buprenorphine, naloxone drug combination profile

Buprenorphine, Naloxone Drug Combination: A pharmaceutical preparation that combines buprenorphine, an OPIOID ANALGESICS with naloxone, a NARCOTIC ANTAGONISTS to reduce the potential for NARCOTIC DEPENDENCE in the treatment of pain. It may also be used for OPIOID SUBSTITUTION THERAPY. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

ID Source	ID
PubMed CID	11274356
MeSH ID	M0498625

Synonym
buprenorphine-naloxone combination
buprenorphine hydrochloride and naloxone hydrochloride
naloxone-buprenorphine
bunavail
buprenorphine-naloxone
buprenorphine / naloxone
zubsolv
buprenorphine and naloxone
buprenorphine, naloxone drug combination
352020-56-5
DTXSID50188706
(4r,4as,7ar,12bs)-4a,9-dihydroxy-3-prop-2-enyl-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;(1s,2s,6r,14r,15r,16r)-5-(cyclopropylmethyl)-16-[(2s)-2-hydroxy-3,3-dimethylbutan-2-yl]-15-methoxy-13-oxa-5-azahexacyclo[13.2.2.12,8.01

Excerpt	Reference
" Two participants experienced grade 3 clinical adverse events, which were categorized as probably not related to the study drug."	( Short-term safety of buprenorphine/naloxone in HIV-seronegative opioid-dependent Chinese and Thai drug injectors enrolled in HIV Prevention Trials Network 058. Aramrattana, A; Beauchamp, G; Celentano, DD; Fu, L; Jackson, JB; Liu, W; Lucas, GM; Metzger, D; Richardson, P; Shao, Y, 2012)
"In Chinese and Thai opioid-dependent injectors, we found BUP/NX to be effective in reducing opioid withdrawal symptoms and safe during short-term use."	( Short-term safety of buprenorphine/naloxone in HIV-seronegative opioid-dependent Chinese and Thai drug injectors enrolled in HIV Prevention Trials Network 058. Aramrattana, A; Beauchamp, G; Celentano, DD; Fu, L; Jackson, JB; Liu, W; Lucas, GM; Metzger, D; Richardson, P; Shao, Y, 2012)
"8%) reported 557 treatment-emergent adverse events, most commonly headache (3."	( Safety of a Rapidly Dissolving Buprenorphine/Naloxone Sublingual Tablet (BNX-RDT) for Treatment of Opioid Dependence: A Multicenter, Open-label Extension Study. Hoffman, K; Peyton, ML; Sumner, M, )
" In Norway, there has been vocal patient resistance to the newest medication, buprenorphine-naloxone (BNX), and complaints have focused on the side effect profile."	( Dissatisfaction with opioid maintenance treatment partly explains reported side effects of medications. Bjørnestad, R; Clausen, T; Muller, AE, 2018)
" Among each medication group, dissatisfaction with medications or OMT in general along with poor health status increased the relative risk ratio of reporting the heaviest side effect burden."	( Dissatisfaction with opioid maintenance treatment partly explains reported side effects of medications. Bjørnestad, R; Clausen, T; Muller, AE, 2018)
"Data on retention, use of heroin and other illicit substances, opioid craving, treatment satisfaction, addiction-related problems and adverse events were reported every fourth week."	( Effectiveness, safety and feasibility of extended-release naltrexone for opioid dependence: a 9-month follow-up to a 3-month randomized trial. Benth, JŠ; Krajci, P; Kunoe, N; Latif, ZE; Opheim, A; Sharma-Haase, K; Solli, KK; Tanum, L, 2018)
"Opioid-dependent individuals who elect to switch from buprenorphine-naltrexone treatment after 3 months to extended-release naltrexone treatment for 9 months appear to experience similar treatment completion and abstinence rates and similar adverse event profiles to individuals who had been on extended-release naltrexone from the start of treatment."	( Effectiveness, safety and feasibility of extended-release naltrexone for opioid dependence: a 9-month follow-up to a 3-month randomized trial. Benth, JŠ; Krajci, P; Kunoe, N; Latif, ZE; Opheim, A; Sharma-Haase, K; Solli, KK; Tanum, L, 2018)
" However, adverse effects of BNX can be a cause of inconsistent use or discontinuation."	( Prescribing the Buprenorphine Monoproduct for Adverse Effects of Buprenorphine-Naloxone. Grande, LA, )
" Although a comprehensive evaluation of TiOAT is of critical importance (including an assessment of the program's adverse events), completion of the evaluation should not preclude scale-up of the program in the interim as a strategy to reduce opioid-related harms."	( Supervised Tablet Injectable Opioid Agonist Therapy (TiOAT): A Strategy to Address Safer Supply for Individuals With an Opioid Use Disorder? Fairbairn, N; Johnson, C; Nolan, S; Sutherland, C; Weng, J, )
" This study assessed (1) the current medication storage practices among a sample of pregnant and parenting people receiving BUP-NAL for OUD; (2) the feasibility and acceptability of providing a lockbox for safe medication storage."	( Harm Reduction Approach to Increasing Self-reported Safe Medication Storage Among Pregnant and Parenting People Receiving Opioid Use Disorder Treatment. Dacha, P; Grist, E; Lutins, E; Martin, CE; Maxwell, M; Thakkar, B, )
" The primary outcome of current self-reported safe medication storage practice was defined by storing BUP-NAL in a locked/latched place "almost always" or "always" on the baseline survey."	( Harm Reduction Approach to Increasing Self-reported Safe Medication Storage Among Pregnant and Parenting People Receiving Opioid Use Disorder Treatment. Dacha, P; Grist, E; Lutins, E; Martin, CE; Maxwell, M; Thakkar, B, )
"6%) were practicing safe BUP-NAL medication storage practices."	( Harm Reduction Approach to Increasing Self-reported Safe Medication Storage Among Pregnant and Parenting People Receiving Opioid Use Disorder Treatment. Dacha, P; Grist, E; Lutins, E; Martin, CE; Maxwell, M; Thakkar, B, )
" We examined associations between highest BUP-NX and methadone doses, and (1) percentage of opioid-positive urine drug screens (UDS); (2) retention in the assigned treatment; and (3) adverse events (AEs)."	( Associations of methadone and buprenorphine-naloxone doses with unregulated opioid use, treatment retention, and adverse events in prescription-type opioid use disorders: Exploratory analyses of the OPTIMA study. Ahamad, K; Bakouni, H; Foll, BL; Jutras-Aswad, D; Lim, R; McAnulty, C; Socias, ME; Tatar, O, 2023)

Excerpt	Reference
" The addition of naloxone does not affect the efficacy of buprenorphine for two reasons: (1) naloxone is poorly absorbed sublingually relative to buprenorphine and (2) the half-life for buprenorphine is much longer than for naloxone (32 vs."	( Pharmacokinetics of the combination tablet of buprenorphine and naloxone. Chiang, CN; Hawks, RL, 2003)
" Serial blood samples were taken for pharmacokinetic analysis."	( Effect of steady-state faldaprevir on the pharmacokinetics of steady-state methadone and buprenorphine-naloxone in subjects receiving stable addiction management therapy. Adeniji, A; Elgadi, M; Huang, F; Joseph, D; Riesenberg, RR; Schobelock, MJ; Vince, BD; Webster, LR, 2015)
" Blood samples were collected up to 168 h and pharmacokinetic parameters were calculated using non-compartmental analysis."	( Pharmacokinetics of Sublingual Buprenorphine and Naloxone in Subjects with Mild to Severe Hepatic Impairment (Child-Pugh Classes A, B, and C), in Hepatitis C Virus-Seropositive Subjects, and in Healthy Volunteers. Fudala, PJ; Heidbreder, C; Liu, Y; Nasser, AF, 2015)
" The authors evaluated the pharmacokinetic interaction of boceprevir with methadone or buprenorphine/naloxone in patients on stable maintenance therapy."	( Pharmacokinetic interaction between HCV protease inhibitor boceprevir and methadone or buprenorphine in subjects on stable maintenance therapy. Bruce, RD; Butterton, JR; Feng, HP; Hulskotte, EG; Lin, WH; O'Mara, E; Wagner, JA; Webster, LR; Xuan, F, 2015)
"Study 206216 (NCT02666001) was a Phase I, open-label study, assessing the effect of FTR 600 mg (extended-release formulation) twice daily on pharmacokinetics of MET or BUP and norBUP, in non-HIV-infected participants on stable maintenance therapy with MET (40-120 mg; n = 16) or BUP plus naloxone (8-24 mg plus 2-6 mg; n = 16); pharmacodynamic response was assessed using standard opioid rating scales."	( Methadone and buprenorphine pharmacokinetics and pharmacodynamics when coadministered with fostemsavir to opioid-dependent, human immunodeficiency virus seronegative participants. Ackerman, P; Chang, M; Llamoso, C; Lubin, S; Magee, M; Moore, K; Myers, E; Sevinsky, H, 2019)
" Opioid pharmacodynamic scores were similar with and without MET/BUP with no symptoms of withdrawal/overdose; no new safety signal for FTR when combined with a stable opioid regimen."	( Methadone and buprenorphine pharmacokinetics and pharmacodynamics when coadministered with fostemsavir to opioid-dependent, human immunodeficiency virus seronegative participants. Ackerman, P; Chang, M; Llamoso, C; Lubin, S; Magee, M; Moore, K; Myers, E; Sevinsky, H, 2019)
" As such, kratom may precipitate pharmacokinetic drug interactions when co-consumed with certain medications."	( A Case of Potential Pharmacokinetic Kratom-drug Interactions Resulting in Toxicity and Subsequent Treatment of Kratom Use Disorder With Buprenorphine/Naloxone. Brogdon, HD; Burns, AG; Cox, EJ; McPhee, MM; Paine, MF, )

Excerpt	Reference
" Daclatasvir is a potent pangenotypic inhibitor of the HCV NS5A replication complex recently approved for HCV treatment in Europe and Japan in combination with other antivirals."	( Assessment of drug-drug interactions between daclatasvir and methadone or buprenorphine-naloxone. Bertz, R; Bifano, M; Bruce, RD; DeMicco, M; Garimella, T; Hwang, C; Kandoussi, H; Luo, WL; Wang, R; Wastall, P, 2015)
" Subjects received methadone (arm 1) or buprenorphine-naloxone (arm 2) once daily (QD) per their existing individual prescriptions alone (days 1 to 9) and then in combination with glecaprevir at 300 mg QD and pibrentasvir at 120 mg QD (days 10 to 16) each morning."	( No Clinically Relevant Drug-Drug Interactions between Methadone or Buprenorphine-Naloxone and Antiviral Combination Glecaprevir and Pibrentasvir. Asatryan, A; Geoffroy, P; Kort, J; Kosloski, MP; Liu, W; Zhao, W, 2017)
" Opioid pharmacodynamic scores were similar with and without MET/BUP with no symptoms of withdrawal/overdose; no new safety signal for FTR when combined with a stable opioid regimen."	( Methadone and buprenorphine pharmacokinetics and pharmacodynamics when coadministered with fostemsavir to opioid-dependent, human immunodeficiency virus seronegative participants. Ackerman, P; Chang, M; Llamoso, C; Lubin, S; Magee, M; Moore, K; Myers, E; Sevinsky, H, 2019)
" FTR can be administered with MET or BUP without dose adjustment."	( Methadone and buprenorphine pharmacokinetics and pharmacodynamics when coadministered with fostemsavir to opioid-dependent, human immunodeficiency virus seronegative participants. Ackerman, P; Chang, M; Llamoso, C; Lubin, S; Magee, M; Moore, K; Myers, E; Sevinsky, H, 2019)

Excerpt	Reference
" The addition of naloxone does not affect the efficacy of buprenorphine for two reasons: (1) naloxone is poorly absorbed sublingually relative to buprenorphine and (2) the half-life for buprenorphine is much longer than for naloxone (32 vs."	( Pharmacokinetics of the combination tablet of buprenorphine and naloxone. Chiang, CN; Hawks, RL, 2003)
" We compared the bioavailability and pharmaceutical properties of BNX-RDT with conventional buprenorphine/naloxone sublingual tablets (BNX)."	( Pharmacokinetic and pharmaceutical properties of a novel buprenorphine/naloxone sublingual tablet for opioid substitution therapy versus conventional buprenorphine/naloxone sublingual tablet in healthy volunteers. Jönsson, M; Mundin, G; Sumner, M, 2018)
" These include higher bioavailability transmucosal tablets and films and also 6-month implantable and monthly injectable products."	( Buprenorphine Pharmacology Review: Update on Transmucosal and Long-acting Formulations. Coe, MA; Lofwall, MR; Walsh, SL, )
" Because naloxone has relatively low sublingual bioavailability compared with buprenorphine, adverse effects are generally considered mild and rare."	( The Naloxone Component of Buprenorphine/Naloxone: Discouraging Misuse, but at What Cost? Blazes, C; Gregg, J; Hartley, J; Lawrence, D; Risser, A, )
"Due to the poor oral bioavailability of buprenorphine, an oral formulation has not been thought possible."	( A novel long-acting formulation of oral buprenorphine/naloxone produces prolonged decreases in fentanyl self-administration by rhesus monkeys. Comer, SD; Foltin, RW; Nagaraj, N; Scranton, RE; Sykes, KA; Zale, S, 2022)

Excerpt	Reference
"To compare the effectiveness and cost-effectiveness of unobserved versus observed dosing of patients seeking treatment of heroin dependence."	( A randomized trial of effectiveness and cost-effectiveness of observed versus unobserved administration of buprenorphine-naloxone for heroin dependence. Batey, R; Bell, J; Dunlop, A; Mutch, C; Rea, F; Ryan, A; Shanahan, M; Winstock, A, 2007)
"Participants were allocated randomly to observed or unobserved dosing for 3 months."	( A randomized trial of effectiveness and cost-effectiveness of observed versus unobserved administration of buprenorphine-naloxone for heroin dependence. Batey, R; Bell, J; Dunlop, A; Mutch, C; Rea, F; Ryan, A; Shanahan, M; Winstock, A, 2007)
"Retention and heroin use was not significantly different between observed and unobserved dosing groups."	( A randomized trial of effectiveness and cost-effectiveness of observed versus unobserved administration of buprenorphine-naloxone for heroin dependence. Batey, R; Bell, J; Dunlop, A; Mutch, C; Rea, F; Ryan, A; Shanahan, M; Winstock, A, 2007)
"Non-blinded dosing with Suboxone during the 1-month stabilization phase included 3 weeks of flexible dosing as determined appropriate by the study physicians."	( Buprenorphine tapering schedule and illicit opioid use. Annon, J; Bilangi, R; Boverman, J; Domier, C; Doraimani, G; Hasson, A; Hillhouse, M; Hunter, J; Jenkins, J; Ling, W; Saxon, A; Selzer, J; Thomas, C, 2009)
" Development of opioid withdrawal symptoms was the primary outcome, however the only symptom that was significantly associated with BPN/NLX dosage was the report of "stomach pains" (p = ."	( Lack of reduction in buprenorphine injection after introduction of co-formulated buprenorphine/naloxone to the Malaysian market. Altice, FL; Bruce, RD; Govindasamy, S; Kamarulzaman, A; Sylla, L, 2009)
"After 3 weeks of flexible dosing, 516 participants were categorized by dose provided in the final dosing week (9."	( Participant characteristics and buprenorphine dose. Canamar, CP; Doraimani, G; Hasson, A; Hillhouse, M; Ling, W; Thomas, C, 2011)
" These groups also differed in opioid use during the four dosing weeks, with the lowest use in the 8 mg group and highest use in the 24 mg group (p < ."	( Participant characteristics and buprenorphine dose. Canamar, CP; Doraimani, G; Hasson, A; Hillhouse, M; Ling, W; Thomas, C, 2011)
"The dosing of opioid receptor agonist medications adequately and on an individual basis is crucial in the pharmacotherapy of opioid dependence."	( Evaluation of buprenorphine dosage adequacy in opioid receptor agonist substitution therapy for heroin dependence: first use of the BUprenorphine-naloxone Dosage Adequacy eVAluation (BUDAVA) questionnaire. Amato, P; Armenante, C; Auriemma, F; Biancolillo, V; Cassese, F; D'Amore, A; Del Tufo, S; Lauro, G; Oliva, P; Pizzirusso, A; Romano, F; Ruoppolo, C, 2012)
" Dosage adequacy was assessed with the BUDAVA questionnaire."	( Evaluation of buprenorphine dosage adequacy in opioid receptor agonist substitution therapy for heroin dependence: first use of the BUprenorphine-naloxone Dosage Adequacy eVAluation (BUDAVA) questionnaire. Amato, P; Armenante, C; Auriemma, F; Biancolillo, V; Cassese, F; D'Amore, A; Del Tufo, S; Lauro, G; Oliva, P; Pizzirusso, A; Romano, F; Ruoppolo, C, 2012)
"The buprenorphine-naloxone dosage was found to be inadequate in 61 of the 196 patients."	( Evaluation of buprenorphine dosage adequacy in opioid receptor agonist substitution therapy for heroin dependence: first use of the BUprenorphine-naloxone Dosage Adequacy eVAluation (BUDAVA) questionnaire. Amato, P; Armenante, C; Auriemma, F; Biancolillo, V; Cassese, F; D'Amore, A; Del Tufo, S; Lauro, G; Oliva, P; Pizzirusso, A; Romano, F; Ruoppolo, C, 2012)
" At the longest trial duration, a bell-shaped dose-response curve was obtained with buprenorphine, which was shifted significantly to the right with naloxone combination."	( Rewarding or aversive effects of buprenorphine/naloxone combination (Suboxone) depend on conditioning trial duration. Canestrelli, C; Marie, N; Noble, F, 2014)
" Adequate dosing levels are important to control cravings, prevent withdrawal syndrome, and maintain patients in treatment."	( Analysis of buprenorphine/naloxone dosing impact on treatment duration, resource use and costs in the treatment of opioid-dependent adults: a retrospective study of US public and private health care claims. Kharitonova, E; Khemiri, A; Ruby, J; Toumi, M; Zah, V, 2014)
" The threshold for differentiating the dosing groups was set at 15 and 15."	( Analysis of buprenorphine/naloxone dosing impact on treatment duration, resource use and costs in the treatment of opioid-dependent adults: a retrospective study of US public and private health care claims. Kharitonova, E; Khemiri, A; Ruby, J; Toumi, M; Zah, V, 2014)
" Although individual data showed moderate variability in the exposures between subjects and treatments, there was no evidence of symptoms of opiate overdose or withdrawal either during the coadministration of faldaprevir with methadone or buprenorphine-naloxone or after faldaprevir dosing was stopped."	( Effect of steady-state faldaprevir on the pharmacokinetics of steady-state methadone and buprenorphine-naloxone in subjects receiving stable addiction management therapy. Adeniji, A; Elgadi, M; Huang, F; Joseph, D; Riesenberg, RR; Schobelock, MJ; Vince, BD; Webster, LR, 2015)
" Given that sub-optimal dosing of BNX increases the risk of diversion, more attention should be paid to providing patients with an optimal medical dose."	( Diversion of opioid maintenance treatment medications and predictors for diversion among Finnish maintenance treatment patients. Alho, H; Kotovirta, E; Launonen, E; Simojoki, K; Wallace, I, 2015)
" This study examined (i) how initiations and transfers were implemented, (ii) the profile and predictors of adverse effects as self-reported by BNX film clients, and (iii) dosing issues."	( The introduction of buprenorphine-naloxone film in opioid substitution therapy in Australia: Uptake and issues arising from changing buprenorphine formulations. Ali, R; Degenhardt, L; Dietze, P; Jenkinson, R; Larance, B; Lintzeris, N; White, N, 2015)
"BUP induction dosing was guided by an objective measure of opioid withdrawal."	( Treatment outcomes in opioid dependent patients with different buprenorphine/naloxone induction dosing patterns and trajectories. Ang, A; Blaine, JD; Hillhouse, MP; Jacobs, P; Mai, BE; Mooney, LJ; Nielsen, S; S Potter, J; Saxon, AJ; Wakim, PG, 2015)
"The objective of this systematic review is to compare the effectiveness of OST with supervised dosing relative to dispensing of medication for off-site consumption."	( Supervised dosing with a long-acting opioid medication in the management of opioid dependence. Gowing, L; Saulle, R; Vecchi, S, 2017)
"Randomised controlled trials (RCTs), controlled clinical trials (CCTs), and prospective controlled cohort studies, involving people who are receiving OST (methadone, buprenorphine) and comparing supervised dosing with dispensing of medication to be consumed away from the dispensing point, usually without supervision."	( Supervised dosing with a long-acting opioid medication in the management of opioid dependence. Gowing, L; Saulle, R; Vecchi, S, 2017)
" There is uncertainty about the effects of supervised dosing compared with unsupervised medication due to the low and very low quality of the evidence for the primary outcomes of interest for this review."	( Supervised dosing with a long-acting opioid medication in the management of opioid dependence. Gowing, L; Saulle, R; Vecchi, S, 2017)
"The Opiate Dosage Adequacy Scale (ODAS) is a clinical tool to individually measure the "adequacy" of opioid doses in patients on maintenance treatment."	( Evidence of validity and reliability of the Opiate Dosage Adequacy Scale (ODAS) in a sample of heroin addicted patients in buprenorphine/naloxone maintenance treatment. Alcaraz, S; González-Saiz, F; Lozano Rojas, O; Pérez de Los Cobos, J; Siñol, N; Trujols, J, 2018)
" Most studies to date have been conducted among heroin users, in controlled settings, and using similar strict dosing schedules (i."	( The OPTIMA study, buprenorphine/naloxone and methadone models of care for the treatment of prescription opioid use disorder: Study design and rationale. Ahamad, K; Bruneau, J; Fischer, B; Jutras-Aswad, D; Le Foll, B; Lim, R; Socias, ME; Wild, TC; Wood, E, 2018)
"Buprenorphine dosage is a crucial factor influencing outcomes of buprenorphine treatment for heroin use disorders."	( A cluster-analytic profiling of heroin-dependent patients based on level, clinical adequacy, and patient-desired adjustment of buprenorphine dosage during buprenorphine-naloxone maintenance treatment in sixteen Spanish centers. Alcaraz, S; González-Saiz, F; Pérez de Los Cobos, J; Siñol, N; Trujols, J; Vergara-Moragues, E, 2018)
" Patients were grouped using cluster analysis based on three key indicators of buprenorphine dosage management: dose, adequacy according to physician, and adjustment according to patient."	( A cluster-analytic profiling of heroin-dependent patients based on level, clinical adequacy, and patient-desired adjustment of buprenorphine dosage during buprenorphine-naloxone maintenance treatment in sixteen Spanish centers. Alcaraz, S; González-Saiz, F; Pérez de Los Cobos, J; Siñol, N; Trujols, J; Vergara-Moragues, E, 2018)
"Our results show notable differences between clusters of heroin-dependent patients regarding buprenorphine dosage management."	( A cluster-analytic profiling of heroin-dependent patients based on level, clinical adequacy, and patient-desired adjustment of buprenorphine dosage during buprenorphine-naloxone maintenance treatment in sixteen Spanish centers. Alcaraz, S; González-Saiz, F; Pérez de Los Cobos, J; Siñol, N; Trujols, J; Vergara-Moragues, E, 2018)
" Future studies require standardized reporting of median doses, details on the route of delivery, dosing schedules and any dosing changes, and rates of addiction relapse, including long-term morbidity and mortality where possible."	( The perioperative patient on buprenorphine: a systematic review of perioperative management strategies and patient outcomes. Azargive, S; Bordman, J; Clarke, H; Di Renna, T; Duggan, S; Englesakis, M; Goel, A; Hanlon, J; Ladha, K; Lamba, W; Peng, P; Shanthanna, H; Srikandarajah, S, 2019)
"Extended-release naltrexone hydrochloride, 380 mg, administered as an injection every 4 weeks or flexible doses (4-24 mg; target dosage 16 mg/d) of daily oral combined BP-NLX."	( Anxiety, Depression, and Insomnia Among Adults With Opioid Dependence Treated With Extended-Release Naltrexone vs Buprenorphine-Naloxone: A Randomized Clinical Trial and Follow-up Study. Krajci, P; Kunoe, N; Latif, ZE; Opheim, A; Šaltyte Benth, J; Sharma-Haase, K; Solli, KK; Tanum, L, 2019)
"We recruited 3,620 patients in 27 addiction units in Italy and collected data on the self-reported rate of intravenous injection of methadone (MET), buprenorphine (BUP), BUP-naloxone (NLX), OMT dosage and type, experience of and reason for misuse, concurrent intravenous benzodiazepine misuse, pattern of -misuse in relation to admission to the addiction unit and ER -admissions because of misuse."	( Intravenous Misuse of Methadone, Buprenorphine and Buprenorphine-Naloxone in Patients Under Opioid Maintenance Treatment: A Cross-Sectional Multicentre Study. Cibin, M; Lugoboni, F; Tamburin, S; Zamboni, L, 2019)
" OMT dosage was lower than the recommended maintenance dosage."	( Intravenous Misuse of Methadone, Buprenorphine and Buprenorphine-Naloxone in Patients Under Opioid Maintenance Treatment: A Cross-Sectional Multicentre Study. Cibin, M; Lugoboni, F; Tamburin, S; Zamboni, L, 2019)
"Following coadministration with FTR, dose-normalized MET (R-, S- and total) exposures (maximum concentration in plasma, area under the plasma concentration-time curve over the dosing interval and concentration in plasma at 24 hours) increased 9-15% and BUP and norBUP exposures increased 24-39%."	( Methadone and buprenorphine pharmacokinetics and pharmacodynamics when coadministered with fostemsavir to opioid-dependent, human immunodeficiency virus seronegative participants. Ackerman, P; Chang, M; Llamoso, C; Lubin, S; Magee, M; Moore, K; Myers, E; Sevinsky, H, 2019)
" Supervised dosage and other control measures are important provisions in the prevention of drug diversion and non-prescribed use among people not undergoing OST."	( Non-prescribed use of methadone and buprenorphine prior to opioid substitution treatment: lifetime prevalence, motives, and drug sources among people with opioid dependence in five Swedish cities. Johnson, B; Richert, T, 2019)
" Study outcomes were based on presence of withdrawal symptoms, instances of unauthorized substances in urine drug tests (UDTs), and sublingual buprenorphine/naloxone (SBN) dose with standard-of-care (SOC) dosing versus pharmacogenomics (PGx)-based dosing."	( Pharmacogenomics and Opioid Use Disorder: Clinical Decision Support in an African American Cohort. Briggs, J; Chapman, E; Ettienne, EB; Ezeude, G; Maneno, MK; Ofoegbu, A; Walker, C; Williams, S, 2019)
"We aimed to use a microdosing regimen to initiate regular dosing of buprenorphine/naloxone in a high-risk patient with a history of failed initiations due, in part, to withdrawal symptoms."	( Case report: Successful induction of buprenorphine/naloxone using a microdosing schedule and assertive outreach. Azar, P; Barbic, SP; Durante, SE; Lin, D; Mathias, S; Mitchell, K; Nikoo, M; Rozylo, J, 2020)
" The aims of this review were to summarize eligibility criteria for entry to OAT, doses in routine clinical practice, access to and eligibility for unsupervised dosing and urine drug screening practices in OAT programs globally."	( Global opioid agonist treatment: a review of clinical practices by country. Ali, R; Bruneau, J; Degenhardt, L; Fiellin, DA; Hickman, M; Jin, H; Larney, S; Marshall, BDL; Strang, J, 2020)
" Access to unsupervised dosing under some conditions was reported in 18 of 27 countries."	( Global opioid agonist treatment: a review of clinical practices by country. Ali, R; Bruneau, J; Degenhardt, L; Fiellin, DA; Hickman, M; Jin, H; Larney, S; Marshall, BDL; Strang, J, 2020)
" According to the Canadian National clinical practice guideline on the management of opioid use disorders, given the superior safety profile of buprenorphine/naloxone and its potential for flexible take-home dosing in comparison to other opioid agonist medication it is strongly recommended to initiate opioid agonist treatment with buprenorphine/naloxone as the preferred first-line treatment when possible."	( Rapid Micro-induction of Buprenorphine/Naloxone for Opioid Use Disorder in a Critically ill Intubated Patient: A Case Report. Griesdale, D; Hamata, B; Hann, J; Rezazadeh-Azar, P, 2020)
" Our primary objective is to synthesize available evidence on the effectiveness of micro-inductions on patient and clinical outcomes compared to standard dosing or other approaches, or evaluated without a comparator group."	( Effectiveness of micro-induction approaches to buprenorphine initiation: A systematic review protocol. Azar, P; Doyle-Waters, MM; Hohl, CM; Moe, J; O'Sullivan, F, 2020)
"Dynamic, adaptive pharmacologic treatment for opioid use disorder (OUD) has been previously recommended over static dosing to prevent relapse, and is aligned with personalized medicine."	( Association between dynamic dose increases of buprenorphine for treatment of opioid use disorder and risk of relapse. Díaz, I; Fishman, M; Nunes, EV; Rotrosen, J; Rudolph, KE; Shulman, M, 2022)
" counterfactual) intervention in which their BUP-NX dosage would be increased following their own subject-specific opioid use during the first 12 weeks of treatment versus a hypothetical intervention in which dose would remain constant."	( Association between dynamic dose increases of buprenorphine for treatment of opioid use disorder and risk of relapse. Díaz, I; Fishman, M; Nunes, EV; Rotrosen, J; Rudolph, KE; Shulman, M, 2022)
" The secondary aim was to identify if comorbidities, sex, co-prescribed medications, or dosing site and observation were associated with BPN detection."	( Buprenorphine not detected on urine drug screening in supervised treatment. Athavale, A; Jamshidi, N; Murnion, B, 2021)
"Data extracted included UDS results, age, sex, indication for BPN, frequency of observed doses, dose of BPN, dosing site, comorbid medical conditions, and medications."	( Buprenorphine not detected on urine drug screening in supervised treatment. Athavale, A; Jamshidi, N; Murnion, B, 2021)
" No significant association between median dose, dosing site, and observed dosing and BPN detection was identified."	( Buprenorphine not detected on urine drug screening in supervised treatment. Athavale, A; Jamshidi, N; Murnion, B, 2021)
" We also examine the effect of buprenorphine dosage on retention."	( Association of Counseling and Psychotherapy on Retention in Medication for Addiction Treatment Within a Large Medicaid Population. Eren, K; Herschell, A; Houck, P; Hurford, M; Loveland, D; Mihalyo, M; Neimark, G; Ryan, N; Schuster, J, )
"The addition of counseling and psychotherapy within the first 8 weeks of treatment was associated with greater total retention in treatment and there was a dose-response relationship."	( Association of Counseling and Psychotherapy on Retention in Medication for Addiction Treatment Within a Large Medicaid Population. Eren, K; Herschell, A; Houck, P; Hurford, M; Loveland, D; Mihalyo, M; Neimark, G; Ryan, N; Schuster, J, )
" During the transition, she experienced some withdrawal in the setting of swallowed buprenorphine/naloxone tablets, which were intended to be dosed sublingually."	( Transition from Oxycodone to Buprenorphine/Naloxone in a Hospitalized Patient with Sickle Cell Disease: A Case Report. DeFries, T; Leyde, S; Pratt, L; Suen, L, 2022)
"Clinical studies examining once-daily versus multiple-daily dosing of buprenorphine/naloxone in patients with opioid use disorder (OUD) in the absence of comorbid pain are lacking."	( Outcomes associated with once-daily versus multiple-daily dosing of buprenorphine/naloxone for opioid use disorder. Allen, SM; Fawcett, J; Lin, S; Nichols, TA, 2022)
"This retrospective chart review aimed to compare 100 patients prescribed single-daily buprenorphine/naloxone (n = 50) to those prescribed multiple-daily buprenorphine/naloxone (n = 50) to elucidate the impact that dosing frequency has on negative urine drug screens (UDS) and the number of relapses in OUD."	( Outcomes associated with once-daily versus multiple-daily dosing of buprenorphine/naloxone for opioid use disorder. Allen, SM; Fawcett, J; Lin, S; Nichols, TA, 2022)
"Once-daily dosing was associated with more negative UDSs and fewer opioid relapses compared with multiple-daily dosing."	( Outcomes associated with once-daily versus multiple-daily dosing of buprenorphine/naloxone for opioid use disorder. Allen, SM; Fawcett, J; Lin, S; Nichols, TA, 2022)
"This was the first study to evaluate buprenorphine/naloxone dosing frequency for opioid use disorder, in the absence of chronic pain."	( Outcomes associated with once-daily versus multiple-daily dosing of buprenorphine/naloxone for opioid use disorder. Allen, SM; Fawcett, J; Lin, S; Nichols, TA, 2022)
" However, given that changes were small, strategies to improve retention in OAT and ensure equitable access to take-home dosing should continue."	( Impact of the COVID-19 pandemic on the provision of take-home doses of opioid agonist therapy in Ontario, Canada: A population-based time-series analysis. Antoniou, T; Bozinoff, N; Campbell, TJ; Gomes, T; Kitchen, SA; Men, S; Munro, C; Tadrous, M; Werb, D; Wyman, J, 2022)
"Flexible take-home dosing buprenorphine/naloxone or supervised methadone models of care for 24 weeks."	( Impact of fentanyl use on initiation and discontinuation of methadone and buprenorphine/naloxone among people with prescription-type opioid use disorder: secondary analysis of a Canadian treatment trial. Bozinoff, N; Bruneau, J; Choi, JC; Hassan, A; Jutras-Aswad, D; Le Foll, B; Lim, R; Mok, WY; Rehm, J; Socias, ME; Wild, TC; Wood, E, 2022)
" Once young people initiated OAT, staying on it was difficult and complicated by daily witnessed dosing requirements and strict rules around repeated missed doses, especially for those receiving methadone."	( Navigating Opioid Agonist Therapy among Young People who use Illicit Opioids in Vancouver, Canada. Buxton, JA; DeBeck, K; Fast, D; Joe, R; Kwa, Y; Pilarinos, A; Thulien, M, 2022)
" Complete fentanyl dose-response functions were determined during each session."	( A novel long-acting formulation of oral buprenorphine/naloxone produces prolonged decreases in fentanyl self-administration by rhesus monkeys. Comer, SD; Foltin, RW; Nagaraj, N; Scranton, RE; Sykes, KA; Zale, S, 2022)
"We analyzed data from a multicentric, pragmatic, 24-week open-label randomized controlled trial conducted in participants with POUD (N = 272) who were randomly assigned to BUP/NX model of care with flexible take-home dosing (n = 138) or the standard model of care with closely supervised methadone (n = 134)."	( Buprenorphine/naloxone and methadone effectiveness for reducing craving in individuals with prescription opioid use disorder: Exploratory results from an open-label, pragmatic randomized controlled trial. Bastien, G; Brissette, S; Bruneau, J; Eugenia Socias, M; Foll, BL; Jutras-Aswad, D; Ledjiar, O; Lim, R; Marsan, S; McAnulty, C; Talbot, A, 2022)
"Compared to the standard methadone model of care, flexible take-home dosing of BUP/NX was associated with lower craving in individuals with POUD."	( Buprenorphine/naloxone and methadone effectiveness for reducing craving in individuals with prescription opioid use disorder: Exploratory results from an open-label, pragmatic randomized controlled trial. Bastien, G; Brissette, S; Bruneau, J; Eugenia Socias, M; Foll, BL; Jutras-Aswad, D; Ledjiar, O; Lim, R; Marsan, S; McAnulty, C; Talbot, A, 2022)
" Participants receive inpatient rotation to either BuNa or methadone with a flexible dosing regimen."	( Buprenorphine/naloxone versus methadone opioid rotation in patients with prescription opioid use disorder and chronic pain: study protocol for a randomized controlled trial. Dahan, A; Ellerbroek, H; Kramers, C; Schellekens, AFA; Timmerman, H; van den Heuvel, SAS, 2022)
" We estimated the extent to which different dosing strategies would affect risk of relapse over 12 weeks of treatment, separately for BUP-NX and methadone."	( Buprenorphine & methadone dosing strategies to reduce risk of relapse in the treatment of opioid use disorder. Díaz, I; Fishman, M; Goodwin, ATS; Luo, S; Nunes, EV; Rotrosen, J; Rudolph, KE; Shulman, M; Williams, NT, 2022)
" We examined four dosing strategies: 1) increasing dose in response to participant-specific opioid use, 2) increasing dose weekly until some minimum dose (16 mg BUP, 100 mg methadone) was reached, 3) increasing dose weekly until some minimum and increasing dose in response to opioid use thereafter (referred to as the "hybrid strategy"), and 4) keeping dose constant after the first 2 weeks of treatment."	( Buprenorphine & methadone dosing strategies to reduce risk of relapse in the treatment of opioid use disorder. Díaz, I; Fishman, M; Goodwin, ATS; Luo, S; Nunes, EV; Rotrosen, J; Rudolph, KE; Shulman, M; Williams, NT, 2022)
"This study aimed to evaluate the effectiveness of flexible take-home dosing of buprenorphine/naloxone (BUP/NX) and methadone standard model of care in reducing depressive symptoms in people with prescription-type opioid use disorder (POUD)."	( Effects of Buprenorphine/Naloxone and Methadone on Depressive Symptoms in People with Prescription Opioid Use Disorder: A Pragmatic Randomised Controlled Trial. Bastien, G; Brissette, S; Hassan, AN; Jutras-Aswad, D; Le Foll, B; Ledjiar, O; Lim, R; Marsan, S; McAnulty, C; Socias, ME; Talbot, A, 2023)
"gov identifier: NCT03033732), a pragmatic randomised controlled trial comparing flexible take-home dosing of BUP/NX and methadone standard model of care for reducing opioid use in people with POUD."	( Effects of Buprenorphine/Naloxone and Methadone on Depressive Symptoms in People with Prescription Opioid Use Disorder: A Pragmatic Randomised Controlled Trial. Bastien, G; Brissette, S; Hassan, AN; Jutras-Aswad, D; Le Foll, B; Ledjiar, O; Lim, R; Marsan, S; McAnulty, C; Socias, ME; Talbot, A, 2023)
"The introduction of depot buprenorphine for the treatment of opioid dependence allows for reduced dosing frequency compared with conventional treatments, such as oral methadone and sublingual buprenorphine-naloxone."	( Exploring patient experience and satisfaction with depot buprenorphine formulations: A mixed-methods study. Allen, E; Altobelli, G; Holmwood, C; Johnson, J; Samadian, S, 2023)
" There were mixed experiences with the ability for depot buprenorphine to 'hold' participants throughout the dosing interval."	( Exploring patient experience and satisfaction with depot buprenorphine formulations: A mixed-methods study. Allen, E; Altobelli, G; Holmwood, C; Johnson, J; Samadian, S, 2023)
" The potential for disconnection from services and mixed experiences of efficacy throughout the dosing period may negatively influence patient experience."	( Exploring patient experience and satisfaction with depot buprenorphine formulations: A mixed-methods study. Allen, E; Altobelli, G; Holmwood, C; Johnson, J; Samadian, S, 2023)
" In this exploratory analysis, we examined the effect of recent cannabis use on opioid use, craving, and withdrawal symptoms, in individuals participating in a trial comparing flexible buprenorphine/naloxone (BUP/NX) take-home dosing model to witnessed ingestion of methadone."	( Differential effect of cannabis use on opioid agonist treatment outcomes: Exploratory analyses from the OPTIMA study. Bakouni, H; Bastien, G; Brissette, S; Elkrief, L; Hébert, FO; Jutras-Aswad, D; Le Foll, B; Ledjiar, O; Lim, R; Marsan, S; McAnulty, C; Socias, ME, 2023)
" A coding tool was developed based on a review of a sample of forms, including fields for behavioral health treatment recommendations or mandates, drug screening requirements, and dosage limitations."	( Thematic Analysis of State Medicaid Buprenorphine Prior Authorization Requirements. Abrams, M; Aronowitz, SV; Dolan, A; Meisel, Z; Nguemeni Tiako, MJ; Oyekanmi, K, 2023)
" Eighteen states (36%) specified dosage maximums; among them, 11 (22%) required additional steps for a daily dosage higher than 16 mg."	( Thematic Analysis of State Medicaid Buprenorphine Prior Authorization Requirements. Abrams, M; Aronowitz, SV; Dolan, A; Meisel, Z; Nguemeni Tiako, MJ; Oyekanmi, K, 2023)
"In this qualitative study of state Medicaid PA requirements for buprenorphine, themes were identified that included patient surveillance with drug screenings and pill counts, behavioral health treatment recommendations or mandates, patient education, and dosing guidance."	( Thematic Analysis of State Medicaid Buprenorphine Prior Authorization Requirements. Abrams, M; Aronowitz, SV; Dolan, A; Meisel, Z; Nguemeni Tiako, MJ; Oyekanmi, K, 2023)
"Describe case series of successful management of kratom use disorder using telehealth followed by unobserved buprenorphine-naloxone home induction and highlight implications for future management, including maintenance dosage and induction method."	( Kratom use disorder: case reports on successful treatment with home induction of buprenorphine-naloxone. Cape, MC; Kiyokawa, M; Kwon, AK; Streltzer, JM, 2023)
"In clinical practice, sublingual (SL) buprenorphine-naloxone is prescribed as once daily or split daily dosing for the management of opioid use disorder (OUD)."	( Evaluation of opioid use disorder treatment outcomes in patients receiving split daily versus once daily dosing of buprenorphine-naloxone. Borris, JB; Bowman, LA; Dowd-Green, C; Fingerhood, M; Nesbit, SA; Stewart, RW, 2024)
" We characterized study groups by dosing frequency, either once daily or split dosing."	( Evaluation of opioid use disorder treatment outcomes in patients receiving split daily versus once daily dosing of buprenorphine-naloxone. Borris, JB; Bowman, LA; Dowd-Green, C; Fingerhood, M; Nesbit, SA; Stewart, RW, 2024)
"8 %) were prescribed once daily dosing and 193 patients (77."	( Evaluation of opioid use disorder treatment outcomes in patients receiving split daily versus once daily dosing of buprenorphine-naloxone. Borris, JB; Bowman, LA; Dowd-Green, C; Fingerhood, M; Nesbit, SA; Stewart, RW, 2024)

Timeframe	Studies, This Drug (%)	All Drugs %
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	24 (5.27)	29.6817
2010's	247 (54.29)	24.3611
2020's	184 (40.44)	2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Publication Type	This drug (%)	All Drugs (%)
Trials	119 (22.00%)	5.53%
Reviews	39 (7.21%)	6.00%
Case Studies	80 (14.79%)	4.05%
Observational	12 (2.22%)	0.25%
Other	291 (53.79%)	84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (114)

Trial Overview

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 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)
Suboxone and Methadone for HIV Risk Reduction in Subutex Injectors[NCT01131273]	Phase 3	68 participants (Actual)	Interventional	2010-06-30	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
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
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.)
A Method to Increase Buprenorphine Treatment Capacity[NCT03580902]	Phase 1/Phase 2	51 participants (Actual)	Interventional	2019-01-22	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
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
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
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
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
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
Treatment for Opioid Dependent Offenders[NCT01082679]	Phase 2/Phase 3	16 participants (Actual)	Interventional	2009-06-30	Completed
Houston Emergency Engagement System for Youths and Adolescents[NCT04811014]	Phase 4	15 participants (Anticipated)	Interventional	2021-04-19	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)
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
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
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
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 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)
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
Rapid Initiation of Buprenorphine/Naloxone to Optimize MAT Utilization in Philadelphia[NCT03908437]	Phase 4	104 participants (Actual)	Interventional	2019-07-15	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 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 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
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
The Impact of Intravenous Heroin Use on Immune Activation in Treated HIV[NCT03976258]		190 participants (Actual)	Observational	2017-07-14	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)
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
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 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
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
A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users[NCT00604188]	Phase 4	188 participants (Actual)	Interventional	2008-02-22	Completed
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
Optimizing Outcomes Using Suboxone for Opiate Dependence[NCT00591617]		202 participants (Actual)	Interventional	2006-09-30	Completed
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
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
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
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
Efficacy of Computer Delivered CRA (Bup II) Grant No. R01DA012997-10[NCT00929253]		170 participants (Actual)	Interventional	2007-09-30	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
HCV Treatment of IDUs After Buprenorphine Stabilization[NCT00249574]		10 participants (Anticipated)	Interventional	2003-06-30	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
The Acute and Protracted Blockade Efficacy of Buprenorphine/Naloxone[NCT00134888]		8 participants (Actual)	Interventional	2000-12-31	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
Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections[NCT04677114]	Phase 2	90 participants (Anticipated)	Interventional	2021-03-16	Recruiting
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
Bup/Nx - Facilitated Rehab for Opioid Dependent Adolescents[NCT00078130]	Phase 3	223 participants	Interventional	2003-07-31	Completed
Buprenorphine/Naloxone Versus Clonidine for Inpatient Opiate Detoxification[NCT00032955]	Phase 3	163 participants	Interventional	2001-02-28	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)
Starting Treatment With Agonist Replacement Therapies (START)[NCT00315341]	Phase 4	1,269 participants (Actual)	Interventional	2006-04-30	Completed
Pilot for Improved Office Based Treatment of Opioid-Dependence[NCT03586466]		80 participants (Anticipated)	Interventional	2018-12-01	Recruiting
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
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
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
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
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
Providing Comprehensive Harm Reduction Via Telemedicine for PWID Using Syringe Services Programs: a Feasibility Study[NCT04521920]		17 participants (Actual)	Interventional	2020-11-09	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
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
Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence[NCT00555425]	Phase 4	113 participants (Actual)	Interventional	2008-07-31	Completed
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 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)
Remote Observed Dosing of Suboxone to Improve Clinical Practice[NCT03769025]	Phase 1/Phase 2	16 participants (Actual)	Interventional	2019-04-01	Completed
Medications Development for Drug Abuse Disorders[NCT01188421]	Phase 1/Phase 2	106 participants (Actual)	Interventional	2010-10-31	Completed
Buprenorphine Combination Tablet Feasibility[NCT00000298]	Phase 2	0 participants	Interventional	1995-08-31	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
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
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
Buprenorphine Pharmacology Related to Addiction Treatment[NCT00000236]	Phase 2	0 participants	Interventional		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
Efficacy/Safety Trial of Buprenorphine/Nx for Opiate Dependence[NCT00000353]	Phase 2	0 participants	Interventional	1996-10-31	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)
Prescription Opioid Abuse Among Pain Patients: Predictors of Relapse[NCT01967641]	Phase 2	51 participants (Actual)	Interventional	2005-11-30	Completed
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
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 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
Health Promotion and Public Safety: Community-based Collaborative Services to Addicted Offenders[NCT01843751]	Phase 3	24 participants (Actual)	Interventional	2013-03-31	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.)
Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone[NCT00637000]	Phase 2	38 participants (Actual)	Interventional	2008-03-31	Completed
Randomized Trial of Buprenorphine Microdose Initiation for Ambulatory Settings[NCT05450718]	Phase 4	70 participants (Anticipated)	Interventional	2024-01-31	Not yet recruiting
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
Houston Emergency Opioid Engagement System (HEROES)[NCT03396276]	Phase 4	1,500 participants (Anticipated)	Interventional	2018-04-01	Enrolling by invitation
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
Cocaine Use Reduction With Buprenorphine (CURB)[NCT01402492]	Phase 2/Phase 3	302 participants (Actual)	Interventional	2011-09-30	Completed
Sublingual Buprenorphine Treatment for Neonatal Abstinence Syndrome - Pilot Study[NCT02249026]	Phase 1/Phase 2	40 participants (Anticipated)	Interventional	2014-10-31	Recruiting
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
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 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
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Trial	Outcome
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
NCT00270257 (7) [back to overview]	Evidence of HIV-1 Infection or Death for Visits up to 104 Weeks
NCT00315341 (1) [back to overview]	Hepatic Safety
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]	Health Status
NCT00555425 (7) [back to overview]	Changes in HIV Risk
NCT00555425 (7) [back to overview]	Retention in Treatment
NCT00555425 (7) [back to overview]	Reduction in Cocaine Use
NCT00555425 (7) [back to overview]	Proportion of Patients Protectively Transferred
NCT00555425 (7) [back to overview]	Patient Satisfaction
NCT00555425 (7) [back to overview]	Illicit Opioid Use
NCT00574067 (7) [back to overview]	Criminal Activity
NCT00574067 (7) [back to overview]	Drug Abuse Treatment Entry and Retention in the Community
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
NCT00574067 (7) [back to overview]	Number of Days of Cocaine Use
NCT00574067 (7) [back to overview]	Number of Days of Heroin Use
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]	Illicit Opioid and Non-opioid Drug Use: Substance Use Inventory (SUI)
NCT00604188 (8) [back to overview]	Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS)
NCT00604188 (8) [back to overview]	Observer-rated Opioid Withdrawal Symptoms (OOWS)
NCT00604188 (8) [back to overview]	Responders at Day 28
NCT00604188 (8) [back to overview]	Responders at Day 3
NCT00604188 (8) [back to overview]	Self-reported Opioid Withdrawal Symptoms (SOWS)
NCT00604188 (8) [back to overview]	Compliance Rate
NCT00605033 (1) [back to overview]	Response Rate
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: Do You Feel Any Drug Effect?"
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]	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]	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]	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]	Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)
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) 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: Does the Drug Have Any Good Effects?"
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]	Pupil Diameter Measurements at Baseline and the Maximum 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: 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: Does the Drug Make You Sick?"
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]	"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]	"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) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: Do You Feel Any Drug Effect?"
NCT00640835 (2) [back to overview]	Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity.
NCT00640835 (2) [back to overview]	Number of Subjects With Mild, Moderate or Severe 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®).
NCT00710385 (2) [back to overview]	"Drug Liking"
NCT00710385 (2) [back to overview]	Drug's Breakpoint
NCT00723749 (4) [back to overview]	Retention Rate After 12 Months of Treatment With Suboxone
NCT00723749 (4) [back to overview]	Dosage of SUBOXONE®
NCT00723749 (4) [back to overview]	Drug Craving (Subjective Effects of Therapy)
NCT00723749 (4) [back to overview]	Take Home Prescriptions of SUBOXONE®
NCT00725608 (3) [back to overview]	Retention Rate
NCT00725608 (3) [back to overview]	Dispensing of Suboxone (Buprenorphine Plus Naloxone)
NCT00725608 (3) [back to overview]	Dosing of Suboxone (Buprenorphine Plus Naloxone)
NCT00879996 (4) [back to overview]	Self-reported Illicit Opioid Use
NCT00879996 (4) [back to overview]	Number of Participants Retained in Treatment
NCT00879996 (4) [back to overview]	Numerical Rating Score for Functioning
NCT00879996 (4) [back to overview]	Numerical Rating Score for Pain
NCT00929253 (1) [back to overview]	Abstinence
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.
NCT01396005 (6) [back to overview]	AUC 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]	Cmax of Buprenorphine (Administered in Combination With Naloxone) at Steady State 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]	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
NCT01402492 (1) [back to overview]	Cocaine Use Days as Measured by Self-report, Corroborated by Thrice-weekly Urine Drug Screens
NCT01550341 (12) [back to overview]	Log Viral Load
NCT01550341 (12) [back to overview]	Log Viral Load
NCT01550341 (12) [back to overview]	Viral Load
NCT01550341 (12) [back to overview]	Viral Load
NCT01550341 (12) [back to overview]	Viral Load
NCT01550341 (12) [back to overview]	CD4 Count Absolute
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]	CD4 Percent
NCT01550341 (12) [back to overview]	CD4 Count Absolute
NCT01550341 (12) [back to overview]	CD4 Count Absolute
NCT01559454 (6) [back to overview]	Analgesia
NCT01559454 (6) [back to overview]	Cravings
NCT01559454 (6) [back to overview]	Illicit Drug Use
NCT01559454 (6) [back to overview]	Functioning
NCT01559454 (6) [back to overview]	Depression
NCT01559454 (6) [back to overview]	Treatment Retention
NCT01690546 (10) [back to overview]	Withdrawal Intensity as Measured by the Clinical Opiate Withdrawal Scale (COWS)
NCT01690546 (10) [back to overview]	Satisfaction With Treatment, Measured by a Treatment Satisfaction Questionnaire
NCT01690546 (10) [back to overview]	Number of Participants That Self Reported Illicit Drug Use
NCT01690546 (10) [back to overview]	Craving
NCT01690546 (10) [back to overview]	Illicit Drug Use, Measured by Urine Drug Testing
NCT01690546 (10) [back to overview]	Percentage of Participants Who Adhered to Study Visits.
NCT01690546 (10) [back to overview]	Percentage of Participants With Adherence to Medication (Naltrexone)
NCT01690546 (10) [back to overview]	Retention in Treatment
NCT01690546 (10) [back to overview]	Use of Ancillary Medications.
NCT01690546 (10) [back to overview]	Withdrawal Intensity as Measured by the Subjective Opiate Withdrawal Scale (SOWS)
NCT01843751 (5) [back to overview]	Number of Emergency Room Visits
NCT01843751 (5) [back to overview]	Number of Participants With New Crime
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
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 COWS Total Score After Day 3 (Maintenance Phase)
NCT01848054 (8) [back to overview]	Mean Change From Baseline in SOWS Total Score After Day 3 (Maintenance Phase)
NCT01875848 (2) [back to overview]	Patient Global Impression of Change (PGIC)
NCT01875848 (2) [back to overview]	Change in Numeric Rating Scale of Pain Severity
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 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]	Number of Patients Reporting Treatment-Related, Treatment-Emergent Adverse Events
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 and OX219-007) in Visual Analog Scale (VAS) Craving Scores
NCT01903005 (11) [back to overview]	Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHP
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]	Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score
NCT01936857 (5) [back to overview]	Number of Participants With HIV Viral Suppression
NCT01936857 (5) [back to overview]	Participants With Heroin Use (Urine Drug Screen)
NCT01936857 (5) [back to overview]	Participants With Heroin Use (Self-report)
NCT01936857 (5) [back to overview]	Number of Participants in Retention in HIV Care
NCT01936857 (5) [back to overview]	Number of Participants in Receipt of Antiretroviral Therapy (ART)
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
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]	Cigarette Smoking, W24 31 or More
NCT02032433 (58) [back to overview]	Cigarette Smoking, W24 21-30
NCT02032433 (58) [back to overview]	Cigarette Smoking, W24 11-20
NCT02032433 (58) [back to overview]	Opioid Abstinence Over Time While on Study Medication (Objective)
NCT02032433 (58) [back to overview]	Cigarette Smoking, W0 31 or More
NCT02032433 (58) [back to overview]	Score on Trail Making Test Part B
NCT02032433 (58) [back to overview]	Cigarette Smoking, W0, 10 or Less
NCT02032433 (58) [back to overview]	Cigarette Smoking, W24 0
NCT02032433 (58) [back to overview]	Score on Trail Making Test Part B
NCT02032433 (58) [back to overview]	Opioid Abstinence Over Time While on Study Medication (Subjective)
NCT02032433 (58) [back to overview]	Number Successfully Inducted Onto Assigned Study Medication
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]	Score on Word Card of Stoop Test
NCT02032433 (58) [back to overview]	Score on Word Card of Stoop Test
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]	Opioid Craving Over Time W0
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 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]	Dissolution Time of Intervention as Recorded by a Trained Observer
NCT02038790 (14) [back to overview]	Overall Intervention Preference As Assessed by Participants
NCT02038790 (14) [back to overview]	Participant Assessments With Regard to Ease of Dissolution of Interventions
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 Favorable and Unfavorable Response to the Question: How Easily Did the Medication Dissolve in Your Mouth?
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 Favorable and Unfavorable Response to the Question: How Easy or Difficult Were the Package Instructions to Follow?
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]	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 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: If You Did Want to Abuse This Medication, Would You Prefer to......
NCT02294253 (1) [back to overview]	Successful Induction Onto XR-NTX
NCT02357901 (15) [back to overview]	Percentage of Participants Considered A Treatment Success
NCT02357901 (15) [back to overview]	Participants Who Are Abstinent at Week 24
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]	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]	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]	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]	Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) From Week 2 - 24
NCT02357901 (15) [back to overview]	Participants With Adverse Events During the Treatment Period
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 From Week 5 Through Week 24
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]	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]	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]	Worst Injection Site Pain From Injections 1-6 as Measured by Participant-Reported Visual Analog Scale (VAS)
NCT02357901 (15) [back to overview]	"Participants Who Complete the Week 24 Visit (Completers)"
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]	Worst Local Injection Site Pain From Injections as Measured by Participant-Reported Visual Analog Scale (VAS)
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]	Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period
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]	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]	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 Clinical Opiate Withdrawal Scale (COWS) at End of Study (Weeks 25 and 49)
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]	Change From Baseline in the Opioid Craving Visual Analog Scale (VAS) at End of Study (Weeks 25 and 49)
NCT02696096 (3) [back to overview]	Changes in Working Memory - Within Groups During Satiation and Withdrawal
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
NCT03026790 (14) [back to overview]	PODS Concerns
NCT03026790 (14) [back to overview]	Pain Response
NCT03026790 (14) [back to overview]	PHQ-8
NCT03026790 (14) [back to overview]	50% Reduction in Opioid Daily Dose
NCT03026790 (14) [back to overview]	GAD-7
NCT03026790 (14) [back to overview]	PODS Problems
NCT03026790 (14) [back to overview]	Brief Pain Inventory (BPI) Total Score
NCT03026790 (14) [back to overview]	VR-12 Physical Component Score
NCT03026790 (14) [back to overview]	Composite Response
NCT03026790 (14) [back to overview]	VR-12 Mental Component Score
NCT03026790 (14) [back to overview]	Symptom Checklist
NCT03026790 (14) [back to overview]	PROMIS Sleep Disturbance
NCT03026790 (14) [back to overview]	PROMIS Fatigue
NCT03026790 (14) [back to overview]	Headache Impact Test
NCT03248947 (8) [back to overview]	Pharmacists' Use of the Prescription Drug Monitoring Program (PDMP)
NCT03248947 (8) [back to overview]	Treatment Fidelity
NCT03248947 (8) [back to overview]	Number of Participants With Opioid and Other Substance Use
NCT03248947 (8) [back to overview]	Number of Medication-Compliant Months Across All Participants
NCT03248947 (8) [back to overview]	Treatment Retention
NCT03248947 (8) [back to overview]	Treatment Satisfaction
NCT03248947 (8) [back to overview]	Recruitment Rate
NCT03248947 (8) [back to overview]	Participant Safety
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]	Total Fetal Movement at 24 Weeks Gestation
NCT03291847 (8) [back to overview]	Total Fetal Movement at 28 Weeks Gestation
NCT03291847 (8) [back to overview]	Total Fetal Movement at 36 Weeks Gestation
NCT03291847 (8) [back to overview]	Total Fetal Movement at 32 Weeks Gestation
NCT03291847 (8) [back to overview]	Fetal Heart Rate at 36 Weeks Gestation
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]	Mean # of Weeks (0-8) on Any Buprenorphine Treatment
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]	Urine Samples Opioid-negative
NCT03604159 (8) [back to overview]	The Mean In-jail Medical Visits Per Day Following Randomization and Induction on Study Medication
NCT03604159 (8) [back to overview]	The # of Participants Who Received Their Randomly Assigned Study Medication Prior to Release From Jail as Scheduled
NCT03711318 (1) [back to overview]	Proportion of Heroin-dependent Patients Successfully Inducted Onto Vivitrol
NCT03769025 (2) [back to overview]	Percent of Urine Positive Drug Screens
NCT03769025 (2) [back to overview]	Mean Urinary Buprenorphine Levels
NCT03908437 (4) [back to overview]	Overdose During the 6-month Follow-up
NCT03908437 (4) [back to overview]	Enrollment in Medication Assisted Treatment at 6-month Post-enrollment
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
NCT04447287 (22) [back to overview]	Change From Baseline in Blood Oxygen Saturation (SpO2) at 1 Hour Postdose
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: Maximum Concentration (Cmax)
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]	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 Norbuprenorphine (Buprenorphine's Metabolite) in Plasma: AUC24
NCT04447287 (22) [back to overview]	Pharmacokinetics (PK) of Naloxone in Plasma: Cmax
NCT04447287 (22) [back to overview]	Pharmacokinetics (PK) of Naloxone in Plasma: AUC24
NCT04447287 (22) [back to overview]	Pharmacokinetics (PK) of Buprenorphine in Plasma: 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]	Change From Baseline in End Tidal Carbon Dioxide (CO2) at Predose
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 2 Hour Postdose
NCT04447287 (22) [back to overview]	Change From Baseline in Blood Oxygen Saturation (SpO2) at 12 Hour Postdose
NCT04521920 (6) [back to overview]	Number of Participants Who Demonstrate no or Minimal Opioid Use at 6 Months
NCT04521920 (6) [back to overview]	Number of Participants Who Remain HIV Negative at 3 Months
NCT04521920 (6) [back to overview]	Number of Participants Who Remain HIV Negative at 6 Months
NCT04521920 (6) [back to overview]	Persistence in Care at 6 Months
NCT04521920 (6) [back to overview]	Persistence in Care at 3 Months
NCT04521920 (6) [back to overview]	Number of Participants Who Demonstrate no or Minimal Opioid Use at 3 Months

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

Intervention	participants (Number)
Long Term Medication Assisted Treatment (LT-MAT)	23
Short Term Medication Assisted Treatment (ST-MAT)	28

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

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

Intervention	Participants (Number)
Tapering Doses of Buprenorphine	4
Steady Dose of Buprenorphine	4

Intervention	units on a scale (Mean)
	Baseline	In-Treatment
Maintenance Condition	67.6	66.6
Taper Condition	67.2	68.7

Intervention	units on a scale (Mean)
	Baseline	18 weeks
Maintenance Condition	67.6	74.4
Taper Condition	66.7	74.5

Intervention	Score on a scale (Least Squares Mean)
	Medical	Employment	Employment satisfaction	Alcohol use	Drug use (Original)	Drug use (Modified)	Legal status	Family/Social relations	Other Family/Social relations	Psychiatric
Direct Suboxone Induction	-0.05	-0.04	-0.10	-0.03	-0.24	-0.36	-0.09	-0.10	-0.08	-0.12
Subutex-to-Suboxone Induction	-0.05	-0.02	-0.01	-0.01	-0.23	-0.34	-0.08	-0.10	-0.06	-0.08

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

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

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

Intervention	days (Mean)
Bup+OTP	3.4
Bup+CHC	5.4
Counseling+OTP	3.3
Counseling+CHC	3.2

Intervention	participants (Number)
B+OTP	22
B+CHC	26
C+OTP	23
C+CHC	11

Intervention	days (Mean)
B+OTP	30.0
B+CHC	29.6
C+OTP	22.3
C+CHC	31.4

Intervention	times (Mean)
B+OTP	59.7
B+CHC	36.1
C+OTP	33.3
C+CHC	50.4

Intervention	Participants (Number)
	Responder	Non-responder
Direct Suboxone Induction	46	47
Subutex-to-Suboxone Induction	55	39

Intervention	Participants (Number)
	Responders	Non responders
Direct Suboxone Induction	85	8
Subutex-to-Suboxone Induction	85	9

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

Intervention	Percentage of days (Mean)
Direct Suboxone Induction	98.7
Subutex-to-Suboxone Induction	98.4

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

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

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

Intervention	Participants (Number)
Buprenorphine/Naloxone Film Strip Administered Sublingually	11
Buprenorphine/Naloxone Film Strip Administered Buccally	16

Intervention	Participants (Number)
	Mild	Moderate	Severe
Buprenorphine/Naloxone Film Strip Administered Buccally	12	3	1
Buprenorphine/Naloxone Film Strip Administered Sublingually	9	2	0

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

buprenorphine, naloxone drug combination

Description

Cross-References

Synonyms (12)

Toxicity

Pharmacokinetics

Compound-Compound Interactions

Bioavailability

Dosage Studied

Research

Studies (455)

Study Types

Clinical Trials (114)

Trial Overview

Trial Outcomes

Incident Hepatitis B Infections

Incident Hepatitis C Infections for Thailand and China

Number of Participants Reported Using Injection Equipment (Needles, Syringes, Cookers, Cottons, and Rinse Water) in the Prior 6 Months

Number of Participants With Urinalysis Results Positive for Opiates

Self-report of Continued Injection Opiate Use in the Last 30 Days

Self-reported Number of Injections in the Last Month

Evidence of HIV-1 Infection or Death for Visits up to 104 Weeks

Hepatic Safety

Number of Participants With Better Overall Quality of Life at Six Months as Compared to Baseline.

Relapse to Substance Abuse

Treatment Retention.

Health Status

Changes in HIV Risk

Retention in Treatment

Reduction in Cocaine Use

Proportion of Patients Protectively Transferred

Patient Satisfaction

Illicit Opioid Use

Criminal Activity

Drug Abuse Treatment Entry and Retention in the Community

Employment Status

HIV Risk Behavior

HIV Risk Behavior Needle Sharing

Number of Days of Cocaine Use

Number of Days of Heroin Use

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

Illicit Opioid and Non-opioid Drug Use: Substance Use Inventory (SUI)

Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS)

Observer-rated Opioid Withdrawal Symptoms (OOWS)

Responders at Day 28

Responders at Day 3

Self-reported Opioid Withdrawal Symptoms (SOWS)

Compliance Rate

Response Rate

"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?"

"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?"

"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?"

Pupil Diameter Measurements At End of Induction (End of Day 2) and the Minimum Pupil Diameter During the Post Induction Period (Days 3-5)

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

Severity of Withdrawal Symptoms Measured Using the Clinical Opiate Withdrawal Scale (COWS) at the End of Induction and the Peak COWS Post Induction

Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)

"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?"

"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?"

"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?"

Pupil Diameter Measurements at Baseline and the Minimum Pupil Diameter up to 23.5 Hours After the First Administration

Pupil Diameter Measurements at Baseline and the Maximum Pupil Diameter up to 23.5 Hours After the First Administration

"Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: How High Are You?"

"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?"

"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?"

"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?"

"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?"

"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?"

Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity.

Number of Subjects With Mild, Moderate or Severe Treatment-emergent Adverse Events Associated With the Oral Cavity

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®).

"Drug Liking"

Drug's Breakpoint

Retention Rate After 12 Months of Treatment With Suboxone

Dosage of SUBOXONE®

Drug Craving (Subjective Effects of Therapy)

Take Home Prescriptions of SUBOXONE®

Retention Rate

Dispensing of Suboxone (Buprenorphine Plus Naloxone)

Dosing of Suboxone (Buprenorphine Plus Naloxone)

Self-reported Illicit Opioid Use

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

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

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

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

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

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

Intervention	(pg.hr/mL)/mg (Geometric Mean)
Buprenorphine/Naloxone Alone	3020
Buprenorphine/Naloxone + Boceprevir	4040

Intervention	(pg/mL)/mg (Geometric Mean)
Buprenorphine/Naloxone Alone	58.5
Buprenorphine/Naloxone + Boceprevir	65.2

Intervention	(ng.hr/mL)/mg (Geometric Mean)
	R-methadone	S-methadone
Methadone + Boceprevir	42.4	44.6
Methadone Alone	50.1	56.9

Intervention	participants (Number)
	illicit drug use at 6 months	no illicit drug use at 6 months
Buprenorphine/Naloxone	0	4
Methadone	0	6