | weeks (Median) |
---|
Extended-Release Naltrexone | 8.4 |
Buprenorphine-Naloxone | 14.4 |
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Time to Relapse (Per Protocol Population)
Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week. (NCT02032433)
Timeframe: Weeks 3-24
Intervention | weeks (Median) |
---|
Extended-Release Naltrexone | 20.4 |
Buprenorphine-Naloxone | 15.2 |
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Alcohol Use Over Time, Drinks Per Day
Alcohol use over time, drinks per day (NCT02032433)
Timeframe: Week 24
Intervention | drinks per day (Mean) |
---|
Extended-Release Naltrexone | .1 |
Buprenorphine-Naloxone | .4 |
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Alcohol Use Over Time, Drinks Per Day, Past 30 Days, W0
Alcohol use over time, drinks per day, past 30 days, at week 0 (NCT02032433)
Timeframe: Week 0
Intervention | drinks per day (Mean) |
---|
Extended-Release Naltrexone | .8 |
Buprenorphine-Naloxone | 1.2 |
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Cigarette Smoking
Participants average cigarettes/day, in past 4 weeks, at week 24, equals 10 or less. (NCT02032433)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
Extended-Release Naltrexone | 70 |
Buprenorphine-Naloxone | 78 |
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Cigarette Smoking, W0 0
Participants average cigarettes/day, in past 4 weeks, at week 0, equals none (NCT02032433)
Timeframe: Week 0
Intervention | Participants (Count of Participants) |
---|
Extended-Release Naltrexone | 17 |
Buprenorphine-Naloxone | 18 |
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Cigarette Smoking, W0 11-20
Participants average cigarettes/day, in past 4 weeks, at week 0, equals 11-20. (NCT02032433)
Timeframe: Week 0
Intervention | Participants (Count of Participants) |
---|
Extended-Release Naltrexone | 106 |
Buprenorphine-Naloxone | 112 |
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Cigarette Smoking, W0 21-30
Participants average cigarettes/day, in past 4 weeks, at week 0, equals 21-30 (NCT02032433)
Timeframe: Week 0
Intervention | Participants (Count of Participants) |
---|
Extended-Release Naltrexone | 18 |
Buprenorphine-Naloxone | 21 |
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Cigarette Smoking, W0 31 or More
Participants average cigarettes/day, in past 4 weeks, at week 0, equals 31 or more (NCT02032433)
Timeframe: Week 0
Intervention | Participants (Count of Participants) |
---|
Extended-Release Naltrexone | 3 |
Buprenorphine-Naloxone | 8 |
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Cigarette Smoking, W0, 10 or Less
Participants average cigarettes/day, in past 4 weeks, at week 0, equals 10 or less. (NCT02032433)
Timeframe: Week 0
Intervention | Participants (Count of Participants) |
---|
Extended-Release Naltrexone | 112 |
Buprenorphine-Naloxone | 109 |
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Cigarette Smoking, W24 0
Participants average cigarettes/day, in past 4 weeks, at week 24, equals none (NCT02032433)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
Extended-Release Naltrexone | 32 |
Buprenorphine-Naloxone | 29 |
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Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Was it to Open the Package?
Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1. (NCT02038790)
Timeframe: Days 0-1
Intervention | percentage of participants (Number) |
---|
| Favorable response | Unfavorable response |
---|
Suboxone Sublingual Film 8/2 | 61.29 | 38.71 |
,Zubsolv Sublingual Tablets 5.7/1.4 | 51.61 | 48.39 |
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Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters?
Participant responses were captured on a 10-point scale with 0 = None and 9= Extreme. (NCT02038790)
Timeframe: Days 0-1
Intervention | percentage of participants (Number) |
---|
| 0 (none) | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 (extreme) |
---|
Suboxone Sublingual Film 8/2 | 70.97 | 22.58 | 3.23 | 0 | 0 | 3.23 | 0 | 0 | 0 | 0 |
,Zubsolv Sublingual Tablets 5.7/1.4 | 70.97 | 29.03 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging?
Participant responses were captured on a 10-point scale with 0 = None and 9= Extreme. (NCT02038790)
Timeframe: Days 0-1
Intervention | percentage of participants (Number) |
---|
| 0 (none) | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 (extreme) |
---|
Suboxone Sublingual Film 8/2 | 67.74 | 19.35 | 6.45 | 3.23 | 0 | 3.23 | 0 | 0 | 0 | 0 |
,Zubsolv Sublingual Tablets 5.7/1.4 | 58.06 | 19.35 | 16.13 | 0 | 0 | 3.23 | 0 | 0 | 0 | 3.23 |
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Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Were the Package Instructions to Follow?
Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1. (NCT02038790)
Timeframe: Days 0-1
Intervention | percentage of participants (Number) |
---|
| Favorable response | Unfavorable response |
---|
Suboxone Sublingual Film 8/2 | 100 | 0 |
,Zubsolv Sublingual Tablets 5.7/1.4 | 90.32 | 9.68 |
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Overall Intervention Preference As Assessed by Participants
At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: When thinking about the two medications you evaluated over the last two days, which medication type did you prefer? (NCT02038790)
Timeframe: Day 1
Intervention | percentage of participants (Number) |
---|
| Suboxone | Zubsolv |
---|
All Participants | 54.84 | 45.16 |
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Percentage of Participant Response to the Question: Compared to the Medication That You Are Currently Using for Treatment of Opioid Dependence, The Study Medication You Just Used Was.....
"Choices to the question above are:~More effective as a treatment for opioid dependence~Equally effective as a treatment for opioid dependence~Less effective as a treatment for opioid dependence~The same medication that I normally use" (NCT02038790)
Timeframe: Days 0-1
Intervention | percentage of participants (Number) |
---|
| More effective | Equally effective | Less effective | Same medication I normally use |
---|
Suboxone Sublingual Film 8/2 | 3.23 | 29.03 | 0 | 67.74 |
,Zubsolv Sublingual Tablets 5.7/1.4 | 0 | 51.61 | 32.26 | 16.13 |
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Participant Assessments With Regard to Ease of Dissolution of Interventions
At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: Which one did you think dissolve easier in your mouth? (NCT02038790)
Timeframe: Day 1
Intervention | percentage of participants (Number) |
---|
| Suboxone | Zubsolv |
---|
All Participants | 19.35 | 80.65 |
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Dissolution Time of Intervention as Recorded by a Trained Observer
The subject was observed and times documented for time of administration and time dissolution (recorded in minutes and seconds) was completed by designated qualified study personnel at the site. (NCT02038790)
Timeframe: Days 0-1
Intervention | minutes (Mean) |
---|
Suboxone Sublingual Film 8/2 | 6.59 |
Zubsolv Sublingual Tablets 5.7/1.4 | 2.98 |
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Participant Preference With Regard to Overall Taste of Interventions
At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: Which one did you prefer in regards to overall taste? (NCT02038790)
Timeframe: Day 1
Intervention | percentage of participants (Number) |
---|
| Suboxone | Zubsolv |
---|
All Participants | 29.03 | 70.97 |
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Percentage of Participant Favorable and Unfavorable Response to the Question: How Comfortable Did It Feel In Your Mouth?
Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1. (NCT02038790)
Timeframe: Days 0-1
Intervention | percentage of participants (Number) |
---|
| Favorable response | Unfavorable response |
---|
Suboxone Sublingual Film 8/2 | 54.84 | 45.16 |
,Zubsolv Sublingual Tablets 5.7/1.4 | 77.42 | 22.58 |
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Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication
Participant responses were captured on a 10-point scale with 0 = No desire to abuse and 9= Extremely high desire to abuse. (NCT02038790)
Timeframe: Days 0-1
Intervention | percentage of participants (Number) |
---|
| 0 (no high) | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 (extremely strong high) |
---|
Suboxone Sublingual Film 8/2 | 70.97 | 16.13 | 9.68 | 0 | 0 | 3.23 | 0 | 0 | 0 | 0 |
,Zubsolv Sublingual Tablets 5.7/1.4 | 61.29 | 35.48 | 3.23 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High'
Participant responses were captured on a 10-point scale with 0 = No high and 9= Extremely strong high. (NCT02038790)
Timeframe: Days 0-1
Intervention | percentage of participants (Number) |
---|
| 0 (no high) | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 (extremely strong high) |
---|
Suboxone Sublingual Film 8/2 | 70.97 | 16.13 | 9.68 | 0 | 0 | 3.23 | 0 | 0 | 0 | 0 |
,Zubsolv Sublingual Tablets 5.7/1.4 | 61.29 | 32.26 | 6.45 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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Percentage of Participant Response to the Question: If You Did Want to Abuse This Medication, Would You Prefer to......
"Choices to the question above are:~Crush and snort~Liquefy and inject~Not able to abuse this formulation" (NCT02038790)
Timeframe: Days 0-1
Intervention | percentage of participants (Number) |
---|
| Crush and snort | Liquefy and inject | Not able to abuse this formulation |
---|
Suboxone Sublingual Film 8/2 | 0 | 0 | 100 |
,Zubsolv Sublingual Tablets 5.7/1.4 | 25.81 | 3.23 | 70.97 |
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Percentage of Participant Favorable and Unfavorable Response to the Question: How Easily Did the Medication Dissolve in Your Mouth?
Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1. (NCT02038790)
Timeframe: Days 0-1
Intervention | percentage of participants (Number) |
---|
| Favorable response | Unfavorable response |
---|
Suboxone Sublingual Film 8/2 | 54.84 | 45.16 |
,Zubsolv Sublingual Tablets 5.7/1.4 | 96.77 | 3.23 |
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Participants With Treatment-Emergent Adverse Events (TEAE)
"TEAE=any untoward medical occurrence that develops or worsens in severity after administration of study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required intervention to prevent one of the outcomes listed above.~All adverse events that occurred between Day 1 to Day 91 are reported under the Depot Buprenorphine treatment arm.~Adverse events that occurred on the day of a hydromorphone challenge are also reported under the appropriate hydromorphone challenge arm." (NCT02044094)
Timeframe: Depot Buprenorphine: Day 1 to Day 91. The three hydromorphone challenge levels were randomly assigned to one day in each of the three-day groupings spanning 12 weeks: Days 5-7, 11-14, 19-21, 26-28, 33-35, 40-42, 47-49, 54-56, 61-63, 68-70, 75-77, 82-84
Intervention | Participants (Count of Participants) |
---|
| >=1 TEAE | >=1 Severe TEAE | Deaths | >=1 SAE other than death | Withdrew from study due to a TEAE |
---|
Hydromorphone 18 mg Challenge | 25 | 0 | 0 | 0 | 0 |
,Hydromorphone 6 mg Challenge | 26 | 0 | 0 | 0 | 0 |
,Placebo Challenge | 29 | 0 | 0 | 0 | 0 |
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"VAS Score for Does the Drug Have Any Good Effects? by Study Week Analyzed by Mixed Model for Repeated Measures"
"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme good effect 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11." (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline Week -1 | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 |
---|
Hydromorphone 18 mg | 61.640 | 7.072 | 5.263 | 7.395 | 8.130 | 2.270 | 1.164 | 2.225 | 3.146 | 4.815 | 0.681 | 3.712 | 2.251 |
,Hydromorphone 6 mg | 43.888 | 4.252 | 2.364 | 2.930 | 4.508 | 2.264 | 0.761 | 0.504 | 0.188 | 0.270 | 0.564 | 1.023 | 0.681 |
,Placebo | 3.131 | 1.239 | 1.768 | 1.221 | 0.476 | 0.863 | 0.410 | 0.574 | 1.289 | 0.399 | 0.536 | 1.149 | 0.550 |
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"VAS Score for How High Are You Right Now? by Study Week Analyzed by Mixed Model for Repeated Measures"
"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme high from the drug 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11." (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline Week -1 | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 |
---|
Hydromorphone 18 mg | 53.597 | 6.240 | 5.173 | 5.731 | 7.737 | 2.304 | 2.555 | 2.481 | 3.277 | 4.534 | 0.624 | 2.460 | 0.994 |
,Hydromorphone 6 mg | 33.052 | 4.444 | 2.539 | 3.028 | 4.251 | 2.406 | 0.878 | 0.540 | 0.261 | 0.265 | 0.417 | 0.987 | 0.458 |
,Placebo | 2.654 | 1.386 | 2.020 | 1.362 | 0.595 | 0.860 | 0.463 | 0.661 | 1.431 | 0.519 | 0.644 | 0.950 | 0.289 |
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"Visual Analog Scale (VAS) Score for Do You Like the Drug? by Study Week Analyzed by Mixed Model for Repeated Measures"
"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme liking of the drug 30 minutes before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11." (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline Week -1 | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 |
---|
Hydromorphone 18 mg | 63.503 | 8.374 | 4.750 | 6.246 | 7.211 | 2.258 | 3.600 | 2.550 | 3.203 | 4.616 | 0.722 | 4.709 | 3.756 |
,Hydromorphone 6 mg | 48.252 | 5.103 | 2.436 | 2.183 | 3.849 | 1.785 | 0.789 | 0.521 | 0.225 | 0.328 | 0.507 | 1.154 | 0.939 |
,Placebo | 2.892 | 1.447 | 1.850 | 1.320 | 0.534 | 1.048 | 0.440 | 0.672 | 1.270 | 0.451 | 0.596 | 1.471 | 0.973 |
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Change From Placebo in Reinforcing Effects (Breakpoint) by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)
"This endpoint explores the correlation between the reinforcing effects of hydromorphone and simulated mu opioid receptor occupancy.~Data are reported as change from placebo least square mean of Log10 transformed values for reinforcing effects. Reinforcing Effects tasks began >= 5 hours after hydromorphone challenge. Participants made 12 choices between a preference for working for the amount of hydromorphone dosed that day or for money. The hydromorphone break point value is assigned to the highest level of hydromorphone units earned, with 1 unit having a breakpoint value of 5 and 12 units with a value of 2160.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: predicted mu opioid receptor occupancy for 6 mg / 18 mg challenge dosages" (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)
Intervention | log10 transformed ratio (Least Squares Mean) |
---|
| Baseline Week -1: 0.00/0.00 % | Week 1: 67.88/67.09 % | Week 2: 66.06/66.49 % | Week 3: 66.00/66.44 % | Week 4: 65.11/65.35 % | Week 5: 76.29/76.42 % | Week 6: 75.70/75.69 % | Week 7: 75.64/75.43 % | Week 8: 74.79/75.18 % | Week 9: 73.97/74.04 % | Week 10: 73.08/74.18 % | Week 11: 73.05/73.51 % | Week 12: 71.31/71.30 % |
---|
Hydromorphone 18 mg | 0.89 | 0.41 | 0.63 | 0.40 | 0.82 | 0.16 | 0.43 | 0.38 | 0.37 | 0.48 | 0.20 | 0.32 | 0.69 |
,Hydromorphone 6 mg | 0.93 | 0.27 | 0.32 | 0.41 | 0.60 | -0.04 | 0.05 | 0.31 | 0.23 | 0.04 | 0.01 | -0.09 | 0.26 |
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Participants With Treatment-Emergent Adverse Events (TEAE)
"TEAE=any untoward medical occurrence that develops or worsens in severity after administration of study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required intervention to prevent one of the outcomes listed above.~All adverse events that occurred between Day 1 to Day 91 are reported under the Depot Buprenorphine treatment arm.~Adverse events that occurred on the day of a hydromorphone challenge are also reported under the appropriate hydromorphone challenge arm." (NCT02044094)
Timeframe: Depot Buprenorphine: Day 1 to Day 91. The three hydromorphone challenge levels were randomly assigned to one day in each of the three-day groupings spanning 12 weeks: Days 5-7, 11-14, 19-21, 26-28, 33-35, 40-42, 47-49, 54-56, 61-63, 68-70, 75-77, 82-84
Intervention | Participants (Count of Participants) |
---|
| >=1 TEAE | >=1 TEAE related to study drug | >=1 Severe TEAE | Deaths | >=1 SAE other than death | Withdrew from study due to a TEAE |
---|
Depot Buprenorphine | 39 | 25 | 0 | 0 | 0 | 0 |
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Plasma Concentrations of Buprenorphine Summarized by Study Week
"PK Sampling Schedule:~Day -17 to -15: before hydromorphone admin~Day -4: before Suboxone admin~Day 2: 24 hours after RBP-6000 admin~Days 5-7, 12-14, 19-21 and 26-28: immediately before hydromorphone admin~Days 29: before RBP-6000 admin~Day 30: 24 hours after RBP-6000 admin~Days 33-35, 40-42, 47-49, 54-56, 61-63, 68-70, 75-77, and 82-84: immediately before hydromorphone admin" (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)
Intervention | ng/mL (Mean) |
---|
| Week -1 | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 |
---|
Hydromorphone 18 mg | 0.000 | 2.042 | 1.970 | 1.916 | 1.812 | 3.667 | 3.521 | 3.466 | 3.497 | 3.210 | 1.150 | 1.083 | 2.624 |
,Hydromorphone 6 mg | 0.000 | 2.164 | 1.874 | 1.882 | 1.776 | 3.649 | 3.530 | 3.495 | 3.365 | 3.122 | 3.039 | 2.985 | 2.646 |
,Placebo | 0.000 | 2.030 | 1.892 | 1.933 | 1.722 | 3.684 | 3.423 | 3.427 | 3.326 | 3.156 | 2.985 | 3.117 | 2.626 |
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Predicted mu Opioid Receptor Occupancy (μORO) by Mean Buprenorphine Concentrations and Study Week
"A population pharmacokinetic/pharmacodynamic (PK/PD) model was developed to model the relationship between buprenorphine plasma concentrations and brain μORO based on 2 published clinical trials. This model used individual buprenorphine plasma concentrations measured to derive muORO individual predictions that were further described using summary statistics. The relationship between buprenorphine plasma concentration and μORO was best described by a maximal effect (Emax) model:~µORO = E(max)*Cp / EC(50) + Cp~Where Cp is the plasma concentration of buprenorphine, Emax is the maximal μORO, and EC50 is the plasma concentration of buprenorphine that is expected to achieve 50% of the maximal μORO. A direct (instantaneous) relationship between buprenorphine plasma concentration and µORO, i.e. without equilibration delay, was assumed.~Row title format: Study Week: buprenorphine plasma concentrations for placebo/ 6 mg / 18 mg challenge dosages" (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)
Intervention | percentage receptor occupancy (Mean) |
---|
| Baseline Week -1: 0.00/0.00/0.00 | Week 1: 2.03/2.16/2.04 | Week 2: 1.89/1.87/1.97 | Week 3: 1.93/1.88/1.92 | Week 4: 1.72/1.78/1.81 | Week 5: 3.68/3.65/3.67 | Week 6: 3.42/3.53/3.52 | Week 7: 3.43/3.50/3.47 | Week 8: 3.33/3.37/3.50 | Week 9: 3.16/3.12/3.21 | Week 10: 2.99/3.04/3.19 | Week 11: 3.12/2.99/3.08 | Week 12: 2.63/2.65/2.62 |
---|
Hydromorphone 18 mg | 0.000 | 67.089 | 66.485 | 66.438 | 65.349 | 76.417 | 75.686 | 75.429 | 75.179 | 74.036 | 74.179 | 73.507 | 71.303 |
,Hydromorphone 6 mg | 0.000 | 67.875 | 66.059 | 66.000 | 65.108 | 76.285 | 75.699 | 75.641 | 74.792 | 73.970 | 73.075 | 73.054 | 71.313 |
,Placebo | 0.000 | 67.077 | 66.071 | 66.442 | 64.270 | 76.346 | 75.432 | 75.351 | 74.544 | 74.000 | 73.002 | 73.385 | 71.274 |
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Reinforcing Effects (Breakpoint) by Study Week Analyzed by Mixed Model for Repeated Measures
"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Reinforcing Effects tasks began >= 5 hours after hydromorphone challenge. Participants made 12 choices between a preference for working for the amount of hydromorphone dosed that day or for money. The hydromorphone break point value is assigned to the highest level of hydromorphone units earned, with 1 unit having a breakpoint value of 5 and 12 units with a value of 2160.~A repeated measures mixed-effects analysis of variance (ANOVA) was performed with the log transformed hydromorphone break point value as the dependent variable with period, hydromorphone sequence and hydromorphone dose as fixed effects, and subject nested within hydromorphone sequence as a random effect.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11." (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline Week -1 | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 |
---|
Hydromorphone 18 mg | 7.042 | 5.708 | 5.496 | 5.669 | 6.030 | 4.936 | 5.282 | 5.965 | 4.747 | 5.437 | 4.997 | 5.076 | 5.615 |
,Hydromorphone 6 mg | 7.121 | 5.379 | 4.779 | 5.706 | 5.533 | 4.470 | 4.419 | 5.808 | 4.418 | 4.432 | 4.578 | 4.114 | 4.623 |
,Placebo | 4.984 | 4.767 | 4.036 | 4.760 | 4.144 | 4.564 | 4.303 | 5.092 | 3.899 | 4.342 | 4.546 | 4.330 | 4.029 |
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Reinforcing Effects Of the Daily Randomized Hydromorphone Challenge as Measured by the Mean Hydromorphone Break Point Value at Weeks 1-12
"The ability of RBP-6000 to reduce the reinforcing effects of hydromorphone used money as a choice alternative to hydromorphone.~Reinforcing Effects Tasks began no earlier than 5 hours after randomised hydromorphone administration for each day. Each test consisted of the participant making 12 choices between a preference for working for the amount of hydromorphone dosed earlier that day or for money (each choice therefore has a scale of 0-12). The hydromorphone break point value is the ratio of the highest number of choices for hydromorphone to the highest number of choices for money. Hydromorphone breakpoint values were then analysed by week using a repeated measures mixed-effects model with period, hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect. Analyses were carried out on the log10 transformed hydromorphone breakpoint value." (NCT02044094)
Timeframe: Weeks 1 (Days 5-7), 2 (Days 12-14), 3 (Days 19-21), 4 (Days 26-28), 5 (Days 33-35), 6 (Days 40-42), 7 (Days 47-49), 8 (Days 53-56), 9 (Days 61-63), 10 (Days 68-70), 11 (Days 75-77), 12 (Days 82-84)
Intervention | log10 transformed ratio (Least Squares Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 |
---|
Hydromorphone 18 mg | 2.479 | 2.387 | 2.462 | 2.619 | 2.144 | 2.294 | 2.591 | 2.062 | 2.361 | 2.170 | 2.205 | 2.438 |
,Hydromorphone 6 mg | 2.336 | 2.075 | 2.478 | 2.403 | 1.941 | 1.919 | 2.522 | 1.919 | 1.925 | 1.988 | 1.787 | 2.008 |
,Placebo | 2.070 | 1.753 | 2.067 | 1.800 | 1.982 | 1.869 | 2.212 | 1.694 | 1.886 | 1.974 | 1.880 | 1.750 |
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"Change From Placebo in VAS Score for How High Are You Right Now? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"
"Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme high from the drug 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo. For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: mean predicted mu opioid receptor occupancy 6 mg / 18 mg" (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline Week -1: 0.00/0.00 % | Week 1: 67.88/67.09 % | Week 2: 66.06/66.49 % | Week 3: 66.00/66.44 % | Week 4: 65.11/65.35 % | Week 5: 76.29/76.42 % | Week 6: 75.70/75.69 % | Week 7: 75.64/75.43 % | Week 8: 74.79/75.18 % | Week 9: 73.97/74.04 % | Week 10: 73.08/74.18 % | Week 11: 73.05/73.51 % | Week 12: 71.31/71.30 % |
---|
Hydromorphone 18 mg | 50.94 | 4.85 | 3.15 | 4.37 | 7.14 | 1.44 | 2.09 | 1.82 | 1.85 | 4.02 | -0.02 | 1.51 | 0.71 |
,Hydromorphone 6 mg | 30.40 | 3.06 | 0.52 | 1.67 | 3.66 | 1.55 | 0.42 | -0.12 | -1.17 | -0.25 | -0.23 | 0.04 | 0.17 |
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"Opioid Blockade Following Administration of Hydromorphone Challenge As Measured Using the Subjective Opioid Effects Rating for the Question Do You Like the Drug? Visual Analog Scale (VAS) at Weeks 1-4 Analyzed by Mixed Model for Repeated Measures"
"The study's primary objective was to determine if the opioid blocking effect for the first injection of buprenorphine 300 mg (RBP-6000) on Day 1 was not inferior to placebo when challenged by hydromorphone.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme liking of the drug 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone administration on the challenge days listed in the time frame field. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis." (NCT02044094)
Timeframe: Weeks 1 (Days 5-7), 2 (Days 12-14), 3 (Days 19-21), 4 (Days 26-28)
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 |
---|
Hydromorphone 18 mg | 8.374 | 4.750 | 6.246 | 7.211 |
,Hydromorphone 6 mg | 5.103 | 2.436 | 2.183 | 3.849 |
,Placebo | 1.447 | 1.850 | 1.320 | 0.534 |
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"VAS Score for Do You Feel Any Drug Effect? by Study Week Analyzed by Mixed Model for Repeated Measures"
"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme drug effect 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11." (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline Week -1 | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 |
---|
Hydromorphone 18 mg | 58.912 | 6.433 | 5.466 | 6.046 | 8.269 | 2.388 | 1.364 | 2.269 | 3.240 | 5.033 | 0.709 | 2.935 | 1.269 |
,Hydromorphone 6 mg | 39.047 | 4.214 | 2.787 | 2.933 | 4.491 | 2.497 | 0.872 | 0.533 | 0.329 | 0.305 | 0.491 | 1.118 | 0.524 |
,Placebo | 3.274 | 1.200 | 1.775 | 1.193 | 0.514 | 0.933 | 0.673 | 0.625 | 1.297 | 0.522 | 0.654 | 0.993 | 0.285 |
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"VAS Score for Do You Feel Sedated? by Study Week Analyzed by Mixed Model for Repeated Measures"
"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme sedation 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11." (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline Week -1 | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 |
---|
Hydromorphone 18 mg | 30.979 | 5.401 | 7.048 | 4.897 | 5.774 | 2.445 | 3.354 | 3.894 | 3.395 | 4.996 | 1.032 | 3.299 | 0.086 |
,Hydromorphone 6 mg | 14.504 | 3.979 | 3.508 | 1.975 | 3.462 | 2.873 | 0.923 | 2.233 | 1.142 | 1.041 | 0.567 | 1.403 | 2.408 |
,Placebo | 3.399 | 1.199 | 3.126 | 1.135 | 0.661 | 1.110 | 1.152 | 2.348 | 1.787 | 0.506 | 1.155 | 0.858 | 0.344 |
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"VAS Score for Does the Drug Have Any Bad Effects? by Study Week Analyzed by Mixed Model for Repeated Measures"
"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme bad effect 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11." (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline Week -1 | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 |
---|
Hydromorphone 18 mg | 11.046 | 1.107 | 1.507 | 1.228 | 1.117 | 0.690 | 0.525 | 0.642 | 0.508 | 0.434 | 0.403 | 0.569 | 0.368 |
,Hydromorphone 6 mg | 7.145 | 1.159 | 1.120 | 0.926 | 0.663 | 0.817 | 0.521 | 0.666 | 0.553 | 0.395 | 0.420 | 0.629 | 0.387 |
,Placebo | 4.797 | 1.117 | 0.980 | 0.842 | 0.691 | 0.785 | 0.494 | 0.760 | 0.544 | 0.376 | 0.504 | 0.523 | 0.393 |
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"Change From Placebo in VAS Score for Do You Feel Sedated? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"
"Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme sedation 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo. For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: mean predicted mu opioid receptor occupancy for 6 mg / 18 mg challenge dosages" (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline Week -1: 0.00/0.00 % | Week 1: 67.88/67.09 % | Week 2: 66.06/66.49 % | Week 3: 66.00/66.44 % | Week 4: 65.11/65.35 % | Week 5: 76.29/76.42 % | Week 6: 75.70/75.69 % | Week 7: 75.64/75.43 % | Week 8: 74.79/75.18 % | Week 9: 73.97/74.04 % | Week 10: 73.08/74.18 % | Week 11: 73.05/73.51 % | Week 12: 71.31/71.30 % |
---|
Hydromorphone 18 mg | 27.58 | 4.20 | 3.92 | 3.76 | 5.11 | 1.34 | 2.20 | 1.55 | 1.61 | 4.49 | -0.12 | 2.44 | -0.26 |
,Hydromorphone 6 mg | 11.10 | 2.78 | 0.38 | 0.84 | 2.80 | 1.76 | -0.23 | -0.12 | -0.64 | 0.54 | -0.59 | 0.55 | 2.06 |
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"Change From Placebo in VAS Score for Does the Drug Have Any Good Effects? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"
"Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme good effect 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo. For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: mean predicted mu opioid receptor occupancy for 6 mg / 18 mg challenge dosages" (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline Week -1: 0.00/0.00 % | Week 1: 67.88/67.09 % | Week 2: 66.06/66.49 % | Week 3: 66.00/66.44 % | Week 4: 65.11/65.35 % | Week 5: 76.29/76.42 % | Week 6: 75.70/75.69 % | Week 7: 75.64/75.43 % | Week 8: 74.79/75.18 % | Week 9: 73.97/74.04 % | Week 10: 73.08/74.18 % | Week 11: 73.05/73.51 % | Week 12: 71.31/71.30 % |
---|
Hydromorphone 18 mg | 58.51 | 5.83 | 3.50 | 6.17 | 7.65 | 1.41 | 0.75 | 1.65 | 1.86 | 4.42 | 0.15 | 2.56 | 1.70 |
,Hydromorphone 6 mg | 40.76 | 3.01 | 0.60 | 1.71 | 4.03 | 1.40 | 0.35 | -0.07 | -1.10 | -0.13 | 0.03 | -0.13 | 0.13 |
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"Change From Placebo in VAS Score for Do You Feel Any Drug Effect? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"
"Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme drug effect 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo. For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: mean predicted mu opioid receptor occupancy for 6 mg / 18 mg challenge dosages" (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline Week -1: 0.00/0.00 % | Week 1: 67.88/67.09 % | Week 2: 66.06/66.49 % | Week 3: 66.00/66.44 % | Week 4: 65.11/65.35 % | Week 5: 76.29/76.42 % | Week 6: 75.70/75.69 % | Week 7: 75.64/75.43 % | Week 8: 74.79/75.18 % | Week 9: 73.97/74.04 % | Week 10: 73.08/74.18 % | Week 11: 73.05/73.51 % | Week 12: 71.31/71.30 % |
---|
Hydromorphone 18 mg | 55.64 | 5.23 | 3.69 | 4.85 | 7.76 | 1.46 | 0.69 | 1.64 | 1.94 | 4.51 | 0.06 | 1.94 | 0.98 |
,Hydromorphone 6 mg | 35.77 | 3.01 | 1.01 | 1.74 | 3.98 | 1.56 | 0.20 | -0.09 | -0.97 | -0.22 | -0.16 | 0.13 | 0.24 |
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"Change From Placebo in VAS Score for Do You Like the Drug? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"
"Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme liking of the drug 30 minutes before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo. For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: mean predicted mu opioid receptor occupancy for 6 mg / 18 mg challenge dosages" (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline Week -1: 0.00/0.00 % | Week 1: 67.88/67.09 % | Week 2: 66.06/66.49 % | Week 3: 66.00/66.44 % | Week 4: 65.11/65.35 % | Week 5: 76.29/76.42 % | Week 6: 75.70/75.69 % | Week 7: 75.64/75.43 % | Week 8: 74.79/75.18 % | Week 9: 73.97/74.04 % | Week 10: 73.08/74.18 % | Week 11: 73.05/73.51 % | Week 12: 71.31/71.30 % |
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Hydromorphone 18 mg | 60.61 | 6.93 | 2.90 | 4.93 | 6.68 | 1.21 | 3.16 | 1.88 | 1.93 | 4.17 | 0.13 | 3.24 | 2.78 |
,Hydromorphone 6 mg | 45.36 | 3.66 | 0.59 | 0.86 | 3.32 | 0.74 | 0.35 | -0.15 | -1.05 | -0.12 | -0.09 | -0.32 | -0.03 |
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"Change From Placebo in VAS Score for Does the Drug Have Any Bad Effects? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"
"Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme bad effect 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo. For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: mean predicted mu opioid receptor occupancy for 6 mg / 18 mg challenge dosages" (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline Week -1: 0.00/0.00 % | Week 1: 67.88/67.09 % | Week 2: 66.06/66.49 % | Week 3: 66.00/66.44 % | Week 4: 65.11/65.35 % | Week 5: 76.29/76.42 % | Week 6: 75.70/75.69 % | Week 7: 75.64/75.43 % | Week 8: 74.79/75.18 % | Week 9: 73.97/74.04 % | Week 10: 73.08/74.18 % | Week 11: 73.05/73.51 % | Week 12: 71.31/71.30 % |
---|
Hydromorphone 18 mg | 6.25 | -0.01 | 0.53 | 0.39 | 0.43 | -0.10 | 0.03 | -0.12 | -0.04 | 0.06 | -0.10 | 0.05 | -0.02 |
,Hydromorphone 6 mg | 2.35 | 0.04 | 0.14 | 0.08 | -0.03 | 0.03 | 0.03 | -0.09 | 0.01 | 0.02 | -0.08 | 0.11 | -0.01 |
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Change From Baseline to Week 5 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts. (NCT02158533)
Timeframe: Baseline and 5 weeks for each stage
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo S1 | -11.1 |
ALKS 5461 0.5mg/0.5mg S1 | -8.4 |
ALKS 5461 2mg/2mg S1 | -13.0 |
Placebo S2 | -2.2 |
ALKS 5461 0.5mg/0.5mg S2 | -4.8 |
ALKS 5461 2mg/2mg S2 | -3.9 |
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Number of Subjects With Adverse Events (AEs)
(NCT02158533)
Timeframe: 5 weeks for Stage 1 and 6 weeks for Stage 2
Intervention | Participants (Count of Participants) |
---|
Placebo S1 | 142 |
ALKS 5461 0.5mg/0.5mg S1 | 34 |
ALKS 5461 2mg/2mg S1 | 41 |
Placebo S2 | 29 |
ALKS 5461 0.5mg/0.5mg S2 | 27 |
ALKS 5461 2mg/2mg S2 | 29 |
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Montgomery-Asberg Depression Rating Scale (MADRS)
"Measure of depression severity, range of 0-60~We calculated the mean change in depression severity for both groups using baseline MADRS and week 8 MADRS scores.~Greater mean change represents better outcome." (NCT02176291)
Timeframe: baseline and 8 weeks
Intervention | units on a scale (Mean) |
---|
| Change in MADRS | Final MADRS score |
---|
Buprenorphine | 3.47 | 16.93 |
,Placebo | 4.09 | 14.64 |
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Brief Symptom Inventory--Anxiety Subscale (BSI)
"Measure of Anxiety Theoretical Range 0-2.4 with lower numbers indicating a better outcome.~We calculated the mean change in anxiety for both groups using Phase 1 week 12 time point (baseline) and Phase 2 week 8 time point (final time point)." (NCT02176291)
Timeframe: Baseline and 8 weeks
Intervention | units on a scale (Mean) |
---|
| Change in BSI | Final BSI Score |
---|
Buprenorphine | 0.07 | 0.74 |
,Placebo | 0.06 | 0.64 |
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Measures of Withdrawal: Clinical Opiate Withdrawal Scale (COWS)
The secondary outcome measures the change in baseline in the Clinical opiate withdrawal scale (COWS), which is a scale consisting of 11 common opiate withdrawal signs or symptoms, rated on a numeric scale with higher scores associated with greater withdrawal symptoms. A total score was calculated as the sum of the responses to the 11 signs/symptoms for a total range of 0-48. Withdrawal severity was classified, based on the total score, as follows: 0-4=none/normal, 5-12=mild, 13-24=moderate, 25-36=moderately severe, more than 36=severe withdrawal. (NCT02180659)
Timeframe: 24 weeks
Intervention | units on a scale (Mean) |
---|
| Day 1 (Baseline) | Week 4(Change from BL) | Week 8(Change from BL) | Week 12(Change from BL) | Week 16(Change from BL) | Week 20(Change from BL) | Week 24(Change from BL) |
---|
Buprenorphine Implants + Placebo Tablets | 5.4 | -0.8 | -2.0 | -2.3 | -2.4 | -2.8 | -2.7 |
,Buprenorphine Tablets + Placebo Implants | 6.0 | -1.2 | -1.9 | -2.4 | -2.3 | -3.4 | -1.9 |
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Measures of Craving: Desire to Use Visual Analogue Scale (VAS)
The secondary outcome of measures of craving: desire to use is a change from Day 1 (baseline) in the unipolar visual analogue scale (VAS), which is a 0-100 mm scale, where 0 mm is no desire, and 100 mm is strongest possible desire. (NCT02180659)
Timeframe: 24 weeks
Intervention | units on a scale (Mean) |
---|
| Day 1 (Baseline) | Week 4(Change from BL) | Week 8(Change from BL) | Week 12(Change from BL) | Week 16(Change from BL) | Week 20(Change from BL) | Week 24(Change from BL) |
---|
Buprenorphine Implants + Placebo Tablets | 5.4 | 1.1 | -1.8 | -2.0 | -2.2 | -2.3 | -2.3 |
,Buprenorphine Tablets + Placebo Implants | 6.8 | -1.5 | -2.2 | -2.2 | -2.3 | -3.8 | -2.8 |
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Percent of Subjects With no Urine Illicit Opioid Use by Month;
The secondary outcome is the percent of subjects with no urine illicit opioid use by month. (NCT02180659)
Timeframe: 24 weeks
Intervention | Participants (Count of Participants) |
---|
| Month 171962209 | Month 171962210 | Month 271962209 | Month 271962210 | Month 371962209 | Month 371962210 | Month 471962209 | Month 471962210 | Month 571962209 | Month 571962210 | Month 671962209 | Month 671962210 |
---|
| No | Yes |
---|
Buprenorphine Tablets + Placebo Implants | 84 |
Buprenorphine Implants + Placebo Tablets | 4 |
Buprenorphine Tablets + Placebo Implants | 5 |
Buprenorphine Implants + Placebo Tablets | 80 |
Buprenorphine Tablets + Placebo Implants | 79 |
Buprenorphine Implants + Placebo Tablets | 83 |
Buprenorphine Tablets + Placebo Implants | 78 |
Buprenorphine Implants + Placebo Tablets | 1 |
Buprenorphine Tablets + Placebo Implants | 11 |
Buprenorphine Tablets + Placebo Implants | 80 |
Buprenorphine Tablets + Placebo Implants | 9 |
Buprenorphine Implants + Placebo Tablets | 81 |
Buprenorphine Implants + Placebo Tablets | 3 |
Buprenorphine Tablets + Placebo Implants | 10 |
Buprenorphine Implants + Placebo Tablets | 76 |
Buprenorphine Tablets + Placebo Implants | 76 |
Buprenorphine Implants + Placebo Tablets | 8 |
Buprenorphine Tablets + Placebo Implants | 13 |
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Percent of Subjects With no Self-reported Illicit Drug Use by Month
Subjects in the ITT population with no self-reported use of any illicit drugs (opioid or non-opioid) by month of evaluation (NCT02180659)
Timeframe: 24 weeks
Intervention | Participants (Count of Participants) |
---|
| Week 471962210 | Week 471962209 | Week 871962209 | Week 871962210 | Week 1271962209 | Week 1271962210 | Weeek 1671962209 | Weeek 1671962210 | Week 2071962209 | Week 2071962210 | Week 24/EOT71962209 | Week 24/EOT71962210 |
---|
| Yes | No |
---|
Buprenorphine Implants + Placebo Tablets | 72 |
Buprenorphine Tablets + Placebo Implants | 75 |
Buprenorphine Implants + Placebo Tablets | 12 |
Buprenorphine Implants + Placebo Tablets | 75 |
Buprenorphine Tablets + Placebo Implants | 71 |
Buprenorphine Implants + Placebo Tablets | 8 |
Buprenorphine Tablets + Placebo Implants | 17 |
Buprenorphine Implants + Placebo Tablets | 68 |
Buprenorphine Tablets + Placebo Implants | 74 |
Buprenorphine Implants + Placebo Tablets | 13 |
Buprenorphine Tablets + Placebo Implants | 14 |
Buprenorphine Implants + Placebo Tablets | 70 |
Buprenorphine Tablets + Placebo Implants | 70 |
Buprenorphine Implants + Placebo Tablets | 11 |
Buprenorphine Tablets + Placebo Implants | 16 |
Buprenorphine Tablets + Placebo Implants | 68 |
Buprenorphine Tablets + Placebo Implants | 18 |
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Number of Participants With Evidence of Urine Illicit Opioid Use by Month
Secondary efficacy endpoint measures number of participants with evidence of urine illicit opioid use by month. (NCT02180659)
Timeframe: 24 weeks
Intervention | Participants (Count of Participants) |
---|
| Month 171962210 | Month 171962209 | Month 271962209 | Month 271962210 | Month 371962209 | Month 371962210 | Month 471962209 | Month 471962210 | Month 571962209 | Month 571962210 | Month 671962209 | Month 671962210 |
---|
| No | Yes |
---|
Buprenorphine Implants + Placebo Tablets | 4 |
Buprenorphine Tablets + Placebo Implants | 5 |
Buprenorphine Implants + Placebo Tablets | 80 |
Buprenorphine Tablets + Placebo Implants | 84 |
Buprenorphine Implants + Placebo Tablets | 7 |
Buprenorphine Tablets + Placebo Implants | 12 |
Buprenorphine Implants + Placebo Tablets | 77 |
Buprenorphine Tablets + Placebo Implants | 77 |
Buprenorphine Tablets + Placebo Implants | 21 |
Buprenorphine Tablets + Placebo Implants | 68 |
Buprenorphine Tablets + Placebo Implants | 22 |
Buprenorphine Tablets + Placebo Implants | 67 |
Buprenorphine Implants + Placebo Tablets | 8 |
Buprenorphine Implants + Placebo Tablets | 76 |
Buprenorphine Implants + Placebo Tablets | 12 |
Buprenorphine Tablets + Placebo Implants | 25 |
Buprenorphine Implants + Placebo Tablets | 72 |
Buprenorphine Tablets + Placebo Implants | 64 |
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Measures of Withdrawal: Subjective Opioid Withdrawal Scale (SOWS) (ITT Population)
The secondary outcome measures the change in baseline in the subjective opioid withdrawal scale (SOWS), which is a scale which is a subject self-assessment of withdrawal symptoms. The scale consists of 16 questions that rate the intensity of withdrawal from 0 (not at all) to 4 (extremely) with a cumulative score ranging from 0-64 (0 =not at all, 64=extremely) (NCT02180659)
Timeframe: 24 weeks
Intervention | units on a scale (Mean) |
---|
| Day 1 (Baseline) | Week 4 (Change from BL) | Week 8(Change from BL) | Week 12(Change from BL) | Week 16(Change from BL) | Week 20(Change from BL) | Week 24(Change from BL) |
---|
Buprenorphine Implants + Placebo Tablets | 2.7 | 0.3 | -1.1 | -0.4 | -0.2 | -0.9 | 0.1 |
,Buprenorphine Tablets + Placebo Implants | 2.2 | 0.3 | 0.4 | -0.1 | -0.4 | -0.1 | 0.1 |
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Measures of Craving: Need to Use Visual Analogue Scale (VAS)
The secondary outcome of measures of craving: Need to use is a change from Day 1 (baseline) in the unipolar visual analogue scale (VAS), which is a 0-100 mm scale, where 0 mm is no need, and 100 mm is strongest possible need. (NCT02180659)
Timeframe: 24 weeks
Intervention | units on a scale (Mean) |
---|
| Day 1 (Baseline) | Week 4(Change from BL) | Week 8(Change from BL) | Week 12(Change from BL) | Week 16(Change from BL) | Week 20(Change from BL) | Week 24(Change from BL) |
---|
Buprenorphine Implants + Placebo Tablets | 5.4 | -0.8 | -2.0 | -2.3 | -2.4 | -2.8 | -2.7 |
,Buprenorphine Tablets + Placebo Implants | 6.0 | -1.2 | -1.9 | -2.4 | -2.3 | -3.4 | -1.9 |
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Numeric Scale of Pain (NRS-P)
"Measure used to assess pain, ranging from 0-10, with 10 being the worst possible pain.~We calculated the mean change in pain for both groups using baseline and week 8 (last time point)." (NCT02181231)
Timeframe: Baseline and 8 weeks
Intervention | units on a scale (Mean) |
---|
| Change in NRS-P | Final NRS-P score |
---|
Buprenorphine | -1.1 | 2.9 |
,Placebo | -1.3 | 2.8 |
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Brief Symptom Inventory-Anxiety Subscale (BSI)
Measure of anxiety. Six anxiety symptoms are rated based on how distressed the subject is for each symptom. The range for each symptom is 0-4, with 4 representing extreme distress. We computed the mean of the final BSI score (range 0-24), with a lower number indicating a better outcome. We also calculated the mean change in anxiety for both groups using baseline and Phase 2 week 8 (final time point) data. (NCT02181231)
Timeframe: Baseline and 8 weeks
Intervention | units on a scale (Mean) |
---|
| Change in BSI | Final BSI score |
---|
Buprenorphine | .7 | 3 |
,Placebo | 0 | 2.7 |
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Frequency, Intensity, and Burden of Side Effects Rating (FIBSER)
"Three item side effect scale used to assess frequency and intensity of side effects (range 0-6 for each item). We calculated the total score of all three items (range 0-18) with lower numbers indicating less frequency.~We calculated the mean score at baseline and week 8 (final timepoint)." (NCT02181231)
Timeframe: Week 1 and week 8
Intervention | score on a scale (Mean) |
---|
| Mean baseline score | Final FIBSER Score |
---|
Buprenorphine | 5.6 | 3.8 |
,Placebo | 1.3 | .5 |
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Montgomery-Asberg Depression Rating Scale (MADRS)
Measure of depression severity, range of 0-60, with higher scores indicating more severe depression. We calculated the mean change in depression for both groups using baseline MADRS and week 8 MADRS scores. (NCT02181231)
Timeframe: Baseline and 8 weeks
Intervention | units on a scale (Mean) |
---|
| Change in MADRS | Final MADRS Score |
---|
Buprenorphine | -1 | 21.3 |
,Placebo | -5.3 | 15.3 |
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Antidepressant Side Effect Checklist (ASEC)
Measure of side effects, consisting of 21 items, ranging from 0-3 (0 indicates no side effect, 3 indicates severe side effect). We calculated the total final score for the 21 items (total range is 0-63). A higher total number represents a greater severity in reported side effects. We calculated the mean change in side effects for both groups using baseline and 8 week data. (NCT02181231)
Timeframe: Baseline and 8 weeks
Intervention | units on a scale (Mean) |
---|
| Change in ASEC | Final ASEC score |
---|
Buprenorphine | 1 | 11.4 |
,Placebo | 1.8 | 8.5 |
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Suicide Ideation Scale (SIS)
A 19 item scale used to measure the presence or absence of suicidal ideations and the degree of severity of suicidal ideas. For this study, we computed the total score for all 19 items (total range 0-90). Higher scores represent a worse outcome. We also calculated the mean change in suicidal ideation for both groups using baseline and week 8 (final timepoint). (NCT02181231)
Timeframe: Baseline and 8 weeks
Intervention | units on a scale (Mean) |
---|
| Change in SIS | Final SIS score |
---|
Buprenorphine | -.2 | 1.1 |
,Placebo | -1 | 4.7 |
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Urine Toxicology for Opiate Use
Will be used to document opioid use, a urine toxicology screening will be completed weekly during study participation (12 week study) (NCT02187198)
Timeframe: Weeks 1-12
Intervention | Participants (Count of Participants) |
---|
| Negative urine toxicology for opiates | One positive urine toxicology for opiates during 12 week study | Two positive urine toxicology for opiates during 12 week study |
---|
Buprenorphine High Dose | 4 | 0 | 0 |
,Buprenorphine Low Dose | 2 | 2 | 1 |
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Urine Toxicology
Will be used to document cannabinoid use, a urine toxicology screening will be completed weekly during study participation (12 week study) (NCT02187198)
Timeframe: Weeks 1-12
Intervention | Participants (Count of Participants) |
---|
| Negative urine toxicology for cannabinoids | Less than 6 positive urine toxicology for cannabinoids during 12 week study | More than 6 positive urine toxicology for cannabinoids during 12 week study |
---|
Buprenorphine High Dose | 3 | 0 | 1 |
,Buprenorphine Low Dose | 3 | 1 | 1 |
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Numeric Rating Scale (NRS) Pain Score With Movement
Pain with movement at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain) (NCT02198235)
Timeframe: 24 hours after the popliteal block is given
Intervention | units on a scale (Mean) |
---|
Control Nerve Block + IV Dexamethasone | 1.9 |
Control Nerve Block + IV Dexamethasone + IV Buprenorphine | 1 |
Nerve Block With Dexamethasone + Buprenorphine in Block. | 1.3 |
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Numeric Rating Scale (NRS) Pain Score at Rest
Pain at rest at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain) (NCT02198235)
Timeframe: 24 hours after the popliteal block is given
Intervention | units on a scale (Mean) |
---|
Control Nerve Block + IV Dexamethasone | 1.8 |
Control Nerve Block + IV Dexamethasone + IV Buprenorphine | .9 |
Nerve Block With Dexamethasone + Buprenorphine in Block. | .8 |
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Block Duration
When did the nerve block entirely wear off? (NCT02198235)
Timeframe: 24 hours and 48 hours after the popliteal block is given
Intervention | hours (Median) |
---|
Control Nerve Block + IV Dexamethasone | 30 |
Control Nerve Block + IV Dexamethasone + IV Buprenorphine | 37.9 |
Nerve Block With Dexamethasone + Buprenorphine in Block. | 45.6 |
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Successful Induction Onto XR-NTX
Proportion of participants inducted onto XR-NTX at the end of the 30-day buprenorphine/naloxone stabilization/taper. (NCT02294253)
Timeframe: One week after completing 30-day buprenorphone/naloxone stabilization/taper.
Intervention | Participants (Count of Participants) |
---|
Buprenorphine/Naloxone Stabilization | 8 |
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NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours After Time 0
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug). A lower value indicates improvement in pain. (NCT02310581)
Timeframe: 4, 8, 24 and 48 hours after Time 0
Intervention | units on a scale (Mean) |
---|
| 4 Hours | 8 Hours | 24 Hours | 48 Hours |
---|
Buprenorphine 0.5 mg TID | 2.2 | 3.5 | 1.8 | 1.0 |
,Buprenorphine 1.0 mg BID | 2.9 | 2.3 | 3.3 | 2.1 |
,Buprenorphine 1.0 mg TID | 4.0 | 3.9 | 4.6 | 3.9 |
,Placebo | 4.9 | 5.2 | 3.9 | 3.2 |
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NRS SPID Over 0 to 8 Hours After Time 0 (NRS SPID-8)
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 8 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-8 range is -80 to 80. The NRS SPID-8 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate. (NCT02310581)
Timeframe: Baseline and 0 to 8 hours after Time 0
Intervention | units on a scale (Least Squares Mean) |
---|
Buprenorphine 0.5 mg TID | 24.283 |
Buprenorphine 1.0 mg BID | 19.223 |
Buprenorphine 1.0 mg TID | 19.761 |
Placebo | -2.382 |
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NRS SPID Over 0 to 24 Hours After Time 0 (NRS SPID-24)
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 24 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-24 range is -240 to 240. The NRS SPID-24 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate. (NCT02310581)
Timeframe: Baseline and 0 to 24 hours after Time 0
Intervention | units on a scale (Least Squares Mean) |
---|
Buprenorphine 0.5 mg TID | 83.668 |
Buprenorphine 1.0 mg BID | 70.071 |
Buprenorphine 1.0 mg TID | 76.666 |
Placebo | 19.787 |
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NRS SPID Over 0 to 4 Hours After Time 0 (NRS SPID-4)
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 4 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-4 range is -40 to 40. The NRS SPID-4 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate. (NCT02310581)
Timeframe: Baseline and 0 to 4 hours after Time 0
Intervention | units on a scale (Least Squares Mean) |
---|
Buprenorphine 0.5 mg TID | 11.430 |
Buprenorphine 1.0 mg BID | 5.088 |
Buprenorphine 1.0 mg TID | 7.095 |
Placebo | -2.968 |
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Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48)
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-48 range is -480 to 480. The NRS SPID-48 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate. (NCT02310581)
Timeframe: Baseline and 0 to 48 hours after Time 0
Intervention | units on a scale (Least Squares Mean) |
---|
Buprenorphine 0.5 mg TID | 169.621 |
Buprenorphine 1.0 mg BID | 150.964 |
Buprenorphine 1.0 mg TID | 129.133 |
Placebo | 64.648 |
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Percentage of Participants Who Used Rescue Medication for Pain
The percentage of participants who needed to take an alternate medication for pain relief during the study. (NCT02310581)
Timeframe: From Time 0 (first dose of study drug) up to Day 9
Intervention | percentage of participants (Number) |
---|
Buprenorphine 0.5 mg TID | 44.4 |
Buprenorphine 1.0 mg BID | 54.5 |
Buprenorphine 1.0 mg TID | 60.0 |
Placebo | 100 |
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NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug). NRS PID is defined as the difference in pain at each scheduled timepoint relative to Baseline (PID=pain intensity at baseline - pain intensity at time point). A higher value of NRS PID score indicates a higher decrease in pain from Baseline. (NCT02310581)
Timeframe: Baseline and 4, 8, 24 and 48 hours after Time 0
Intervention | units on a scale (Mean) |
---|
| 4 Hours | 8 Hours | 24 Hours | 48 Hours |
---|
Buprenorphine 0.5 mg TID | 4.7 | 3.4 | 5.5 | 6.3 |
,Buprenorphine 1.0 mg BID | 3.4 | 4.0 | 3.0 | 4.2 |
,Buprenorphine 1.0 mg TID | 3.8 | 3.9 | 3.4 | 4.1 |
,Placebo | 1.6 | 1.2 | 2.6 | 3.2 |
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Change From Baseline in the Clinical Global Impression - Improvement Scale (CGI-I) Prior to Injections From Week 5 Through Week 24 Analyzed by Mixed Model for Repeated Measures
"The CGI-I was used to rate the change in clinical status since the start of the treatment on an ordinal scale ranging from 1 (very much improved; nearly all better; good level of functioning; minimal symptoms; represents a very substantial change) to 7 (very much worse; severe exacerbation of symptoms and loss of functioning). Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Measurements taken during the treatment period were taken at the end of each 28 day treatment and prior to dosing of the next treatment.~Negative change from baseline values indicate an improved clinical global impression.~Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect." (NCT02357901)
Timeframe: Baseline: Day 1 (prior to dosing), Days 29, 57, 85, 113, 141, 169
Intervention | units on a scale (Least Squares Mean) |
---|
RBP-6000 300mg/100mg | 1.6 |
RBP-6000 300mg/300mg | 1.5 |
Combined Placebo | 2.4 |
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Cumulative Distribution Function (CDF) of the Percentage of Urine Samples Negative for Opioids Combined With Self-Reports Negative for Illicit Opioid Use Collected From Week 5 Through Week 24
Data represent the count of participants at various percentage abstinence levels. Abstinence was defined as urine samples being negative for opioids AND negative self-reports (obtained from Timeline Followback (TLFB) interviews) for illicit opioid use. The primary endpoint was based on visits in which paired urine samples and self-reports were expected for each subject as specified in the schedule of events. Missing urine drug screen(s) (UDS) samples and/or self-reports were considered as non-negative. (NCT02357901)
Timeframe: Weekly from Weeks 5-24
Intervention | Participants (Count of Participants) |
---|
| >=0% | >=10% | >=20% | >=30% | >=40% | >=50% | >=60% | >=70% | >=80% | >=90% |
---|
Combined Placebo | 99 | 11 | 7 | 6 | 6 | 4 | 4 | 2 | 2 | 2 |
,RBP-6000 300mg/100mg | 194 | 139 | 115 | 101 | 90 | 86 | 78 | 66 | 55 | 41 |
,RBP-6000 300mg/300mg | 196 | 126 | 111 | 101 | 90 | 82 | 70 | 67 | 57 | 48 |
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"Participants Who Complete the Week 24 Visit (Completers)"
A completer was defined as a participant who completed either the urine drug screen (UDS) or Timeline Followback (TLFB) assessment at the Week 24 visit. (NCT02357901)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
RBP-6000 300mg/100mg | 119 |
RBP-6000 300mg/300mg | 126 |
Combined Placebo | 33 |
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Change From Baseline in the Clinical Global Impression - Severity Scale (CGI-S) Prior to Injections From Week 5 Through Week 24 Analyzed by Mixed Model for Repeated Measures
"The CGI-S was an assessment completed by the clinician to rate the severity of symptoms on an ordinal scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill subjects; pathology drastically interferes in many life functions). Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Measurements taken during the treatment period were taken at the end of each 28 day treatment and prior to dosing of the next treatment.~Negative change from baseline values indicate an improvement in the severity of symptoms.~Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect." (NCT02357901)
Timeframe: Baseline: Day 1 (prior to dosing), Days 29, 57, 85, 113, 141, 169
Intervention | units on a scale (Least Squares Mean) |
---|
RBP-6000 300mg/100mg | -0.7 |
RBP-6000 300mg/300mg | -0.7 |
Combined Placebo | -0.0 |
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Participants Who Are Abstinent at Week 24
Participants with both a negative urine sample and negative self-report for illicit opioid use at Week 24. (NCT02357901)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
RBP-6000 300mg/100mg | 71 |
RBP-6000 300mg/300mg | 87 |
Combined Placebo | 2 |
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Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) Through Week 24 Analyzed by Mixed Model for Repeated Measures
"COWS is an 11-item instrument used to assess signs and symptoms of opioid withdrawal (Wesson et al., 1999). The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderately severe withdrawal, and 37-48 severe withdrawal. Negative change from baseline values indicate a lessening of withdrawal symptoms.~Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. The COWS was completed each week; measurements were taken prior to dosing on weeks 5, 9, 13, 17 and 21.~Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate." (NCT02357901)
Timeframe: Baseline: Day 1 (prior to dosing), Baseline: Day 1 (prior to dosing), Days 2, 8, 5, 22, 29, 30, 36, 43, 50, 57, 58, 64, 71, 78, 85, 86, 92, 99, 106, 113, 114, 120, 127, 134, 141, 142, 148, 155, 162, 169
Intervention | units on a scale (Least Squares Mean) |
---|
RBP-6000 300mg/100mg | -0.5 |
RBP-6000 300mg/300mg | -1.1 |
Combined Placebo | -0.1 |
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Change From Baseline in the Opioid Craving Visual Analog Scale (VAS) Prior to Injections From Week 5 Through Week 24 Analyzed by Mixed Model for Repeated Measures
"The opioid craving scale was a 100 mm scale with 0= 'no craving' on the left end and 100= 'strongest craving ever' on the right end of the scale. Participants marked where along the scale reflected their craving for opioids. The full range of the change from baseline scale was therefore 100 (no craving at baseline, strongest craving during study) to -100 (strongest craving at baseline, no craving during study).~Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. The opioid craving VAS was completed each week; measurements were taken prior to dosing on weeks 5, 9, 13, 17 and 21.~Negative change from baseline values indicate a lessening of craving symptoms.~Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect." (NCT02357901)
Timeframe: Baseline: Day 1 (prior to dosing), Weeks 5-24
Intervention | units on a scale (Least Squares Mean) |
---|
RBP-6000 300mg/100mg | 2.1 |
RBP-6000 300mg/300mg | -0.9 |
Combined Placebo | 11.5 |
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Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) Through Week 24 Analyzed by Mixed Model for Repeated Measures
"The Subjective Opiate Withdrawal Scale (SOWS) contains 16 symptoms whose intensity the participant rates on a scale of 0 (not at all) to 4 (extremely) for a full scale of 0 (no withdrawal symptoms) to 64 (extreme withdrawal symptoms). Negative change from baseline values indicate a lessening of withdrawal symptoms.~Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. The SOWS was completed each week; measurements were taken prior to dosing on weeks 5, 9, 13, 17 and 21.~Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate." (NCT02357901)
Timeframe: Baseline: Day 1 (prior to dosing), Baseline: Day 1 (prior to dosing), Days 2, 8, 5, 22, 29, 30, 36, 43, 50, 57, 58, 64, 71, 78, 85, 86, 92, 99, 106, 113, 114, 120, 127, 134, 141, 142, 148, 155, 162, 169
Intervention | units on a scale (Least Squares Mean) |
---|
RBP-6000 300mg/100mg | -0.9 |
RBP-6000 300mg/300mg | -2.0 |
Combined Placebo | 0.7 |
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Percentage of Participants Considered A Treatment Success
Treatment success is defined as a participant having ≥80% of urine samples negative for opioids combined with self-reports negative for illicit opioid use between weeks 5-24. (NCT02357901)
Timeframe: Weeks 5-24
Intervention | percentage of participants (Number) |
---|
RBP-6000 300mg/100mg | 28.4 |
RBP-6000 300mg/300mg | 29.1 |
Combined Placebo | 2.0 |
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Total Number of Weeks of Abstinence as Assessed From Urine Samples Negative for Opioids Combined With Self-Reports Negative for Illicit Opioid Use Collected From Week 5 Through Week 24
The total number of weeks of abstinence was assessed from urine samples negative for opioids combined with self-reports negative for illicit opioid use collected from week 5 through week 24. All missing reports for opioids were considered non-negative. (NCT02357901)
Timeframe: Weeks 5 through 24
Intervention | weeks (Least Squares Mean) |
---|
RBP-6000 300mg/100mg | 8.5 |
RBP-6000 300mg/300mg | 8.5 |
Combined Placebo | 1.0 |
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Worst Injection Site Pain From Injections 1-6 as Measured by Participant-Reported Visual Analog Scale (VAS)
"Injection site pain as measured by participant-reported VAS The participant-reported VAS for injection site pain was measured on a 100 mm scale with 'no pain' on the left end and 'strongest pain ever' on the right end of the scale (total scale of 0-100). Participants marked where along the scale reflected their localized injection pain.~The injection site pain VAS scores were obtained (after the completion of the injection) within 1 minute and at 5, 10, 15, 30, 60 and 120 minutes (+- 5 minutes). The timing of the injection site pain VAS should have been measured from the end of the injection.~Data represents the worst pain recorded for each participant across all 6 injections and all VAS records. The mean value is presented." (NCT02357901)
Timeframe: Days 1, 29, 57, 85, 113, 141
Intervention | units on a scale (Mean) |
---|
RBP-6000 300mg/100mg | 55.8 |
RBP-6000 300mg/300mg | 63.3 |
Combined Placebo | 61.0 |
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Cumulative Distribution Function (CDF) of the Percentage of Self-Reports Negative for Illicit Opioid Use From Week 5 Through Week 24
Data represent the count of participants at various percentage levels in which self-reports were negative for illicit use of opioids. Self-reports were obtained from Timeline Followback (TLFB) interviews. All missing self-reports were considered non-negative. (NCT02357901)
Timeframe: Weekly from Weeks 5-24
Intervention | Participants (Count of Participants) |
---|
| >=0% | >=10% | >=20% | >=30% | >=40% | >=50% | >=60% | >=70% | >=80% | >=90% |
---|
Combined Placebo | 99 | 37 | 29 | 24 | 20 | 18 | 17 | 14 | 9 | 7 |
,RBP-6000 300mg/100mg | 194 | 163 | 155 | 139 | 132 | 125 | 120 | 108 | 102 | 92 |
,RBP-6000 300mg/300mg | 196 | 162 | 152 | 139 | 132 | 125 | 117 | 112 | 101 | 91 |
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Cumulative Distribution Function (CDF) of the Percentage of Urine Samples Negative for Opioids From Week 5 Through Week 24
Data represent the count of participants at various percentage levels in which urine samples tested negative for opioids. All missing reports for urine samples were considered non-negative. (NCT02357901)
Timeframe: Weekly from Weeks 5-24
Intervention | Participants (Count of Participants) |
---|
| >=0% | >=10% | >=20% | >=30% | >=40% | >=50% | >=60% | >=70% | >=80% | >=90% |
---|
Combined Placebo | 99 | 17 | 9 | 8 | 7 | 6 | 5 | 4 | 4 | 2 |
,RBP-6000 300mg/100mg | 194 | 140 | 120 | 106 | 97 | 91 | 82 | 73 | 64 | 47 |
,RBP-6000 300mg/300mg | 196 | 129 | 114 | 109 | 98 | 88 | 74 | 69 | 61 | 51 |
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Participants With Adverse Events During the Treatment Period
Treatment-emergent adverse event (TEAE) = any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent one of the outcomes listed in this definition. (NCT02357901)
Timeframe: Day 1 through Week 24
Intervention | Participants (Count of Participants) |
---|
| >=1 TEAE | >=1 TEAE related to study drug | >=1 serious TEAE | >=1 serious study treatment-related TEAE | Death | >=1 severe TEAE | TEAE leading to study treatment discontinuation |
---|
Combined Placebo | 56 | 23 | 5 | 0 | 0 | 4 | 2 |
,RBP-6000 300mg/100mg | 155 | 67 | 4 | 0 | 0 | 15 | 7 |
,RBP-6000 300mg/300mg | 134 | 70 | 7 | 0 | 1 | 13 | 10 |
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Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) From Week 2 - 24
The C-SSRS asks questions of study participants regarding whether they had suicidal ideation and/or suicidal behavior since the last visit using the electronic version of the scale. The C-SSRS was completed each week; measurements were taken prior to dosing on weeks 5, 9, 13, 17 and 21. (NCT02357901)
Timeframe: Weekly - Week 2 through Week 24
Intervention | Participants (Count of Participants) |
---|
| Suicidal Ideation: Wish to be dead | Non-specific active suicidal thoughts | (subset of above) No plan nor intent to act | (subset of above) Non-specific plan, some intent | (subset of above) Specific plan and intent | Suicidal Behaviour: Preparatory acts or behaviour | Aborted attempt | Interrupted attempt | Actual attempt |
---|
Combined Placebo | 9 | 2 | 1 | 1 | 0 | 0 | 1 | 1 | 0 |
,RBP-6000 300mg/100mg | 15 | 6 | 2 | 3 | 0 | 0 | 1 | 1 | 0 |
,RBP-6000 300mg/300mg | 11 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
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Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) at End of Study (Weeks 25 and 49)
"COWS is an 11-item instrument used to assess signs and symptoms of opioid withdrawal. The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderately severe withdrawal, and 37-48 severe withdrawal. Negative change from baseline values indicate a lessening of withdrawal symptoms.~Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Baseline value is reported as an observed actual value. Weeks 25 and 49 represent change from baseline values." (NCT02510014)
Timeframe: Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)
Intervention | units on a scale (Mean) |
---|
| Baseline (actual value) | Change from baseline: Week 25 |
---|
Roll-over Subjects | 1.5 | -0.3 |
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Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) at End of Study (Weeks 25 and 49)
"COWS is an 11-item instrument used to assess signs and symptoms of opioid withdrawal. The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderately severe withdrawal, and 37-48 severe withdrawal. Negative change from baseline values indicate a lessening of withdrawal symptoms.~Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Baseline value is reported as an observed actual value. Weeks 25 and 49 represent change from baseline values." (NCT02510014)
Timeframe: Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)
Intervention | units on a scale (Mean) |
---|
| Baseline (actual value) | Change from baseline: Week 25 | Change from baseline: Week 49 |
---|
De Novo Subjects | 2.1 | -1.0 | -1.0 |
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Change From Baseline in the Opioid Craving Visual Analog Scale (VAS) at End of Study (Weeks 25 and 49)
"The opioid craving scale was a 100 mm scale with 'no craving' indicated by 0 mm and 'strongest craving ever' indicated by 100 mm. Participants marked where along the scale reflected their craving for opioids.~Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Baseline value is reported as an observed actual value. Weeks 25 and 49 represent change from baseline values." (NCT02510014)
Timeframe: Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)
Intervention | units on a scale (Mean) |
---|
| Baseline (actual value) | Change from baseline: Week 25 |
---|
Roll-over Subjects | 4.4 | 4.2 |
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Change From Baseline in the Opioid Craving Visual Analog Scale (VAS) at End of Study (Weeks 25 and 49)
"The opioid craving scale was a 100 mm scale with 'no craving' indicated by 0 mm and 'strongest craving ever' indicated by 100 mm. Participants marked where along the scale reflected their craving for opioids.~Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Baseline value is reported as an observed actual value. Weeks 25 and 49 represent change from baseline values." (NCT02510014)
Timeframe: Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)
Intervention | units on a scale (Mean) |
---|
| Baseline (actual value) | Change from baseline: Week 25 | Change from baseline: Week 49 |
---|
De Novo Subjects | 5.9 | -0.2 | -2.0 |
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Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) at End of Study (Weeks 25 and 49)
"The Subjective Opiate Withdrawal Scale (SOWS) contains 16 symptoms whose intensity the participant rates on a scale of 0 (not at all) to 4 (extremely) for a full scale of 0 (no withdrawal symptoms) to 64 (extreme withdrawal symptoms). Negative change from baseline values indicate a lessening of withdrawal symptoms.~Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Baseline value is reported as an observed actual value. Weeks 25 and 49 represent change from baseline values." (NCT02510014)
Timeframe: Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)
Intervention | units on a scale (Mean) |
---|
| Baseline (actual value) | Change from baseline: Week 25 |
---|
Roll-over Subjects | 2.8 | 1.1 |
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Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) at End of Study (Weeks 25 and 49)
"The Subjective Opiate Withdrawal Scale (SOWS) contains 16 symptoms whose intensity the participant rates on a scale of 0 (not at all) to 4 (extremely) for a full scale of 0 (no withdrawal symptoms) to 64 (extreme withdrawal symptoms). Negative change from baseline values indicate a lessening of withdrawal symptoms.~Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Baseline value is reported as an observed actual value. Weeks 25 and 49 represent change from baseline values." (NCT02510014)
Timeframe: Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)
Intervention | units on a scale (Mean) |
---|
| Baseline (actual value) | Change from baseline: Week 25 | Change from baseline: Week 49 |
---|
De Novo Subjects | 3.8 | -1.1 | -1.6 |
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Cumulative Distribution Function (CDF) of the Percentage Abstinence Collected From Week 1 Through End of Study (Weeks 25 and 49)
"Participants' self-reported illicit opioid drug use from the timeline followback (TLFB) interview and results from the urine drug screens (UDS) for opioids were combined into a single endpoint. Opioids assessed included codeine, hydrocodone, hydromorphone, methadone, morphine, opiates, oxycodone, and oxymorphone (by UDS) and amphetamine/methadone, buprenorphine, methadone, and opioids in the TLFB.~Data represent the count of participants at various percentage abstinence levels. Abstinence was defined as urine samples being negative for opioids AND negative self-reports (obtained from Timeline Followback (TLFB) interviews) for illicit opioid use. The endpoint was based on visits in which paired urine samples and self-reports were expected for each subject as specified in the schedule of events. All missing reports for opioids were considered nonnegative." (NCT02510014)
Timeframe: Weekly during Month 1, Every other week from Month 2-6, Monthly from Month 7-12. De novo arm stopped at Week 49. Roll-over arm stopped at Week 25
Intervention | Participants (Count of Participants) |
---|
| >=0% | >=10% | >=20% | >=30% | >=40% | >=50% | >=60% | >=70% | >=80% | >=90% | =100% |
---|
De Novo Subjects | 412 | 315 | 278 | 239 | 217 | 187 | 166 | 132 | 98 | 62 | 32 |
,Roll-over Subjects | 257 | 206 | 200 | 189 | 159 | 150 | 137 | 110 | 96 | 74 | 47 |
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Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period
TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent one of the outcomes listed in this definition. (NCT02510014)
Timeframe: Day 1 to Week 49 (De novo arm); Day 1 to Week 25 (Roll-over arm)
Intervention | Participants (Count of Participants) |
---|
| >=1 TEAE | >=1 TEAE related to study drug | >=1 serious TEAE | >=1 serious study treatment-related TEAE | Death | >=1 severe TEAE | TEAE leading to study treatment discontinuation | TEAE leading to dose reduction |
---|
De Novo Subjects | 302 | 172 | 16 | 0 | 0 | 36 | 13 | 29 |
,Roll-over Subjects | 145 | 61 | 9 | 0 | 0 | 7 | 4 | 17 |
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Percentage Change From Baseline to End of Study (Weeks 25 and 49) in Vital Signs
"Vital signs include~systolic blood pressure (mmHg)~diastolic blood pressure (mmHg)~respiratory rate (breaths/minute)~weight (kg)~body mass index (kg/m^2)~waist-to-hip ratio~Baseline is defined as the last non-missing value prior to subcutaneous injection of RBP-6000 on Day 1." (NCT02510014)
Timeframe: Baseline (Day 1 predose) End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)
Intervention | percentage change from baseline (Mean) |
---|
| Systolic blood pressure | Diastolic blood pressure | Respiratory rate | Body weight | Body mass index | Waist-to-hip ratio |
---|
De Novo Subjects | 0.2 | 0.1 | -1.2 | 1.52 | 1.53 | 1.828 |
,Roll-over Subjects | 1.3 | 1.6 | 1.0 | -0.94 | -0.93 | 1.015 |
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Worst Local Injection Site Pain From Injections as Measured by Participant-Reported Visual Analog Scale (VAS)
"Injection site pain as measured by participant-reported VAS. The participant-reported VAS for injection site pain was measured on a 100 mm scale with 'no pain' at 0 mm and 'strongest pain ever' at 100 mm (total scale of 0-100). Participants marked where along the scale reflected their localized injection pain.~The injection site pain VAS scores were obtained (after the completion of the injection) within 1 minute and at 5, 10, 15, 30 and 60 minutes (+- 5 minutes). The timing of the injection site pain VAS should have been measured from the end of the injection.~Data represents the worst pain recorded for each participant across all injections and all VAS records. The mean value is presented.~De Novo subjects were given injections on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281 and 309.~Roll-over subjects were given injections on Days 1, 29, 57, 85, 113, 141." (NCT02510014)
Timeframe: De Novo Subjects: Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281 and 309 Roll-over Subjects: Days 1, 29, 57, 85, 113, 141
Intervention | units on a scale (Mean) |
---|
| Injection 1 | Injection 2 | Injection 3 | Injection 4 | Injection 5 | Injection 6 | Injection 7 | Injection 8 | Injection 9 | Injection 10 | Injection 11 | Injection 12 |
---|
De Novo Subjects | 44.0 | 39.8 | 38.9 | 33.6 | 30.6 | 30.5 | 28.9 | 28.6 | 30.2 | 31.8 | 25.8 | 24.7 |
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Worst Local Injection Site Pain From Injections as Measured by Participant-Reported Visual Analog Scale (VAS)
"Injection site pain as measured by participant-reported VAS. The participant-reported VAS for injection site pain was measured on a 100 mm scale with 'no pain' at 0 mm and 'strongest pain ever' at 100 mm (total scale of 0-100). Participants marked where along the scale reflected their localized injection pain.~The injection site pain VAS scores were obtained (after the completion of the injection) within 1 minute and at 5, 10, 15, 30 and 60 minutes (+- 5 minutes). The timing of the injection site pain VAS should have been measured from the end of the injection.~Data represents the worst pain recorded for each participant across all injections and all VAS records. The mean value is presented.~De Novo subjects were given injections on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281 and 309.~Roll-over subjects were given injections on Days 1, 29, 57, 85, 113, 141." (NCT02510014)
Timeframe: De Novo Subjects: Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281 and 309 Roll-over Subjects: Days 1, 29, 57, 85, 113, 141
Intervention | units on a scale (Mean) |
---|
| Injection 1 | Injection 2 | Injection 3 | Injection 4 | Injection 5 | Injection 6 |
---|
Roll-over Subjects | 33.5 | 32.7 | 30.2 | 31.3 | 32.2 | 30.5 |
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Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA)
"Subjects will evaluate the degree of their sleep disturbance due to pain and improvement in quality of sleep using the GSQA questionnaire comprising of 8 questions, at baseline (Visit 1) and Visit 6 (3 months from baseline visit).~The scores at baseline and Visit 6 are calculated for the following 8 items with scores of:~Trouble falling asleep due to pain -- on a scale of 0 to 10 where 0 is never and 10 is always~Need for pain medication to sleep -- as above~Need for sleep medication to sleep -- as above~Awakened by pain at night -- as above~Awakened by pain in the morning -- as above~Pain affecting partner's sleep -- as above~Rate own sleep quality -- on a scale of 1 to 5 where 1 is very good and 5 is very poor~Number of hours of sleep per night in last 7 days" (NCT02519387)
Timeframe: Baseline, 3 months
Intervention | units on a scale (Mean) |
---|
| Trouble falling asleep due to pain (Baseline) | Trouble falling asleep due to pain (3 Months) | Need for pain medication to sleep (Baseline) | Need for pain medication to sleep (3 Months) | Need for sleep medication to sleep (Baseline) | Need for sleep medication to sleep (3 Months) | Awakened by pain at night (Baseline) | Awakened by pain at night (3 Months) | Awakened by pain in the morning (Baseline) | Awakened by pain in the morning (3 Months) | Pain affecting partner's sleep (Baseline) | Pain affecting partner's sleep (3 Months) | Rate own sleep quality (Baseline) | Rate own sleep quality (3 Months) | Average hours of sleep per night (Baseline) | Average hours of sleep per night (3 Months) |
---|
Buprenorphine Transdermal Patch | 3.4 | 2.5 | 2.2 | 1.4 | 0.3 | 0.2 | 2.6 | 2.0 | 1.9 | 1.3 | 1.2 | 1.0 | 2.8 | 2.5 | 5.7 | 5.8 |
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Physicians' and Patients' Treatment Satisfaction of Buprenorphine Patch Usage Assessed Using Physician's Global Impression of Change Scale and Patient's Global Impression of Change Scale Respectively
"The overall assessment of the change in pain intensity from baseline is measured at Visit 6.~Physician's Global Impression of Change scale: Investigator's opinion on a scale of 1 to 7 where 1 is very much improved and 7 is very much worse Patient's Global Impression of Change scale: Subject's opinion on a scale of 1 to 7 where 1 is very much improved and 7 is very much worse" (NCT02519387)
Timeframe: 3 months
Intervention | units on a scale (Mean) |
---|
| Physician Impression | Patient Impression |
---|
Buprenorphine Transdermal Patch | 2.0 | 2.3 |
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Daily Use of Breakthrough Pain Medication as Measured by Number of Subjects With at Least 1 Day of Breakthrough (Rescue) Pain Medication Usage
Patients will record any other pain medication used in a patient home diary (NCT02519387)
Timeframe: 3 months
Intervention | participants (Number) |
---|
Buprenorphine Transdermal Patch | 46 |
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Tolerability of Buprenorphine Patch Determined by Number of Patients Who Withdrew From the Study Due to Adverse Events
(NCT02519387)
Timeframe: 3 months
Intervention | participants (Number) |
---|
Buprenorphine Transdermal Patch | 17 |
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Change in Box Scale-11 (BS-11) Pain Score
"The BS-11 (Box score-11) pain score was the main efficacy outcome measured in this study. The scores at baseline (Visit 1) and Visit 6 (3 months from baseline visit) are reported.~BS-11 is an 11-point scale measuring pain intensity. It ranges from 0 to 10, whereby 0 represents no pain and 10 represents the worst imaginable pain. Subjects selected a number based on the pain intensity they were feeling at that time." (NCT02519387)
Timeframe: Baseline,3 months
Intervention | units on a scale (Mean) |
---|
| Baseline (Visit 1) | 3 Months (Visit 6) |
---|
Buprenorphine Transdermal Patch | 6.2 | 4.0 |
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Number of Participants With Opioid Abstinence at 8 Weeks
Opioid abstinence will be based on self-reported opioid use in the prior 30 days at the 8 week visit and the results of urine toxicology test at the 8 week visit. Abstinence (yes) will require no self-reported opioid use and negative urine toxicology test for opiates, methadone, and oxycodone. (NCT02526212)
Timeframe: 8 weeks
Intervention | Participants (Count of Participants) |
---|
G-BMT, Buprenorphine | 0 |
Treatment as Usual, Buprenorphine | 1 |
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Number of Participants Who Reported Sharing Injection Equipment at 8 Weeks
We used the HIV risk measure from the NIDA Seek, Test, Treat, and Retain for Vulnerable Populations study. Items for sexual risk behavior are from the Women's Health CoOp Baseline Questionnaire. Items for injection risk behavior are from the STTR Criminal Justice instrument. We will report the number of participants reporting sharing of injection equipment at 8 weeks following enrollment. (NCT02526212)
Timeframe: 8 weeks
Intervention | Participants (Count of Participants) |
---|
G-BMT, Buprenorphine | 0 |
Treatment as Usual, Buprenorphine | 0 |
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Acceptability (Scale)
Satisfaction with BMT will be measured on a 5-point Likert scale for participants following completion of the intervention. We used 17 items from the Primary Care Buprenorphine Satisfaction Scale. Each item addressed satisfaction with a specific component of buprenorphine treatment, which participants rated on a scale from 1 (very unsatisfied) to 5 (very satisfied). A higher score indicates greater satisfaction. (NCT02526212)
Timeframe: 16 weeks
Intervention | units on a scale (Mean) |
---|
G-BMT, Buprenorphine | 4.6 |
Treatment as Usual, Buprenorphine | 4.8 |
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Feasibility (Percentage of Visits Attended)
Visit adherence will be measured as the number of buprenorphine visits attended divided by the number of buprenorphine visits required per protocol and multiplied by 100 to give a percentage (NCT02526212)
Timeframe: 8 weeks
Intervention | percentage of visits attended (Median) |
---|
G-BMT, Buprenorphine | 69 |
Treatment as Usual, Buprenorphine | 71 |
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Number of Participants Who Were Retained in Buprenorphine Treatment at 3 Months and 6 Months
Retention is defined as having a medical visit or active buprenorphine prescription 12-16 weeks (3 month retention) and 24-28 weeks (6 month retention) after protocol initiation. (NCT02526212)
Timeframe: 3 months, 6 months
Intervention | Participants (Count of Participants) |
---|
| 3 month retention | 6 month retention |
---|
G-BMT, Buprenorphine | 8 | 8 |
,Treatment as Usual, Buprenorphine | 7 | 6 |
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Vivitrol Injection Receivers
% of participants starting the NTX transition who received Vivitrol injection (NCT02543944)
Timeframe: 5 days (week 4 day 1 to week 4 day 5)
Intervention | Participants (Count of Participants) |
---|
Gabapentin | 12 |
Placebo | 12 |
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NTX Transition Initiation
% of Participants who completed the detox and started the NTX transition (NCT02543944)
Timeframe: 3 days (wk 4 day 1 - week 4 day 3)
Intervention | Participants (Count of Participants) |
---|
Gabapentin | 33 |
Placebo | 29 |
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Detoxification Phase: Changes in Percent of Illicit Opioid-positive Urine Samples Over Time
Thrice weekly urine samples obtained during weeks 1-3; data include assessments from week 1 day 1 through week 4 day 1 (up to 10 total samples per participant) (NCT02543944)
Timeframe: Week 1 day 1 (study entry) through Week 4 day 1 (first day of NTX transition)
Intervention | percentage of urine positive samples (Mean) |
---|
Gabapentin | 35.0 |
Placebo | 41.6 |
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Detox Phase Completers
% of enrolled participants who completed the Detox Phase (NCT02543944)
Timeframe: 3 weeks (week 1-3)
Intervention | Participants (Count of Participants) |
---|
Gabapentin | 41 |
Placebo | 34 |
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Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 32 mg
"Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) item At this moment, my liking of this drug is for Qualification/Baseline and Four Challenge sessions (Completer Population) for CAM2038 q1w, 32 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome." (NCT02611752)
Timeframe: 17 days
Intervention | units on a scale (Least Squares Mean) |
---|
| Qualification/Baseline | Days 1-3 | Days 4-6 | Days 8 -10 | Days 11-13 |
---|
CAM2038 q1w, 32 mg - Hydromorphone 18 mg- Hydromorphone 0mg | 40.3 | 2.4 | 4.5 | 2.5 | 3.6 |
,CAM2038 q1w, 32 mg - Hydromorphone 18 mg- Hydromorphone 6 mg | 13.7 | 1.5 | 3.0 | 2.0 | 2.6 |
,CAM2038 q1w, 32 mg - Hydromorphone 6 Mg-Hydromorphone 0 mg | 26.7 | 0.9 | 1.5 | 0.5 | 1.0 |
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Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) for Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 24 mg
"Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) item At this moment, my liking of this drug is for Qualification/Baseline and Four Challenge sessions (Completer Population) for CAM2038 q1w, 24 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome." (NCT02611752)
Timeframe: 17 days
Intervention | units on a scale (Least Squares Mean) |
---|
| Qualification/Baseline | Days 1-3 | Days 4-6 | Days 8 -10 | Days 11-13 |
---|
CAM2038 q1w, 24 mg - Hydromorphone 18 mg- Hydromorphone 0mg | 42.1 | 1.8 | 7.4 | 1.8 | 3.6 |
,CAM2038 q1w, 24 mg - Hydromorphone 18 mg- Hydromorphone 6 mg | 9.5 | 0.9 | 6.2 | 0.3 | 2.7 |
,CAM2038 q1w, 24 mg - Hydromorphone 6 Mg-Hydromorphone 0 mg | 32.7 | 0.9 | 1.3 | 1.5 | 0.9 |
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Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
"Analysis Results for Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) comparing hydromorphone challenge doses in each of the baseline and four challenge sequence with each other, presented as Least Squares (LS) Mean with Standard Error (SE) and 95% Confidence Interval (CI). VAS item At this moment, I desire opiods where values can range from 0 (Definitely not) to 100 (Definitely so)." (NCT02611752)
Timeframe: 15 days
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline HMO 6mg-HMO 0mg | Baseline HMO 18mg-HMO 0mg | Baseline HMO18mg-HMO 6mg | Challenge Session 1 HMO 6mg - HMO 0mg | Challenge Session 1 HMO 18mg - HMO 0mg | Challenge Session 1 HMO 18mg-HMO 6mg | Challenge Session 2 HMO 6mg - HMO 0mg | Challenge Session 2 HMO 18mg - HMO 0mg | Challenge Session 2 HMO 18mg - HMO 6mg | Challenge Session 3 HMO6mg - HMO 0mg | Challenge Session 3 HMO 18mg - HMO 0mg | Challenge Session 3 HMO 18mg - HMO 6mg | Challenge Session 4 HMO 6mg - HMO 0mg | Challenge Session 4 HMO 18mg - HMO 0mg | Challenge Session 4 HMO 18mg - HMO 6mg |
---|
CAM2038 q1w, 24 mg | -18.0 | -31.0 | 013.0 | -0.2 | 1.8 | 2.0 | -3.8 | -6.2 | -2.4 | -2.8 | -1.8 | 1.0 | -2.2 | -4.5 | -2.3 |
,CAM2038 q1w, 32 mg | 14.1 | -29.2 | -15.1 | 8.7 | -5.7 | -14.4 | -3.1 | 0.7 | 3.7 | 2.2 | 0.4 | -1.8 | -0.2 | 0.9 | 1.1 |
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Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
"Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) presented as Least Squares (LS) mean with Standard Error (SE) for all 3 doses of hydromorphone in baseline and 4 Challenge Sessions. VAS item At this moment, I fell any drug effects where values can range from 0 (Not at all) to 100 (Extremely)." (NCT02611752)
Timeframe: 15 days
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline HMO 6mg-HMO 0mg | Baseline HMO 18mg-HMO 0mg | Baseline HMO18mg-HMO 6mg | Challenge Session 1 HMO 6mg - HMO 0mg | Challenge Session 1 HMO 18mg - HMO 0mg | Challenge Session 1 HMO 18mg-HMO 6mg | Challenge Session 2 HMO 6mg - HMO 0mg | Challenge Session 2 HMO 18mg - HMO 0mg | Challenge Session 2 HMO 18mg - HMO 6mg | Challenge Session 3 HMO6mg - HMO 0mg | Challenge Session 3 HMO 18mg - HMO 0mg | Challenge Session 3 HMO 18mg - HMO 6mg | Challenge Session 4 HMO 6mg - HMO 0mg | Challenge Session 4 HMO 18mg - HMO 0mg | Challenge Session 4 HMO 18mg - HMO 6mg |
---|
CAM2038 q1w, 24 mg | 63.2 | 83.9 | 20.7 | 4.0 | 3.5 | -0.5 | 1.6 | 13.6 | 11.9 | 2.4 | 4.6 | 2.2 | 1.5 | 6.9 | 5.4 |
,CAM2038 q1w, 32 mg | 47.8 | 76.4 | 28.6 | 3.2 | 6.8 | 3.6 | 3.6 | 5.9 | 2.2 | -1.1 | 3.3 | 4.4 | -1.1 | 2.1 | 3.2 |
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Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
"Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) comparing hydromorphone challenge doses in each of the baseline and four challenge sequence with each other, presented as Least Squares (LS) Mean with Standard Error (SE) and 95% Confidence Interval (CI). VAS item At this moment, I feel high where values can range from 0 (Not at all High) to 100 (Extremely High)." (NCT02611752)
Timeframe: 15 days
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline HMO 6mg-HMO 0mg | Baseline HMO18mg-HMO 0 mg | Baseline HMO 18mg - HMO 6mg | Challenge Session 1 HMO 6mg - HMO 0mg | Challenge Session 1 HMO 18mg - HMO 0mg | Challenge Session 1 HMO 18mg-HMO 6mg | Challenge Session 2 HMO 6mg - HMO 0mg | Challenge Session 2 HMO 18mg - HMO 0mg | Challenge Session 2 HMO 18mg - HMO 6mg | Challenge Session 3 HMO6mg - HMO 0mg | Challenge Session 3 HMO 18mg - HMO 0mg | Challenge Session 3 HMO 18mg - HMO 6mg | Challenge Session 4 HMO 6mg - HMO 0mg | Challenge Session 4 HMO 18mg - HMO 0mg | Challenge Session 4 HMO 18mg - HMO 6mg |
---|
CAM2038 q1w, 24 mg | 62.4 | 84.6 | 22.2 | 4.3 | 3.6 | -0.8 | 1.8 | 15.3 | 13.5 | 2.6 | 3.9 | 1.3 | 2.1 | 6.4 | 4.2 |
,CAM2038 q1w, 32 mg | 47.3 | 77.0 | 29.7 | 3.1 | 3.2 | 0.1 | 1.5 | 6.5 | 5.0 | 0.9 | 5.4 | 4.5 | 1.3 | 6.0 | 4.7 |
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Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
"Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) comparing hydromorphone challenge doses in each of the baseling and four challenge sequences with each other, presented as Least Squares (LS) Mean with Standard Error (SE) and 95% Confidence Interval (CI). VAS item At this moment, I feel good drug effects where values can range from 0 (Not at all ) to 100 (Extremely)." (NCT02611752)
Timeframe: 15 days
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline HMO 6mg-HMO 0mg | Baseline HMO 18mg-HMO 0mg | Baseline HMO18mg-HMO 6mg | Challenge Session 1 HMO 6mg - HMO 0mg | Challenge Session 1 HMO 18mg - HMO 0mg | Challenge Session 1 HMO 18mg-HMO 6mg | Challenge Session 2 HMO 6mg - HMO 0mg | Challenge Session 2 HMO 18mg - HMO 0mg | Challenge Session 2 HMO18mg - HMO 6mg | Challenge Session 3 HMO6mg - HMO 0mg | Challenge Session 3 HMO 18mg - HMO 0mg | Challenge Session 3 HMO 18mg - HMO 6mg | Challenge Session 3 HMO 6mg - HMO 0mg | Challenge Session 4 HMO 18mg - HMO 0mg | Challenge Session 4 HMO 18mg - HMO 6mg |
---|
CAM2038 q1w, 24 mg | 61.6 | 85.4 | 23.9 | 0.8 | 1.3 | 0.6 | 1.8 | 15.8 | 14.0 | 2.4 | 4.7 | 2.3 | 2.2 | 7.1 | 4.9 |
,CAM2038 q1w, 32 mg | 52.8 | 81.8 | 29.1 | 2.8 | 4.9 | 2.1 | 1.7 | 7.3 | 5.6 | 0.8 | 4.9 | 4.1 | 0.7 | 6.0 | 5.2 |
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Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 24 mg CAM2038 q1w Group (Completer Population)
"Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 24 mg CAM2038 q1w group (Completer Population) , presented as Least Squares (LS) mean with Standard Error (SE) for all 3 doses of hydromorphone in baseline and 4 Challenge Sessions. VAS item At this moment, I feel bad effects where values can range from 0 (Not at all) to 100 (Extremely)." (NCT02611752)
Timeframe: 15 days
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline | Challenge Session 1 (Days 1-3) | Challenge Session 2 (Days 4-6) | Challenge Session 3 (Days 8-10) | Challenge Session 4 (Days 11-13) |
---|
CAM2038 q1w, 24 mg - Hydromorphone 0 mg | 3.0 | 5.0 | 1.5 | 0.8 | 1.0 |
,CAM2038 q1w, 24 mg - Hydromorphone 18 mg | 13.1 | 0.8 | 1.6 | 1.6 | 0.9 |
,CAM2038 q1w, 24 mg - Hydromorphone 6 mg | 8.4 | 0.9 | 0.8 | 0.7 | 1.0 |
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Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 32 mg CAM2038 q1w Group (Completer Population)
"Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 32 mg CAM2038 q1w group (Completer Population) , presented as Least Squares (LS) mean with Standard Error (SE) for all 3 doses of hydromorphone in baseline and 4 Challenge Sessions. VAS item At this moment, I feel bad effects where values can range from 0 (Not at all) to 100 (Extremely)." (NCT02611752)
Timeframe: 15 days
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline | Challenge Session 1 (Days 1-3) | Challenge Session 2 (Days 4-6) | Challenge Session 3 (Days 8-10) | Challenge Session 4 (Days 11-13) |
---|
CAM2038 q1w, 32 mg - Hydromorphone 0 mg | 5.9 | 1.2 | 0.5 | 0.6 | 0.6 |
,CAM2038 q1w, 32 mg - Hydromorphone 18 mg | 12.6 | 1.4 | 2.1 | 2.8 | 1.3 |
,CAM2038 q1w, 32 mg - Hydromorphone 6 mg | 13.1 | 1.3 | 1.4 | 0.8 | 1.0 |
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Treatment Phase Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 32 mg
"Treatment Phase Drug Liking Visual Analog Scale (VAS) item At this moment, my liking of this drug is for Baseline and Four Challenge sessions Compared to Baseline (Completer Population), where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome." (NCT02611752)
Timeframe: 17 days
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline | Days 1-3 | Days 4-6 | Days 8 -10 | Days 11-13 |
---|
CAM2038 q1w, 32 mg - Hydromorphone 0 mg | 52.9 | 51.6 | 51.5 | 51.7 | 51.2 |
,CAM2038 q1w, 32 mg - Hydromorphone 18 mg | 93.2 | 54.0 | 56.0 | 54.2 | 54.8 |
,CAM2038 q1w, 32 mg - Hydromorphone 6 mg | 79.6 | 52.5 | 53.0 | 52.3 | 52.1 |
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Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg
"Treatment Phase Drug Liking Visual Analog Scale (VAS) item At this moment, my liking of this drug is for Baseline and Four Challenge sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome." (NCT02611752)
Timeframe: 17 days
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline | Days 1-3 | Days 4-6 | Days 8 -10 | Days 11-13 |
---|
CAM2038 q1w, 24 mg - Hydromorphone 0 mg | 50.6 | 51.3 | 50.8 | 51.1 | 51.0 |
,CAM2038 q1w, 24 mg - Hydromorphone 18 mg | 92.7 | 53.1 | 58.3 | 52.9 | 54.6 |
,CAM2038 q1w, 24 mg - Hydromorphone 6 mg | 83.2 | 52.2 | 52.1 | 52.6 | 51.9 |
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Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
"Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) presented as Least Squares (LS) mean with Standard Error (SE) for all 3 doses of hydromorphone in baseline and 4 Challenge Sessions. VAS item At this moment, my mental state is where values can range from 0 (Very Drowsy) to 100 (Very alert), with 50 being neutral (Neither drowsy nor alert)." (NCT02611752)
Timeframe: 15 days
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline HMO 6mg-HMO 0mg | Baseline HMO 18mg-HMO 0mg | Baseline HMO18mg-HMO 6mg | Challenge Session 1 HMO 6mg - HMO 0mg | Challenge Session 1 HMO 18mg - HMO 0mg | Challenge Session 1 HMO 18mg-HMO 6mg | Challenge Session 2 HMO 6mg - HMO 0mg | Challenge Session 2 HMO 18mg - HMO 0mg | Challenge Session 2 HMO 18mg - HMO 6mg | Challenge Session 3 HMO6mg - HMO 0mg | Challenge Session 3 HMO 18mg - HMO 0mg | Challenge Session 3 HMO 18mg - HMO 6mg | Challenge Session 4 HMO 6mg - HMO 0mg | Challenge Session 4 HMO 18mg - HMO 0mg | Challenge Session 4 HMO 18mg - HMO 6mg |
---|
CAM2038 q1w, 24 mg | -18.0 | -31.0 | -13.0 | -2.2 | -4.9 | -2.8 | -6.2 | -8.3 | -2.1 | -0.2 | -7.5 | -7.4 | 0.7 | -2.1 | -2.8 |
,CAM2038 q1w, 32 mg | -14.1 | -29.2 | -15.1 | 1.7 | -0.8 | -2.5 | -2.0 | -2.7 | -0.7 | -0.9 | -4.3 | -3.4 | 1.8 | -0.2 | -2.0 |
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Total Pain Relief (TOTPAR) Over 4, 8, 24 and 48 Hours After Time 0
TOTPAR was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). TOTPAR scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (first dose of study drug). The TOTPAR scores are the sum of the pain relief at each time point multiplied by the duration in hours since the previous time point. Larger positive numbers indicate more pain relief (maximum=4 at each time point) and smaller positive numbers indicate less pain relief (minimum=0 at each time point). The overall minimum is 0 for each variable and the overall maximum is 4 times the number of hours specified for the variable: TOTPAR-4=(0 to 16), TOTPAR-8=(0 to 32), TOTPAR-24=(0 to 96) and TOTPAR-48=(0 to 192). TOTPAR-4, TOTPAR-8, TOTPAR-24 and TOTPAR-48 were analyzed using an ANCOVA model with factors for treatment, site and baseline pain intensity. (NCT02634788)
Timeframe: 4, 8, 24 and 48 hours after Time 0
Intervention | units on a scale (Least Squares Mean) |
---|
| TOTPAR-4 | TOTPAR-8 | TOTPAR-24 | TOTPAR-48 |
---|
Buprenorphine 0.125 mg TID | 4.38 | 8.95 | 40.45 | 100.15 |
,Buprenorphine 0.25 mg TID | 4.07 | 9.22 | 40.50 | 95.73 |
,Buprenorphine 0.5 mg TID | 6.23 | 13.85 | 53.30 | 118.12 |
,Placebo | 2.50 | 5.48 | 27.33 | 73.88 |
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Percentage of Participants With Scores in Each Pain Relief Category at 4, 8, 24 and 48 Hours After Time 0
Pain relief was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). The percentage of participants with scores in each pain relief category are reported. Missing values were imputed. (NCT02634788)
Timeframe: 4, 8, 24 and 48 hours after Time 0 (first dose of study drug)
Intervention | percentage of participants (Number) |
---|
| 4 Hours - No relief | 4 Hours - A little relief | 4 Hours - Some relief | 4 Hours - A lot of relief | 4 Hours - Complete relief | 8 Hours - No relief | 8 Hours - A little relief | 8 Hours - Some relief | 8 Hours - A lot of relief | 8 Hours - Complete relief | 24 Hours - No relief | 24 Hours - A little relief | 24 Hours - Some relief | 24 Hours - A lot of relief | 24 Hours - Complete relief | 48 Hours - No relief | 48 Hours - A little relief | 48 Hours - Some relief | 48 Hours - A lot of relief | 48 Hours - Complete relief |
---|
Buprenorphine 0.125 mg TID | 41.5 | 23.2 | 11.0 | 13.4 | 8.5 | 32.9 | 28.0 | 18.3 | 12.2 | 3.7 | 11.0 | 12.2 | 19.5 | 39.0 | 12.2 | 4.9 | 6.1 | 20.7 | 35.4 | 26.8 |
,Buprenorphine 0.25 mg TID | 43.8 | 22.5 | 13.8 | 13.8 | 6.3 | 32.5 | 22.5 | 21.3 | 12.5 | 8.8 | 7.5 | 21.3 | 25.0 | 26.3 | 15.0 | 8.8 | 11.3 | 20.0 | 32.5 | 21.3 |
,Buprenorphine 0.5 mg TID | 24.7 | 16.0 | 21.0 | 19.8 | 18.5 | 18.5 | 14.8 | 27.2 | 23.5 | 12.3 | 6.2 | 2.5 | 23.5 | 38.3 | 19.8 | 2.5 | 8.6 | 12.3 | 38.3 | 27.2 |
,Placebo | 60.8 | 21.5 | 13.9 | 1.3 | 1.3 | 43.0 | 35.4 | 7.6 | 10.1 | 1.3 | 20.3 | 19.0 | 29.1 | 17.7 | 8.9 | 17.7 | 13.9 | 20.3 | 27.8 | 15.2 |
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Percentage of Participants With Peak Scores in Each Pain Relief Category
Peak pain relief is the highest value of pain relief experienced during the study. Pain relief was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). The percentage of participants with peak scores in each pain relief category are reported. (NCT02634788)
Timeframe: From Time 0 (first dose of study drug) up to 48 hours
Intervention | percentage of participants (Number) |
---|
| No relief | A little relief | Some relief | A lot of relief | Complete relief | A lot of relief + Complete relief |
---|
Buprenorphine 0.125 mg TID | 3.7 | 1.2 | 13.4 | 40.2 | 41.5 | 81.7 |
,Buprenorphine 0.25 mg TID | 1.3 | 3.8 | 12.5 | 46.3 | 36.3 | 82.6 |
,Buprenorphine 0.5 mg TID | 0 | 2.5 | 9.9 | 42.0 | 45.7 | 87.7 |
,Placebo | 6.3 | 11.4 | 19.0 | 36.7 | 26.6 | 63.3 |
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Participant's Global Evaluation of Study Drug
Global evaluation of study drug was completed at the end of treatment (Day 3) or before early termination if a participant discontinued early. Participants were asked to provide an overall rating of their study medication in controlling pain on a 5-point NRS, where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent. The percentage of participants with scores in each pain relief category are reported. (NCT02634788)
Timeframe: End of treatment (Day 3) or early termination
Intervention | percentage of participants (Number) |
---|
| Poor | Fair | Good | Very Good | Excellent |
---|
Buprenorphine 0.125 mg TID | 14.6 | 15.9 | 14.6 | 24.4 | 28.0 |
,Buprenorphine 0.25 mg TID | 5.0 | 16.3 | 26.3 | 30.0 | 18.8 |
,Buprenorphine 0.5 mg TID | 2.5 | 7.4 | 16.0 | 32.1 | 38.3 |
,Placebo | 25.3 | 25.3 | 19.0 | 19.0 | 10.1 |
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NRS SPID Over 4 Hours (SPID-4), 8 Hours (SPID-8) and 24 Hours (SPID-24) After Time 0
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [max=10 at each time point] and negative numbers indicate an increase in pain [min=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified: SPID-4=(-40 to 40), SPID-8=(-80 to 80) and SPID-24=(-240 to 240). The NRS SPID-4, 8 and 24 were analyzed using an ANCOVA model which included treatment and site as main effects and Baseline pain intensity as the covariate. (NCT02634788)
Timeframe: Baseline and 0 to 4, 0 to 8 and 0 to 24 hours after Time 0
Intervention | units on a scale (Least Squares Mean) |
---|
| SPID-4 | SPID-8 | SPID-24 |
---|
Buprenorphine 0.125 mg TID | 3.74 | 7.08 | 44.17 |
,Buprenorphine 0.25 mg TID | 3.67 | 8.26 | 48.85 |
,Buprenorphine 0.5 mg TID | 7.70 | 17.57 | 75.67 |
,Placebo | 0.67 | 1.32 | 24.16 |
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NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours After Time 0
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug). A lower value indicates improvement in pain. (NCT02634788)
Timeframe: 4, 8, 24 and 48 hours after Time 0
Intervention | units on a scale (Mean) |
---|
| 4 Hours | 8 Hours | 24 Hours | 48 Hours |
---|
Buprenorphine 0.125 mg TID | 5.6 | 5.9 | 3.4 | 2.6 |
,Buprenorphine 0.25 mg TID | 5.5 | 5.1 | 3.4 | 2.8 |
,Buprenorphine 0.5 mg TID | 4.1 | 4.2 | 2.7 | 1.9 |
,Placebo | 6.5 | 5.9 | 4.2 | 2.9 |
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NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug). NRS PID is defined as the difference in pain at each scheduled timepoint relative to Baseline (PID=pain intensity at baseline - pain intensity at time point). A higher value of NRS PID score indicates a higher decrease in pain from Baseline. (NCT02634788)
Timeframe: Baseline and 4, 8, 24 and 48 hours after Time 0
Intervention | units on a scale (Mean) |
---|
| 4 Hours | 8 Hours | 24 Hours | 48 Hours |
---|
Buprenorphine 0.125 mg TID | 1.1 | 0.7 | 3.2 | 4.1 |
,Buprenorphine 0.25 mg TID | 0.9 | 1.2 | 3.0 | 3.5 |
,Buprenorphine 0.5 mg TID | 2.6 | 2.5 | 4.0 | 4.9 |
,Placebo | -0.1 | 0.5 | 2.2 | 3.5 |
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Time to Peak Pain Relief
Time to peak pain relief is the time to the highest value of pain relief experienced during the study. Pain relief was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). If no pain relief was observed, then the time was censored at the time of the last pain assessment. (NCT02634788)
Timeframe: From Time 0 (first dose of study drug) to time of peak pain relief (up to 1437 minutes)
Intervention | minutes (Median) |
---|
Placebo | 1200.0 |
Buprenorphine 0.5 mg TID | 360.0 |
Buprenorphine 0.25 mg TID | 720.0 |
Buprenorphine 0.125 mg TID | 1200.0 |
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Time to Onset of Analgesia
Time to onset of analgesia was measured as time to first perceptible pain relief confirmed by meaningful pain relief using the 2-stopwatch method. The study staff started 2 stopwatches as soon as the first dose of study drug was administered. Each participant was instructed to stop the first stopwatch when he or she experienced any perceptible pain relief and the second stopwatch when he or she experienced pain relief that was meaningful to them. If the second stopwatch was not stopped, time was censored at the time of the second dose of study drug or the use of rescue medication, whichever came first. If both stopwatches were not stopped time was censored at the time of the second dose of study drug or the use of rescue medication whichever came first. Time to onset of analgesia was defined as the time when the first stopwatch was stopped given that the second stopwatch is stopped. (NCT02634788)
Timeframe: From Time 0 (first dose of study drug) to time of confirmed meaningful pain relief (up to 64 minutes)
Intervention | minutes (Median) |
---|
Placebo | NA |
Buprenorphine 0.5 mg TID | 43.0 |
Buprenorphine 0.25 mg TID | NA |
Buprenorphine 0.125 mg TID | NA |
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Percentage of Participants Using Rescue Medication for Pain
The percentage of participants who needed to take an alternate medication for pain relief during the treatment period. (NCT02634788)
Timeframe: From Time 0 (first dose of study drug) up to 48 hours
Intervention | percentage of participants (Number) |
---|
Placebo | 97.5 |
Buprenorphine 0.5 mg TID | 55.6 |
Buprenorphine 0.25 mg TID | 87.5 |
Buprenorphine 0.125 mg TID | 87.8 |
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Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48)
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum(max)=10 at each time point], and negative numbers indicate an increase in pain [minimum(min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-48 range is -480 to 480. The NRS SPID-48 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate. (NCT02634788)
Timeframe: Baseline and 0 to 48 hours after Time 0
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | 89.40 |
Buprenorphine 0.5 mg TID | 171.33 |
Buprenorphine 0.25 mg TID | 125.58 |
Buprenorphine 0.125 mg TID | 124.85 |
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Time to Meaningful Pain Relief
Time to meaningful pain relief was evaluated using the 2 stopwatch method and is defined as the time when the participant stops the second stopwatch. If it was not stopped time was censored at the time that the second stopwatch was stopped or the time of the second dose or the time that rescue medication was used whichever came first. (NCT02634788)
Timeframe: From Time 0 (first dose of study drug) to time of meaningful pain relief (up to 227 minutes)
Intervention | minutes (Median) |
---|
Placebo | 238.0 |
Buprenorphine 0.5 mg TID | 92.0 |
Buprenorphine 0.25 mg TID | 122.0 |
Buprenorphine 0.125 mg TID | 166.0 |
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Time to First Perceptible Pain Relief
Time to first perceptible pain relief was evaluated using the 2 stopwatch method and is defined as the time when the participant stops the first stopwatch. If it was not stopped time was censored at the time that the second stopwatch was stopped or the time of the second dose or the time that rescue medication was used whichever came first. (NCT02634788)
Timeframe: From Time 0 (first dose of study drug) to time of first perceptible pain relief (up to 83 minutes)
Intervention | minutes (Median) |
---|
Placebo | 29.0 |
Buprenorphine 0.5 mg TID | 23.0 |
Buprenorphine 0.25 mg TID | 15.0 |
Buprenorphine 0.125 mg TID | 27.0 |
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Time to First Use of Rescue Medication for Pain
Time to first use of rescue medication is the time from Time 0 (time of administration of the first dose of study drug) to the first use of rescue medication. If rescue medication was not taken the time was censored at the time of the last pain assessment. (NCT02634788)
Timeframe: From Time 0 to time of first use of rescue medication (up to 280 minutes)
Intervention | minutes (Median) |
---|
Placebo | 107.0 |
Buprenorphine 0.5 mg TID | 937.0 |
Buprenorphine 0.25 mg TID | 219.5 |
Buprenorphine 0.125 mg TID | 193.0 |
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Total Use of Rescue Medication Over 0 to 24 Hours and 0 to 48 Hours
Total use of rescue medication is defined as the number of times a participant took rescue medication. (NCT02634788)
Timeframe: Over 24 and 48 hours after Time 0 (first dose of study drug)
Intervention | number of uses (Mean) |
---|
| 0-24 Hours | 0-48 Hours |
---|
Buprenorphine 0.125 mg TID | 2.9 | 3.9 |
,Buprenorphine 0.25 mg TID | 2.6 | 3.7 |
,Buprenorphine 0.5 mg TID | 2.2 | 2.9 |
,Placebo | 3.8 | 5.6 |
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Number of Subjects Remaining in the Study (Retention Rate)
Number of Subjects Remaining in the Study (Retention Rate) on SL BPN/NX and CAM2038 (NCT02651584)
Timeframe: 24 weeks
Intervention | Participants (Count of Participants) |
---|
| Retained | Not Retained |
---|
Group 1: SL BPN/NX Tablets + Placebo SC Injections | 126 | 89 |
,Group 2: CAM2038 SC Injections + SL Placebo Tablets | 121 | 92 |
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Cumulative Distribution Function (CDF) of Percentage of Urine Samples Negative for Illicit Opioids
Cumulative distribution function (CDF) of percentage of urine samples negative for illicit opioids comparing CAM2038 to SL BPN/NX as (supported by self-reported opioid use results) (NCT02651584)
Timeframe: 24 weeks
Intervention | percentage of negative urine samples (Median) |
---|
| With Subjects' Self Reported Opioid Use | Without Subjects' Self reported Opioid Use |
---|
Group 2: CAM2038 SC Injections + SL Placebo Tablets | 26.7 | 26.7 |
,SL BPN Tablets + Placebo Subcutaneous (SC) Injections | 0.0 | 6.7 |
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Number of Subjects With Sustained Abstinence of Opioid Use
Number of Subjects with Sustained Abstinence of Opioid Use taking SL BPN/NX and CAM2038 (NCT02651584)
Timeframe: 24 weeks
Intervention | Participants (Count of Participants) |
---|
| Subjects with sustained abstinence of opioids | Subjects without sustained abstinence of opioids |
---|
Group 1: SL BPN/NX Tabs+ Placebo Subcutaneous (SC) Injections | 30 | 185 |
,Group 2: CAM2038 SC Injections + SL Placebo Tablets | 39 | 174 |
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"Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire Subjective Response With and Without Buprenorphine"
"The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: Feel Drug, Feel High, and Want More. The Feel Drug, Feel High, Like Drug, and Want More subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0 -100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome." (NCT02659787)
Timeframe: 0 through 3 hours after dosing.
Intervention | units on a scale (Mean) |
---|
| Feel Drug | Like Drug | Feel High | Want More |
---|
Low Dose Buprenorphine | 21.03 | 23.09 | 10.91 | 17.46 |
,Placebo | 10.64 | 19.8 | 5.74 | 16.76 |
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Summary of Subjective Opiate Withdrawal Scale (SOWS) at Selected Time Points (Efficacy Population)
"Summary of SOWS over time to show withdrawal symtons, from baseline to end of treatment. This form contains 16 questions that rate the intensity of withdrawal from 0 (Not at all) to 4 (Extremely), with higher scores associated with greater withdrawal symptoms and total range for all items of 0-64" (NCT02672111)
Timeframe: 12 months- 48 week
Intervention | score on a scale (Mean) |
---|
| Baseline | Visit 3 Day 8 | Visit 26 Day 169 | End of Treatment |
---|
CAM2038 q1w or q4w New to BPN Treatment | 27.1 | 8.9 | 3.0 | 3.9 |
,CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | 4.7 | 8.4 | 4.3 | 3.3 |
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Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Full Exposure Safety Population
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period. Safety Assessments: Adverse events (AEs) and serious adverse events (SAEs)-Full Exposure Safety Population (NCT02672111)
Timeframe: 12 months- 48 week
Intervention | participants (Number) |
---|
| Subject had at least 1 TEAE | Subject had at least 1 drug-related TEAE | Subject had at least 1 severe TEAE | Deaths | Subject had at least 1 non-fatal SAE | Subject had at least 1 non-fatal drug related SAE | Hospitalizations | Subject discontinued study drug due to a TEAE |
---|
CAM2038 q1w or q4w New to BPN Treatment | 8 | 1 | 1 | 0 | 1 | 0 | 1 | 0 |
,CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | 95 | 41 | 11 | 0 | 8 | 0 | 7 | 0 |
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Summary of Need to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population)
"The following results summarize the need to use VAS over a period of 12 months - 48 weeks. Need to Use assessments were administered using a unipolar 100 mm VAS. Subjects were asked Since your last scheduled assessment visit, indicate your worst or strongest need to use opioids, where 0 = No need to use and 100 mm = Strongest possible need." (NCT02672111)
Timeframe: 12 months- 48 week
Intervention | score on a scale (Mean) |
---|
| Baseline | Visit 3 Day 8 | Visit 26 Day 169 | End of Treatment |
---|
CAM2038 q1w or q4w New to BPN Treatment | 76.3 | 34.3 | 8.0 | 5.3 |
,CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | 11.7 | 18.0 | 5.6 | 5.4 |
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Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period. Safety Assessments: Adverse events (AEs) and serious adverse events (SAEs)-Overall Safety Population (NCT02672111)
Timeframe: 12 months- 48 week
Intervention | participants (Number) |
---|
| Subject had at least 1 TEAE | Subject had at least 1 drug-related TEAE | Subject had at least 1 severe TEAE | Deaths | Subject had at least 1 non-fatal SAE | Subject had at least 1 non-fatal drug related SAE | Hospitalizations | Subject discontinued study drug due to a TEAE |
---|
CAM2038 q1w or q4w New to BPN Treatment | 12 | 2 | 2 | 0 | 2 | 0 | 1 | 1 |
,CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | 131 | 58 | 13 | 0 | 10 | 0 | 9 | 4 |
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Summary of Clinical Opiate Withdrawal Scale (COWS) at Selected Time Points (Efficacy Population)
A summary of COWS (administered by the Clinician) over 48 weeks to show withdrawal symptoms from baseline to end of treatment. This scale consists of 11 common opiate withdrawal signs or symptoms, rated on a numeric scale from 0 to 4 or 5 and based on a timed period of observation of the subject by the rater. Higher scores are associated with greater withdrawal symptoms with a total range for all items of between 0-48 (NCT02672111)
Timeframe: 12 months- 48 week
Intervention | score on a scale (Mean) |
---|
| Baseline | Visit 3 Day 8 | Visit 26 Day 169 | End of Treatment |
---|
CAM2038 q1w or q4w New to BPN Treatment | 10.6 | 3.0 | 0.2 | 0.3 |
,CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | 2.0 | 3.7 | 1.9 | 1.4 |
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Summary of Desire to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population)
"The following table summarizes the desire to use measurements over a period of 12 months - 48 weeks. Desire to Use assessments were administered using a unipolar 100 mm VAS. Subjects were asked Since your last scheduled assessment visit, indicate your worst or strongest desire to use opioids, where 0 = No desire to use and 100 mm = Strongest possible desire." (NCT02672111)
Timeframe: 12 months- 48 week
Intervention | score on a scale (Mean) |
---|
| Baseline | Visit 3 Day 8 | Visit 26 Day 169 | End of Treatment |
---|
CAM2038 q1w or q4w New to BPN Treatment | 74.8 | 23.0 | 5.8 | 2.8 |
,CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | 11.7 | 18.8 | 6.4 | 6.4 |
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Mean Percentage of Negative Urine Toxicology Results for Illicit Opioid Use Supported by Self Reported Illicit Opioid Use (Efficacy Population)
The following is a summary of Mean Percentage of Negative Urine Toxicology Results for Illicit Opioid Use Supported by Self Reported Illicit Opioid Use (Efficacy Population) (NCT02672111)
Timeframe: 12 months (48 weeks)
Intervention | percentage of negative urine samples (Mean) |
---|
CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | 82.8 |
CAM2038 q1w or q4w New to BPN Treatment | 41.2 |
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Mean Percentage of Self-reported No Illicit Opioid Use (Efficacy Population)
"The following is a summary of Mean Percentage of Self-Reported No Illicit Opioid Use during the entire study (Efficacy Population). The proportion of patients who reported no illicit opioid use during the study was analyzed. For example if a subject provided 10 self reports and 2 out of the 10 were Used, the percentage for the subject would be 20%. The average percentage of all patients is provided." (NCT02672111)
Timeframe: 12 months (48 weeks)
Intervention | Mean percentage of no illicit opioid use (Mean) |
---|
CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | 92.5 |
CAM2038 q1w or q4w New to BPN Treatment | 74.0 |
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Summary of Retention in Treatment (Efficacy Population)
The following is a summary of treatment retention over 48 weeks (NCT02672111)
Timeframe: 48 weeks of treatment
Intervention | weeks (Mean) |
---|
CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | 38.3 |
CAM2038 q1w or q4w New to BPN Treatment | 43.6 |
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Working Memory - Between Groups at Baseline by Lapsed Category
fMRI working memory differences between participants who lapse back to opioid use and those who don't (NCT02696096)
Timeframe: Baseline
Intervention | % fMRI signal change (Mean) |
---|
| bilateral SMA | R middle frontal gyrus | R inferior parietal lobule | L inferior parietal lobule | L middle frontal gyrus (a) | L middle frontal gyrus (b) | L middle frontal gyrus (c) | bilateral precuneus | R anterior insula |
---|
Lapse | 0.42 | 0.40 | 0.33 | 0.32 | 0.49 | 0.33 | 0.36 | 0.37 | 0.39 |
,No Lapse | 0.45 | 0.39 | 0.34 | 0.36 | 0.46 | 0.36 | 0.39 | 0.38 | 0.42 |
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Changes in Resting State Disorganization Between Baseline and One Week by Person by Lapsed Category
"The measure of resting state organization is a z-value derived from Pearson's r-values. They represent the effect of the association between the brain activity of the seed region and each brain voxel over time during the resting state FMRI scan. A central z-value of 0 means that there is no association between the seed region and the voxel.~Positive and negative z-values approaching 0 reflect increasingly weaker associations, and more extreme positive and negative values reflect stronger associations. Attributing the qualitative labels better or worse to these values depend upon the brain network and context. In many networks (eg, task-positive cognitive control network), a stronger positive correlation is thought to reflect better network organization. In the task-negative default mode network a stronger positive relationship is considered by some as worse. For this study, these are not yet used as clinical measures and there are not known cutoffs." (NCT02696096)
Timeframe: Baseline and 1 week
Intervention | Mean default mode network (DMN) z-scores (Mean) |
---|
| DMN synchrony active use | DMN synchrony abstinent |
---|
Lapse | 0.328 | 0.394 |
,No Lapse | 0.315 | 0.384 |
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Changes in Working Memory - Within Groups During Satiation and Withdrawal
fMRI working memory differences under satiation vs withdrawal from opioids (NCT02696096)
Timeframe: Baseline and 1 week
Intervention | % fMRI signal change (Mean) |
---|
| Mean Brain Response in R middle frontal gyrus | Mean Brain Response in R inferior parietal lobule | Mean Brain Response in L inferior parietal lobule | Mean Brain Response in bilateral supplementary motor |
---|
fMRI During Opioid Use | 0.37 | 0.42 | 0.54 | 0.35 |
,fMRI During Withdrawal | 0.35 | 0.33 | 0.47 | 0.34 |
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Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection on Day 8
Demonstrated by mild opioid withdrawal symptoms (Clinical Opiate Withdrawal Scale [COWS] =12 or Subjective Opiate Withdrawal Scale [SOWS] =10) following VIVITROL administration. The COWS is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal). The SOWS is a 16-item self-report questionnaire designed to measure the severity of opioid withdrawal symptoms. The subject rates the intensity of symptoms using a 5-point scale. The range of SOWS scores is 1-10 (mild); 11-20 (moderate); and 21-30 (severe). (NCT02696434)
Timeframe: 8 days
Intervention | Participants (Count of Participants) |
---|
NTX + BUP | 35 |
PBO NTX + BUP | 38 |
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Proportion of Post-VIVITROL Days (Days 9-11) in Which Subjects in Each Group Demonstrate Mild Opioid Withdrawal
COWS score =12; The Clinical Opiate Withdrawal Scale (COWS) is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal). (NCT02696434)
Timeframe: Days 9-11
Intervention | Days (Mean) |
---|
NTX + BUP | 2.4 |
PBO NTX + BUP | 2.6 |
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Mean Peak COWS Scores During the Treatment Period (Days 1/1a-7)
The Clinical Opiate Withdrawal Scale (COWS) is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal). (NCT02696434)
Timeframe: Up to 7 days
Intervention | score on a scale (Mean) |
---|
NTX + BUP | 6.0 |
PBO NTX + BUP | 5.0 |
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Incidence of Adverse Events (AEs)
Number and percentage of subjects who experienced AEs. (NCT02696434)
Timeframe: Up to 42 days
Intervention | Participants (Count of Participants) |
---|
NTX + BUP | 38 |
PBO NTX + BUP | 37 |
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Area Under the Curve (AUC) for COWS Scores During the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation Period
The Clinical Opiate Withdrawal Scale (COWS) is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal). The daily AUC COWS score is derived based on the actual time (unit in minutes) COWS administered on each day by using the linear trapezoidal rule, and then divided by the COWS administration duration (last COWS administration time minus first COWS administration time) for that day. The normalized AUC COWS score is the summation of daily AUC COWS score during the relevant period divided by the number of days with daily AUC COWS score. (NCT02696434)
Timeframe: The COWS was administered 4-6 times per day during the Treatment Period
Intervention | score on a scale (Mean) |
---|
NTX + BUP | 4.5 |
PBO NTX + BUP | 3.9 |
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"Mean Score for Desire for Opioids Visual Analog Scale (VAS) During the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation Period"
"The Desire for Opioids VAS uses a 100-mm, horizontal linear scale, with 0 anchored on the left representing no desire for opioids and 100 anchored on the right representing strongest imaginable desire for opioids." (NCT02696434)
Timeframe: Up to 11 days
Intervention | score on a scale (Mean) |
---|
NTX + BUP | 6.3 |
PBO NTX + BUP | 8.3 |
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Proportion of Days With COWS Peak Score =12 During the Treatment Period Prior to the VIVITROL Injection
The Clinical Opiate Withdrawal Scale (COWS) is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal). (NCT02696434)
Timeframe: 1 week
Intervention | Days (Mean) |
---|
NTX + BUP | 5.8 |
PBO NTX + BUP | 6.3 |
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Maximum Steady State Concentration-Norbuprenorphine
Maximum steady state concentration-Norbuprenorphine-Pharmacokinetic (PK) Population (NCT02710526)
Timeframe: PK samples at pre-dose, 0.5, 1, 2, 4, 6,10 hrs and approx. 24, 48, 72, 96, 120, 168, 240, 336, 504 and 672 hrs after CAM2038 q4w Dose 4 and pre-dose (within 45 mins), 10, 20, 30 and 40 mins, and 1, 1.5, 2, 3, 4, 6, 10, and 24 hrs after SL BPN dose 7
Intervention | ng/mL (Geometric Mean) |
---|
128 mg CAM2038 Monthly Injection | 2.14 |
160 mg CAM2038 Monthly Injection | 4.61 |
24 mg SL BPN | 7.92 |
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Norbuprenorphine/Buprenorphine Ratios at Maximum Concentration at Steady State
Norbuprenorphine/buprenorphine ratios at maximum concentration at steady state Evaluable Pharmacokinetic (PKEVAL) Population (NCT02710526)
Timeframe: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
Intervention | ratio (Geometric Mean) |
---|
32 mg CAM2038 Weekly-Buttock | 0.305 |
32 mg CAM2038 Weekly-Abdomen | 0.307 |
32 mg CAM2038 Weekly-Thigh | 0.366 |
32 mg CAM2038 Weekly-Upper Arm | 0.366 |
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Norbuprenorphine/Buprenorphine Ratios for Area Under the Curve at Steady State
Norbuprenorphine/buprenorphine ratios for Area Under the Curve at steady state Evaluable Pharmacokinetic (PKEVAL) Population (NCT02710526)
Timeframe: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
Intervention | ratio (Geometric Mean) |
---|
32 mg CAM2038 Weekly-Buttock | 0.354 |
32 mg CAM2038 Weekly-Abdomen | 0.341 |
32 mg CAM2038 Weekly-Thigh | 0.355 |
32 mg CAM2038 Weekly-Upper Arm | 0.370 |
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Time to Maximum Concentration at Steady State-Buprenorphine
Time to maximum concentration at steady state-Buprenorphine Pharmacokinetic (PK) Population (NCT02710526)
Timeframe: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4
Intervention | h (Median) |
---|
128 mg CAM2038 Monthly Injection | 10.0 |
160 mg CAM2038 Monthly Injection | 24.0 |
24 mg SL BPN | 1.69 |
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Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site
Tss,max (time to maximum concentration at steady state) for each injection site-buprenorphine (NCT02710526)
Timeframe: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
Intervention | h (Median) |
---|
32 mg CAM2038 Weekly-Buttock | 24.0 |
32 mg CAM2038 Weekly-Abdomen | 24.0 |
32 mg CAM2038 Weekly-Thigh | 24.0 |
32 mg CAM2038 Weekly-Upper Arm | 24.0 |
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Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site
Tss,max (time to maximum concentration at steady state) for each injection site-Norbuprenorphine-Evaluable Pharmacokinetic (PKEVAL) Population (NCT02710526)
Timeframe: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
Intervention | h (Median) |
---|
32 mg CAM2038 Weekly-Buttock | 72.0 |
32 mg CAM2038 Weekly-Abdomen | 72.0 |
32 mg CAM2038 Weekly-Thigh | 72.0 |
32 mg CAM2038 Weekly-Upper Arm | 30.0 |
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Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038
Number of Participants with Adverse Events for Both weekly and monthly CAM2038-Safety Population (NCT02710526)
Timeframe: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3
Intervention | participants (Number) |
---|
| Subjects with TEAEs | Subjects with Serious TEAEs | Subjects with suspected to be drug-related TEAEs | Subjects with AEs that resulted in death | Subjects with at least 1 AE | Subjects with mild grade AEs | Subjects with moderate grade AEs | Subjects with severe grade AEs | Subjects with at least 1 injection site TEAE | Subjects with mild grade injection site AEs | Subjects with moderate grade injection site AEs | Subjects with severe grade injection site AEs | Subjects with at least 1 non-injection site AE | Subject with mild grade non-injection site AEs | Subject with moderate grade non-injection site AEs | Subjects with severe grade non-injection site AEs | Subjects with TEAEs that led to drug withdrawn |
---|
128 mg CAM2038 Monthly Injection | 10 | 0 | 3 | 0 | 10 | 4 | 5 | 1 | 1 | 0 | 1 | 0 | 10 | 4 | 5 | 1 | 0 |
,160 mg CAM2038 Monthly Injection | 9 | 0 | 2 | 0 | 9 | 4 | 5 | 0 | 0 | 0 | 0 | 0 | 9 | 4 | 5 | 0 | 0 |
,32 mg CAM2038 Weekly | 14 | 0 | 4 | 0 | 14 | 3 | 11 | 0 | 3 | 0 | 3 | 0 | 13 | 3 | 10 | 0 | 0 |
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Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Number of Participants with confirmed Opiate Independence as confirmed by Negative Urine Toxicology Tests-ITT Population (NCT02710526)
Timeframe: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3
Intervention | Participants (Count of Participants) |
---|
| Baseline | Day 1 | Day 2 | Day 8 | Day 15 | Day 22 | Day 29 | Day 31 | Day 36 | Day 43 | Day 50 | Day 57 | Day 59 | Day 64 | Day 71 | Day 78 | Day 85 | Day 86 | Day 87 | Day 88 | Day 89 | Day 90 | Day 92 | Day 95 | Day 99 | Day 106 | Day 113 | Day 134 | Day 155 |
---|
128 mg CAM2038 Monthly Injection | 12 | 11 | 12 | 12 | 10 | 9 | 9 | 8 | 9 | 10 | 8 | 10 | 9 | 10 | 9 | 9 | 10 | 9 | 9 | 9 | 9 | 8 | 9 | 8 | 10 | 8 | 11 | 5 | 7 |
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Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Number of Participants with confirmed Opiate Independence as confirmed by Negative Urine Toxicology Tests-ITT Population (NCT02710526)
Timeframe: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3
Intervention | Participants (Count of Participants) |
---|
| Baseline | Day 1 | Day 2 | Day 8 | Day 15 | Day 22 | Day 23 | Day 24 | Day 25 | Day 26 | Day 27 | Day 29 | Day 30 | Day 31 | Day 32 | Day 33 | Day 34 | Day 36 | Day 37 | Day 38 | Day 39 | Day 40 | Day 41 | Day 43 | Day 44 | Day 45 | Day 46 | Day 47 | Day 48 | Day 50 | Day 71 | Day 92 |
---|
32 mg CAM2038 Weekly | 16 | 13 | 14 | 13 | 11 | 12 | 14 | 14 | 13 | 13 | 15 | 12 | 9 | 11 | 12 | 10 | 10 | 11 | 10 | 11 | 10 | 10 | 9 | 10 | 9 | 9 | 9 | 9 | 9 | 8 | 7 | 6 |
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Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Number of Participants with confirmed Opiate Independence as confirmed by Negative Urine Toxicology Tests-ITT Population (NCT02710526)
Timeframe: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3
Intervention | Participants (Count of Participants) |
---|
| Baseline | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | Day 7 | Day 8 | Day 9 | Day 15 | Day 22 | Day 29 | Day 36 | Day 38 | Day 43 | Day 50 | Day 57 | Day 64 | Day 66 | Day 71 | Day 78 | Day 85 | Day 92 | Day 93 | Day 94 | Day 95 | Day 96 | Day 97 | Day 99 | Day 102 | Day 106 | Day 113 | Day 120 |
---|
160 mg CAM2038 Monthly Injection | 14 | 13 | 15 | 15 | 13 | 13 | 15 | 15 | 11 | 14 | 12 | 9 | 10 | 13 | 11 | 14 | 8 | 13 | 12 | 12 | 10 | 12 | 13 | 9 | 9 | 9 | 9 | 9 | 10 | 9 | 7 | 9 | 8 | 12 |
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Subject-rated Worst Daily Pain
Subject-rated worst daily pain, using an 11-point numerical rating scale (NRS) for pain, following repeated subcutaneous administration of CAM2038 weekly and CAM2038 monthly in adult opioid-dependent subjects-Safety Population. 11 point scale ranging from 0-10, with 0 being the least amount of pain to 10 being the worst pain imaginable. (NCT02710526)
Timeframe: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3
Intervention | score on a scale (Mean) |
---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 |
---|
32 mg CAM2038 Weekly | 7.6 | 5.8 | 5.4 | 5.3 | 4.6 | 4.8 | 4.7 | 4.3 | 5.2 | 5.3 | 4.9 | 5.2 | 5.2 | 5.1 | 6.4 |
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Subject-rated Worst Daily Pain
Subject-rated worst daily pain, using an 11-point numerical rating scale (NRS) for pain, following repeated subcutaneous administration of CAM2038 weekly and CAM2038 monthly in adult opioid-dependent subjects-Safety Population. 11 point scale ranging from 0-10, with 0 being the least amount of pain to 10 being the worst pain imaginable. (NCT02710526)
Timeframe: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3
Intervention | score on a scale (Mean) |
---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 | Week 15 | Week 16 | Week 17 |
---|
160 mg CAM2038 Monthly Injection | 6.1 | 5.6 | 5.4 | 5.4 | 5.6 | 5.3 | 5.2 | 5.8 | 6.1 | 4.9 | 5.2 | 5.3 | 5.9 | 4.4 | 5.1 | 5.5 | 5.8 | 4.3 |
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Subject-rated Worst Daily Pain
Subject-rated worst daily pain, using an 11-point numerical rating scale (NRS) for pain, following repeated subcutaneous administration of CAM2038 weekly and CAM2038 monthly in adult opioid-dependent subjects-Safety Population. 11 point scale ranging from 0-10, with 0 being the least amount of pain to 10 being the worst pain imaginable. (NCT02710526)
Timeframe: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3
Intervention | score on a scale (Mean) |
---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 | Week 15 | Week 16 | Week 17 | Week 18 | Week 19 | Week 20 | Week 21 | Week 22 | Week 23 |
---|
128 mg CAM2038 Monthly Injection | 8.3 | 4.9 | 5.2 | 5.3 | 5.5 | 4.2 | 4.6 | 4.9 | 5.5 | 5.2 | 4.8 | 4.5 | 5.2 | 4.4 | 4.6 | 4.5 | 5.5 | 5.9 | 5.7 | 5.8 | 6.3 | 6.1 | 5.8 | 8.0 |
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Summary of Average Daily Pain by Week (ITT Population)
Summary of Average Daily Pain, using an 11-point Numerical Rating Scale (NRS) for pain, following repeated subcutaneous administration of CAM2038 weekly and CAM2038 monthly in adult opioid-dependent subjects. 11 point scale ranging from 0-10, with 0 being the least amount of pain to 10 being the worst pain imaginable. (ITT Population) (NCT02710526)
Timeframe: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3
Intervention | score on a scale (Mean) |
---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 |
---|
32 mg CAM2038 Weekly | 5.7 | 4.4 | 4.0 | 3.9 | 3.2 | 3.3 | 3.2 | 3.0 | 3.5 | 3.7 | 3.3 | 3.9 | 3.6 | 3.9 | 6.0 |
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Summary of Average Daily Pain by Week (ITT Population)
Summary of Average Daily Pain, using an 11-point Numerical Rating Scale (NRS) for pain, following repeated subcutaneous administration of CAM2038 weekly and CAM2038 monthly in adult opioid-dependent subjects. 11 point scale ranging from 0-10, with 0 being the least amount of pain to 10 being the worst pain imaginable. (ITT Population) (NCT02710526)
Timeframe: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3
Intervention | score on a scale (Mean) |
---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 | Week 15 | Week 16 | Week 17 |
---|
160 mg CAM2038 Monthly Injection | 5.0 | 4.5 | 4.1 | 4.5 | 4.4 | 4.0 | 3.7 | 4.3 | 4.8 | 3.7 | 4.1 | 4.1 | 4.4 | 3.1 | 3.8 | 4.1 | 4.5 | 4.3 |
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Summary of Average Daily Pain by Week (ITT Population)
Summary of Average Daily Pain, using an 11-point Numerical Rating Scale (NRS) for pain, following repeated subcutaneous administration of CAM2038 weekly and CAM2038 monthly in adult opioid-dependent subjects. 11 point scale ranging from 0-10, with 0 being the least amount of pain to 10 being the worst pain imaginable. (ITT Population) (NCT02710526)
Timeframe: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3
Intervention | score on a scale (Mean) |
---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 | Week 15 | Week 16 | Week 17 | Week 18 | Week 19 | Week 20 | Week 21 | Week 22 | Week 23 |
---|
128 mg CAM2038 Monthly Injection | 6.7 | 3.4 | 3.7 | 4.0 | 3.9 | 3.0 | 3.2 | 3.7 | 3.9 | 3.5 | 3.3 | 3.0 | 3.6 | 2.8 | 3.2 | 3.2 | 3.9 | 4.1 | 3.9 | 4.2 | 4.4 | 4.3 | 4.2 | 6.0 |
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Time to Maximum Concentration at Steady State-Norbuprenorphine
Time to maximum concentration at steady state-Norbuprenorphine-Pharmacokinetic (PK) Population (NCT02710526)
Timeframe: PK samples at pre-dose, 0.5, 1, 2, 4, 6,10 hrs and approx. 24, 48, 72, 96, 120, 168, 240, 336, 504 and 672 hrs after CAM2038 q4w Dose 4 and pre-dose (within 45 mins), 10, 20, 30 and 40 mins, and 1, 1.5, 2, 3, 4, 6, 10, and 24 hrs after SL BPN dose 7
Intervention | h (Median) |
---|
128 mg CAM2038 Monthly Injection | 84.1 |
160 mg CAM2038 Monthly Injection | 121 |
24 mg SL BPN | 1.78 |
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Area Under the Curve at Steady State (AUC During a 28-day Dosing Interval at Steady State)-Buprenorphine
Area Under the Curve at steady state (AUC during a 28-day dosing interval at steady state)-Buprenorphine for Pharmacokinetic Population (NCT02710526)
Timeframe: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4
Intervention | ng*h/mL (Geometric Mean) |
---|
128 mg CAM2038 Monthly Injection | 2610 |
160 mg CAM2038 Monthly Injection | 3540 |
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Area Under the Curve at Steady State (AUC During a 28-day Dosing Interval at Steady State)-Norepinephrine
Area Under the Curve at steady state (AUC during a 28-day dosing interval at steady state)-Norepinephrine-Pharmacokinetic (PK) Population (NCT02710526)
Timeframe: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4
Intervention | ng*h/mL (Geometric Mean) |
---|
128 mg CAM2038 Monthly Injection | 795 |
160 mg CAM2038 Monthly Injection | 1590 |
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AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm for the Evaluable Pharmacokinetic (PKEVAL) Population
AUCss (area under the plasma concentration-time curve during a 7-day dosing interval at steady state) for each injection site, i.e., buttock (reference), abdomen, thigh and back of upper arm-Buprenorphine for the Evaluable Pharmacokinetic (PKEVAL) Population (NCT02710526)
Timeframe: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
Intervention | ng*h/mL (Geometric Mean) |
---|
32 mg CAM2038 Weekly-Buttock | 700 |
32 mg CAM2038 Weekly-Abdomen | 657 |
32 mg CAM2038 Weekly-Thigh | 613 |
32 mg CAM2038 Weekly-Upper Arm | 591 |
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AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm.
AUCss (area under the plasma concentration-time curve during a 7-day dosing interval at steady state) for each injection site, i.e., buttock (reference), abdomen, thigh and back of upper arm-Norbuprenorphine Evaluable Pharmacokinetic (PKEVAL) Population (NCT02710526)
Timeframe: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
Intervention | ng*h/mL (Geometric Mean) |
---|
32 mg CAM2038 Weekly-Buttock | 204 |
32 mg CAM2038 Weekly-Abdomen | 192 |
32 mg CAM2038 Weekly-Thigh | 208 |
32 mg CAM2038 Weekly-Upper Arm | 197 |
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Average Steady State Concentration-Buprenorphine
Average steady state concentration-Buprenorphine-Pharmacokinetic Population (NCT02710526)
Timeframe: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4
Intervention | ng/mL (Geometric Mean) |
---|
128 mg CAM2038 Monthly Injection | 3.89 |
160 mg CAM2038 Monthly Injection | 5.27 |
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Average Steady State Concentration-Norbuprenorphine
Average steady state concentration-Norbuprenorphine-Pharmacokinetic (PK) Population (NCT02710526)
Timeframe: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4
Intervention | ng/mL (Geometric Mean) |
---|
128 mg CAM2038 Monthly Injection | 1.18 |
160 mg CAM2038 Monthly Injection | 2.37 |
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Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site
Css,av (average plasma concentration during a dosing interval at steady state) for each injection site-Norbuprenorphine-Evaluable Pharmacokinetic (PKEVAL) Population (NCT02710526)
Timeframe: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
Intervention | ng/mL (Geometric Mean) |
---|
32 mg CAM2038 Weekly-Buttock | 1.22 |
32 mg CAM2038 Weekly-Abdomen | 1.15 |
32 mg CAM2038 Weekly-Thigh | 1.24 |
32 mg CAM2038 Weekly-Upper Arm | 1.17 |
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Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site for the Evaluable Pharmacokinetic (PKEVAL) Population
Css,av (average plasma concentration during a dosing interval at steady state) for each injection site-Buprenorphine for the Evaluable Pharmacokinetic (PKEVAL) Population (NCT02710526)
Timeframe: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
Intervention | ng/mL (Geometric Mean) |
---|
32 mg CAM2038 Weekly-Buttock | 4.17 |
32 mg CAM2038 Weekly-Abdomen | 3.91 |
32 mg CAM2038 Weekly-Thigh | 3.65 |
32 mg CAM2038 Weekly-Upper Arm | 3.52 |
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Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site.
Css,max (maximum observed plasma concentration during a dosing interval at steady state) for each injection site-Buprenorphine (NCT02710526)
Timeframe: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
Intervention | ng/mL (Geometric Mean) |
---|
32 mg CAM2038 Weekly-Buttock | 6.87 |
32 mg CAM2038 Weekly-Abdomen | 6.56 |
32 mg CAM2038 Weekly-Thigh | 5.37 |
32 mg CAM2038 Weekly-Upper Arm | 5.69 |
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Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site.
Css,max (maximum observed plasma concentration during a dosing interval at steady state) for each injection site-Norbuprenorphine-Evaluable Pharmacokinetic (PKEVAL) Population (NCT02710526)
Timeframe: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
Intervention | ng/mL (Geometric Mean) |
---|
32 mg CAM2038 Weekly-Buttock | 1.85 |
32 mg CAM2038 Weekly-Abdomen | 1.78 |
32 mg CAM2038 Weekly-Thigh | 1.74 |
32 mg CAM2038 Weekly-Upper Arm | 1.84 |
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Maximum Steady State Concentration-Buprenorphine
Maximum steady state concentration-BuprenorphinePharmacokinetic (PK) Population (NCT02710526)
Timeframe: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4
Intervention | ng/mL (Geometric Mean) |
---|
128 mg CAM2038 Monthly Injection | 11.1 |
160 mg CAM2038 Monthly Injection | 15.4 |
24 mg SL BPN | 11.1 |
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Number of Participants Who Achieve Opioid Cessation
For Phase II, the primary outcome measure will be number of participants opioid who achieve cessation 8 weeks after stabilization at Week 10, evidenced as a score of 3 points when summing the following measures: self-report of no opioid use = 1 point; prescription drug monitoring data showing no opioid prescriptions filled in past 30 days = 1 point; and confirmatory negative urine toxicology for a full panel of opioids = 1 point. (NCT02737826)
Timeframe: 8 weeks after stabilization at Week 10
Intervention | Participants (Count of Participants) |
---|
Phase II - Gabapentin + Buprenorphine Taper | 1 |
Phase II - Placebo + Buprenorphine Taper | 0 |
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Number of Participants Who Achieved Opioid Cessation Post-taper - 3 Months
Opioid cessation is evidenced as a score of 3 points when summing the following measures: self-report of no opioid use = 1 point; prescription drug monitoring data showing no opioid prescriptions filled in past 30 days = 1 point; and confirmatory negative urine toxicology for a full panel of opioids = 1 point. (NCT02737826)
Timeframe: Post-taper - 3 months
Intervention | Participants (Count of Participants) |
---|
Gabapentin + Buprenorphine Taper - Opioid Cessation 3 Months Post-taper | 1 |
Placebo + Buprenorphine Taper - Opioid Cessation 3 Months Post-taper | 0 |
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Number of Participants Who Achieved Opioid Cessation Post-taper - 6 Months
Opioid cessation is evidenced as a score of 3 points when summing the following measures: self-report of no opioid use = 1 point; prescription drug monitoring data showing no opioid prescriptions filled in past 30 days = 1 point; and confirmatory negative urine toxicology for a full panel of opioids = 1 point. (NCT02737826)
Timeframe: Post-taper - 6 months
Intervention | Participants (Count of Participants) |
---|
Gabapentin + Buprenorphine Taper - Opioid Cessation 6 Months Post-taper | 1 |
Placebo + Buprenorphine Taper - Opioid Cessation 6 Months Post-taper | 0 |
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Number of Participants Who Achieved Opioid Cessation Post-taper - 12 Months
Opioid cessation is evidenced as a score of 3 points when summing the following measures: self-report of no opioid use = 1 point; prescription drug monitoring data showing no opioid prescriptions filled in past 30 days = 1 point; and confirmatory negative urine toxicology for a full panel of opioids = 1 point. (NCT02737826)
Timeframe: Post-taper - 12 months
Intervention | Participants (Count of Participants) |
---|
Gabapentin + Buprenorphine Taper - Opioid Cessation 12 Months Post-taper | 1 |
Placebo + Buprenorphine Taper - Opioid Cessation 12 Months Post-taper | 0 |
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Percentage of Patients Who Tolerate Buprenorphine Initiation
"For Phase I, the primary outcome measure is the percentage of patients who tolerate buprenorphine initiation within an 8-hour initiation period, as evidenced by a total score of 3 points when summing the following measures (1) moderate-good level of pain control (same or improved rating on a 0-10 visual analogue scale for pain) = 1 point, (2) mild to no withdrawal symptoms (≤10 on the Subjective Opioid Withdrawal Scale) = 1 point, and (3) willingness to continue to the stabilization and tapering phase of the study; yes = 1 point." (NCT02737826)
Timeframe: 8 hours post dose
Intervention | Participants (Count of Participants) |
---|
Phase I - Buprenorphine Initiation | 27 |
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Pain Self-report: Pain Catastrophizing Scale - Baseline
The Self Reporting Pain Catastrophizing scale consists of 13 items scored from 0 to 4. The total possible score is 52. A higher score indicates more catastrophizing thoughts are present. A lower score indicates less catastrophizing thoughts. (NCT02737826)
Timeframe: Baseline
Intervention | units on a scale (Mean) |
---|
Gabapentin + Buprenorphine Taper | 21.9 |
Placebo + Buprenorphine Taper | 21.2 |
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Mean Score Pittsburgh Sleep Quality Index
The PSQI is a 19 item self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components (time gone to bed, how long it takes to go to sleep, wake up time, hours slept, issues sleeping, total hours slept etc.) that produce one global score. Each item is weighted on a 0-3 interval scale. The global score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, A lower scale is indicative of better sleep quality and higher score represents poor sleep quality. (NCT02737826)
Timeframe: baseline
Intervention | units on a scale (Mean) |
---|
Gabapentin + Buprenorphine Taper | 12.5 |
Placebo + Buprenorphine Taper | 10.6 |
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Number of Participants Who Achieve Opioid Cessation Post-taper: 1 Month
Opioid cessation post taper: 1 month with opioid cessation measured through self-report, prescription drug monitoring data, and confirmatory UDS for a full panel of opioids. (NCT02737826)
Timeframe: 1 month post-taper
Intervention | Participants (Count of Participants) |
---|
Gabapentin + Buprenorphine Taper - Opioid Cessation 1 Month Post-taper | 0 |
Placebo + Buprenorphine Taper - Opioid Cessation 1 Month Post-taper | 0 |
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Pain Laboratory Testing: Mechanical - Baseline
Mechanical (Pressure) Pain Threshold Assessment (PPTh): A digital anesthesiometer (IITC Life Sciences ElectroVonFrey) will be used to assess mechanical pain perception. Pain threshold to static mechanical stimuli will be determined by applying the rigid monofilament to the dorsum of each subject's right hand with increasing pressure (10 grams per second) until the participant indicates verbally that the pain threshold has been reached. (NCT02737826)
Timeframe: Baseline
Intervention | grams per second (Mean) |
---|
Gabapentin + Buprenorphine Taper | 284.2 |
Placebo + Buprenorphine Taper | 289.1 |
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Pain Laboratory Measures - Descending Noxious Inhibitory Control (DNIC) - Average, Baseline
DNIC will be measured as the percent change in PPTh during the cold pressor tasks relative to baseline. A percent increase represents normal functioning of pain inhibitory processes. (NCT02737826)
Timeframe: Baseline
Intervention | percentage of change (Mean) |
---|
Gabapentin + Buprenorphine Taper | 312.5 |
Placebo + Buprenorphine Taper | 326.4 |
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Mean Score of Subjective Opioid Withdrawal Scale (SOWS)
The Subjective Opiate Withdrawal Scale (SOWS) consist of 16 symptoms rated in intensity by patients on a 5-point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. The total score is a sum of item ratings, and ranges from 0 to 64. (NCT02737826)
Timeframe: baseline
Intervention | units on a scale (Mean) |
---|
Gabapentin + Buprenorphine Taper | 17.3 |
Placebo + Buprenorphine Taper | 11.9 |
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Mean Score of Current Opioid Measure (COMM)
COMM is a 17 item questionnaire that is used to examine concurrent misuse. The score range is from 0-28. A lower score represents participant showing less aberrant behaviors associates with misuse of option medications, and a higher score represents more aberrant behaviors associated with opioid medical misuse. (NCT02737826)
Timeframe: Baseline
Intervention | units on a scale (Mean) |
---|
Gabapentin + Buprenorphine Taper | 16 |
Placebo + Buprenorphine Taper | 15 |
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Quality of Recovery 15 Item Scale (QoR-15) Total Score
Quality of Recovery 15 Item Scale, total score 0-150, 150 reflecting a perfect score and better recovery. (NCT02891798)
Timeframe: Day after surgery (7AM-9AM EST)
Intervention | score on a scale (Mean) |
---|
Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone) | 106.08 |
Bupivacaine Only (Control Arm) | 90.13 |
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Quality of Recovery 15 Item Scale (QoR-15) Total Score
Quality of Recovery 15 Item Scale, total score 0-150, 150 reflecting a perfect score and better recovery. (NCT02891798)
Timeframe: 6 weeks post-operation
Intervention | score on a scale (Mean) |
---|
Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone) | 128.89 |
Bupivacaine Only (Control Arm) | 130.06 |
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SF-MPQ2 Intermittent Pain Subscore Difference From Baseline
Intermittent pain subscore difference of Post-Operative Day 1 value minus the Baseline value. Differences can range from -10 to +10. Negative scores indicate a decrease in pain. (NCT02891798)
Timeframe: Baseline, Post-Operative day after surgery (7AM-9AM EST)
Intervention | units on a scale (Mean) |
---|
Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone) | -2.79 |
Bupivacaine Only (Control Arm) | -1.14 |
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SF-MPQ2 Continuous Pain Subscore Difference From Baseline
Continuous pain subscore difference of Post-Operative Day 1 value minus the Baseline value. Differences can range from -10 to +10. Negative scores indicate a decrease in pain. (NCT02891798)
Timeframe: Baseline, Post-Operative day after surgery (7AM-9AM EST)
Intervention | units on a scale (Mean) |
---|
Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone) | -2.29 |
Bupivacaine Only (Control Arm) | 0.33 |
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Percentage Change From Baseline to Week 25 in Vital Signs
"Vital signs include:~systolic blood pressure (mmHg)~diastolic blood pressure (mmHg)~respiratory rate (breaths/minute)~pulse oximetry (%)~pulse rate (beats/min)~temperature (C)" (NCT02896296)
Timeframe: Day 1, Week 25
Intervention | percentage change from baseline (Mean) |
---|
| Systolic blood pressure | Diastolic blood pressure | Pulse oximetry | Pulse rate | Respiratory rate | Temperature |
---|
RBP-6000 (100/300 mg Flex) | 1.93 | 2.61 | 0.13 | 6.04 | 0.67 | 0.02 |
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Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period
TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical or surgical intervention to prevent one of the outcomes listed in this definition. (NCT02896296)
Timeframe: Day 1 up to Week 29
Intervention | Participants (Count of Participants) |
---|
| >=1 TEAE | >=1 TEAE related to study drug | >=1 serious TEAE | >=1 serious study treatment-related TEAE | Death | >=1 severe TEAE | TEAE leading to study treatment discontinuation |
---|
RBP-6000 (100/300 mg Flex) | 71 | 14 | 5 | 0 | 0 | 8 | 1 |
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Participants With Treatment-emergent Adverse Events (TEAEs) Pertaining to Laboratory Test Values
TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. The number of participants with TEAEs specific to laboratory tests are summarized. (NCT02896296)
Timeframe: Day 1 up to Week 25
Intervention | Participants (Count of Participants) |
---|
| Aspartate aminotransferase increased | Alanine aminotransferase increased | Blood cholesterol increased | Diabetes mellitus | Hepatic enzyme increased | Liver function test increased |
---|
RBP-6000 (100/300 mg Flex) | 1 | 1 | 1 | 1 | 1 | 1 |
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Summary of Change From Baseline in EuroQoL Group EQ-5D-5L Scores Over Time-Open Label Phase
Change from Open Label Titration baseline in EuroQol Group 5-dimension 5-level self-report questionnaire score in the Open Label Phase. The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) descriptive system is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows subjects to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood, using a 5-level scale. These combinations of attributes were converted into a weighted health-state index score, according to the US population-based algorithm, with higher scores indicating better quality of life. The score ranges from 0-100 with 0 as the worst health and 100 as the best health. (NCT02946073)
Timeframe: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).
Intervention | score on a scale (Mean) |
---|
| Baseline | Change from Baseline at End of Treatment Visit |
---|
CAM2038 | 83.38 | 9.95 |
,De Novo | 76.59 | 5.17 |
,Rollover Placebo Injections | 79.65 | 6.35 |
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Summary of Rescue Medication Usage-Open Label Phase
Rescue medication usage (number of days used) during the Open Label Phase. (NCT02946073)
Timeframe: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).
Intervention | Days (Mean) |
---|
| Baseline | Change from Baseline to Week 4 | Change from Baseline to Week 8 | Change from Baseline to Week 12 | Change from Baseline to Week 16 | Change from Baseline to Week 20 | Change from Baseline to Week 24 | Change from Baseline to Week 28 | Change from Baseline to Week 32 | Change from Baseline to Week 36 | Change from Baseline to Week 40 | Change from Baseline to Week 44 | Change from Baseline to Week 48 |
---|
CAM2038 | 0.352 | -0.793 | -0.671 | -1.180 | -0.418 | -0.745 | -0.959 | -0.553 | -0.577 | -0.359 | -0.980 | -0.767 | -0.929 |
,De Novo | 1.172 | -0.744 | -0.301 | -0.472 | -0.679 | -0.562 | -0.689 | -1.045 | -0.864 | -0.989 | -0.941 | -1.050 | -1.088 |
,Rollover Placebo Injections | 1.330 | -1.124 | -1.672 | -1.817 | -0.990 | -0.490 | -0.933 | -0.875 | -1.280 | -1.479 | -1.339 | -1.465 | -2.302 |
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Number of Subjects Discontinued Due to Loss of Efficacy
Number of Subjects Discontinued due to loss of efficacy, defined as discontinuation of study drug for lack of efficacy. (NCT02946073)
Timeframe: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).
Intervention | Participants (Count of Participants) |
---|
De Novo | 1 |
CAM2038 | 0 |
Rollover Placebo Injections | 1 |
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Subject Discontinued Due to Loss of Efficacy, Defined as Discontinuation of Study Drug for Lack of Efficacy.
Subject Discontinued Due to Loss of Efficacy, Defined as Discontinuation of Study Drug for Lack of Efficacy Open Label Phase. (NCT02946073)
Timeframe: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).
Intervention | Participants (Count of Participants) |
---|
De Novo | 1 |
CAM2038 | 0 |
Rollover Placebo Injections | 1 |
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Change From Baseline in the Weekly Average of (Daily) Worst Pain Intensity Scores at Week 12 of the Double-Blind Phase Based on 11-Point Numerical Rating Scale With 10 Being the Worst Pain.
Change from baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) and the primary timepoint will be Week 12 of the Double-Blind Phase based on the 11-Point numerical rating scale with 0 being no pain and 10 being the worst pain. (NCT02946073)
Timeframe: 12 weeks- from randomization baseline to 12 weeks after randomization
Intervention | score on a scale (Mean) |
---|
| Baseline | Change from Baseline to Week 12 |
---|
CAM2038 | 3.8 | -1.1 |
,Placebo | 3.7 | -2.2 |
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Change From Baseline to Week 12 of the Double-Blind Phase in Patient Global Impression of Improvement (PGI-I) Scale
Change from baseline to Week 12 of the Double-Blind Phase in Patient global Impression of Improvement (PGI-I) Scale. PGI-I)Scale is a single question 7-point likert scale that required the subject to assess how much his/her pain had improved or worsened relative to the start of the study at the beginning of the intervention . Ratings were: 1, much worse; 2, worse; 3, a little worse; 4, no change; 5, a little better; 6, better; or 7, much better (NCT02946073)
Timeframe: 12 weeks- from baseline (randomization) to 12 weeks after randomization
Intervention | units on a scale (Mean) |
---|
| Baseline | Change from Baseline to Week 12 |
---|
CAM2038 | 6.0 | 0.4 |
,Placebo | 6.2 | 1.5 |
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Change From Baseline to Week 12 of the Double-Blind Phase in Work Productivity and Activity Impairment Score
Change from baseline to Week 12 of the Double-Blind Phase in Work Productivity and Activity Impairment score. The Work Productivity and Activity Impairment (WPAI) is a self-administered instrument used to measure the effect of general health and symptom severity on work productivity and regular activities, and yields 4 types of scores (higher scores indicate greater impairment): Absenteeism (work time missed),Presenteeism (impairment at work/reduced on-the-job effectiveness), Work Productivity Loss (overall work impairment/absenteeism plus presenteeism),and Activity Impairment. Scores range from 0-100 for each of the four types with higher scores indicating greater impairment. (NCT02946073)
Timeframe: 23 weeks- from baseline to 12 weeks after randomization
Intervention | score on a scale (Mean) |
---|
| Baseline-Activity Impairment | Change from Baseline to Week 12 after randomization-Activity impairment | Baseline-Absenteesim | Change from Baseline to Week 12 after randomization-Absenteesim | Baseline-Presenteeism | Change from Baseline to Week 12 after randomization-Presenteeism | Baseline-Work Productivity Loss | Change from Baseline to Week 12 after randomization- Work Productivity Loss |
---|
CAM2038 | 58.8 | 18.1 | 5.1 | -0.8 | 38.9 | 5.0 | 41.3 | 5.4 |
,Placebo | 61.2 | 11.7 | 9.9 | -4.6 | 47.8 | 9.0 | 52.3 | 7.8 |
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Change From Open Label Titration Baseline to Week 12 of the Double-Blind Phase in EuroQol Group 5-dimension 5-level Self-report Questionnaire Score.
Change from Open Label Titration baseline to Week 12 of the Double-Blind Phase in EuroQol Group 5-dimension 5-level self-report questionnaire score. The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) descriptive system is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows subjects to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood, using a 5-level scale. These combinations of attributes were converted into a weighted health-state index score, according to the US population-based algorithm, with higher scores indicating better quality of life. The score ranges from 0-100 with 0 as the worst health and 100 as the best health. (NCT02946073)
Timeframe: 12 weeks- from randomization baseline to 12 weeks after randomization
Intervention | units on a scale (Mean) |
---|
| Titration Baseline | Change from Baseline to Week 12 |
---|
CAM2038 | 63.7 | -9.4 |
,Placebo | 61.3 | -7.2 |
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Number of Subjects Discontinued Due to Loss of Efficacy
Number of Subjects Discontinued due to loss of efficacy, defined as discontinuation of study drug for lack of efficacy. (NCT02946073)
Timeframe: 12 weeks- from randomization baseline to 12 weeks after randomization
Intervention | Participants (Count of Participants) |
---|
CAM2038 | 7 |
Placebo | 21 |
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Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) and the Primary Timepoint Will be Week 12 of the Double-Blind Phase.
Change from baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) and the primary timepoint will be Week 12 of the Double-Blind Phase based on the 11-Point numerical rating scale with 0 being no pain and 10 being the worst pain. (NCT02946073)
Timeframe: 12 weeks- from randomization baseline to 12 weeks after randomization
Intervention | score on a scale (Mean) |
---|
| Baseline | Change from Baseline to Week 12 |
---|
CAM2038 (Buprenorphine FluidCrystal®) q1w and q4w | 2.7 | -0.9 |
,Placebo Subcutaneous Injections | 2.4 | -1.9 |
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Summary of Rescue Medication Usage- Double-Blind Phase.
Rescue medication usage (number of days used) during the Double-Blind Phase. (NCT02946073)
Timeframe: 12 weeks- from randomization baseline to 12 weeks after randomization
Intervention | Days (Mean) |
---|
| Baseline | Change from Baseline to Week 12 |
---|
CAM2038 | 3.4 | -1.5 |
,Placebo | 3.5 | -2.1 |
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Summary of Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Open Label Phase
Change from baseline in the Open Label Phase in Work Productivity and Activity Impairment score with a range of 0-100 for 4 types of scores with higher scores indicating greater impairment. The Work Productivity and Activity Impairment (WPAI) is a self-administered instrument used to measure the effect of general health and symptom severity on work productivity and regular activities, and yields 4 types of scores (higher scores indicate greater impairment): Absenteeism (work time missed),Presenteeism (impairment at work/reduced on-the-job effectiveness), Work Productivity Loss (overall work impairment/absenteeism plus presenteeism),and Activity Impairment. Scores range from 0-100 for each of the four types with higher scores indicating greater impairment. (NCT02946073)
Timeframe: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).
Intervention | score on a scale (Mean) |
---|
| Baseline-Absenteesim | Change from Baseline at End of Treatment Visit-Absenteesim | Baseline-Presenteeism | Change from Baseline at End of Treatment Visit-Presenteeism | Baseline-Work Productivity Loss | Change from Baseline at End of Treatment Visit- Work Productivity Loss | Baseline-Activity Impairment | Change from Baseline at End of Treatment Visit-Activity Impairment |
---|
CAM2038 | 0 | -2.137 | 22.9 | 1.7 | 22.857 | -0.043 | 29.0 | -6.5 |
,De Novo | 1.538 | 0 | 26.9 | 1.0 | 27.846 | 1.000 | 32.1 | -12.1 |
,Rollover Placebo Injections | 0 | 0 | 21.0 | 6.7 | 21.000 | 6.667 | 22.9 | -18.2 |
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Summary of Change From Baseline in Patient Global Impression of Improvement (PGI-I) Scale
Change from baseline in the Open Label Phase in Patient global Impression of Improvement (PGI-I) Scale. PGI-I Scale is a single question 7-point likert scale that required the subject to assess how much his/her pain had improved or worsened relative to the start of the study. Ratings were: 1, much worse; 2, worse; 3, a little worse; 4, no change; 5, a little better; 6, better; or 7, much better (NCT02946073)
Timeframe: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).
Intervention | score on a scale (Mean) |
---|
| Baseline | Change from Baseline at End of Treatment Visit |
---|
CAM2038 | 6.1 | -0.2 |
,De Novo | 5.8 | 0.2 |
,Rollover Placebo Injections | 6.3 | 0.5 |
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Summary of Change From Baseline in Clinical Global Impression of Improvement (CGI-I) Scale-Open Label
Summary of Change from Baseline in Clinical Global Impression of Improvement (CGI-I) scale. The Clinician Global Impression of Improvement (CGI-I) Scale is a 7-point scale that required the clinician to assess how much the subject's Pain had improved or worsened relative to the start of the study. Assessments were rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse (NCT02946073)
Timeframe: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).
Intervention | score on a scale (Mean) |
---|
| Baseline | Change from Baseline at End of Treatment Visit |
---|
CAM2038 | 1.7 | -0.1 |
,De Novo | 1.9 | -0.4 |
,Rollover Placebo Injections | 2.0 | 0.1 |
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Number of Subjects With a 30% and 50% Reduction in WAAPI From Baseline to Week 12 of the Double-Blind Phase.
Number of Responders With a 30% and 50% Reduction in WAAPI from the Open-Label Titration Period Baseline to Week 12 of the Double-Blind Treatment Period (mITT Population) (NCT02946073)
Timeframe: 12 weeks- from randomization baseline to 12 weeks after randomization
Intervention | Participants (Count of Participants) |
---|
| >= 30% improvement | >= 50% improvement |
---|
CAM2038 | 60 | 44 |
,Placebo | 47 | 32 |
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Change From Baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) of the Open Label Phase.
Change from baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) and the primary timepoint will be Week 52 of the Open Label Phase based on the 11-Point numerical rating scale with 10 being the worst pain. Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects. (NCT02946073)
Timeframe: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).
Intervention | score on a scale (Mean) |
---|
| Baseline | Change from Baseline to Week 4 | Change from Baseline to Week 8 | Change from Baseline to Week 12 | Change from Baseline to Week 16 | Change from Baseline to Week 20 | Change from Baseline to Week 24 | Change from Baseline to Week 28 | Change from Baseline to Week 32 | Change from Baseline to Week 36 | Change from Baseline to Week 40 | Change from Baseline to Week 44 | Change from Baseline to Week 48 |
---|
CAM2038 | 3.717 | -0.859 | -1.066 | -1.157 | -0.487 | -0.592 | -0.902 | -0.518 | -0.322 | -0.682 | -0.658 | -0.764 | -0.896 |
,De Novo | 4.139 | -0.517 | -0.625 | -0.846 | -0.689 | -0.725 | -0.735 | -1.013 | -0.996 | -1.044 | -0.935 | -0.897 | -1.059 |
,Rollover Placebo Injections | 3.246 | -1.734 | -2.404 | -2.455 | -1.587 | -1.391 | -1.461 | -1.531 | -1.462 | -1.112 | -1.087 | -1.216 | -1.292 |
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Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase.
Change from baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase based on the 11-Point numerical rating scale with 10 being the worst pain. Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects. (NCT02946073)
Timeframe: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).
Intervention | score on a scale (Mean) |
---|
| Baseline | Change from Baseline to Week 4 | Change from Baseline to Week 8 | Change from Baseline to Week 12 | Change from Baseline to Week 16 | Change from Baseline to Week 20 | Change from Baseline to Week 24 | Change from Baseline to Week 28 | Change from Baseline to Week 32 | Change from Baseline to Week 36 | Change from Baseline to Week 40 | Change from Baseline to Week 44 | Change from Baseline to Week 48 |
---|
CAM2038 | 2.256 | -0.531 | -0.729 | -0.767 | -0.312 | -0.566 | -0.872 | -0.338 | -0.275 | -0.623 | -0.519 | -0.560 | -0.619 |
,De Novo | 2.839 | -0.434 | -0.555 | -0.752 | -0.543 | -0.690 | -0.718 | -0.905 | -0.941 | -0.920 | -0.913 | -0.767 | -0.996 |
,Rollover Placebo Injections | 1.944 | -1.586 | -2.165 | -2.079 | -1.229 | -1.013 | -1.220 | -1.212 | -1.111 | -1.119 | -1.113 | -1.282 | -1.215 |
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GAD-7
General Anxiety Disorders 7-item questionnaire (GAD-7) score (range 0-21; higher is worse) (NCT03026790)
Timeframe: 12 months
Intervention | units on a scale (Mean) |
---|
Active Comparator: Telecare Collaborative Management (TCM) | 6.01 |
Active Comparator: Integrated Pain Team (IPT) | 5.55 |
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PROMIS Sleep Disturbance
Patient Reported Outcomes Measurement Information System (PROMIS) sleep disturbance short-form 4a T-score (higher is worse). Raw scores were rescaled into standardized T-scores with a mean of 50 representing the average for the US population and a standard deviation (SD) of 10. A person with a T-score of 40 is one SD below the mean. (NCT03026790)
Timeframe: 12 months
Intervention | T-score (Mean) |
---|
Active Comparator: Telecare Collaborative Management (TCM) | 57.2 |
Active Comparator: Integrated Pain Team (IPT) | 55.5 |
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Symptom Checklist
Medication-related adverse symptoms count (0-19; higher is worse) (NCT03026790)
Timeframe: 12 months
Intervention | symptom count (Mean) |
---|
Active Comparator: Telecare Collaborative Management (TCM) | 4 |
Active Comparator: Integrated Pain Team (IPT) | 3.5 |
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VR-12 Mental Component Score
Veterans RAND 12-item health survey (VR-12) Mental Component Score (range 0-100; higher is better) (NCT03026790)
Timeframe: 12 months
Intervention | units on a scale (Mean) |
---|
Active Comparator: Telecare Collaborative Management (TCM) | 41.9 |
Active Comparator: Integrated Pain Team (IPT) | 42.5 |
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VR-12 Physical Component Score
Veterans RAND 12-item health survey (VR-12) Physical Component Score (range 0-100; higher is better) (NCT03026790)
Timeframe: 12 months
Intervention | units on a scale (Mean) |
---|
Active Comparator: Telecare Collaborative Management (TCM) | 41.9 |
Active Comparator: Integrated Pain Team (IPT) | 42.5 |
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PODS Concerns
Prescribed Opioids Difficulty Scale (PODS) Concerns score (range 0-28; higher is worse) (NCT03026790)
Timeframe: 12 months
Intervention | units on a scale (Mean) |
---|
Active Comparator: Telecare Collaborative Management (TCM) | 3.8 |
Active Comparator: Integrated Pain Team (IPT) | 4 |
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Brief Pain Inventory (BPI) Total Score
Brief Pain Inventory (BPI) total score calculated as average of 11 items (range 0-10; higher is worse) (NCT03026790)
Timeframe: 12 months
Intervention | units on a scale (Mean) |
---|
Active Comparator: Telecare Collaborative Management (TCM) | 6.07 |
Active Comparator: Integrated Pain Team (IPT) | 6.01 |
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50% Reduction in Opioid Daily Dose
Binary response variable defined by reduction of at least 50% in opioid daily dose (morphine-equivalent mg) from baseline (NCT03026790)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
Active Comparator: Telecare Collaborative Management (TCM) | 102 |
Active Comparator: Integrated Pain Team (IPT) | 98 |
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Composite Response
Binary composite response variable defined by achieving at least a 30% reduction in BPI total score and at least 50% reduction in opioid daily dose from baseline. (NCT03026790)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
Active Comparator: Telecare Collaborative Management (TCM) | 17 |
Active Comparator: Integrated Pain Team (IPT) | 17 |
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Headache Impact Test
Headache Impact Test score (range 36-78; higher is worse) (NCT03026790)
Timeframe: 12 months
Intervention | units on a scale (Mean) |
---|
Active Comparator: Telecare Collaborative Management (TCM) | 50.77 |
Active Comparator: Integrated Pain Team (IPT) | 49.84 |
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Pain Response
Binary response variable defined by reduction of at least 30% in Brief Pain Inventory (BPI) total score from baseline (NCT03026790)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
Active Comparator: Telecare Collaborative Management (TCM) | 58 |
Active Comparator: Integrated Pain Team (IPT) | 54 |
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PHQ-8
Patient Health Questionnaire 8-item (PHQ-8) depression scale score (range 0-24; higher is worse) (NCT03026790)
Timeframe: 12 months
Intervention | units on a scale (Mean) |
---|
Active Comparator: Telecare Collaborative Management (TCM) | 8.79 |
Active Comparator: Integrated Pain Team (IPT) | 5.2 |
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PODS Problems
Prescribed Opioids Difficulty Scale (PODS) Problems score (range 0-32; higher is worse) (NCT03026790)
Timeframe: 12 months
Intervention | units on a scale (Mean) |
---|
Active Comparator: Telecare Collaborative Management (TCM) | 3.4 |
Active Comparator: Integrated Pain Team (IPT) | 2.5 |
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PROMIS Fatigue
Patient Reported Outcomes Measurement Information System (PROMIS) fatigue short-form 4a T-score (higher is worse). Raw scores were rescaled into standardized T-scores with a mean of 50 representing the average for the US population and a standard deviation (SD) of 10. A person with a T-score of 40 is one SD below the mean. (NCT03026790)
Timeframe: 12 months
Intervention | T-score (Mean) |
---|
Active Comparator: Telecare Collaborative Management (TCM) | 57.1 |
Active Comparator: Integrated Pain Team (IPT) | 55.7 |
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Percentage of Patients Who Receive the Second Injection of XR-NTX.
Percentage of patient who initiated Procedure 1 and completed the study receiving the 2nd injection of XR-NTX (NCT03113409)
Timeframe: 4 weeks after 1st injection
Intervention | Participants (Count of Participants) |
---|
Procedure 1 | 6 |
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Number of Patients Reporting Nausea in the PACU
PACU (Post-Anesthesia Care Unit) assessment of nausea (NCT03117140)
Timeframe: Post-op day 0 (Baseline)
Intervention | Participants (Count of Participants) |
---|
Plain Ropivacaine | 4 |
Ropivacaine + Buprenorphine | 9 |
Ropivacaine + Clonidine | 2 |
Ropivacaine + Dexamethasone | 9 |
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Number of Patients Vomiting in the PACU (Post-Anesthesia Care Unit)
Vomiting in PACU (Post-Anesthesia Care Unit) for patients was looked at (NCT03117140)
Timeframe: Post-op Day 0 (Baseline)
Intervention | Participants (Count of Participants) |
---|
Plain Ropivacaine | 0 |
Ropivacaine + Buprenorphine | 1 |
Ropivacaine + Clonidine | 0 |
Ropivacaine + Dexamethasone | 0 |
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Number of Patients With Blood Pressure (BP) Changes in the PACU
Blood pressure changes in PACU (Post-Anesthesia Care Unit) for patients was looked at (NCT03117140)
Timeframe: Post-op Day 0 (baseline)
Intervention | Participants (Count of Participants) |
---|
Plain Ropivacaine | 8 |
Ropivacaine + Buprenorphine | 3 |
Ropivacaine + Clonidine | 7 |
Ropivacaine + Dexamethasone | 2 |
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Pain Score Reported by Patients at First Phone Call
Patients are called 1-3 days post-operatively to assess pain. Pain score is 0-10 scale with 0 is no pain and 10 is most severe pain. (NCT03117140)
Timeframe: Day 1-3
Intervention | units on a scale (Median) |
---|
Plain Ropivacaine | 4 |
Ropivacaine + Buprenorphine | 3 |
Ropivacaine + Clonidine | 4 |
Ropivacaine + Dexamethasone | 3 |
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Patient Reporting Vomiting at Home
Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded. (NCT03117140)
Timeframe: 1-3 days
Intervention | Participants (Count of Participants) |
---|
Plain Ropivacaine | 0 |
Ropivacaine + Buprenorphine | 3 |
Ropivacaine + Clonidine | 2 |
Ropivacaine + Dexamethasone | 1 |
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Surgical Length
Surgical length was recorded (NCT03117140)
Timeframe: Post op Day 0 (Baseline)
Intervention | minutes (Median) |
---|
Plain Ropivacaine | 68.5 |
Ropivacaine + Buprenorphine | 65 |
Ropivacaine + Clonidine | 73.5 |
Ropivacaine + Dexamethasone | 71 |
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Surgical Position
Surgical position was recorded (NCT03117140)
Timeframe: Post-op Day 0 (Baseline)
Intervention | Participants (Count of Participants) |
---|
| Beach Chair | Lateral | Supine |
---|
Plain Ropivacaine | 38 | 2 | 0 |
,Ropivacaine + Buprenorphine | 31 | 6 | 3 |
,Ropivacaine + Clonidine | 31 | 7 | 2 |
,Ropivacaine + Dexamethasone | 32 | 6 | 2 |
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Sensory Duration of Block
Patients are called 1-3 days post-operatively to assess when the sensory component of their nerve block wore off (NCT03117140)
Timeframe: Day 1-3
Intervention | minutes (Median) |
---|
Plain Ropivacaine | 923.5 |
Ropivacaine + Buprenorphine | 982 |
Ropivacaine + Clonidine | 940.5 |
Ropivacaine + Dexamethasone | 1066 |
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Block Set up Time
Patients are assessed from needle removal to when they are no longer able to feel cold on the blocked extremity (NCT03117140)
Timeframe: Day one
Intervention | minutes (Median) |
---|
Plain Ropivacaine | 6 |
Ropivacaine + Buprenorphine | 3 |
Ropivacaine + Clonidine | 6 |
Ropivacaine + Dexamethasone | 4.5 |
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Duration of Analgesia
Patients are called 1-3 days post-operatively to assess when the analgesia of their nerve block wore off (NCT03117140)
Timeframe: 1-3 days post-operative
Intervention | minutes (Median) |
---|
Plain Ropivacaine | 911 |
Ropivacaine + Buprenorphine | 1026.5 |
Ropivacaine + Clonidine | 1181 |
Ropivacaine + Dexamethasone | 982 |
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Motor Duration of Block
Patients are called 1-3 days post-operatively to assess when motor component of their nerve block wore off (NCT03117140)
Timeframe: Day 1-3
Intervention | minutes (Median) |
---|
Plain Ropivacaine | 1120 |
Ropivacaine + Buprenorphine | 1198 |
Ropivacaine + Clonidine | 1090 |
Ropivacaine + Dexamethasone | 1143.5 |
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Number of Patient With Blood Pressure Changes in the Second Stage Recovery Area
Blood pressure changes in Second Stage Recovery Area for patients was looked at (NCT03117140)
Timeframe: Post-op Day 0 (baseline)
Intervention | Participants (Count of Participants) |
---|
Plain Ropivacaine | 5 |
Ropivacaine + Buprenorphine | 1 |
Ropivacaine + Clonidine | 5 |
Ropivacaine + Dexamethasone | 0 |
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Number of Patients Reporting Itching at Home
Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded. (NCT03117140)
Timeframe: 1-3 days
Intervention | Participants (Count of Participants) |
---|
Plain Ropivacaine | 1 |
Ropivacaine + Buprenorphine | 2 |
Ropivacaine + Clonidine | 2 |
Ropivacaine + Dexamethasone | 0 |
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Number of Patients Reporting Itching in the PACU
Patients itching was assessed post-op in the PACU. (NCT03117140)
Timeframe: Post-op day 0 (baseline)
Intervention | Participants (Count of Participants) |
---|
Plain Ropivacaine | 5 |
Ropivacaine + Buprenorphine | 2 |
Ropivacaine + Clonidine | 6 |
Ropivacaine + Dexamethasone | 3 |
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Number of Patients Reporting Nausea at Home
Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded. (NCT03117140)
Timeframe: 1-3 days
Intervention | Participants (Count of Participants) |
---|
Plain Ropivacaine | 4 |
Ropivacaine + Buprenorphine | 9 |
Ropivacaine + Clonidine | 2 |
Ropivacaine + Dexamethasone | 3 |
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Change From Baseline to the End of Treatment (EOT) in the Montgomery Asberg Depression Rating Scale-10 (MADRS-10) Scores
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of Major Depressive Disorder (MDD) symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts. (NCT03188185)
Timeframe: Baseline and 5 weeks for Stage 1, Baseline and 6 weeks for Stage 2
Intervention | score on a scale (Least Squares Mean) |
---|
S1: Placebo | -11.4 |
S1: ALKS 5461 2mg/2mg | -13.9 |
S2: Placebo | -4.2 |
S2: ALKS 5461 2mg/2mg | -4.7 |
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Percent of Patients Successfully Transitioned Off Buprenorphine
Percent of patients retained in treatment and abstinent from opioids at the end of the trial (NCT03232346)
Timeframe: Week 25
Intervention | Participants (Count of Participants) |
---|
Regimen 1 | 2 |
Regimen 2 | 3 |
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Treatment Satisfaction
Indicators of satisfaction with treatment delivery measured by participants, pharmacists, and physicians using the Treatment Satisfaction Scale after each study visit. A score of 5=very satisfied, 4=satisfied, 3=neither satisfied or dissatisfied, 2=dissatisfied, and 1=very dissatisfied. (NCT03248947)
Timeframe: Up to six months
Intervention | Participants (Count of Participants) |
---|
| Overall satisfaction with experience in study72207790 | Overall satisfaction with experience in study72207791 | Overall satisfaction with quality of study treatmt72207791 | Overall satisfaction with quality of study treatmt72207790 |
---|
| Very Satisfied | Satisfied | Neither Satisfied or Dissatisfied | Dissatisfied | Very Dissatisfied |
---|
Pharmacist-administered Buprenorphine Maintenance Care | 59 |
Study Physicians and Pharmacists | 12 |
Pharmacist-administered Buprenorphine Maintenance Care | 3 |
Pharmacist-administered Buprenorphine Maintenance Care | 57 |
Study Physicians and Pharmacists | 11 |
Pharmacist-administered Buprenorphine Maintenance Care | 5 |
Study Physicians and Pharmacists | 1 |
Pharmacist-administered Buprenorphine Maintenance Care | 1 |
Study Physicians and Pharmacists | 0 |
Pharmacist-administered Buprenorphine Maintenance Care | 0 |
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Recruitment Rate
Measured by a composite of the number of participants with opioid use disorder recruited (i.e., signed the informed consent form) per month, and by site and the average monthly rate of participants enrolled among potential participants who were screened. (NCT03248947)
Timeframe: Up to six months
Intervention | Participants (Count of Participants) |
---|
| Pre-screened participants consented | Consented participants enrolled into study |
---|
Consented Participants | NA | 71 |
,Pre-screened Participants | 76 | NA |
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Treatment Fidelity
Number of monitored study visits with physicians and pharmacists showing 80% adherence or higher to study specific tasks and responsibilities. Adherence will be calculated as the number of items completed on the Buprenorphine Visit Checklist divided by the sum of the number of complete and incomplete items. (NCT03248947)
Timeframe: Up to six months
Intervention | Monitored study visits (Count of Units) |
---|
Pharmacist-administered Buprenorphine Maintenance Care | 142 |
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Treatment Retention
Number of scheduled visits completed. (NCT03248947)
Timeframe: Up to six months
Intervention | Visits (Count of Units) |
---|
Pharmacist-administered Buprenorphine Maintenance Care | 406 |
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Number of Participants With Opioid and Other Substance Use
Measured via a composite of urine drug screen (UDS) and self-report via Timeline Follow-Back over 30 days. (NCT03248947)
Timeframe: Up to six months
Intervention | Participants (Count of Participants) |
---|
| Positive opioid UDS at month 6 | Positive other substance UDS at month 6 | Self-reported opioid use at month 6 |
---|
Pharmacist-administered Buprenorphine Maintenance Care | 10 | 38 | 10 |
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Participant Safety
A composite of self-report and medical record abstraction to measure any fatal or non-fatal opioid overdose and any opioid or other substance-related emergency department visit or hospitalization. (NCT03248947)
Timeframe: Up to six months
Intervention | Participants (Count of Participants) |
---|
| Overdoses | Substance-related ED visits | Substance-related hospitalizations |
---|
Pharmacist-administered Buprenorphine Maintenance Care | 0 | 1 | 1 |
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Number of Medication-Compliant Months Across All Participants
Medication compliance is defined as taking any of the dispensed medication during the past month as measured by pill count/dose reconciliation at each study visit. Medication compliance is calculated as the percentage of compliant months out of the overall number of expected study months. (NCT03248947)
Timeframe: Up to six months
Intervention | Months (Count of Units) |
---|
Pharmacist-administered Buprenorphine Maintenance Care | 406 |
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Pharmacists' Use of the Prescription Drug Monitoring Program (PDMP)
Measured at each study visit via an action item checklist to confirm whether the PDMP was inquired to identify the following for each participant: measures of multiple buprenorphine prescriptions, any prescriptions for class II and III medications, and any other information that may be useful for the participant's treatment such as documented drug-related medical interventions or disciplinary charges. (NCT03248947)
Timeframe: Up to six months
Intervention | Visits (Count of Units) |
---|
Pharmacist-administered Buprenorphine Maintenance Care | 396 |
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Percentage of Participants Provided Rescue Medication for Nausea
Zofran was used at the clinician's discretion as rescue medication for nausea. (NCT03254459)
Timeframe: Days 1 to7
Intervention | percentage of participants (Number) |
---|
Standard of Care Narcotic Therapy | 12 |
Buprenorphine Sublingual Spray 0.5 mg | 35 |
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Time to First Use of Rescue Medication for Nausea Following Each Dose of the Investigational Product (IP)
"Zofran was used at the clinician's discretion as rescue medication for nausea. Time 0 is defined as the time of the administration of study drug." (NCT03254459)
Timeframe: Days 1 to 7
Intervention | hours (Median) |
---|
Standard of Care Narcotic Therapy | NA |
Buprenorphine Sublingual Spray 0.5 mg | 11.25 |
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Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. A TEAE is an AE with onset that occurs after receiving study drug. (NCT03254459)
Timeframe: Days 1 to 8
Intervention | Participants (Count of Participants) |
---|
Standard of Care Narcotic Therapy | 33 |
Buprenorphine Sublingual Spray 0.5 mg | 47 |
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Number of Participants With Abnormal Electrocardiograms (ECGs) Findings at 90 Minutes,12, 24, 48 and 72 Hours
A standard 12-lead ECG will be performed after the participant is in the supine (lying face up) position for 5 minutes. (NCT03254459)
Timeframe: Pre-dose and 90 minutes, 12, 24, 48 and 72 hours after first dose
Intervention | Participants (Count of Participants) |
---|
| Pre-dose | 90 minutes | 12 hours | 24 hours | 48 hours | 72 hours |
---|
Buprenorphine Sublingual Spray 0.5 mg | 32 | 30 | 34 | 29 | 25 | 18 |
,Standard of Care Narcotic Therapy | 26 | 33 | 31 | 23 | 18 | 14 |
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Number of Participants With Abnormal Oral Cavity Examinations
Study staff will perform a sublingual (under the tongue) assessment, noting the color of mucosa and whether inflammation is present. (NCT03254459)
Timeframe: Pre-dose and 90 minutes, 12, 24, 48 and 72 hours after first dose on Days 1 to 4 and End of Study Day 8
Intervention | Participants (Count of Participants) |
---|
| Pre-dose | 90 minutes | 12 hours | 24 hours | 48 hours | 72 hours |
---|
Buprenorphine Sublingual Spray 0.5 mg | 0 | 0 | 0 | 0 | 1 | 0 |
,Standard of Care Narcotic Therapy | 0 | 0 | 0 | 0 | 0 | 0 |
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Pulse Oximetry Levels at 90 Minutes,12, 24, 48 and 72 Hours
Pulse oximetry is a non-invasive method to measure a person's oxygen saturation. (NCT03254459)
Timeframe: 90 Minutes,12, 24, 48 and 72 Hours
Intervention | percentage of oxygen saturation (Mean) |
---|
| 90 minutes | 12 hours | 24 hours | 48 hours | 72 hours |
---|
Buprenorphine Sublingual Spray 0.5 mg | 96.0 | 95.8 | 96.6 | 96.0 | 96.2 |
,Standard of Care Narcotic Therapy | 96.3 | 96.0 | 96.9 | 96.5 | 97.3 |
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Total Use of Rescue Medication for Nausea Over 0 to 24 Hours, Over 0 to 48 Hours, Over 0-72 Hours and 0-7 Days
Zofran was used at the clinician's discretion as rescue medication for nausea. The total use of rescue medication was calculated for the following 4 time-frames: 0 to 24 hours, 0 to 48 hours, 0 to 72 hours and 0 to 7 days. (NCT03254459)
Timeframe: 0 to 24 hours, 0 to 48 hours, 0 to 72 hours and 0 to 7 days
Intervention | cumulative number of rescue doses (Number) |
---|
| 0 to 24 hours | 0 to 48 hours | 0 to 72 hours | 0 to 7 days |
---|
Buprenorphine Sublingual Spray 0.5 mg | 68 | 92 | 110 | 152 |
,Standard of Care Narcotic Therapy | 9 | 18 | 22 | 42 |
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Total Fetal Movement at 36 Weeks Gestation
Total fetal movement over 60 minutes via fetal monitoring at 36 weeks of gestation. Nimber of fetal movements over 60 minutes via fetal monitoring at times of peak maternal plasma drug concentrations at 36 weeks of gestation. (NCT03291847)
Timeframe: 36 weeks of gestation
Intervention | fetal movements (Mean) |
---|
Buprenorphine-naloxone Treated | 59.07 |
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Fetal Heart Rate at 24 Weeks
Fetal heart rate in beats per minute, mean over 60 minutes gestation. Fetal heart rate in msec at 24 weeks of gestation at times of peak maternal plasma drug concentrations (NCT03291847)
Timeframe: 24 weeks of gestation
Intervention | beats per minute (Mean) |
---|
Buprenorphine-naloxone Treated | 143.64 |
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Fetal Heart Rate at 28 Weeks Gestation
Fetal heart rate in beats per minute, mean over 60 minutes gestation. Fetal heart rate at 28 weeks of gestation at times of tpeak maternal plasma drug concentrations. (NCT03291847)
Timeframe: 28 weeks of gestation
Intervention | beats per minute (Mean) |
---|
Buprenorphine-naloxone Treated | 139.14 |
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Fetal Heart Rate at 32 Weeks Gestation
Fetal heart rate in beats per minute, mean over 60 minutes. Fetal heart rate at 32 weeks of gestation at times of peak maternal plasma drug concentrations (NCT03291847)
Timeframe: 32 weeks of gestation
Intervention | beats per minute (Mean) |
---|
Buprenorphine-naloxone Treated | 135.82 |
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Fetal Heart Rate at 36 Weeks Gestation
Fetal heart rate in beats per minute, mean over 60 minutes. Fetal heart rate at 36 weeks of gestation at times of peak maternal plasma drug concentrations. (NCT03291847)
Timeframe: 36 weeks of gestation
Intervention | beats per minute (Mean) |
---|
Buprenorphine-naloxone Treated | 131.99 |
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Total Fetal Movement at 24 Weeks Gestation
Total fetal movement at 24 weeks of gestation. Total number of fetal moves over 60 minutes via fetal monitoring at time of peak maternal plasma drug concentrations at 24 weeks of gestation. (NCT03291847)
Timeframe: 24 weeks of gestation
Intervention | fetal movements (Mean) |
---|
Buprenorphine-naloxone Treated | 71.91 |
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Total Fetal Movement at 32 Weeks Gestation
Total fetal movement over 60 minutes via fetal monitoring at 32 weeks of gestation. Number of fetal moves over 60 minutes via fetal monitoring at times of peak maternal plasma drug concentrations at 32 weeks of gestation. (NCT03291847)
Timeframe: 32 weeks of gestation
Intervention | fetal movements (Mean) |
---|
Buprenorphine-naloxone Treated | 66.00 |
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Total Fetal Movement at 28 Weeks Gestation
Total fetal movement over 60 minutes via fetal monitoring. Total fetal movement over 60 minutes via fetal monitoring at times of trough and peak maternal plasma drug concentrations at 28 weeks of gestation. (NCT03291847)
Timeframe: 28 weeks of gestation
Intervention | fetal movements (Mean) |
---|
Buprenorphine-naloxone Treated | 70.06 |
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Number of Subjects Who Require Hospitalization Within 72 Hours Post Conversion From Full Agonist Opioids to Buprenorphine-based Pain Treatment
Data will be collected on need for hospitalization within 72 hours of conversion due to withdrawal induced vaso-occlusive crisis (VOC). If 2 out of the first 5 patients require hospitalization within 72 hours of conversion the study will be stopped and we will assess what changes need to be made in the protocol to decrease the risk of hospitalization triggered by the conversion. (NCT03492099)
Timeframe: 72 hours after buprenorphine initiation
Intervention | Participants (Count of Participants) |
---|
Buprenorphine Arm | 1 |
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Number of Participants Continuing Buprenorphine Therapy After 6 Months of Induction
After induction, clinical team will continue to follow up with patients to see if they would like to continue buprenorphine therapy during the next 6 months after induction. The date of discontinuation and the reason why will be recorded. The number of participants reported in the outcome is the number of participants that continued buprenorphine therapy 6 months after induction. (NCT03492099)
Timeframe: 6 months after induction
Intervention | Participants (Count of Participants) |
---|
Buprenorphine Arm | 38 |
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Change in the Number of Acute Care Visits Per Subject in the 6 Months Prior to Buprenorphine (BUP) Induction and in the 6 Months Post to BUP Induction
Change in the number of acute care visits per subject in the 6 months prior to BUP induction and in the 6 months post to BUP induction will be observed by comparing the mean number of acute care visits per patient- either to Emergency Department (ED) or to Sickle Cell Infusion Center - in the six months prior to BUP induction and in the six months post to BUP induction. (NCT03492099)
Timeframe: 6 months pre BUP induction, 6 months post BUP induction
Intervention | acute care visits per patient (Mean) |
---|
| Number of Acute Visits per patient 6 months prior to BUP induction | Number of Acute Visits per patient 6 months post BUP induction |
---|
Buprenorphine Arm | 11.86 | 3.35 |
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Change in Severity of Opiate Withdrawal, Based on the Clinical Opiate Withdrawal Scale (COWS) Score
Change in severity of opiate withdrawal will be observed by comparing the mean COWS score at BUP induction and 1 day post induction. All patients will be in opiate withdrawal at the time of buprenorphine induction and at the end of the first day of induction. The level of withdrawal will be measured by the COWS score, an 11-item scale designed to be administered by a clinician. The score ranges from 0-4 (no withdrawal), 5-12 (mild withdrawal), 13-24 (moderate withdrawal), 25-36 (severe withdrawal), and 36-48 (most severe withdrawal). (NCT03492099)
Timeframe: COWS score at BUP induction, COWS score at the end of the first day of induction
Intervention | score on a scale (Mean) |
---|
| COWS score at BUP induction | COWS score at the end of the first day of induction |
---|
Buprenorphine Arm | 8.92 | 3.32 |
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The # of Participants Who Received Their Randomly Assigned Study Medication Prior to Release From Jail as Scheduled
Received assigned study medication prior to release as scheduled (NCT03604159)
Timeframe: 0-3 months (pre-release)
Intervention | Participants (Count of Participants) |
---|
Buprenorphine Extended-Release | 21 |
Sublingual Buprenorphine | 26 |
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The # of Participants That Received Their Randomly Assigned Study Medication
Received assigned study medication (NCT03604159)
Timeframe: 8 Weeks
Intervention | Participants (Count of Participants) |
---|
Buprenorphine Extended-Release | 24 |
Sublingual Buprenorphine | 26 |
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the # of Participants Re-incarcerated
Re-incarceration (NCT03604159)
Timeframe: 8 weeks
Intervention | Participants (Count of Participants) |
---|
Buprenorphine Extended-Release | 2 |
Sublingual Buprenorphine | 4 |
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Mean # of Weeks (0-8) on Any Buprenorphine Treatment
Weeks (0-8) on buprenorphine treatment, mean (SD) (NCT03604159)
Timeframe: 8 weeks
Intervention | weeks (Mean) |
---|
Buprenorphine Extended-Release | 6.1 |
Sublingual Buprenorphine | 2.6 |
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# of Participants Retained on Their Randomly Assigned Treatment at Week 8
Retained on assigned treatment at Week 8 (NCT03604159)
Timeframe: 8 weeks
Intervention | Participants (Count of Participants) |
---|
Buprenorphine Extended-Release | 15 |
Sublingual Buprenorphine | 9 |
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Urine Samples Opioid-negative
number of opioid-negative urine samples (NCT03604159)
Timeframe: 8 weeks
Intervention | urine samples (Number) |
---|
Buprenorphine Extended-Release | 72 |
Sublingual Buprenorphine | 50 |
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The Mean In-jail Medical Visits Per Day Following Randomization and Induction on Study Medication
Jail medical clinic visits per day following study medication induciton, mean (NCT03604159)
Timeframe: Post-randomization and pre-release, (0-3 months)
Intervention | jail clinic visits per day (Mean) |
---|
Buprenorphine Extended-Release | 0.11 |
Sublingual Buprenorphine | 1.06 |
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Length of Treatment
Length of treatment with buprenrophine for NAS (hours) of a model-based optimized dose of buprenorphine for infants treated for NAS. (NCT03608696)
Timeframe: Duration of pharmacologic treatment for neonatal abstinence syndrome up to 70 days of age
Intervention | days (Median) |
---|
Buprenorphine | 30 |
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Proportion of Heroin-dependent Patients Successfully Inducted Onto Vivitrol
Number of patients who received the first Vivitrol injection among those who initiated the induction (NCT03711318)
Timeframe: 12 weeks
Intervention | Participants (Count of Participants) |
---|
Short-term Treatment With Buprenorphine | 3 |
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Treatment Engagement
Treatment engagement as measured by number of outpatient clinic visits (attendance), receipt of SUBLOCADE injections (buprenorphine treatment) at 3 and 6 months. (NCT03818399)
Timeframe: 3 and 6 months
Intervention | visits (Mean) |
---|
| 3 months | 6 months |
---|
Overdose Patients | 8.1 | 13.3 |
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Composite Outcome Measure for a Reduction in Both Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD) Symptoms
AUD is measured by the Timeline Follow Back (TLFB). This instrument documents the amount of daily alcohol consumption (in grams) and categorizes the World Health Organization Risk Levels of Alcohol Use. The are 4 different WHO Risk Levels: Very High Risk, High Risk, Medium Risk, and Low Risk (including abstinence). An AUD reduction is defined as a WHO risk reduction of at least one category from baseline to week 8. PTSD symptom is measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). This 30-item interview assesses PTSD diagnosis and symptom severity. The CAPS-5 Total Symptom Severity Score (TSSS) ranges from 0 to 80, with higher scores indicating worse symptoms. A reduction in PTSD symptom is defined as a 10+ point decrease in the TSSS from baseline to week 8. A positive response for the composite primary outcome measure is defined as at least a 1-category risk reduction on the WHO s and at least a 10-point decrease in TSSS from baseline to Week 8. (NCT03852628)
Timeframe: Baseline and 8 Weeks
Intervention | Participants (Count of Participants) |
---|
2mg Buprenex and 380mg Vivitrol | 10 |
Placebo | 12 |
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Number of Participants With a Reduction in CAPS-5 Total Symptom Severity Score (TSSS) of 10 or More Points
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a 30-item structured interview to assess PTSD diagnosis and symptom severity. The CAPS-5 produces a PTSD Total Symptom Severity Score (TSSS) that ranges from 0 to 80, with a higher score indication worse PTSD symptoms. For this study, a reduction in PTSD symptoms is defined as a 10 or more point decrease in the CAPS-5 Total Symptom Severity Score (TSSS) from baseline to week 8. (NCT03852628)
Timeframe: Baseline and 8 weeks
Intervention | Participants (Count of Participants) |
---|
2mg Buprenex and 380mg Vivitrol | 14 |
Placebo | 15 |
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Sublocade Induction
Number of participants successfully inducted onto Sublocade (BXR) (NCT03861338)
Timeframe: Study week 1
Intervention | Participants (Count of Participants) |
---|
Sublocade | 10 |
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Enrollment in Medication Assisted Treatment at 6-month Post-enrollment
Number of participants who are receiving treatment with medication for opioid use disorder at 6-month post-enrollment (NCT03908437)
Timeframe: 6-month follow-up
Intervention | Participants (Count of Participants) |
---|
Mobile Unit Intervention | 15 |
Crisis Response Center | 1 |
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Overdose During the 6-month Follow-up
Number of participants who experienced fatal and non-fatal overdoses between baseline and 6-month follow-up (NCT03908437)
Timeframe: 6 months
Intervention | participants (Number) |
---|
Mobile Unit Intervention | 0 |
Crisis Response Center | 2 |
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Change in Opioid Use From Baseline to 6-month Follow-up
Number of participants with a positive urine drug screen and report opioid use (except treatment, e.g., methadone, buprenorphine, buprenorphine/naloxone) at 6-month follow-up (NCT03908437)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
Mobile Unit Intervention | 14 |
Crisis Response Center | 18 |
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Enrollment in Medication Assisted Treatment at 1-month Post-enrollment
Number of participants receiving treatment with medication for opioid use disorder at 1-month post-enrollment (NCT03908437)
Timeframe: 1-month post-enrollment
Intervention | participants (Number) |
---|
Mobile Unit Intervention | 33 |
Crisis Response Center | 1 |
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Total Score on Opioid Craving Visual Analogue Scale (OC-VAS) At Timepoints During the Treatment Period
Participants indicated their level of craving for opioids by marking a 100mm visual analogue scale where 0 = no craving and 100 = maximal craving. (NCT03993392)
Timeframe: Day 1 to Day 29
Intervention | units on a scale (Mean) |
---|
| Day 1 Check-in | Pre TM Buprenephrine | Pre-SUBLOCADE | 1 hour post-SUBLOCADE dose | 2 hours post-SUBLOCADE dose | 3 hours post-SUBLOCADE dose | 4 hours post-SUBLOCADE dose | 6 hours post-SUBLOCADE dose | 8 hours post-SUBLOCADE dose | 12 hours post-SUBLOCADE dose | 16 hours post-SUBLOCADE dose | 20 hours post-SUBLOCADE dose | 24 hours post-SUBLOCADE dose | 30 hours post-SUBLOCADE dose | 36 hours post-SUBLOCADE dose | 48 hours post-SUBLOCADE dose | Day 8 | Day 15 | Day 22 | End of Treatment Day 29 |
---|
TM Buprenorphine Followed by SUBLOCADE 300 mg | 66.0 | 65.0 | 57.0 | 56.5 | 52.8 | 53.9 | 44.5 | 42.6 | 43.1 | 39.3 | 29.7 | 33.5 | 27.3 | 16.7 | 13.8 | 12.1 | 7.6 | 6.4 | 13.1 | 7.3 |
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COWS Total Score Normalized Area Under the Curve (AUC) Through Key Timepoints Post SUBLOCADE Injection
"The area under the curve (AUC) for COWS total score from the pre-SUBLOCADE value to a later time point were calculated using the linear trapezoidal method. For each analysis time interval (AUC0-1hr, AUC0-6hrs, AUC0-12hrs, AUC0-24hrs, AUC0-48hrs) the AUC value was normalized across participants for the actual duration (in hours) of the time interval. The normalized AUC for COWS can be interpreted as the averaged AUC per hour or the averaged COWS over a time interval, as if the COWS was measured hourly during that time interval.~Participants were included in a given interval if they had a pre-SUBLOCADE COWS assessment and a COWS assessment at the terminal timepoint for the interval." (NCT03993392)
Timeframe: SUBLOCADE injection on Day 1 through 1, 6, 12, 24 and 48 hours after SUBLOCADE injection
Intervention | hours*units on a scale (Mean) |
---|
| Through 1 hour post SUBLOCADE | Through 6 hours post SUBLOCADE | Through 12 hours post SUBLOCADE | Through 24 hours post SUBLOCADE | Through 48 hours post SUBLOCADE |
---|
TM Buprenorphine Followed by SUBLOCADE 300 mg | 11.91 | 9.27 | 7.91 | 6.59 | 5.03 |
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Participants Who Experienced Any Precipitated Withdrawal Within One Hour After SUBLOCADE Administration
"Clinical Opiate Withdrawal Scale (COWS) is an 11-item instrument used to assess signs and symptoms of opioid withdrawal. The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderately severe withdrawal, and 37-48 severe withdrawal.~Precipitated withdrawal was defined as in increase in Clinical Opioid Withdrawal Scale (COWS) score by ≥6 from the pre-SUBLOCADE value within 1 hour SUBLOCADE injection." (NCT03993392)
Timeframe: Day 1: Pre-SUBLOCADE evaluation taken after TM buprenorphine treatment and prior to injection: SUBLOCADE evaluation taken within one hour of SUBLOCADE injection
Intervention | Participants (Count of Participants) |
---|
TM Buprenorphine Followed by SUBLOCADE 300 mg | 1 |
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Cumulative Number of Participants Who Experienced a >=6 Point Clinical Opiate Withdrawal Scale (COWS) Total Score Increase After SUBLOCADE Administration From the Pre-SUBLOCADE Value at Key Timepoints
"COWS is an 11-item instrument used to assess signs and symptoms of opioid withdrawal. The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderately severe withdrawal, and 37-48 severe withdrawal.~Cumulative number of participants in key timepoints who had a COWS total score increase of ≥6 points from the pre-SUBLOCADE value." (NCT03993392)
Timeframe: Day 1: Pre-SUBLOCADE evaluation taken after TM buprenorphine treatment and prior to injection: SUBLOCADE evaluations taken 1, 6, 12, 24 and 48 hours after SUBLOCADE injection.
Intervention | Participants (Count of Participants) |
---|
| >0 to 1 hour | > 1 to 6 hours | >6 to 12 hours | >12 to 24 hours | >24 to 48 hours |
---|
TM Buprenorphine Followed by SUBLOCADE 300 mg | 1 | 2 | 2 | 2 | 2 |
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Participants With Treatment-Emergent Adverse Events (TEAE)
"A TEAE was an AE that started after the administration of TM buprenorphine for induction on Day 1.~TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator as mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical or surgical intervention to prevent one of the outcomes listed in this definition. AEs of special interest include SUBOCADE depot removal, occurrences of alanine aminotransferase (ALT) >3*upper limit of normal (ULN) and bilirubin >2*ULN." (NCT03993392)
Timeframe: Day 1 to Day 28
Intervention | Participants (Count of Participants) |
---|
| Any TEAE | Study Drug-related TEAE | Serious TEAE | Related and Serious TEAE | Severe TEAE | TEAE leading to death | TEAE leading to discontinuation of drug | TEAE leading to interruption of drug | Serious TEAEs - discontinuation of drug | Serious TEAEs - interruption of drug | AE of Special Interest |
---|
TM Buprenorphine Followed by SUBLOCADE 300 mg | 20 | 5 | 0 | 0 | 5 | 0 | 0 | 0 | 0 | 0 | 0 |
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Participants With Treatment-Emergent Adverse Events (TEAE) Within 48 Hours Post-SUBLOCADE Injection
"A TEAE was an AE that started after the administration of TM buprenorphine for induction on Day 1.~TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator as mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical or surgical intervention to prevent one of the outcomes listed in this definition. AEs of special interest include SUBOCADE depot removal, occurrences of alanine aminotransferase (ALT) >3*upper limit of normal (ULN) and bilirubin >2*ULN." (NCT03993392)
Timeframe: Day 1 SUBLOCADE injection up to 48 hours later
Intervention | Participants (Count of Participants) |
---|
| Any TEAE | Study Drug-related TEAE | Serious TEAE | Related and Serious TEAE | Severe TEAE | TEAE leading to death | TEAE leading to discontinuation of drug | TEAE leading to interruption of drug | Serious TEAEs - discontinuation of drug | Serious TEAEs - interruption of drug | AE of Special Interest |
---|
TM Buprenorphine Followed by SUBLOCADE 300 mg | 19 | 4 | 0 | 0 | 5 | 0 | 0 | 0 | 0 | 0 | 0 |
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Total Score on COWS At Timepoints During the Treatment Period
Clinical Opiate Withdrawal Scale (COWS) is an 11-item instrument used to assess signs and symptoms of opioid withdrawal. The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderately severe withdrawal, and 37-48 severe withdrawal. (NCT03993392)
Timeframe: Day 1 to Day 29
Intervention | units on a scale (Mean) |
---|
| Day 1 Check-in | Pre TM Buprenephrine | Pre-SUBLOCADE | 1 hour post-SUBLOCADE dose | 2 hours post-SUBLOCADE dose | 3 hours post-SUBLOCADE dose | 4 hours post-SUBLOCADE dose | 6 hours post-SUBLOCADE dose | 8 hours post-SUBLOCADE dose | 12 hours post-SUBLOCADE dose | 16 hours post-SUBLOCADE dose | 20 hours post-SUBLOCADE dose | 24 hours post-SUBLOCADE dose | 30 hours post-SUBLOCADE dose | 36 hours post-SUBLOCADE dose | 48 hours post-SUBLOCADE dose | Day 8 | Day 15 | Day 22 | End of Treatment Day 29 |
---|
TM Buprenorphine Followed by SUBLOCADE 300 mg | 12.5 | 14.6 | 12.6 | 11.1 | 10.1 | 9.1 | 8.0 | 6.9 | 6.6 | 6.6 | 6.0 | 5.0 | 4.2 | 3.9 | 3.5 | 2.8 | 1.9 | 2.0 | 2.0 | 1.8 |
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Adverse Event (AE) Reporting of Belbuca, Oxycodone Hydrochloride and Placebo for 6 Periods.
Number of Participants with indicated Adverse Event (AE) in subjects receiving Belbuca, oxycodone hydrochloride, and placebo for 6 periods. (NCT03996694)
Timeframe: 44 days
Intervention | participants (Number) |
---|
| Mild | Moderate | Severe |
---|
Treatment A: Belbuca 300 µg and Oral Placebo | 7 | 1 | 0 |
,Treatment B: Belbuca 600 µg and Oral Placebo | 11 | 1 | 0 |
,Treatment C: Belbuca 900 µg and Oral Placebo | 10 | 2 | 0 |
,Treatment D: Oxycodone 30 mg and Buccal Placebo | 8 | 1 | 0 |
,Treatment E: Oxycodone 60 mg and Buccal Placebo | 12 | 2 | 0 |
,Treatment F: Oral Placebo and Buccal Placebo | 2 | 0 | 0 |
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Respiratory Drive
Respiratory drive was evaluated by measuring the Ventilatory Response to Hypercapnia (VRH) through assessment of the maximum decrease (Emax) in minute ventilation (mL/min) after administration of Belbuca, Oxycodone hydrochloride, and placebo. (NCT03996694)
Timeframe: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3 and 4 hours
Intervention | mL/min (Mean) |
---|
Treatment A: Belbuca 300 µg and Oral Placebo | 23957.34 |
Treatment B: Belbuca 600 µg and Oral Placebo | 22460.95 |
Treatment C: Belbuca 900 µg and Oral Placebo | 23626.79 |
Treatment D: Oxycodone 30 mg and Buccal Placebo | 21577.15 |
Treatment E: Oxycodone 60 mg and Buccal Placebo | 17223.80 |
Treatment F: Oral Placebo and Buccal Placebo | 22645.74 |
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Change in Ratio of Minute Ventilation
Change in ratio of maximum decrease (Emax) in minute ventilation (mL/min) over maximum (Emax) end-tidal carbon dioxide (CO2, mmHg) after administration of Belbuca, oxycodone hydrochloride, and placebo. (NCT03996694)
Timeframe: pre-dose, 0.5, 1, 2, 2.5, 3 and 4 hours
Intervention | ratio (Mean) |
---|
Treatment A: Belbuca 300 µg and Oral Placebo | 591.74 |
Treatment B: Belbuca 600 µg and Oral Placebo | 536.28 |
Treatment C: Belbuca 900 µg and Oral Placebo | 576.76 |
Treatment D: Oxycodone 30 mg and Buccal Placebo | 518.81 |
Treatment E: Oxycodone 60 mg and Buccal Placebo | 411.88 |
Treatment F: Oral Placebo and Buccal Placebo | 546.09 |
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Pupil Diameter
Pupil diameter will be assessed by pupillometry predose and at multiple timepoints after completion of Belbuca, oxycodone hydrochloride, and placebo dosing. (NCT03996694)
Timeframe: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3 and 4 hours
Intervention | mm (Mean) |
---|
| Predose | 0.5 hours Post | 1 hour Post | 1.5 hours Post | 2 hours Post | 2.5 hours Post | 3 hours Post | 4 hours Post |
---|
Treatment A: Belbuca 300 µg and Oral Placebo | 4.93 | 4.65 | 4.49 | 4.42 | 3.89 | 3.87 | 3.67 | 3.57 |
,Treatment B: Belbuca 600 µg and Oral Placebo | 5.11 | 5.00 | 4.83 | 4.45 | 3.80 | 3.56 | 3.31 | 3.25 |
,Treatment C: Belbuca 900 µg and Oral Placebo | 4.91 | 4.91 | 4.32 | 3.85 | 3.27 | 3.15 | 2.99 | 2.92 |
,Treatment D: Oxycodone 30 mg and Buccal Placebo | 5.11 | 4.17 | 3.09 | 3.16 | 3.17 | 3.31 | 3.28 | 3.51 |
,Treatment E: Oxycodone 60 mg and Buccal Placebo | 4.82 | 3.48 | 2.77 | 2.81 | 2.7 | 2.87 | 2.82 | 2.90 |
,Treatment F: Oral Placebo and Buccal Placebo | 4.87 | 4.90 | 4.71 | 4.75 | 4.65 | 4.89 | 4.80 | 4.89 |
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Treatment Emergent Adverse Event (TEAE) Occurrence
Study will report the number of participants with the occurrence of any TEAE during the treatment period. (NCT04060654)
Timeframe: From time of informed consent at Day 1 until EOT, assessed up until Day 141
Intervention | Participants (Count of Participants) |
---|
SUBLOCADE | 0 |
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Pain Score 1 Hour After Osmotic Dilator Insertion
Median pain score on a 0 (no pain) to 10 (worst pain) numeric rating scale 1 hour after osmotic dilator insertion assessed via text message (NCT04254081)
Timeframe: 1 hour after osmotic dilator insertion
Intervention | score on a scale (Median) |
---|
Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block | 2 |
1% Lidocaine Paracervical Block | 3.5 |
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Pain Score 2 Hours After Osmotic Dilator Insertion
Median pain score on a 0 (no pain) to 10 (worst pain) numeric rating scale 2 hours after osmotic dilator insertion assessed via text message (NCT04254081)
Timeframe: 2 hours after osmotic dilator insertion
Intervention | score on a scale (Median) |
---|
Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block | 3 |
1% Lidocaine Paracervical Block | 3.5 |
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Pain Score 6 Hours After Osmotic Dilator Insertion
Median pain score on a 0 (no pain) to 10 (worst pain) numeric rating scale 6 hours after osmotic dilator insertion assessed via text message (NCT04254081)
Timeframe: 6 hours after osmotic dilator insertion
Intervention | score on a scale (Median) |
---|
Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block | 3 |
1% Lidocaine Paracervical Block | 3 |
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Pain Score at the Time of Osmotic Dilator Insertion
Median pain score on a 0 (no pain) to 10 (worst pain) numeric rating scale at the time of osmotic dilator insertion (NCT04254081)
Timeframe: Assessed immediately after last dilator inserted
Intervention | score on a scale (Median) |
---|
Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block | 3.5 |
1% Lidocaine Paracervical Block | 4.0 |
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Number of Participants With Suicidal Ideation and/or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician administered assessment tool that evaluates suicidal ideation and behavior. Number of participants that have an affirmative response to the 5 items for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods (not plan) without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and/or to the 5 items for suicidal behavior (1. Preparatory acts or behavior, 2. Aborted attempt, 3. Interrupted attempt, 4. Actual attempt, 5. Completed suicide) were reported. (NCT04447287)
Timeframe: Up to day 27
Intervention | Participants (Count of Participants) |
---|
Buprenorphine/Naloxone (Run-in Period) | 0 |
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | 0 |
ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period) | 0 |
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | 0 |
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period) | 0 |
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Pharmacokinetics (PK) of ASP8062 in Plasma: Area Under the Concentration-time Curve From the Time of Dosing Extrapolated to Time Infinity (AUCinf)
AUCinf was recorded from the PK plasma samples collected. Samples for AUCinf were collected for arm 'ASP8062 in combination with buprenorphine/naloxone' at Day 12. (NCT04447287)
Timeframe: Predose on day 12 and at the following postdose time points on day 12: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216 and 264 hour(s)
Intervention | h*ng/mL (Mean) |
---|
ASP8062 in Combination With Buprenorphine/Naloxone | 4450 |
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Pharmacokinetics (PK) of ASP8062 in Plasma: Area Under the Concentration-time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast)
AUClast was recorded from the PK plasma samples collected. Samples for AUClast were collected for arm 'ASP8062 in combination with buprenorphine/naloxone' at Day 12. (NCT04447287)
Timeframe: Predose on day 12 and at the following postdose time points on day 12: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216 and 264 hour(s)
Intervention | h*ng/mL (Mean) |
---|
ASP8062 in Combination With Buprenorphine/Naloxone | 4270 |
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Pharmacokinetics (PK) of ASP8062 in Plasma: Maximum Concentration (Cmax)
Cmax was recorded from the PK plasma samples collected. Samples for Cmax were collected for arm 'ASP8062 in combination with buprenorphine/naloxone' at Day 12. (NCT04447287)
Timeframe: Predose on day 12 and at the following postdose time points on day 12: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216 and 264 hour(s)
Intervention | ng/mL (Mean) |
---|
ASP8062 in Combination With Buprenorphine/Naloxone | 152 |
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Pharmacokinetics (PK) of Buprenorphine in Plasma: Area Under the Concentration-time Curve From the Time of Dosing to 24 Hours (AUC24)
AUC24 was recorded from the PK plasma samples collected. Samples for AUC24 were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12. (NCT04447287)
Timeframe: Predose on day 11 and at the following postdose time points on day 11: 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 16 hour(s)
Intervention | h*pg/mL (Mean) |
---|
Buprenorphine/Naloxone | 63800 |
ASP8062 in Combination With Buprenorphine/Naloxone | 53500 |
Placebo ASP8062 in Combination With Buprenorphine/Naloxone | 67700 |
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Pharmacokinetics (PK) of Buprenorphine in Plasma: Cmax
Cmax was recorded from the PK plasma samples collected. Samples for Cmax were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12. (NCT04447287)
Timeframe: Predose on day 11 and at the following postdose time points on day 11: 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 16 hour(s)
Intervention | pg/mL (Mean) |
---|
Buprenorphine/Naloxone | 7790 |
ASP8062 in Combination With Buprenorphine/Naloxone | 6790 |
Placebo ASP8062 in Combination With Buprenorphine/Naloxone | 8440 |
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Pharmacokinetics (PK) of Naloxone in Plasma: AUC24
AUC24 was recorded from the PK plasma samples collected. Samples for AUC24 were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12. (NCT04447287)
Timeframe: Predose on day 12 and at the following postdose time points on day 12: 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 168, 216 and 264 hour(s)
Intervention | h*pg/mL (Mean) |
---|
Buprenorphine/Naloxone | 1270 |
ASP8062 in Combination With Buprenorphine/Naloxone | 1060 |
Placebo ASP8062 in Combination With Buprenorphine/Naloxone | 1090 |
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Pharmacokinetics (PK) of Naloxone in Plasma: Cmax
Cmax was recorded from the PK plasma samples collected. Samples for Cmax were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12. (NCT04447287)
Timeframe: Predose on day 12 and at the following postdose time points on day 12: 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 168, 216 and 264 hour(s)
Intervention | pg/mL (Mean) |
---|
Buprenorphine/Naloxone | 464 |
ASP8062 in Combination With Buprenorphine/Naloxone | 382 |
Placebo ASP8062 in Combination With Buprenorphine/Naloxone | 363 |
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Number of Participants With Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered an Investigational Product (IP) and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding; abnormal laboratory test result or other safety assessment, symptom, or disease temporally associated with the use of IP whether or not considered related to the IP. A treatment-emergent adverse event (TEAE) was defined as an AE with onset at any time from first dosing until last scheduled procedure. AEs were considered serious (SAEs) if the AE resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization. (NCT04447287)
Timeframe: From first dose of study drug up to end of study visit (up to day 27)
Intervention | Participants (Number) |
---|
| TEAE | Drug-Related TEAE | Serious TEAE | Drug-Related Serious TEAE | TEAE Leading to Death | Drug-Related TEAE Leading to Death | TEAE Leading to Withdrawal of Treatment | Drug-Related TEAE Leading to Withdrawal of Treatment | Death |
---|
ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period) | 7 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | 6 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Buprenorphine/Naloxone (Run-in Period) | 16 | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period) | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | 6 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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Change From Baseline in End Tidal Carbon Dioxide (CO2) at 8 Hour Postdose
End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. (NCT04447287)
Timeframe: 'buprenorphine/naloxone': Baseline and 8 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 8 hour postdose Day 12
Intervention | mmHg (Mean) |
---|
Buprenorphine/Naloxone (Run-in Period) | 3.1 |
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | 1.4 |
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | 6.0 |
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Change From Baseline in End Tidal Carbon Dioxide (CO2) at 4 Hour Postdose
End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. (NCT04447287)
Timeframe: 'buprenorphine/naloxone': Baseline and 4 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 4 hour postdose Day 12
Intervention | mmHg (Mean) |
---|
Buprenorphine/Naloxone (Run-in Period) | 0.9 |
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | -1.0 |
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | 5.3 |
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Change From Baseline in End Tidal Carbon Dioxide (CO2) at 2 Hour Postdose
End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. (NCT04447287)
Timeframe: 'buprenorphine/naloxone': Baseline and 2 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 2 hour postdose Day 12
Intervention | mmHg (Mean) |
---|
Buprenorphine/Naloxone (Run-in Period) | 1.2 |
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | 0.3 |
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | 4.2 |
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Change From Baseline in End Tidal Carbon Dioxide (CO2) at 1 Hour Postdose
End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. (NCT04447287)
Timeframe: 'buprenorphine/naloxone': Baseline and 1 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 1 hour postdose Day 12
Intervention | mmHg (Mean) |
---|
Buprenorphine/Naloxone (Run-in Period) | 1.3 |
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | -0.5 |
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | 3.7 |
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Change From Baseline in Blood Oxygen Saturation (SpO2) at Predose
The blood oxygen saturation (SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose. (NCT04447287)
Timeframe: 'buprenorphine/naloxone': Baseline and 1 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 1 hour postdose Day 12
Intervention | Percentage of oxygen saturation (Mean) |
---|
Buprenorphine/Naloxone (Run-in Period) | 0.2 |
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | -0.4 |
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | -0.3 |
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Change From Baseline in Blood Oxygen Saturation (SpO2) at 8 Hour Postdose
The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose. (NCT04447287)
Timeframe: 'buprenorphine/naloxone': Baseline and 8 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 8 hour postdose Day 12
Intervention | Percentage of oxygen saturation (Mean) |
---|
Buprenorphine/Naloxone (Run-in Period) | 0.1 |
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | -0.1 |
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | 0.7 |
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Change From Baseline in Blood Oxygen Saturation (SpO2) at 4 Hour Postdose
The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose. (NCT04447287)
Timeframe: 'buprenorphine/naloxone': Baseline and 4 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 4 hour postdose Day 12
Intervention | Percentage of oxygen saturation (Mean) |
---|
Buprenorphine/Naloxone (Run-in Period) | 0.3 |
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | -0.4 |
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | -0.2 |
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Change From Baseline in Blood Oxygen Saturation (SpO2) at 12 Hour Postdose
The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose. (NCT04447287)
Timeframe: 'buprenorphine/naloxone': Baseline and 12 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 12 hour postdose Day 12
Intervention | Percentage of oxygen saturation (Mean) |
---|
Buprenorphine/Naloxone (Run-in Period) | -0.6 |
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | -0.3 |
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | -0.5 |
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Change From Baseline in Blood Oxygen Saturation (SpO2) at 1 Hour Postdose
The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose. (NCT04447287)
Timeframe: 'buprenorphine/naloxone': Baseline and 1 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 1 hour postdose Day 12
Intervention | Percentage of oxygen saturation (Mean) |
---|
Buprenorphine/Naloxone (Run-in Period) | 0.1 |
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | -0.6 |
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | -0.7 |
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Change From Baseline in End Tidal Carbon Dioxide (CO2) at Predose
End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. (NCT04447287)
Timeframe: 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and predose Day 12
Intervention | mmHg (Mean) |
---|
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | -1.3 |
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | 0.5 |
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Change From Baseline in Blood Oxygen Saturation (SpO2) at 2 Hour Postdose
The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose. (NCT04447287)
Timeframe: 'buprenorphine/naloxone': Baseline and 2 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 2 hour postdose Day 12
Intervention | Percentage of oxygen saturation (Mean) |
---|
Buprenorphine/Naloxone (Run-in Period) | 0.2 |
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | -0.8 |
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | 0.3 |
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