| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| Using Sleep Health to Optimize Smoking Cessation Treatment Response in HIV-Positive Adults[NCT04725617] | | 200 participants (Anticipated) | Interventional | 2021-11-16 | Recruiting |
| A Phase 1, Investigator And Subject Blind (Sponsor Open), Randomized, Placebo Controlled, Parallel Cohort, Escalating Multiple Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of A Varenicline Transdermal Delivery System In Adult Smoke[NCT01234142] | Phase 1 | 45 participants (Actual) | Interventional | 2010-11-30 | Completed |
| Safety and Efficacy of the Novel Selective Nicotinic Receptor Partial Agonist, CHANTIX (Varenicline) in Patients With Acute Coronary Syndrome[NCT01170338] | Phase 4 | 100 participants (Anticipated) | Interventional | 2008-01-31 | Recruiting |
| Varenicline Treatment for Active Alcoholic Smokers[NCT01347112] | Phase 2/Phase 3 | 33 participants (Actual) | Interventional | 2011-06-30 | Completed |
| Achieving Smoking Cessation Milestones in Opioid Treatment Patients: a Randomized 2 x 2 Factorial Trial of Directly Observed and Long-term Varenicline[NCT03365362] | Phase 4 | 450 participants (Anticipated) | Interventional | 2018-10-25 | Recruiting |
| Varenicline and Mobile Behavioral Assistance for Tobacco Cessation in HIV Care in India[NCT05786547] | Phase 3 | 400 participants (Anticipated) | Interventional | 2023-12-15 | Not yet recruiting |
| Individualizing Pharmacotherapy: A Novel Optimization Strategy to Increase Smoking Cessation in the African American Community[NCT03897439] | Phase 3 | 392 participants (Actual) | Interventional | 2019-05-01 | Completed |
| Smoking Interventions for Hospital Patients: A Comparative Effectiveness Trial[NCT01177176] | | 397 participants (Actual) | Interventional | 2010-07-31 | Completed |
| Effects of a Combination of Varenicline and Transdermal Nicotine Patch on Post-quitting Urges to Smoke[NCT01184664] | Phase 3 | 117 participants (Actual) | Interventional | 2011-04-30 | Completed |
| UW Quitting Using Intensive Treatment Study[NCT03176784] | Phase 4 | 1,251 participants (Actual) | Interventional | 2017-11-11 | Completed |
| Effect of Varenicline on Cognitive Function in Cigarette Smokers With Schizophrenia[NCT01093365] | Phase 2 | 58 participants (Actual) | Interventional | 2010-03-31 | Completed |
| Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation[NCT02859142] | Phase 4 | 122 participants (Actual) | Interventional | 2018-03-29 | Completed |
| Feasibility, Acceptability, and Preliminary Efficacy of Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: An Open-Label Pilot Study[NCT06006143] | | 30 participants (Anticipated) | Interventional | 2024-09-01 | Not yet recruiting |
| Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease Experiment 3 - Project #3[NCT04403399] | Phase 2 | 34 participants (Actual) | Interventional | 2017-06-29 | Completed |
| Developing Precision Smoking Treatment in the Southern Community Cohort Study[NCT03521141] | Phase 2/Phase 3 | 67 participants (Actual) | Interventional | 2018-05-18 | Completed |
| Combination of E-cigarettes and Varenicline for Tobacco Harm Reduction[NCT04210180] | Phase 2/Phase 3 | 25 participants (Actual) | Interventional | 2019-11-19 | Completed |
| Varenicline Adjunctive Treatment in Schizophrenia[NCT00492349] | Phase 4 | 91 participants (Actual) | Interventional | 2007-05-31 | Completed |
| A Phase 4, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction[NCT01370356] | Phase 4 | 1,510 participants (Actual) | Interventional | 2011-07-31 | Completed |
| A Randomized, Investigator and Subject Blind, Sponsor Open Parallel Group Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pro-Cognitive Effects of Varenicline, Under Various Titration Schemes, in Healthy Elderly Non-Smoking Subje[NCT00694044] | Phase 1 | 50 participants (Actual) | Interventional | 2008-04-30 | Completed |
| Smoking Cessation & Opioid Dependence Treatment Integration: Does Timing Matter?[NCT02854800] | Phase 2/Phase 3 | 74 participants (Actual) | Interventional | 2016-07-08 | Completed |
| Smoking Cessation in a Drug Treatment Program: A Randomized Trial of Varenicline Versus Placebo.[NCT01286584] | Phase 4 | 33 participants (Actual) | Interventional | 2011-06-30 | Completed |
| Effects of a Tailored Dose of Varenicline on Post-quitting Urges to Smoke[NCT01206010] | Phase 3 | 200 participants (Actual) | Interventional | 2011-07-31 | Completed |
| Testing Novel Pharmacogenetic and Adherence Optimization Treatments to Improve the Effectiveness of Smoking Cessation Treatments for Smokers With HIV[NCT04176172] | Phase 3 | 340 participants (Anticipated) | Interventional | 2020-02-17 | Recruiting |
| Effect of Varenicline on Smoking Cessation in Patients With Schizophrenia: Evaluation of Antipsychotic Drug-Induced Neurological Symptoms as Correlates of Response[NCT03495024] | Phase 4 | 10 participants (Anticipated) | Interventional | 2019-01-01 | Recruiting |
| Web-based Smoking Cessation Program for Tribal College Students[NCT02050308] | Phase 3 | 251 participants (Actual) | Interventional | 2015-05-31 | Completed |
| Varenicline, a Partial Nicotinic Receptor Agonist for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease: a Placebo-controlled Cross-over Pilot Study[NCT02473562] | Phase 4 | 22 participants (Actual) | Interventional | 2013-05-31 | Terminated(stopped due to insufficient patient enrollment, insufficient funds for completion) |
| Effect of Smoking Reduction on Endothelial Glucocalyx and Arterial Wall Properites During Medically-aided Smoking Cessation Program.[NCT02307045] | Phase 4 | 600 participants (Anticipated) | Interventional | 2014-12-03 | Active, not recruiting |
| UW-CTRI Smoking Cessation Medication Tolerability Study[NCT02681510] | Phase 4 | 36 participants (Actual) | Interventional | 2016-02-29 | Completed |
| Randomized Clinical Trial to Reduce Harm From Tobacco[NCT02328794] | | 6,006 participants (Actual) | Interventional | 2015-01-01 | Completed |
| A Randomized, Controlled, Double-Masked, Two-Arm Investigator-Initiated Study to Assess the Efficacy of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease in Subjects Following Laser-assisted in Situ Keratomileusis (LASIK)[NCT05082974] | Phase 3 | 40 participants (Actual) | Interventional | 2021-10-20 | Completed |
| A Randomized Open-label Parallel-group Trial is to Analyze the Efficacy and the Efficiency of the Social-Local-Mobile (So-Lo-Mo) Intervention Applied to the Smoking Cessation Process.[NCT03553173] | | 240 participants (Actual) | Interventional | 2016-10-24 | Completed |
| Evaluating the Real-world Effectiveness of Varenicline and Bupropion for Long-term Smoking Cessation[NCT02146911] | | 968 participants (Actual) | Interventional | 2014-05-01 | Completed |
| A Single-Center, Randomized, Controlled, Masked Clinical Trial to Evaluate the Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation (The IMPERIAL Study)[NCT03688802] | Phase 2 | 18 participants (Actual) | Interventional | 2018-09-25 | Completed |
| Pilot Trial of Varenicline and Prazosin to Treat Heavy Drinking Smokers[NCT02193256] | Early Phase 1 | 5 participants (Actual) | Interventional | 2014-07-31 | Completed |
| A 10-Week Pilot Study of Varenicline (Champix) Versus Placebo for Smoking Cessation/Reduction in Patients With Bipolar Disorder[NCT01093937] | | 30 participants (Anticipated) | Interventional | 2009-11-30 | Completed |
| Varenicline for the Treatment of Postural and Gait Dysfunction in Parkinson Disease[NCT01341080] | Phase 2 | 40 participants (Actual) | Interventional | 2010-12-28 | Completed |
| Effectiveness of Inpatient Initiated Varenicline Tartrate for Smoking Cessation, for Smoking Related Illnesses.[NCT01141855] | Phase 2/Phase 3 | 392 participants (Actual) | Interventional | 2008-05-31 | Completed |
| Effectiveness of Varenicline vs. Varenicline Plus Bupropion or Placebo for Smoking Cessation[NCT00943618] | Phase 3 | 641 participants (Actual) | Interventional | 2010-05-17 | Completed |
| Long-term Varenicline Treatment for Smoking Cessation[NCT00828113] | Phase 4 | 101 participants (Actual) | Interventional | 2009-01-31 | Completed |
| Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients[NCT01378858] | | 100 participants (Actual) | Interventional | 2011-07-31 | Completed |
| Human Behavioral Pharmacology Laboratory Study of Varenicline's Impact on Cocaine Reinforcement[NCT01143857] | Phase 2 | 0 participants (Actual) | Interventional | 2010-06-30 | Withdrawn |
| A Randomized, Placebo Controlled, Double Blind, Double Dummy, Multicenter Trial Comparing Electronic Cigarettes With Nicotine to Varenicline and to Electronic Cigarettes Without Nicotine.[NCT03630614] | Phase 3 | 650 participants (Anticipated) | Interventional | 2018-10-17 | Recruiting |
| A Randomized, Open-label, 2-Way, 2-Period, Single-Dose Crossover Clinical Study to Compare the Pharmacokinetic Characteristics and the Safety Between Zeropix Tablet 1 mg and Champix® Tablet 1 mg in Healthy Adult Male Subjects[NCT03362008] | Phase 1 | 31 participants (Actual) | Interventional | 2017-07-06 | Completed |
| Using Non-invasive Brain Stimulation (tDCS) to Improve the Effectiveness of Varenicline for Treating Tobacco Dependence: a Randomized Controlled Trial[NCT03841292] | | 41 participants (Actual) | Interventional | 2018-10-01 | Completed |
| An Effectiveness and Safety Study of Varenicline for Smoking Cessation in Hospitalized Patients With Psychiatric Disorders[NCT03809897] | Phase 4 | 0 participants (Actual) | Interventional | 2019-01-31 | Withdrawn(stopped due to Budget not sufficient to cover the study scope proposed and recruitment rates expected to be no sufficient.) |
| Influence of Varenicline on the Antiplatelet Action of Clopidogrel : the Randomized, Open-label VACL (Varenicline Clopidogrel) Study[NCT01308671] | | 198 participants (Anticipated) | Interventional | 2010-10-31 | Recruiting |
| Effect of Varenicline on a Laboratory Model of Tobacco Addiction and on Withdrawal-Induced Cognitive Impairment[NCT01309685] | Phase 1 | 0 participants (Actual) | Interventional | 2011-02-13 | Withdrawn |
| Characterizing Alpha5 Nicotinic Receptors in Alcohol and Nicotine Dependence[NCT01011907] | | 99 participants (Actual) | Interventional | 2010-01-31 | Completed |
| A Phase 4 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Re-Treatment With Varenicline In Subjects Who Are Currently Smoking, And Who Have Previously Taken Varenicline[NCT01244061] | Phase 4 | 498 participants (Actual) | Interventional | 2010-12-31 | Completed |
| Champix Tablets Special Investigation -Retrospective Survey For Subjects Who Have Been Retreated With Champix.-(Regulatory Post Marketing Commitment Plan).[NCT01061710] | | 20 participants (Actual) | Observational | 2010-07-31 | Completed |
| Connect to Quit: Coordinated Care for Smoking Cessation Among Low Income Veterans[NCT01299896] | | 633 participants (Actual) | Interventional | 2011-03-31 | Completed |
| Varenicline (Chantix) Treatment for Waterpipe Smoking Cessation[NCT02575183] | Phase 4 | 152 participants (Actual) | Interventional | 2016-08-31 | Completed |
| An Experimental Medicine, Randomized, Double-Blind Study Assessing Neuropsychiatric Symptoms In Quitting Smokers Treated With Varenicline Tartrate Or Placebo[NCT00749944] | Phase 4 | 110 participants (Actual) | Interventional | 2008-09-30 | Completed |
| An Innovative Approach to Maximizing the Impact of Efficacious Pharmacotherapies on Smoking Cessation Attempts.[NCT01023659] | Phase 4 | 893 participants (Actual) | Interventional | 2010-04-30 | Completed |
| A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date[NCT00691483] | Phase 4 | 659 participants (Actual) | Interventional | 2008-09-30 | Completed |
| Efficacy and Tolerability of Combination Varenicline With Hydroxyzine as a Potential Smoking Cessation Treatment[NCT04188106] | Phase 4 | 26 participants (Actual) | Interventional | 2019-06-17 | Completed |
| Effect of Varenicline on Reactivity to Smoking and Drinking Cues in Individuals With Concurrent Tobacco Dependence and Alcohol Use[NCT00873535] | | 48 participants (Actual) | Interventional | 2008-10-31 | Completed |
| Preventing Lung Cancer Through Tobacco Cessation at FDNY[NCT05997225] | Phase 4 | 220 participants (Anticipated) | Interventional | 2024-01-31 | Not yet recruiting |
| Smoking Young Asthmatics: Change of Inflammation During Tobacco Cessation and Steroid Treatment[NCT02233231] | Phase 4 | 52 participants (Actual) | Interventional | 2011-08-31 | Completed |
| Varenicline for Nicotine Vaping Cessation in Adolescents[NCT05367492] | Phase 4 | 300 participants (Anticipated) | Interventional | 2022-06-22 | Recruiting |
| Optimization of Smoking Cessation Strategies Concurrent With Treatment of Tobacco Related Malignancies[NCT02048917] | Phase 1 | 93 participants (Actual) | Interventional | 2014-07-22 | Completed |
| A Preliminary Test of Concurrent vs. Sequential Cessation of Dual Cigarette and E-cigarette Use on Behavior, Tobacco Toxicant Exposure, and Health Effects[NCT06027840] | Phase 1 | 40 participants (Anticipated) | Interventional | 2023-12-31 | Not yet recruiting |
| Metabolism Informed Smoking Treatment in Medicaid and Medicare Patients: The MIST RCT[NCT04590404] | Phase 3 | 608 participants (Actual) | Interventional | 2020-11-17 | Active, not recruiting |
| A Two-Part Pilot Study of Dosing, Safety and Efficacy of Varenicline Initiated During an Acute Smoke-free Hospitalization and Continued Post-Hospitalization[NCT01413516] | Phase 2 | 17 participants (Actual) | Interventional | 2011-08-31 | Completed |
| Smoking Cessation Treatment for Head & Neck Cancer Patients: Acceptance and Commitment Therapy[NCT01098955] | Early Phase 1 | 51 participants (Actual) | Interventional | 2010-03-24 | Active, not recruiting |
| Early In-hospital Initiation of Pharmacotherapy for Smoking Cessation, Concomitant With Nurse-Led Support, in Patients After an Acute Coronary Syndrome (ACS)[NCT02106637] | | 300 participants (Anticipated) | Interventional | 2016-10-31 | Recruiting |
| Metabolism-informed Care for Smoking Cessation[NCT03227679] | | 82 participants (Actual) | Interventional | 2016-05-18 | Completed |
| Centralized Health System Interventions to Enhance Reach: A Factorial Screening Experiment[NCT04199117] | Phase 4 | 210 participants (Actual) | Interventional | 2020-03-11 | Active, not recruiting |
| An Examination of the Efficacy, Safety, and Gender Differences in Using Varenicline as an Aid to Smoking Cessation in a Population of Methadone Maintained Opioid Dependent Patients (Pilot Trial)[NCT00906386] | Phase 2 | 112 participants (Anticipated) | Interventional | 2009-05-31 | Enrolling by invitation |
| Varenicline Treatment in Alcohol and Nicotine Dependent Patients With Schizophrenia - a Double Blind, Placebo Controlled Trial[NCT00727103] | Phase 4 | 10 participants (Actual) | Interventional | 2008-07-31 | Completed |
| A Human Laboratory Assessment of the Safety and Potential Efficacy of Varenicline In Methamphetamine-Dependent Volunteers Receiving Methamphetamine[NCT00733967] | Phase 1 | 0 participants (Actual) | Interventional | 2008-01-31 | Withdrawn(stopped due to No longer active) |
| A Double Blind Randomized Placebo Controlled Study, for Smoking Cessation in Preadmission Clinic. the Use of a Teachable Moment[NCT00937508] | Phase 4 | 290 participants (Anticipated) | Interventional | 2008-06-30 | Recruiting |
| Varenicline Versus Transdermal Nicotine Patch for Smoking Cessation in Patients With Coronary Heart Disease: a Pilot Randomized Trial[NCT00959972] | Phase 4 | 50 participants (Actual) | Interventional | 2009-04-30 | Completed |
| A Phase 1, Open-Label, Nonrandomized, Single Dose Study To Characterize The Pharmacokinetics Of A Varenicline (CP-526,555) Transdermal Solution And A Varenicline Transdermal Delivery System Applied To The Skin Of Adult Smokers[NCT00774605] | Phase 1 | 12 participants (Actual) | Interventional | 2008-12-31 | Completed |
| Improving Varenicline Adherence and Outcomes in Homeless Smokers[NCT00786149] | Phase 3 | 428 participants (Actual) | Interventional | 2007-09-30 | Completed |
| A Phase 3B 12-Week, Double -Blind, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Varenicline Tartrate (CP-526,555) 1 mg BID for Smoking Cessation in Subjects With Schizophrenia and Schizoaffective Disorder.[NCT00644969] | Phase 3 | 128 participants (Actual) | Interventional | 2008-05-31 | Completed |
| A Phase 2, Multicenter, Randomized, Controlled, Double-Masked, Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray in Subjects With Neurotrophic Keratopathy (the Olympia Study)[NCT04957758] | Phase 2 | 113 participants (Actual) | Interventional | 2021-06-17 | Completed |
| Assessment of Smoking Topography and Behaviors During Response to Varenicline[NCT00948155] | Phase 4 | 48 participants (Actual) | Interventional | 2009-01-31 | Completed |
| Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers[NCT00790569] | | 315 participants (Actual) | Interventional | 2008-09-30 | Completed |
| Improving Medication Compliance and Smoking Cessation Treatment Outcomes for African American Smokers[NCT00781599] | | 72 participants (Actual) | Interventional | 2008-10-31 | Completed |
| Drug Use Investigation Of Champix (Regulatory Post Marketing Commitment Plan)[NCT00772941] | | 3,939 participants (Actual) | Observational | 2009-02-28 | Completed |
| Smoking Cessation Treatment for Head and Neck Cancer Patients[NCT00931021] | Early Phase 1 | 7 participants (Actual) | Interventional | 2009-07-31 | Terminated |
| Validation of a Novel Paradigm for Screening Medications for Nicotine Dependence[NCT00948649] | Phase 4 | 62 participants (Actual) | Interventional | 2006-09-30 | Completed |
| A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1903 in Healthy Volunteers[NCT04225052] | Phase 1 | 34 participants (Actual) | Interventional | 2019-12-19 | Completed |
| A Randomized, Double-blind, Placebo-controlled Multicenter Trial on the Efficacy of Varenicline and Bupropion in Combination and Alone, for Treatment of Alcohol Use Disorder[NCT04167306] | Phase 2 | 380 participants (Anticipated) | Interventional | 2019-03-04 | Recruiting |
| Effect of Smoking Cessation on Clinical and Microbiological Outcomes of the Non-surgical Periodontal Therapy[NCT02744417] | | 63 participants (Actual) | Interventional | 2010-08-31 | Completed |
| Aggressive Smoking Cessation Therapy Post-Acute Coronary Syndrome (ASAP) Trial[NCT05257629] | Phase 3 | 798 participants (Anticipated) | Interventional | 2023-02-02 | Recruiting |
| Combining Varenicline and Guanfacine for Smoking Cessation[NCT04198116] | Phase 2 | 140 participants (Anticipated) | Interventional | 2020-11-01 | Recruiting |
| A Phase 1, Open-Label, Single Dose Study To Characterize The Pharmacokinetics Of A Varenicline (CP-526,555) Transdermal Delivery System Applied To The Skin Of Adult Smokers[NCT01013454] | Phase 1 | 12 participants (Actual) | Interventional | 2009-12-31 | Completed |
| Pharmacogenetics, Emotional Reactivity and Smoking[NCT00507728] | Phase 2/Phase 3 | 646 participants (Actual) | Interventional | 2005-12-08 | Completed |
| Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users. A Double Blind, Placebo Controlled Trial[NCT00977249] | Phase 2/Phase 3 | 200 participants (Anticipated) | Interventional | 2009-09-30 | Recruiting |
| Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets[NCT00483002] | | 3,719 participants (Actual) | Observational | 2007-06-30 | Completed |
| Varenicline for Smoking Cessation in Bipolar Depressed Patients: An Open-Label 12-week Feasibility Trial[NCT00813800] | | 11 participants (Actual) | Interventional | 2009-01-31 | Completed |
| Exercise for Smoking Cessation in Postmenopausal Women[NCT00921388] | | 301 participants (Actual) | Interventional | 2009-03-31 | Completed |
| Varenicline for Smoking Cessation in Heavy Drinking Smokers[NCT00860028] | Phase 2 | 30 participants (Actual) | Interventional | 2008-10-31 | Completed |
| Neural Substrates of Varenicline's (Chantix®) Efficacy for Smoking Cessation[NCT00602927] | | 38 participants (Actual) | Interventional | 2007-11-30 | Completed |
| Varenicline for the Treatment of Smokeless Tobacco Use[NCT00813917] | | 76 participants (Actual) | Interventional | 2009-02-28 | Completed |
| A Phase 2 Multicenter, Double-Blind, Placebo-Controlled, Crossover Trial of Varenicline Tartrate (CP-526,555) in Patients With Mild to Moderate Alzheimer's Disease[NCT00744978] | Phase 2 | 66 participants (Actual) | Interventional | 2009-07-31 | Completed |
| Varenicline Pregnancy Cohort Study Protocol Chantix(Registered)/Champix(Registered) (Varenicline Tartrate)[NCT01290445] | | 885,185 participants (Actual) | Observational | 2007-09-13 | Completed |
| A Randomized, Multicenter, Double Blind, Placebo Controlled Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use[NCT00717093] | Phase 4 | 432 participants (Actual) | Interventional | 2008-08-31 | Completed |
| Extended (6-Week) Varenicline Preloading: Does it Facilitate Smoking Reduction and Cessation?[NCT02634281] | Phase 4 | 242 participants (Actual) | Interventional | 2016-02-29 | Completed |
| Evaluation of Varenicline (Champix) in Smoking Cessation for Patients Post-Acute Coronary Syndrome (EVITA) Trial[NCT00794573] | Phase 3 | 302 participants (Actual) | Interventional | 2009-09-30 | Completed |
| Combination Therapy With Varenicline and Bupropion for Smoking Cessation[NCT00935818] | Phase 2/Phase 3 | 506 participants (Actual) | Interventional | 2009-09-30 | Completed |
| Phase 4 Study of Treating Schizophrenic Smokers Using Varenicline and Behavioral Intervention: Effects on Craving, Cues and Withdrawal[NCT00781755] | Phase 4 | 0 participants (Actual) | Interventional | | Withdrawn(stopped due to Study design was altered such that a treatment component was removed through the VA IRB. We did not and will not begin this clinical trial.) |
| Optimizing Smoking Cessation for People With HIV/AIDS Who Smoke[NCT02460900] | Phase 3 | 184 participants (Actual) | Interventional | 2016-07-31 | Completed |
| An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1502 in Healthy Male Subjects[NCT04018378] | Phase 1 | 30 participants (Actual) | Interventional | 2017-01-06 | Completed |
| A Phase I, Open-Label, Randomized, Single Dose, Cross Over Study to Estimate the Relative Bioavailability of a Varenicline (CP-526,555) Transdermal Delivery System to the Chantix Immediate Release Tablet Formulation in Adult Smokers[NCT00661765] | Phase 1 | 18 participants (Actual) | Interventional | 2008-04-30 | Completed |
| Evaluation of a Tailored Smoking Cessation Treatment Algorithm Based on Initial Treatment Response and Genotype[NCT00894166] | Phase 3 | 606 participants (Actual) | Interventional | 2009-05-31 | Completed |
| Varenicline Attenuates Some of the Subjective and Physiological Effects of Intravenous Nicotine in Humans.[NCT00606892] | | 37 participants (Actual) | Interventional | 2007-08-31 | Completed |
| Extended Duration Pharmacotherapy for Prevention of Relapse to Smoking[NCT00621777] | Phase 4 | 247 participants (Actual) | Interventional | 2008-02-29 | Completed |
| Efficacy of Varenicline for Smokeless Tobacco Use in India[NCT01098305] | Phase 2 | 237 participants (Actual) | Interventional | 2011-04-30 | Completed |
| ASIA CHOICES CHampix Observational Investigation in the CEssation of Smoking[NCT00808015] | | 1,373 participants (Actual) | Observational | 2009-02-28 | Completed |
| Alterations in the Autonomic Nervous System During Smoking Quit Attempts- Possible Effects of Pharmacological Interventions[NCT01474265] | Phase 4 | 85 participants (Actual) | Interventional | 2011-11-30 | Completed |
| Contingency Management for Initiating Smoking Abstinence in Patients With Hypertension[NCT00879177] | Phase 4 | 203 participants (Actual) | Interventional | 2009-04-30 | Completed |
| Project HOPES: Healthy Options for Pain and Ending Smoking. A Program for Cancer Survivors.[NCT06029907] | Phase 4 | 20 participants (Anticipated) | Interventional | 2023-12-15 | Not yet recruiting |
| Open-Label, Single-Center, Randomized, 2-way Crossover Study Evaluating Relative Bioavailability of OC-01 (Varenicline) Nasal Spray as Compared to Orally Administered Varenicline (the Zen Study)[NCT04072146] | Phase 1 | 22 participants (Actual) | Interventional | 2019-08-26 | Completed |
| Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?[NCT00846859] | Phase 2 | 162 participants (Actual) | Interventional | 2009-03-31 | Completed |
| Assessing the Impact of Varenicline on Brain-Behavior Vulnerability in Cocaine Dependence[NCT00895557] | Phase 2 | 0 participants (Actual) | Interventional | 2007-12-31 | Withdrawn(stopped due to This study never started, no funding.) |
| Champix Observational Investigation In The Cessation of Smoking[NCT00669240] | | 567 participants (Actual) | Observational | 2007-11-30 | Completed |
| A Phase 2, Seven Week, Double-Blind, Placebo Controlled, Randomized, Parallel Group Study To Evaluate The Safety And Efficacy Of Three Doses Of A Controlled Release Formulation Of Varenicline For Smoking Cessation[NCT00741884] | Phase 2 | 0 participants (Actual) | Interventional | 2010-08-31 | Withdrawn |
| Post-Marketing Surveillance Study To Observe The Safety And Effectiveness Of Varenicline (Champix) Tablets In Smoking Cessation Among Filipino Subjects[NCT00794365] | | 330 participants (Actual) | Observational | 2008-07-31 | Completed |
| Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes[NCT05642715] | | 400 participants (Anticipated) | Interventional | 2024-03-31 | Not yet recruiting |
| URBAN ARCH 4/5 Russia Cohort-Targeting HIV-comorbidities With Pharmacotherapy to Reduce Alcohol and Tobacco Use in HIV-infected Russians[NCT02797587] | Phase 2/Phase 3 | 400 participants (Actual) | Interventional | 2017-07-19 | Completed |
| Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement[NCT00747643] | | 163 participants (Actual) | Interventional | 2008-09-30 | Completed |
| Smoking Cessation Treatment for Methadone Maintenance Patients[NCT01027754] | Phase 4 | 112 participants (Actual) | Interventional | 2009-08-31 | Completed |
| Pilot Study of Varenicline (Chantix®) in the Treatment of Friedreich's Ataxia[NCT00803868] | Phase 2/Phase 3 | 28 participants (Actual) | Interventional | 2009-05-31 | Terminated(stopped due to The DSMB recommended that the study be stopped as a result of concerns regarding safety and intolerability and insufficient evidence of efficacy.) |
| Comparison of the Efficacy and Safety of Varenicline Versus Placebo for Smoking Cessation Among HIV-infected Patients. A Randomized Double Blind Controlled Trial[NCT00918307] | Phase 3 | 248 participants (Actual) | Interventional | 2009-10-31 | Completed |
| Varenicline and Motivational Advice for Smokers With SUD[NCT00756275] | | 158 participants (Actual) | Interventional | 2009-01-31 | Completed |
| Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder[NCT01010204] | Phase 4 | 60 participants (Actual) | Interventional | 2010-01-31 | Completed |
| Smoking Cessation With Varenicline (Champix) and Integrated Voice Response Technology (IVR)[NCT00832806] | Phase 1 | 100 participants (Actual) | Interventional | 2008-01-31 | Completed |
| Randomized, Controlled, Single-Masked Clinical Trial to Evaluate the Chronic Efficacy of OC-01 Nasal Spray on Signs of Dry Eye Disease (The MYSTIC Study)[NCT03873246] | Phase 2 | 123 participants (Actual) | Interventional | 2019-02-18 | Completed |
| Botswana Smoking and Abstinence Reinforcement Trial[NCT05694637] | Phase 4 | 750 participants (Anticipated) | Interventional | 2023-07-25 | Enrolling by invitation |
| Investigation of the Efficacy and Safety of Varenicline in the Postacute Treatment of Alcohol Dependence - a Prospective, Double-blind, Placebo-controlled, Randomised Phase-II Study[NCT01071187] | Phase 2 | 40 participants (Anticipated) | Interventional | 2010-03-31 | Recruiting |
| Do Treatments for Smoking Cessation Affect Alcohol Drinking?[NCT00580645] | Phase 2 | 60 participants (Actual) | Interventional | 2007-04-30 | Completed |
| Assessment of Response to Open-label Treatment With Varenicline in Psychiatric Inpatients[NCT00525928] | | 0 participants (Actual) | Interventional | 2007-10-31 | Withdrawn(stopped due to insufficient recuirment) |
| RAUORA: Cytisine Versus Varenicline for Smoking Cessation[NCT02957786] | Phase 3 | 679 participants (Actual) | Interventional | 2017-09-18 | Completed |
| A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of Four Dosing Strategies for CP-526,555 ( 0.5 mg BID Titrated, 0.5 mg BID, 1 mg BID, and Titrated 1 mg BID ) in Smoking Cessation[NCT00150254] | Phase 2 | 625 participants | Interventional | 2001-09-30 | Completed |
| A Pilot, Randomized, Double-blind, Placebo-controlled Phase I Study to Determine the Safety and Tolerability of Varenicline (Chantix®) in Treating Spinocerebellar Ataxia Type 3[NCT00992771] | Phase 2 | 20 participants (Actual) | Interventional | 2009-10-31 | Completed |
| A Phase 2B, Multi-Center, Randomized, Double-Blinded, Parallel-Arm , Study to Assess Efficacy and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®) or Placebo Co-Administered With Varenicline (Champix®) as an Aid in[NCT00995033] | Phase 2 | 558 participants (Actual) | Interventional | 2009-10-31 | Completed |
| Varenicline OTC Trial on Efficacy and Safety[NCT03557294] | Phase 4 | 307 participants (Actual) | Interventional | 2018-05-07 | Completed |
| Efficacy and Safety of E-cigarettes for Smoking Cessation in Middle-aged Heavy Smokers[NCT03235505] | Phase 4 | 450 participants (Actual) | Interventional | 2018-08-01 | Completed |
| A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial With 40-Week Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate For Smoking Cessation In Patients With Mild-To-Moderate Chronic Obstructive Pulmonary Disease[NCT00285012] | Phase 3 | 504 participants (Actual) | Interventional | 2006-05-31 | Completed |
| A 12-Week, Double-Blind, Placebo-Controlled, Multicenter Study With A 40 Week Follow Up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 Milligram (Mg) Twice Daily (BID) for Smoking Cessation in Subjects With Cardiovascular Disease[NCT00282984] | Phase 3 | 714 participants (Actual) | Interventional | 2006-02-28 | Completed |
| Effects of Varenicline on Cortical Neuroplasticity and Working Memory in Patients With Schizophrenia and Healthy Controls[NCT01934023] | Phase 2 | 24 participants (Actual) | Interventional | 2013-09-30 | Completed |
| Study on the Model of Smoking Cessation Intervention and Service Ability Improvement in General Hospital[NCT01935505] | | 2,000 participants (Anticipated) | Observational | 2008-10-31 | Enrolling by invitation |
| PISCES I: Precision Implemented Smoking Cessation Evaluation Study[NCT04604509] | Phase 4 | 2,010 participants (Anticipated) | Interventional | 2020-08-04 | Recruiting |
| Feasibility and Preliminary Effectiveness of Varenicline for Co-occurring Cannabis and Tobacco Use[NCT04595318] | Phase 4 | 7 participants (Actual) | Interventional | 2015-01-31 | Completed |
| A Phase 2, Double Blind, Placebo Controlled Trial to Assess the Efficacy of Varenicline Tartrate for Alcohol Dependence in Very Heavy Drinkers[NCT01146613] | Phase 2 | 200 participants (Actual) | Interventional | 2011-02-28 | Completed |
| Placebo-controlled Study of Varenicline Effects on Nicotine Withdrawal Followed by a Test of Smoking Topography, Reward, and Reinforcement[NCT00571805] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2007-09-30 | Withdrawn |
| A Phase 2 6-Week, Double-Blind, Placebo-Controlled, Multicenter Trial Of Varenicline Tartrate (CP-526,555) For Cognitive Impairment In Subjects With Schizophrenia[NCT00743847] | Phase 2 | 0 participants (Actual) | Interventional | 2009-03-31 | Withdrawn |
| Phase 1, Open-Label, Randomized, Single-Dose, Two-Way Crossover Study To Evaluate The Effect Of Food On The Oral Bioavailability Of A Varenicline Controlled Release Formulation In Healthy Adult Smokers[NCT00731562] | Phase 1 | 24 participants (Actual) | Interventional | 2008-07-31 | Completed |
| A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study With Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555-18) 1 Mg Bid For Smoking Cessation (Protocol A3051080)[NCT00594204] | Phase 4 | 593 participants (Actual) | Interventional | 2008-04-30 | Completed |
| Efficacy of Genetic Markers in Choosing Pharmacological Treatment for Smoking Cessation With Bupropion and Varenicline and Its Implications for Combining Drugs: Randomized Control Study.[NCT03362099] | Phase 4 | 361 participants (Actual) | Interventional | 2016-11-01 | Completed |
| Efficacy of Varenicline in Ambivalent Smokers[NCT00595868] | Phase 2 | 220 participants (Actual) | Interventional | 2008-03-31 | Completed |
| A Multicenter, Open-Label Study Exploring the Efficacy and Safety of Varenicline in Japanese Smokers Motivated to Quit Smoking[NCT00635401] | Phase 2 | 30 participants (Actual) | Interventional | 2004-05-31 | Completed |
| A Multicenter, Open Label Study To Investigate The Feasibility And Efficacy Of A Smoking Cessation Program With Varenicline In Patients Undergoing Elective Surgery[NCT00889720] | Phase 4 | 16 participants (Actual) | Interventional | 2009-11-30 | Completed |
| "VIBRATIONS: Varenicline In Patients Ambitioned To Terminate Smoking - A Non-Interventional Study"[NCT01104636] | | 1,177 participants (Actual) | Observational | 2010-05-31 | Completed |
| [NCT02681848] | | 180,000 participants (Anticipated) | Observational | 2006-09-01 | Active, not recruiting |
| Safety and Tolerability of Varenicline When Used for Smoking Cessation/Reduction in Individuals With Severe and Persistent Mental Illness: An Open Label Pilot Trial[NCT00702793] | Phase 4 | 0 participants (Actual) | Interventional | 2008-04-30 | Withdrawn(stopped due to No participants enrolled) |
| Varenicline and Smoking Cessation in Schizophrenia[NCT01111149] | Phase 2 | 24 participants (Actual) | Interventional | 2009-12-31 | Completed |
| Smoking Cessation in Patients With Squamous Cell Cancer of the Head and Neck Undergoing Radiation Therapy With or Without Chemotherapy[NCT02582008] | Early Phase 1 | 9 participants (Actual) | Interventional | 2016-01-31 | Terminated(stopped due to Slow accrual) |
| Effectiveness of Varenicline: Testing Individual Differences[NCT01228175] | Phase 4 | 218 participants (Actual) | Interventional | 2010-03-31 | Completed |
| Smoking Relapse Prevention Among COPD Ex-smokers[NCT02888444] | Phase 3 | 8 participants (Actual) | Interventional | 2017-07-31 | Terminated(stopped due to Poor recruitment) |
| Randomized, Controlled, Double-masked Investigator Initiated Study to Evaluate the Efficacy of OC-01 (Varenicline) Nasal Spray on Objective and Subjective Dry Eye Signs and Symptoms in Daily Disposable Contact Lens Wearers[NCT05161208] | Phase 4 | 75 participants (Actual) | Interventional | 2021-12-03 | Completed |
| "A Phase 1 Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of the CDFF0318 and Champix Tab. 1mg (Varenicline Tartrate) in Healthy Male Volunteers"[NCT04631874] | Phase 1 | 32 participants (Actual) | Interventional | 2019-07-24 | Completed |
| Efficacy And Safety Of Smoking Cessation With Varenicline Tartrate In Diabetic Smokers: A Double-Blind, Placebo-Controlled, Randomized, Trial[NCT01387425] | | 300 participants (Actual) | Interventional | 2011-06-30 | Completed |
| A Phase 4 12-week, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555) 1mg BID For Smoking Cessation In Subjects With Depression[NCT01078298] | Phase 4 | 525 participants (Actual) | Interventional | 2010-03-31 | Completed |
| A Twelve-Week Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of a Flexible-Dosing Strategy for CP-526,555 ( 0.5 mg to 2.0 mg Total Daily Dose ) in Smoking Cessation[NCT00150228] | Phase 2 | 300 participants | Interventional | 2001-12-31 | Completed |
| Evaluating the Effects of Varenicline on Smoking Lapse in Smokers With and Without Schizophrenia: Implications for Treatment[NCT01850953] | Phase 4 | 28 participants (Actual) | Interventional | 2013-06-30 | Completed |
| Varenicline and Advanced Behavioral Support on Smoking Cessation and Quality of Life in Inpatients With Acute Exacerbation of COPD, Bronchial Asthma Attack, or Community-acquired Pneumonia: a Prospective Open-label 52-week Follow-up Trial[NCT02922387] | Phase 4 | 101 participants (Actual) | Interventional | 2012-05-31 | Completed |
| Multicenter, Randomized, Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The ONSET-1 Study)[NCT03636061] | Phase 2 | 182 participants (Actual) | Interventional | 2018-08-15 | Completed |
| Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment[NCT04634071] | Phase 2 | 96 participants (Anticipated) | Interventional | 2021-01-12 | Recruiting |
| A 24-week Open-Label Feasibility Trial of Varenicline for Alcoholic Cigarette Smokers[NCT01169610] | Phase 3 | 1 participants (Actual) | Interventional | 2011-01-31 | Terminated |
| Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence[NCT00749658] | Phase 2/Phase 3 | 121 participants (Actual) | Interventional | 2008-11-30 | Completed |
| [NCT01243203] | | 300 participants (Actual) | Interventional | 2007-11-30 | Completed |
| Varenicline, an Alpha 4 Beta 2 Nicotinic Acetylcholine Receptor Partial Agonist, on Cognitive Dysfunction in 120 Patients With Schizophrenia: a Randomized, Double Blind, 8 Weeks Trial[NCT00523445] | Phase 3 | 120 participants (Anticipated) | Interventional | 2007-09-30 | Completed |
| A Phase 1, Investigator And Subject Blind (Sponsor Open), Randomized, Placebo Controlled, Parallel Group, Multiple Dose Escalation Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Varenicline Amt-8 Controlled Release Formulation In Adult[NCT00527150] | Phase 1 | 48 participants (Actual) | Interventional | 2007-10-31 | Completed |
| A Single-arm Investigator Initiated Study to Evaluate the Efficacy of OC-01 (Varenicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease in Subjects With Sjogren's Syndrome[NCT05700422] | Phase 4 | 39 participants (Actual) | Interventional | 2023-05-01 | Completed |
| "Varenicline for Gradual vs. Abrupt Smoking Cessation in Low-motivated COPD Smokers: A Randomized Pilot Study"[NCT02894957] | Phase 4 | 250 participants (Anticipated) | Interventional | 2019-10-31 | Not yet recruiting |
| A Randomized, Controlled, Double-Masked, Two-Arm Investigator-Initiated Study to Assess the Efficacy of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease in Subjects Following Corneal Collagen Crosslinking (CXL)[NCT05136924] | Phase 2 | 20 participants (Anticipated) | Interventional | 2021-12-01 | Not yet recruiting |
| A Randomized, Controlled, Double-Masked, Two-Arm Investigator-Initiated Study to Assess the Efficacy of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease Following Photorefractive Keratectomy (PRK)[NCT05045508] | Phase 3 | 60 participants (Anticipated) | Interventional | 2021-08-30 | Recruiting |
| Stage Ib Trial of mSMART With Varenicline[NCT03069768] | Phase 1 | 0 participants (Actual) | Interventional | 2018-04-30 | Withdrawn(stopped due to Unable to obtain varenicline to provide to participants) |
| Pharmacogenetics of Nicotine Addiction Treatment (PNAT)[NCT01314001] | Phase 3 | 1,246 participants (Actual) | Interventional | 2010-12-31 | Completed |
| Helping People Adhere to Their Varenicline Treatment by Co-creating a Conversational Agent: A Feasibility Study[NCT05997901] | | 40 participants (Anticipated) | Interventional | 2022-10-12 | Recruiting |
| Feasibility of the Enhanced Tobacco Intervention Protocol (ETIP) to Reduce Smoking and Potentially Alter the Tumor Microenvironment of Head and Neck Squamous Cell Carcinoma and Non-Small Cell Lung Cancer[NCT04694846] | | 40 participants (Anticipated) | Interventional | 2020-08-19 | Active, not recruiting |
| Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia[NCT00554840] | Phase 2 | 16 participants (Actual) | Interventional | 2007-11-30 | Completed |
| A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation[NCT00143286] | Phase 3 | 2,000 participants | Interventional | 2003-04-30 | Completed |
| A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate ( CP-526,555) in Comparison to Zyban for Smoking Cessation[NCT00143364] | Phase 3 | 1,005 participants | Interventional | 2003-06-30 | Completed |
| An Open-Label, Multicenter Study With Follow-Up Evaluating the Safety and Efficacy of Varenicline Tartrate in Comparison to Transdermal Nicotine Patch for Smoking Cessation[NCT00143325] | Phase 3 | 730 participants | Interventional | 2005-01-31 | Completed |
| Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Multiple-Dose Pharmacokinetics, Safety and Tolerability of Varenicline in Healthy Adolescent Smokers[NCT00463918] | Phase 1 | 73 participants (Actual) | Interventional | 2007-05-31 | Completed |
| A Twelve-Week, Double-Blind, Placebo-Controlled, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 MG BID for Smoking Cessation[NCT00141167] | Phase 3 | 250 participants (Actual) | Interventional | 2005-02-28 | Completed |
| A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate ( CP-526,555) in Comparison to Zyban for Smoking Cessation[NCT00141206] | Phase 3 | 1,005 participants | Interventional | 2003-05-31 | Completed |
| Varenicline and Combined NRT for Initial Smoking Cessation and Rescue Treatment in Smokers: A Randomized Pilot Trial[NCT02271919] | Phase 4 | 631 participants (Actual) | Interventional | 2015-05-14 | Active, not recruiting |
| Varenicline for Light Smokers[NCT01639560] | Phase 4 | 93 participants (Actual) | Interventional | 2013-01-31 | Completed |
| Internet-based Medication Adherence Program for Nicotine Dependence Treatment[NCT02136498] | | 66 participants (Actual) | Interventional | 2014-10-31 | Completed |
| Randomized Controlled Smoking Cessation Trial on Adaptive Pharmacotherapy[NCT02501265] | Phase 2 | 188 participants (Actual) | Interventional | 2017-06-06 | Completed |
| A Pilot Smoking Cessation Study for Newly Diagnosed Lung Cancer Patients[NCT00580398] | Phase 1/Phase 2 | 49 participants (Actual) | Interventional | 2008-01-31 | Completed |
| EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking[NCT03262662] | Phase 3 | 320 participants (Actual) | Interventional | 2017-10-01 | Completed |
| Varenicline Versus Cytisine for Smoking Cessation in the Primary Care Setting in Croatia and Slovenia - a Randomized Controlled Trial[NCT04015414] | Phase 3 | 352 participants (Actual) | Interventional | 2020-07-14 | Completed |
| An Open Pilot Study of Varenicline (Chantix) in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD): Effects on ADHD and Cigarette Smoking[NCT00907218] | Phase 4 | 2 participants (Actual) | Interventional | 2009-04-30 | Terminated(stopped due to extremely slow enrollment) |
| Maintaining Nonsmoking[NCT01162239] | Phase 3 | 216 participants (Actual) | Interventional | 2010-05-31 | Completed |
| A Twelve-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study With Follow-up Evaluating The Safety And Efficacy Of Varenicline For Smoking Cessation In Healthy Adolescent Smokers[NCT01312909] | Phase 4 | 312 participants (Actual) | Interventional | 2011-04-30 | Completed |
| Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit[NCT01308736] | | 73 participants (Actual) | Interventional | 2011-01-31 | Completed |
| Concurrent Bupropion / Varenicline for Smoking Cessation[NCT01303861] | Phase 3 | 702 participants (Actual) | Interventional | 2011-03-31 | Completed |
| The Role of Varenicline in Treating Opioid Dependence: A Pilot Study[NCT01436474] | Phase 1 | 21 participants (Actual) | Interventional | 2011-06-30 | Completed |
| Smoking Cessation in Young Adults in Northern Finland[NCT01531049] | Phase 2/Phase 3 | 300 participants (Actual) | Interventional | 2012-05-31 | Completed |
| Treatment of Tobacco Dependence in Breast Cancer Patients: A Randomized Trial of Varenicline (Chantix)[NCT01532232] | | 7 participants (Actual) | Observational | 2012-02-29 | Terminated(stopped due to Lack of accrual) |
| Randomized Double-blind Trial of Two Parallel Groups Design to Evaluate the Efficacy of Smoking Cessation With Combined (Varenicline Plus Nicotine Patches) Versus Monotherapy (Varenicline Plus Placebo Patches)[NCT01538394] | Phase 4 | 322 participants (Actual) | Interventional | 2012-01-31 | Completed |
| Pilot Study of Varenicline vs. Nicotine Patch Delivered by a Telephone Quitline to Promote Smoking Cessation[NCT01771627] | | 300 participants (Actual) | Interventional | 2012-10-22 | Completed |
| A Pilot Study of Varenicline for Tobacco Dependence Treatment in Recovering Alcoholic Smokers: the Clinical Trial[NCT01092702] | Phase 2/Phase 3 | 32 participants (Actual) | Interventional | 2008-04-30 | Completed |
| A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of CP-526,555 In Smokers Motivated To Stop Smoking[NCT00139750] | Phase 2 | 600 participants | Interventional | 2004-12-31 | Completed |
| A 52-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety of Varenicline Tartrate ( CP-526,555) for Smoking Cessation[NCT00143299] | Phase 3 | 375 participants | Interventional | 2003-10-31 | Completed |
| A Human Laboratory Assessment of the Safety and Potential Efficacy of Varenicline in Methamphetamine-Dependent Volunteers Receiving Methamphetamine[NCT01571167] | Phase 1 | 17 participants (Actual) | Interventional | 2011-01-31 | Completed |
| A Translational Randomized Clinical Trial of Varenicline Sampling to Promote Smoking Cessation and Scalable Treatment Dissemination[NCT04525755] | Phase 1/Phase 2 | 648 participants (Anticipated) | Interventional | 2021-02-08 | Recruiting |
| Deep rTMS and Varenicline for Smoking Cessation: A Pilot Study Exploring the Efficacy of a Combined Treatment Approach[NCT04083144] | | 50 participants (Actual) | Interventional | 2019-08-22 | Completed |
| Advancing Varenicline as a Treatment for Cannabis Use Disorder[NCT02892110] | Phase 2 | 72 participants (Actual) | Interventional | 2017-02-13 | Completed |
| A Seven-Week Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of Three Doses of CP-526,555 ( 0.3 mg QD, 1 mg QD, and 1 mg BID ) in Comparison With Zyban in Smoking Cessation[NCT00150241] | Phase 2 | 625 participants | Interventional | 2000-02-29 | Completed |
| Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors, Independent Investigator Study[NCT00802919] | Phase 4 | 93 participants (Actual) | Interventional | 2008-09-30 | Completed |
| Mobile Health Interventions for Varenicline Adherence Among HIV-positive Smokers[NCT04191278] | Phase 4 | 0 participants (Actual) | Interventional | 2021-11-30 | Withdrawn(stopped due to COVID prevented study initiation) |
| A Human Laboratory Assessment of the Safety and Potential Efficacy of Varenicline in Methamphetamine-dependent Volunteers Receiving Methamphetamine[NCT00713479] | Phase 1 | 8 participants (Actual) | Interventional | 2008-07-31 | Completed |
| Multidisciplinary Tools for Improving the Efficacy of Public Prevention Measures Against Smoking[NCT02991781] | | 106 participants (Actual) | Interventional | 2017-01-31 | Completed |
| The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior[NCT00580853] | Phase 2 | 62 participants (Actual) | Interventional | 2007-04-30 | Completed |
| Advancing Tobacco Use Treatment for African American Smokers[NCT02360631] | Phase 4 | 500 participants (Actual) | Interventional | 2015-07-29 | Completed |
| The Feasibility of Treatment for Vaping Cessation[NCT04317300] | Early Phase 1 | 0 participants (Actual) | Interventional | 2023-02-01 | Withdrawn(stopped due to medication has not been available for the intervention) |
| Varenicline for Treatment of E-cigarette Dependence[NCT05541497] | Phase 2 | 40 participants (Actual) | Interventional | 2022-11-04 | Active, not recruiting |
| Dopamine D2/D3 Receptor Upregulation by Varenicline in Methamphetamine Users[NCT03059563] | Phase 1 | 62 participants (Actual) | Interventional | 2018-01-11 | Terminated(stopped due to Global pandemic) |
| Treatment of Nicotine Dependence in a Health Care Setting[NCT00301145] | | 1,200 participants (Anticipated) | Interventional | 2005-10-31 | Completed |
| A Pharmacokinetic, Toleration And Safety Study Of Single And Multiple Oral Doses Of Varenicline In Chinese Healthy Volunteers[NCT00452894] | Phase 1 | 14 participants | Interventional | 2007-03-31 | Completed |
| "Interventions for Cardiovascular Disease: Real-World Effectiveness of Combined Pharmacotherapy and Behavioural Counseling for Smoking Cessation"[NCT01623505] | Phase 4 | 738 participants (Actual) | Interventional | 2010-06-30 | Completed |
| Examining the Effects of Varenicline on Reward Responses,Cognition, and Tobacco Cues in Adolescent Smokers[NCT01624428] | Phase 1 | 16 participants (Actual) | Interventional | 2012-06-30 | Completed |
| Investigating the Effects of Varenicline on D2/3 Receptor Binding in Brain of Tobacco-smokers: a PET/[11C](+)PHNO Study[NCT01632189] | | 8 participants (Actual) | Interventional | 2012-09-30 | Completed |
| An Open-Label, Multiple-Dose Clinical Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of OC-01 (Varenicline Solution) Nasal Spray in Adult Chinese Subjects With Dry Eye Disease[NCT05576415] | Phase 1 | 9 participants (Actual) | Interventional | 2022-12-07 | Completed |
| Efficacy of Varenicline Associated With Intensive Counselling Versus Placebo of Varenicline Associated With Intensive Counselling on Smoking Cessation at the Acute Phase of an Exacerbation of Chronic Obstructive Pulmonary Disease (COPD). A Multicenter Ran[NCT01694732] | Phase 3 | 83 participants (Actual) | Interventional | 2012-08-31 | Completed |
| A Combination of Scheduled Reduced Smoking With Varenicline to Enhance Cessation[NCT01772641] | Phase 4 | 32 participants (Actual) | Interventional | 2012-12-31 | Terminated(stopped due to difficulty recruiting and retaining participants) |
| The Canadian HIV Quit Smoking Trial: Tackling the Co-morbidities of Depression and Cardiovascular Disease in HIV+ Smokers[NCT01800019] | Phase 3 | 256 participants (Anticipated) | Interventional | 2014-01-31 | Active, not recruiting |
| A Placebo Controlled Trial of Varenicline for Smoking Among Those With HIV/AIDS[NCT01710137] | Phase 3 | 179 participants (Actual) | Interventional | 2012-10-31 | Completed |
| Combining Varenicline and Naltrexone for Smoking Cessation and Drinking Reduction[NCT02698215] | Phase 2 | 165 participants (Actual) | Interventional | 2016-05-31 | Completed |
| Pre to Postoperative Smoking Cessation[NCT02683161] | Phase 2 | 5 participants (Actual) | Interventional | 2015-10-31 | Terminated(stopped due to Inability to adequately recruit participants during pre-post operative period.) |
| The Effectiveness of Smoking Cessation in Prediabetic Smokers[NCT01926041] | | 589 participants (Actual) | Interventional | 2013-08-01 | Active, not recruiting |
| A 26-Week Phase II, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Varenicline in Combination With Nicotine Replacement Therapy for Smoking Cessation[NCT01444131] | Phase 2 | 446 participants (Actual) | Interventional | 2011-04-30 | Completed |
| 4th Generation E-cigarettes in African American Smokers: Reducing Harm and Quitting Combustible Cigarettes in Dual Users[NCT05703672] | Phase 3 | 500 participants (Anticipated) | Interventional | 2023-07-17 | Recruiting |
| A Personalized mHealth Approach to Smoking Cessation for Veterans Living With HIV (CDA 17-005)[NCT04135937] | Phase 4 | 12 participants (Actual) | Interventional | 2019-11-18 | Completed |
| A Randomized, Double-blind Trial of Varenicline Versus Placebo, in Conjunction With Cognitive Behavioral Therapy, for Methamphetamine Dependence[NCT01011829] | Phase 2 | 20 participants (Actual) | Interventional | 2009-11-30 | Completed |
| Treatment of Smoking Among Individuals With PTSD: A Phase II, Randomized Study of Varenicline and Cognitive Behavioral Therapy[NCT00937235] | Phase 2 | 142 participants (Actual) | Interventional | 2009-01-31 | Completed |
| Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders[NCT01000987] | Phase 2 | 44 participants (Actual) | Interventional | 2009-10-31 | Completed |
| Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1[NCT03507127] | Phase 2 | 5 participants (Actual) | Interventional | 2018-05-01 | Terminated(stopped due to Low rate of enrollment) |
| Pilot Study on Varenicline in Light and Intermittent Smokers[NCT04089982] | Phase 4 | 11 participants (Actual) | Interventional | 2019-11-04 | Completed |
| Effects of Smoking Environments on Craving and Smoking[NCT02551692] | | 125 participants (Actual) | Interventional | 2016-01-31 | Completed |
| Translational Neuropsychopharmacology Research of Nicotine Addiction[NCT02723162] | Phase 2 | 67 participants (Actual) | Interventional | 2016-05-04 | Completed |
| A Pilot Translational Study of Varenicline Sampling to Promote Treatment Engagement and Smoking Cessation[NCT03742154] | Early Phase 1 | 99 participants (Actual) | Interventional | 2018-12-03 | Completed |
| Effects of Varenicline on Cigarette Self Administration[NCT00731055] | Phase 2 | 16 participants (Actual) | Interventional | 2008-02-29 | Completed |
| Varenicline for Methamphetamine Dependence: Phase II Clinical Trial[NCT01365819] | Phase 2 | 52 participants (Actual) | Interventional | 2012-02-29 | Completed |
| Mechanistic Evaluations of Pre-Cessation Therapies for Smoking Cessation[NCT01406223] | Phase 3 | 282 participants (Actual) | Interventional | 2011-07-31 | Completed |
| Reducing Surgical Complications in Newly Diagnosed Lung Cancer Patients Who Smoke Cigarettes[NCT02856581] | Phase 3 | 23 participants (Actual) | Interventional | 2017-09-29 | Terminated(stopped due to Slow accrual) |
| Tailored Tobacco Intervention[NCT01892813] | Phase 3 | 411 participants (Actual) | Interventional | 2013-07-31 | Active, not recruiting |
| A Randomized, Controlled, Double-masked, Investigator-initiated Trial to Evaluate Tear Film Quality and Stability in Subjects With Dry Eye Disease Using OC-01 (Varenicline Solution) Nasal Spray 0.03 mg as Compared to Vehicle Control Nasal Spray[NCT05514041] | Phase 4 | 60 participants (Anticipated) | Interventional | 2022-08-29 | Recruiting |
| Lorcaserin for Preventing Weight Gain Among Smokers Receiving Varenicline: A Pilot Study[NCT02393547] | Phase 1/Phase 2 | 20 participants (Actual) | Interventional | 2013-09-30 | Completed |
| Varenicline Pharmacological and Expectancy Effects on Medication Adherence (Balanced Placebo Design With Varenicline: Pharmacological and Expectancy Effects on Medication Adherence)[NCT03538808] | Phase 4 | 80 participants (Actual) | Interventional | 2018-11-06 | Completed |
| Varenicline and Lorcaserin for Smoking Cessation and Weight Gain Prevention[NCT02412631] | Phase 2/Phase 3 | 84 participants (Actual) | Interventional | 2016-06-15 | Terminated(stopped due to Lorcaserin removed from market) |
| Endothelial Function and Autonomic Regulation After Short-term Smoking Cessation: Varenicline Versus Placebo[NCT00673595] | | 19 participants (Actual) | Interventional | 2007-03-31 | Terminated(stopped due to Difficulty with recruiting sujects and subjects complying with the protocol) |
| Extended Duration Varenicline for Smoking Among Cancer Patients: A Clinical Trial[NCT01756885] | Phase 3 | 207 participants (Actual) | Interventional | 2013-01-31 | Completed |
| A Smoking Cessation Intervention for Yale Dining Employees[NCT02562521] | Phase 4 | 25 participants (Actual) | Interventional | 2015-09-30 | Completed |
| A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Multinational Study Of Efficacy And Safety Of Varenicline Tartrate For Smoking Cessation[NCT00371813] | Phase 3 | 334 participants (Actual) | Interventional | 2006-09-30 | Completed |
| Behavioral Activation and Varenicline for Smoking Cessation in Depressed Smokers[NCT02378714] | Phase 4 | 300 participants (Actual) | Interventional | 2015-07-24 | Completed |
| A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV[NCT04490057] | Phase 4 | 632 participants (Anticipated) | Interventional | 2020-07-27 | Recruiting |
| Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease Experiments 1 & 2 - Projects #3[NCT02933372] | Phase 2 | 25 participants (Actual) | Interventional | 2015-10-05 | Completed |
| Human Laboratory Study of Varenicline for Alcohol Use Disorder[NCT03035708] | Phase 1/Phase 2 | 47 participants (Actual) | Interventional | 2017-05-01 | Completed |
| A Phase 3, Multicenter, Randomized, Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease in Chinese Population[NCT05378945] | Phase 3 | 340 participants (Actual) | Interventional | 2022-07-22 | Completed |
| Multicenter, Randomized, Controlled, Double-Masked, Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease (The ONSET-2 Study)[NCT04036292] | Phase 3 | 758 participants (Actual) | Interventional | 2019-07-23 | Completed |
| Optimized Chronic Care for Smokers: Developing and Implementing Integrated Clinical and Systems Interventions in Primary Care - Cessation Trial[NCT04188873] | Phase 4 | 608 participants (Anticipated) | Interventional | 2020-12-10 | Enrolling by invitation |
| A Randomized Controlled Trial of Varenicline for Adolescent Smoking Cessation[NCT01509547] | Phase 3 | 157 participants (Actual) | Interventional | 2012-08-31 | Completed |
| [NCT02488889] | Phase 4 | 0 participants (Actual) | Interventional | 2015-08-31 | Withdrawn(stopped due to Investigator left institution prior to enrollment of study participants) |
| Improving Tobacco Treatment Rates for Cancer Patients Who Smoke[NCT04738643] | | 52 participants (Anticipated) | Interventional | 2022-06-28 | Recruiting |
| Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness[NCT04011280] | Phase 4 | 39 participants (Actual) | Interventional | 2019-08-12 | Completed |
| A Comparative Effectiveness & Long Term Health Study in Wisconsin Smokers[NCT01553084] | Phase 4 | 1,086 participants (Actual) | Interventional | 2012-05-31 | Completed |
| Systematic Assessment of Response to Open-label Treatment With Varenicline in Depressed Outpatient Smokers[NCT00525837] | | 18 participants (Actual) | Interventional | 2007-09-30 | Completed |
| Combination Pharmacotherapy With Chantix & Bupropion for Smoking Cessation (ChanBan)[NCT00587769] | Phase 3 | 38 participants (Actual) | Interventional | 2007-07-31 | Completed |
| Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity[NCT00664755] | Phase 2 | 140 participants (Actual) | Interventional | 2007-07-31 | Completed |
| [NCT01151813] | Phase 2 | 15 participants (Actual) | Interventional | 2010-07-31 | Completed |
| A Phase II, Randomized, Double-Blind Trial of Varenicline for the Treatment of Cocaine Dependence[NCT01680887] | Phase 2 | 156 participants (Actual) | Interventional | 2012-08-31 | Completed |
| Varenicline for the Treatment of DSM 5 Cannabis Use Disorder in Adults[NCT03980561] | Phase 2 | 174 participants (Actual) | Interventional | 2020-01-31 | Active, not recruiting |
| Tailored Smoking Cessation Treatment for LIVE FOR LIFE® Participants[NCT01560507] | Phase 2/Phase 3 | 19 participants (Actual) | Interventional | 2012-05-31 | Terminated(stopped due to Low Recruitment) |
| Varenicline For Nicotine Vaping Cessation In Non Smoker Vaper Adolescents[NCT04602494] | Phase 4 | 4 participants (Actual) | Interventional | 2020-12-18 | Terminated(stopped due to The pilot study used apo-varenicline under temp FDA authorization. When varenicline was available an IND exemption was granted to enroll children, IRB approved a trial of varenicline in participants ages 16-25 June 27, 2022, the pilot was terminated) |
| A Phase 4, Non-treatment Follow-up For Cardiac Assessments Following Use Of Smoking Cessation Treatments In Subjects With And Without A History Of Psychiatric Disorders[NCT01574703] | Phase 4 | 4,595 participants (Actual) | Interventional | 2012-05-31 | Completed |
| Characterizing a Cue-vulnerable Pharmaco-responsive Endophenotype in Smokers[NCT01524627] | Phase 2 | 124 participants (Actual) | Interventional | 2011-12-31 | Completed |
| New Approaches to Smoking Cessation in Heavy Drinkers[NCT02151591] | Phase 1 | 26 participants (Actual) | Interventional | 2017-03-01 | Completed |
| Varenicline for Comorbid Tobacco and Cannabis Use in Veterans[NCT05294263] | Phase 2 | 138 participants (Anticipated) | Interventional | 2023-04-17 | Recruiting |
| Cognitive Effects of Mecamylamine and Varenicline in Schizophrenia[NCT00455650] | | 89 participants (Actual) | Interventional | 2007-03-31 | Completed |
| Naltrexone and Varenicline: Weight Gain and Tolerability in Smokers[NCT00502216] | Phase 1/Phase 2 | 40 participants (Actual) | Interventional | 2007-07-31 | Completed |
| Evaluation of Varenicline's Clinical Efficacy for Continued Smoking Abstinence When Used in the Clinical Treatment of Schizophrenic Patients Hospitalized in an Institution With a Ban on Cigarette Smoking[NCT00548470] | Phase 4 | 14 participants (Actual) | Interventional | 2007-06-30 | Completed |
| A Randomized, Double-blind, Placebo Controlled Trial (RCT) of Varenicline to Reduce Alcohol Consumption in Heavy Drinkers[NCT00695500] | Phase 1/Phase 2 | 50 participants (Actual) | Interventional | 2008-06-30 | Completed |
| Smoking Cessation and the Natural History of HIV-Associated Emphysema[NCT00701896] | | 294 participants (Actual) | Interventional | 2008-10-03 | Completed |
| Treating Smokeless Tobacco Use in Rural Veterans[NCT02994082] | | 123 participants (Actual) | Interventional | 2016-12-31 | Active, not recruiting |
| Human Laboratory Study Of Varenicline in Smokers[NCT00709696] | | 7 participants (Actual) | Interventional | 2008-04-30 | Completed |
| The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse[NCT00773422] | Phase 2 | 30 participants (Actual) | Interventional | 2008-01-31 | Completed |
| Extended Varenicline for Smoking Cessation: A Pilot Study[NCT00835900] | Phase 2 | 60 participants (Actual) | Interventional | 2009-03-31 | Completed |
| Tailored Tobacco Cessation Program for Rural Veterans With Comorbid Depression, Alcoholism or Obesity[NCT01592695] | Phase 2 | 63 participants (Actual) | Interventional | 2012-06-30 | Completed |
| Impact of Varenicline on Blood-Oxygen-Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Activation on Smokers (GRAND)[NCT00934024] | | 21 participants (Actual) | Interventional | 2009-04-30 | Completed |
| Relapse Prevention With Varenicline[NCT00944554] | Phase 4 | 104 participants (Actual) | Interventional | 2008-10-31 | Completed |
| Improving Adherence to Smoking Cessation Medication Among PLWHA[NCT01898195] | | 158 participants (Actual) | Interventional | 2013-03-31 | Completed |
| A Double-Blind Placebo-Controlled Pilot Trial of Varenicline (Chantix) for the Treatment of Cocaine Dependence[NCT00567008] | Phase 2 | 37 participants (Actual) | Interventional | 2007-12-31 | Completed |
| Efficacy of Varenicline in Methadone-Stabilized Cocaine Users[NCT00567320] | | 31 participants (Actual) | Interventional | 2007-03-31 | Completed |
| A Comparison of the Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy Versus Varenicline Alone for Smoking Cessation: a Pilot Study[NCT03722966] | Phase 2 | 35 participants (Actual) | Interventional | 2019-12-02 | Terminated(stopped due to Due to the Chantix recall by Pfizer, Pfizer decided to stop funding this study and terminate it prematurely) |
| Effects of an Extended Period of Varenicline Use Prior to Quitting Smoking on Post-quitting Urges to Smoke[NCT00789074] | Phase 3 | 101 participants (Actual) | Interventional | 2009-07-31 | Completed |
| Extended Treatment for Smoking Cessation[NCT01330043] | Phase 4 | 223 participants (Actual) | Interventional | 2010-03-31 | Completed |
| A Novel Human Laboratory Model for Screening Medications for Alcohol Use Disorder[NCT04249882] | Phase 2 | 53 participants (Actual) | Interventional | 2020-01-28 | Completed |
| Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers[NCT01806779] | Phase 2 | 376 participants (Actual) | Interventional | 2013-03-31 | Completed |
| Financial Incentives for Homeless Smokers: A Community-based RCT[NCT04445662] | | 180 participants (Anticipated) | Interventional | 2021-06-10 | Recruiting |
| Multicenter, Randomized, Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The ONSET Study)-Long Term Safety Follow-up[NCT03920215] | Phase 2/Phase 3 | 101 participants (Actual) | Interventional | 2018-08-15 | Completed |
| Understanding Disparities in Quitting in African American and White Smokers[NCT01836276] | Phase 4 | 449 participants (Actual) | Interventional | 2013-02-28 | Completed |
| 1/2-Multi-site Study: Varenicline Treatment of Alcohol Dependent Smokers[NCT01553136] | Phase 2 | 131 participants (Actual) | Interventional | 2012-09-30 | Completed |
| A Prospective Trial of Varenicline and Incentives for Tobacco Cessation in Adults[NCT04228965] | Phase 4 | 208 participants (Anticipated) | Interventional | 2020-01-28 | Recruiting |
| The Effects of Behavioral Counseling Plus Nicotine Replacement Therapy (NRT) or Varenicline on Smoking Cessation Among Smokers High and Low in Intrinsic Reward Sensitivity[NCT02162849] | Phase 4 | 204 participants (Actual) | Interventional | 2015-12-14 | Active, not recruiting |
| A Pilot Randomized, Placebo-Controlled, Crossover Study of the Effect of the Nicotine Nasal Spray and Varenicline on Cigarette Smoking Following Methadone Dosing in Methadone-Maintained Patients[NCT02147132] | Phase 4 | 7 participants (Actual) | Interventional | 2016-03-31 | Terminated(stopped due to Difficulty recruiting eligible participants; study medication was expiring.) |
| A Phase 4, Randomized, Double-blind, Active And Placebo-controlled, Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks Varenicline Tartrate 1mg Bid And Bupropion Hydrochloride 150mg Bid For Smoking Cessation In Subjects With[NCT01456936] | Phase 4 | 8,144 participants (Actual) | Interventional | 2011-11-30 | Completed |
| Evaluating Smoking Cessation Interventions for PWH in South Africa: Efficacy, Implementation, and Cost-effectiveness[NCT05413122] | Phase 2/Phase 3 | 660 participants (Anticipated) | Interventional | 2023-11-27 | Recruiting |
| A Phase II, Randomized, Double-Blind Pilot Trial of Varenicline (Chantix™) for the Treatment of Alcohol Dependence[NCT00705523] | Phase 2 | 40 participants (Actual) | Interventional | 2008-06-30 | Completed |
| Genetically Informed Smoking Cessation Trial[NCT02351167] | Phase 4 | 822 participants (Actual) | Interventional | 2015-05-20 | Completed |
| Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence: Intervention Development and Feasibility Trial[NCT02202499] | Early Phase 1 | 86 participants (Actual) | Interventional | 2014-07-17 | Completed |
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Heavy Drinking Days at End of Treatment
Heavy drinking is defined as 5 standard alcohol drinks or greater for men and 4 standard alcohol drinks or greater for women. The number of heavy drinking days per month was determined using the timeline follow-back method. (NCT01347112)
Timeframe: week 12
| Intervention | days (Mean) |
|---|
| Varenicline | 7.9 |
| Sugar Pill | 9.1 |
Prolonged Abstinence at 24 Weeks
"Prolonged abstinence is identified by a negative response to the question, Since 2 weeks after your TQD, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?" (NCT01347112)
Timeframe: week 24
| Intervention | participants (Number) |
|---|
| Varenicline | 4 |
| Sugar Pil | 0 |
Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment
"Prolonged smoking abstinence will be identified by a negative response to the question, Since 2 weeks after your TQD, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?" (NCT01347112)
Timeframe: 12 weeks
| Intervention | participants (Number) |
|---|
| Varenicline | 6 |
| Sugar Pil | 1 |
Number of Participants With Biochemically Verified Smoking Abstinence at Week 12
Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 12 visit. This will evaluate the short-term efficacy of optimized pharmacotherapy for smoking cessation in African American smokers. (NCT03897439)
Timeframe: Week 12
| Intervention | Participants (Count of Participants) |
|---|
| Usual Care (UC) | 23 |
| Optimized Care (OPT) | 34 |
Number of Participants With Biochemically Verified Smoking Abstinence at Week 18
Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 18 visit. This will evaluate the end-of-treatment efficacy of optimized pharmacotherapy for smoking cessation in African American smokers (NCT03897439)
Timeframe: Week 18
| Intervention | Participants (Count of Participants) |
|---|
| Usual Care (UC) | 31 |
| Optimized Care (OPT) | 32 |
Number of Participants With Biochemically Verified Smoking Abstinence at Week 26
Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 26 visit. This will evaluate the long-term efficacy of optimized pharmacotherapy for smoking cessation in African American smokers (NCT03897439)
Timeframe: Week 26
| Intervention | Participants (Count of Participants) |
|---|
| Usual Care (UC) | 26 |
| Optimized Care (OPT) | 24 |
23-Week Point-Prevalence Abstinence
Biochemically confirmed self-reported total abstinence from any cigarette use (even a single puff) for the seven days preceding the target follow-up day, confirmed with an exhaled carbon monoxide reading of less than or equal to 5 ppm. (NCT03176784)
Timeframe: Assessed 23 weeks after quit date
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline + Patch Standard Duration | 74 |
| Varenicline Only Standard Duration | 66 |
| Varenicline + Patch Extended Duration | 82 |
| Varenicline Only Extended Duration | 70 |
23-Week Prolonged Abstinence
Biochemically confirmed self-reported total abstinence from any cigarette use (even a single puff) from week 2 post-quit through week 23 post-quit, confirmed with an exhaled carbon monoxide reading of less than or equal to 5 ppm. (NCT03176784)
Timeframe: Assessed 23 weeks after quit date
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline + Patch Standard Duration | 66 |
| Varenicline Only Standard Duration | 72 |
| Varenicline + Patch Extended Duration | 73 |
| Varenicline Only Extended Duration | 65 |
52-Week Point-Prevalence Abstinence
Biochemically-confirmed self-reported total abstinence from any cigarette use (even a single puff) for the seven days preceding the target follow-up day, confirmed with an exhaled carbon monoxide reading of less than or equal to 5 ppm. (NCT03176784)
Timeframe: Assessed 52 weeks after quit date
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline + Patch Standard Duration | 74 |
| Varenicline Only Standard Duration | 79 |
| Varenicline + Patch Extended Duration | 78 |
| Varenicline Only Extended Duration | 76 |
52-Week Prolonged Abstinence
Biochemically confirmed self-reported total abstinence from any cigarette use (even a single puff) from week 2 post-quit through week 52 post-quit, confirmed with an exhaled carbon monoxide reading of less than or equal to 5 ppm. (NCT03176784)
Timeframe: Assessed 52 weeks after quit date
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline + Patch Standard Duration | 47 |
| Varenicline Only Standard Duration | 55 |
| Varenicline + Patch Extended Duration | 57 |
| Varenicline Only Extended Duration | 46 |
Change From Baseline in Self-Reported Alcohol Drinking Days at 12 Weeks
Self-reported alcohol drinking days obtained via a past month Timeline Followback Calendar at 12 weeks (NCT02859142)
Timeframe: 12 weeks
| Intervention | days (Mean) |
|---|
| Augmented Treatment | 12.25 |
| Standard Treatment | 11.96 |
Change From Baseline in Self-Reported Alcohol Drinking Days at 26 Weeks
Self reported monthly alcohol drinking days obtained via a past month Timeline Followback Calendar at 26 weeks (NCT02859142)
Timeframe: 26 weeks
| Intervention | days (Mean) |
|---|
| Augmented Treatment | 12.73 |
| Standard Treatment | 11.44 |
Change From Baseline in Self-Reported Heavy Drinking Days at 12 Weeks
Self reported heavy drinking (5+ drinks/day for men, 4+ drinks/day for women) days obtained via a past month Timeline Followback Calendar at 12 weeks (NCT02859142)
Timeframe: 12 weeks
| Intervention | days (Mean) |
|---|
| Augmented Treatment | 5.02 |
| Standard Treatment | 5.58 |
Change From Baseline in Self-Reported Heavy Drinking Days at 26 Weeks
Self reported heavy drinking (5+ drinks/day for men, 4+ drinks/day for women) days obtained via a past month Timeline Followback Calendar at 26 weeks (NCT02859142)
Timeframe: 26 weeks
| Intervention | days (Mean) |
|---|
| Augmented Treatment | 4.79 |
| Standard Treatment | 5.56 |
Change From Baseline Smoking Abstinence Rates at 12 Weeks
Number of participants reporting smoking abstinence at 12 weeks from baseline (smoking quit date) via subjective and biologically verified reports. (NCT02859142)
Timeframe: 12 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Augmented Treatment | 27 |
| Standard Treatment | 17 |
Change From Baseline Smoking Abstinence Rates at 26 Weeks
Number of participants reporting smoking abstinence at 26 weeks from quit date via subjective and biologically verified reports. (NCT02859142)
Timeframe: 26 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Augmented Treatment | 15 |
| Standard Treatment | 16 |
Attention
Attention function will be measured with a standard computer test, the Sustained Attention Test (SAT), without a distractor condition. Results are reported as the vigilance index, a measure that corrects estimates of accurate detection with penalties for false detection and not confounded by errors of omission. (Frey PW, Colliver JA. Sensitivity and responsivity measures for discrimination learning. Learn Motiv 1973; 4:327-342.) The minimum score is -1.00 (indicating that all recorded responses were misses or false alarms) and maximum is +1 (indicating that all recorded responses were hits or correct rejections). Higher values indicate better attentional performance. (NCT04403399)
Timeframe: end of period: days 22 and 64
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Varenicline | 0.73 |
| Placebo | 0.66 |
Gait Speed
Gait speed, how fast a person can walk down a corridor, at normal pace with no distractors (i.e., no dual task). (NCT04403399)
Timeframe: end of each period: 22 and 64 days
| Intervention | cm/s (Least Squares Mean) |
|---|
| Varenicline | 121.27 |
| Placebo | 124.89 |
JERK
JERK is the time based derivative of spontaneous lower trunk accelerations during standing. It was assessed with the Ambulatory Parkinson's Disease Monitoring (APDM) wearable sensor system (APDM Wearable Technologies, Inc.) using the iSWAY protocol, with participants standing on a foam pad with eyes closed. JERK was calculated using the manufacturer's software (Mobility Lab Version 1). (NCT04403399)
Timeframe: end of each period: 22 and 64 days
| Intervention | m^2/sec^5 (Least Squares Mean) |
|---|
| Varenicline | 0.97 |
| Placebo | 1.04 |
Cessation History - Quit Attempts
"Participants who reported making a quit attempt during the trial, as defined by use of a quit aid or reporting not at all for current smoking at any timepoint" (NCT03521141)
Timeframe: Full trial: Baseline - 6 month survey
| Intervention | Participants (Count of Participants) |
|---|
| Guideline-Based Care (GBC) | 16 |
| Nicotine Metabolite Ratio (PC-NMR) | 17 |
| Respiragene (PC-Respiragene) | 17 |
Cessation History - Quitline
"Participants who reported using the quitline (phone support) at any point during the trial" (NCT03521141)
Timeframe: Full trial: Baseline - 6 month survey
| Intervention | Participants (Count of Participants) |
|---|
| Guideline-Based Care (GBC) | 4 |
| Nicotine Metabolite Ratio (PC-NMR) | 5 |
| Respiragene (PC-Respiragene) | 5 |
Cessation History - Self-reported Abstinence
Participants who self-reported abstinence at the 6 month survey (NCT03521141)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Guideline-Based Care (GBC) | 7 |
| Nicotine Metabolite Ratio (PC-NMR) | 5 |
| Respiragene (PC-Respiragene) | 3 |
Cessation History - Medication Use
Participants who received, and those who subsequently used, a smoking cessation medication during the trial (NCT03521141)
Timeframe: Full trial: Baseline - 6 month survey
| Intervention | Participants (Count of Participants) |
|---|
| Received any cessation medication | Started/used any cessation medication |
|---|
| Guideline-Based Care (GBC) | 17 | 14 |
,| Nicotine Metabolite Ratio (PC-NMR) | 15 | 9 |
,| Respiragene (PC-Respiragene) | 16 | 14 |
Cessation History - Validated Abstinence
Participants who completed a salivary cotinine sample; participants who biochemically-verified as abstinent (salivary cotinine ≤10ng/ml) (NCT03521141)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Salivary cotinine sample received by study staff | Validated as abstinent (cotinine ≤10ng/ml) |
|---|
| Guideline-Based Care (GBC) | 5 | 3 |
,| Nicotine Metabolite Ratio (PC-NMR) | 3 | 2 |
,| Respiragene (PC-Respiragene) | 3 | 2 |
Intervention Feasibility: Ability to Retain Participants
Feasibility of delivering precision care (PC) interventions in the Southern Community Cohort Study (SCCS), as evidenced by ability to recruit, engage, and retain participants through end of the study. (NCT03521141)
Timeframe: Full trial: Baseline - 6 month survey
| Intervention | Participants (Count of Participants) |
|---|
| Started Pilot Trial (completed results call) | Still enrolled at end of pilot trial | Completed 6 month survey |
|---|
| Guideline-Based Care (GBC) | 19 | 18 | 17 |
,| Nicotine Metabolite Ratio (PC-NMR) | 19 | 18 | 14 |
,| Respiragene (PC-Respiragene) | 20 | 19 | 12 |
Mean Changes in Arterial Flow When Smokers Switch From Cigarettes to E-cigarettes
"Ankle-Brachial Index (ABI) use to evaluate vascular changes when smokers change from cigarettes to e-cigarettes over a 13-week period. Measurements will be obtained using a manual sphygmomanometer and an 8- to 10- MHz doppler ultrasound probe. Subjects will undergo this testing at Visit 1 (baseline data) and at the end of study (Visit 7).~Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. The normal range for the ankle-brachial index is between 0.90 and 1.30. An index of 0.41 to 0.90 indicates mild to moderate arterial disease and an index of 0.40 and lower indicates severe disease" (NCT04210180)
Timeframe: Baseline (Visit 1) and 13 weeks (Visit 7)
| Intervention | ratio (Mean) |
|---|
| Varenicline Plus E-cigarette | -0.05 |
Number of Participant Reporting Continuous Complete Switching From Cigarettes to Halo G6
The primary switching outcome will be smoking abstinence during weeks 8-11 post-switching date. Complete switching from combustible cigarette use at each time point will be defined by a self-report of no cigarette smoking (not even a puff) since the prior session. (NCT04210180)
Timeframe: Weeks 8-11
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline Plus E-cigarette | 8 |
Number of Participants Confirmed (by Expired Air CO) to Have Switched From Cigarettes to Halo G6
The primary switching outcome will be smoking abstinence during weeks 8-11 post-switching date. Complete switching from combustible cigarette use at each time point confirmed by an expired air CO reading of less than 5 ppm. (NCT04210180)
Timeframe: Weeks 8-11
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline Plus E-cigarette | 8 |
Number of Participants Reporting Point Abstinence From Smoking Cigarettes at 6 Months Post-Switch
Point abstinence will be defined by a self-report of no cigarette smoking (not even a puff) in the last seven days at six months post-switch. (NCT04210180)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline Plus E-cigarette | 16 |
Antisaccade Error Rates
In antisaccade, participants were asked to focus on a central target. When a peripheral cue was presented, participants were asked to look in an equidistant and opposite direction of the peripheral cue. The error rate is calculated as the number of trials in which the participant looked toward the cue, rather than in the opposite direction, divided by the total number of trials. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206. (NCT00492349)
Timeframe: Week 0, Week 2 and Week 8
| Intervention | percentage errors (Mean) |
|---|
| Week 0 | Week 2 | Week 8 |
|---|
| Placebo | 0.54 | 0.54 | 0.53 |
,| Varenicline | 0.61 | 0.49 | 0.45 |
Digit Symbol Test
Digit symbol test score (0 to no definite upper range, higher score is better). Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206. (NCT00492349)
Timeframe: Week 0, Week 2 and Week 8
| Intervention | units on a scale (Mean) |
|---|
| Week 0 | Week 2 | Week 8 |
|---|
| Placebo | 53.2 | 53.8 | 54.3 |
,| Varenicline | 53.9 | 55.9 | 54.2 |
Hamilton Depression Rating Scale (Ham-D)
Ham-D Total Score (range 0 to 54, higher score is worse). Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206. (NCT00492349)
Timeframe: Week 8
| Intervention | units on a scale (Mean) |
|---|
| Smoker | Nonsmoker |
|---|
| Placebo | 20.6 | 18.6 |
,| Varenicline | 22.9 | 19.4 |
Maintenance Pursuit Gain
Pursuit gain is the averaged artifact-free eye velocity divided by target velocity. Eye velocity during the regular eye-tracking period (without foveal stabilization) divided by target velocity was used to calculate the maintenance pursuit gain. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206. (NCT00492349)
Timeframe: Week 8
| Intervention | velocity ratio (Mean) |
|---|
| Smoker | Nonsmoker |
|---|
| Placebo | 0.8 | 0.8 |
,| Varenicline | 0.8 | 0.8 |
Memory Saccadic Positional Error, Degrees
A saccade is a quick eye movement. Spatial working memory was assessed by memory saccade. Participants were asked to focus on a target while a peripheral cue was flashed. Participants were signaled to look in the direction of the peripheral cue when the central target was removed, and the positional error was calculated as the distance between the saccadic and peripheral target positions. Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206. (NCT00492349)
Timeframe: Week 8
| Intervention | degrees (Mean) |
|---|
| Smoker | Nonsmoker |
|---|
| Placebo | 1.7 | 1.8 |
,| Varenicline | 1.6 | 1.7 |
P50
P50 response is a measure of the amplitude of the brain wave in response to a sound, where the positive going amplitude of the brain wave occurring at about 50 milliseconds after the sound. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206. (NCT00492349)
Timeframe: Week 0, Week 2 and Week 8
| Intervention | microvolts (Mean) |
|---|
| Week 0 | Week 2 | Week 8 |
|---|
| Placebo | 3.1 | 3.0 | 2.5 |
,| Varenicline | 3.2 | 3.2 | 3.2 |
Predictive Pursuit Gain
Pursuit gain is the averaged artifact-free eye velocity divided by target velocity. Participants are asked to track a target with their eyes. Participants may use a predictive mechanism to perform the tracking. The pursuit gain using the predictive mechanism is calculated. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206. (NCT00492349)
Timeframe: Week 8
| Intervention | velocity ratio (Mean) |
|---|
| Smoker | Nonsmoker |
|---|
| Placebo | 0.34 | 0.31 |
,| Varenicline | 0.31 | 0.24 |
Percentage of Participants With 4-Week Point Prevalence of Smoking Cessation
"The 4-week point prevalence of abstinence was defined as being abstinent from smoking and using tobacco products during the last 4 weeks of the study. The participant's smoking status and other nicotine use was evaluated based on the last 4 weeks questions on the NUI and confirmed by CO expiration. Responders were defined as those, who answered no to both questions (Has the subject smoked any cigarettes (even a puff) in the last 4 weeks?; and Has the subject used any nicotine products and/or other tobacco.... in the last 4 weeks?) and whose expired CO < 10 ppm. Missing CO was imputed as negative (CO ≤ 10 ppm)." (NCT01370356)
Timeframe: Week 52
| Intervention | percentage of participants (Number) |
|---|
| Varenicline | 32.8 |
| Placebo | 17.3 |
Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking
Percentage of participants who remained abstinent from Week 15 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the Nicotine Use Inventory (NUI) and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 15 through 24, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm). (NCT01370356)
Timeframe: Week 15 - 24
| Intervention | percentage of participants (Number) |
|---|
| Varenicline | 32.1 |
| Placebo | 6.9 |
Percentage of Participants With CO Confirmed 4-Week CA From Smoking
Percentage of participants who remained abstinent from Week 21 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the NUI and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 21 through 24, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm). (NCT01370356)
Timeframe: Week 21 - 24
| Intervention | percentage of participants (Number) |
|---|
| Varenicline | 37.8 |
| Placebo | 12.5 |
Percentage of Participants With CO Confirmed Long Term CA From Smoking
Percentage of participants who remained abstinent from Week 21 to Week 52, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the NUI and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 21 through 52, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm). (NCT01370356)
Timeframe: Weeks 21 - 52
| Intervention | percentage of participants (Number) |
|---|
| Varenicline | 27.0 |
| Placebo | 9.9 |
Percentage of Participants With 7-Day Point Prevalence of Smoking Cessation
"The 7-day point prevalence of abstinence was defined as being abstinent from smoking and using tobacco products during the last 7 days at Week 12, 24, and 52. The participant's smoking status and other nicotine use was evaluated based on the last 7 days questions on the NUI and confirmed by CO expiration. Responders were defined as those, who answered no to both questions (Has the subject smoked any cigarettes (even a puff) in the last 7 days?; and Has the subject used any nicotine products and/or other tobacco.... in the last 7 days?) and whose expired CO < 10 ppm. Missing CO was imputed as negative (CO ≤ 10 ppm)." (NCT01370356)
Timeframe: Week 12, 24, and 52
| Intervention | percentage of participants (Number) |
|---|
| Week 12 | Week 24 | Week 52 |
|---|
| Placebo | 6.7 | 17.5 | 18.3 |
,| Varenicline | 31.2 | 43.2 | 34.1 |
Number of Study Days Until First Cigarette Quit Attempt
A quit attempt was defined as at least one day on which participants reported 0 cigarettes smoked via text message. Reports of >0 cigarettes on subsequent days was indicative of relapse. (NCT02854800)
Timeframe: up to 12 weeks
| Intervention | number of study days (Mean) |
|---|
| Weekly Opioid Tx | 35.5 |
| Bi-weekly Opioid Tx | 11.5 |
| Monthly Opioid Tx | 12.5 |
Cigarettes Smoked Per Day
The number of cigarettes smoked per day were reported via text message by participants daily. These numbers were averaged within weeks to give 12 separate average weekly values for cigarettes per day. (NCT02854800)
Timeframe: up to 12 weeks
| Intervention | cigarettes per day (Mean) |
|---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 |
|---|
| Bi-weekly Opioid Tx | 15.53 | 12.02 | 10.21 | 9.58 | 9.52 | 9.85 | 9.45 | 9.87 | 9.58 | 9.47 | 10.90 | 10.39 |
,| Monthly Opioid Tx | 16.00 | 11.18 | 8.04 | 8.11 | 7.91 | 6.68 | 7.00 | 7.13 | 6.55 | 6.37 | 6.83 | 5.23 |
,| Weekly Opioid Tx | 18.21 | 14.28 | 11.90 | 9.34 | 9.35 | 9.21 | 9.40 | 8.87 | 7.98 | 8.34 | 7.83 | 7.35 |
Drug Withdrawal Ratings
Average self-reported ratings for craving, irritability, restless, alert, bored, calm/relaxed, able to focus, nervous, and other; scores ranged from 0-10 and higher scores indicate higher levels of that withdrawal effect (NCT02854800)
Timeframe: up to 12 weeks
| Intervention | units on a scale (Mean) |
|---|
| Craving | Irritability | Restless | Alert | Bored | Calm/Relaxed | Able to Focus | Nervous |
|---|
| Bi-weekly Opioid Tx | 4.55 | 3.09 | 1.97 | 5.26 | 1.72 | 4.74 | 5.48 | 1.96 |
,| Monthly Opioid Tx | 4.16 | 2.67 | 1.87 | 7.98 | 1.58 | 6.75 | 8.08 | 1.62 |
,| Weekly Opioid Tx | 5.03 | 4.37 | 3.67 | 6.23 | 2.98 | 5.12 | 6.11 | 2.93 |
Expired Air Carbon Monoxide
Expired air carbon monoxide levels were measured for participants every 4 weeks at their in-person study visits, resulting in 4 separate measures across the 12-week period. (NCT02854800)
Timeframe: up to 12 weeks
| Intervention | parts per million (ppm) (Mean) |
|---|
| Baseline | Week 4 | Week 8 | Week 12 |
|---|
| Bi-weekly Opioid Tx | 34.27 | 30.00 | 28.60 | 25.27 |
,| Monthly Opioid Tx | 34.25 | 26.13 | 25.00 | 24.63 |
,| Weekly Opioid Tx | 46.00 | 34.18 | 37.45 | 34.00 |
Medication Acceptability for Completers
Side effect ratings of nausea, headache, sleep problems, gas/constipation, abnormal dreams, depressed mood, and drowsy; scores ranged from 0-10 and higher scores indicate more severe symptoms. (NCT02854800)
Timeframe: up to 12 weeks
| Intervention | points on a scale (Mean) |
|---|
| Nausea | Headache | Sleep Disturbances | Gas/Constipation | Abnormal Dreams | Depressed Mood | Drowsy |
|---|
| Bi-weekly Opioid Tx | 1.46 | 1.61 | 2.18 | 2.30 | 2.94 | 2.15 | 2.05 |
,| Monthly Opioid Tx | 3.09 | 1.92 | 1.07 | 2.48 | 0.82 | 1.10 | 2.36 |
,| Weekly Opioid Tx | 2.55 | 2.21 | 3.35 | 3.41 | 3.42 | 2.94 | 3.40 |
Number of Participants That Moved in Stage of Change for Quitting Smoking
"Participants indicated one of the following stages of change at each of their four in-person study visits: Precontemplation (no plans to quit smoking), Contemplation (plans to quit smoking in the next 6 months), Preparation (plans to quit smoking in the next 30 days), Action (currently engaging in quitting smoking), or Maintenance (quit smoking more than 6 months ago).~Data were quantified by determining the number of participants who moved towards quitting (i.e., moved up one or more stages), the number of participants who moved away from quitting (i.e., moved down one or more stages), and and the number of participants who remained in the same stage." (NCT02854800)
Timeframe: up to 12 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Moved away from quitting | Moved toward quitting | Stayed the same |
|---|
| Bi-weekly Opioid Tx | 1 | 6 | 8 |
,| Monthly Opioid Tx | 0 | 4 | 4 |
,| Weekly Opioid Tx | 4 | 7 | 1 |
Number of Participants With Cigarette Smoking Quit Attempts and Actual Quit
A quit attempt was defined as at least one study day on which 0 cigarettes smoked was reported via text message. Actual quit rates were determined by biochemically verified cigarette abstinence, which was an expired air carbon monoxide reading of < 8 parts per million (ppm). (NCT02854800)
Timeframe: Up to 12 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Quit Attempt Rates | Quit Rates |
|---|
| Bi-weekly Opioid Tx | 2 | 1 |
,| Monthly Opioid Tx | 2 | 2 |
,| Weekly Opioid Tx | 2 | 0 |
Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc)
Relapse was determined by semi-quantitative urine testing (positive vs negative result). Positive results for illicit drugs were assessed separately (opioids, cocaine, THC, benzodiazepines, amphetamines, and atypical antipsychotics). (NCT02854800)
Timeframe: up to 12 weeks
| Intervention | Participants (Count of Participants) |
|---|
| THC | Benzodiazapines | Cocaine | Amphetamine | Atypical antipsychotics |
|---|
| Bi-weekly Opioid Tx | 2 | 1 | 1 | 0 | 0 |
,| Monthly Opioid Tx | 0 | 1 | 0 | 0 | 0 |
,| Weekly Opioid Tx | 5 | 4 | 2 | 1 | 1 |
Number of Study Days With Protocol Non-Adherence
"Medication non-adherence rates: The number of study days on which participants a) self-reported not taking the medication (i.e. provided a response of no) or b) had a missing medication response (i.e. provided no response) via text message.~Text-messaging non-adherence rates: The number of study days in which participants failed to respond to one or more assessments measured via text message." (NCT02854800)
Timeframe: up to 12 weeks
| Intervention | study days (Number) |
|---|
| Days with missing text data | Days of not taking medication | Days of not reporting medication use |
|---|
| All Participants Aggregated | 1105 | 40 | 305 |
Percentage of Days on Which Participants Experienced Each Reason for Attrition
Drug withdrawal and medication side effect ratings were assessed as potential reasons for attrition. This assessment was completed by calculating the mean percentage of days, out of the first four weeks, during which effects were reported by participants who completed the entire 12-week protocol versus participants that dropped out. We limited this analysis to the first four weeks. (NCT02854800)
Timeframe: up to 4 weeks
| Intervention | percentage of study days (Mean) |
|---|
| Nausea | Headache | Sleep Problems | Gas/Constipation | Abnormal Dreams | Depressed Mood | Drowsy | Craving | Irritability | Restlessness |
|---|
| Completers | 43.4 | 39.8 | 46.6 | 48.9 | 53.7 | 49.0 | 50.3 | 78.1 | 70.4 | 56.7 |
,| Dropouts | 60.3 | 47.2 | 37.9 | 45.9 | 42.0 | 39.6 | 52.8 | 86.5 | 72.6 | 58.7 |
Readiness to Quit Smoking
The Readiness to Quit Ladder was administered to participants at each of their in-person study visits, for a total of 4 data collections. Participants were asked to indicate their readiness to quit smoking on a scale ranging from 0 (I have no interest in quitting smoking) to 10 (I have already quit smoking). (NCT02854800)
Timeframe: up to 12 weeks
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Week 4 | Week 8 | Week 12 |
|---|
| Bi-weekly Opioid Tx | 5.87 | 7.20 | 7.47 | 7.53 |
,| Monthly Opioid Tx | 5.63 | 7.88 | 8.38 | 8.13 |
,| Weekly Opioid Tx | 6.17 | 7.50 | 7.50 | 8.33 |
Recruitment, Assignment to Treatment, and Retention Rates
For primary feasibility outcomes, recruitment, assignment to treatment, and retention rates were analyzed using descriptive statistics. (NCT02854800)
Timeframe: up to 12 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Recruited and Consented | Assigned to Treatment | Completed 4 Weeks | Completed 8 Weeks | Completed 12 Weeks |
|---|
| Bi-weekly Opioid Tx | 33 | 28 | 19 | 15 | 15 |
,| Monthly Opioid Tx | 15 | 14 | 13 | 9 | 8 |
,| Weekly Opioid Tx | 40 | 32 | 20 | 12 | 12 |
Cigarettes Per Day
effect of intervention on the number of cigarettes smoked daily among those who continue to smoke at Month 6 (NCT02050308)
Timeframe: Change from Baseline in number of cigarettes smoked daily at 6 months
| Intervention | Cigarettes/day (Mean) |
|---|
| Internet All Nations Breath of Life | 4.00 |
| Honoring the Gift of Heart Health | 5.43 |
Number of Participants With 7-day Point Prevalence Abstinence
self-reported and biochemically (salivary cotinine) verified point prevalence abstinence, defined as no smoking for the previous 7 days, at the 6-month follow-up. (NCT02050308)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Honoring the Gift of Heart Health | 9 |
| Internet-All Nations Breath of Life (I-ANBL) | 9 |
Number of Participants Who Reported Quitting at the End of Treatment
Self-reported Quit Rate at End of Treatment (12 Weeks); assessed as no smoking in the 7 days prior to the Week 12 follow-up call (NCT02681510)
Timeframe: Week 12
| Intervention | Participants (Count of Participants) |
|---|
| Three Drug Intervention | 21 |
Participant Satisfaction With Medications' Ability to Control Withdrawal Symptoms
Satisfaction with Medications' Ability to Control Withdrawal Symptoms assessed on a 1-10 Likert Scale (higher value=greater satisfaction) (NCT02681510)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| Three Drug Intervention | 9.1 |
Participant Satisfaction With Medications' Ability to Help Participant Quit Smoking
Participant Satisfaction with Medications' Ability to Help Participant Quit Smoking assessed on a 1-10 Likert Scale (higher value=greater satisfaction) (NCT02681510)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| Three Drug Intervention | 9.2 |
Number of Participants With Adverse Events
Assess adverse event rates in relation to participant ability to continue use of all 3 medications throughout the treatment period (NCT02681510)
Timeframe: 12 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Insomnia | Vivid Dreams | Nausea | Mood Changes | Dizziness | Skin Rash | Sweating | Shortness of Breath | Vomiting | Chest Tightness | Angina |
|---|
| Three Drug Intervention | 27 | 26 | 23 | 15 | 14 | 7 | 7 | 5 | 5 | 4 | 1 |
Change in Meibomian Gland Area, Upper Lid
Change in Meibomian gland area, upper lid. A larger decrease is indicative of a better outcome (NCT03688802)
Timeframe: Baseline (pre-treatment), 1 day (post treatment)
| Intervention | um (Mean) |
|---|
| OC-01, 1.2 mg/mL | 11.2 |
| Placebo | -143.2 |
Mean Change in Goblet Cell Area
Mean change in Goblet Cell Area with a larger decrease is indicative of a better outcome. (NCT03688802)
Timeframe: Baseline (pre-treatment), 1 day (post treatment)
| Intervention | um (Mean) |
|---|
| OC-01, 1.2 mg/mL | -38.8 |
| Placebo | -6.7 |
Mean Change in Goblet Cell Perimeter
Mean change in Goblet Cell Perimeter. A larger decrease is indicative of a better outcome. (NCT03688802)
Timeframe: Baseline (pre-treatment), 1 day (post treatment)
| Intervention | um (Mean) |
|---|
| OC-01, 1.2 mg/mL | -7.7 |
| Placebo | -1.8 |
Mean Change in Meibomian Gland Area, Lower Lid.
Mean change in Meibomian Gland Area, lower Lid. A larger decrease is indicative of a better outcome. (NCT03688802)
Timeframe: Baseline (pre-treatment), 1 day (post treatment)
| Intervention | um (Mean) |
|---|
| OC-01, 1.2 mg/mL | -29.9 |
| Placebo | -12.4 |
Mean Change in Meibomian Gland Perimeter, Lower Lid
Mean change in Meibomian Gland Perimeter, lower lid. A larger decrease is indicative of a better outcome. (NCT03688802)
Timeframe: Baseline (pre-treatment), 1 day (post treatment)
| Intervention | um (Mean) |
|---|
| OC-01, 1.2 mg/mL | -4 |
| Placebo | 4.2 |
Mean Change in Meibomian Gland Perimeter, Upper Lid.
Chane in Meibomian Gland Perimeter, upper lid. A larger decrease is indicative of a better outcome. (NCT03688802)
Timeframe: Baseline (pre-treatment), 1 day (post treatment)
| Intervention | um (Mean) |
|---|
| OC-01, 1.2 mg/mL | 6.15 |
| Placebo | -19.2 |
Berg Balance Scale
Efficacy was measured as a change on the Berg Balance Scale (BBS) from baseline to the end of the study after 8 weeks on drug. The BBS is a 14-item measure consisting of basic balance tasks, with a final score indicative of overall balance ability. The maximum score is 56 and minimum is 0. Higher scores reflect better balance. (NCT01341080)
Timeframe: 9 weeks
| Intervention | score on a scale (Mean) |
|---|
| Baseline | End Point |
|---|
| Sugar Pill | 41.14 | 45.13 |
,| Varenicline | 43.93 | 43.25 |
Frontal Assessment Battery
The change in cognitive functioning was measured with the Frontal Assessment Battery (FAB, score range 0-18) and the Mini-Mental State Exam (MMSE, score range 0-30) from baseline to 8 weeks on drug. High scores on both scales indicate better performance. The FAB measures executive functioning and consists of the following 6 sections: conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy. (NCT01341080)
Timeframe: 9 weeks
| Intervention | score on a scale (Mean) |
|---|
| Baseline | End point |
|---|
| Sugar Pill | 15.25 | 15.19 |
,| Varenicline | 17.40 | 17.70 |
Mini Mental Status Exam (MMSE)
The change in cognitive functioning was measured with the Mini-Mental State Exam (MMSE) from baseline to 8 weeks on drug. The maximum score on the MMSE is 30 and lowest score 0, with higher score indicating better cognitive function. (NCT01341080)
Timeframe: 9 weeks
| Intervention | score on a scale (Mean) |
|---|
| Baseline | End point |
|---|
| Sugar Pill | 28.19 | 28.13 |
,| Varenicline | 29.08 | 28.00 |
Smoking Abstinence at 12 Months
Prolonged Abstinence is defined as no smoking from the quit date to 12 Months post quit date. (NCT00943618)
Timeframe: From quit date to 12 months.
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline + Bupropion | 30 |
| Varenicline | 33 |
| Placebo | 2 |
Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52
Self-report of no smoking (not even a puff) in the previous seven days confirmed by an expired carbon monoxide reading of < 10 parts per million as assessed at Week 52 (NCT00828113)
Timeframe: 7-day point prevalence
| Intervention | participants (Number) |
|---|
| Extended Treatment | 10 |
| Standard Treatment | 11 |
Tobacco Abstinence Biochemically Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. at 12 Weeks
Number of participants achieving self reported, seven day point prevalence abstinence, biochemically verified with expired carbon monoxide (CO) < 8 p.p.m., missing = smoking (NCT01378858)
Timeframe: Week 12 of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline Treatment as Usual (TAU) | 9 |
| Varenicline Directly Observed Therapy | 5 |
Tobacco Abstinence Biochemically Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. at 24 Weeks
Number of participants achieving self reported, seven day point prevalence abstinence, biochemically verified with expired carbon monoxide (CO) < 8 p.p.m. (NCT01378858)
Timeframe: 24 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline Treatment as Usual (TAU) | 6 |
| Varenicline Directly Observed Therapy | 2 |
Varenicline Adherence as Measured by Pill Count
Pill count adherence, measured as pills taken divided by pills dispensed, analyzed as a continuous measure (NCT01378858)
Timeframe: Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12
| Intervention | percentage pills taken/pills dispensed (Mean) |
|---|
| Varenicline Treatment as Usual (TAU) | 61.8 |
| Varenicline Directly Observed Therapy | 78.5 |
Alcohol Craving as Measured by the Obsessive Compulsive Drinking Scale (OCDS) Between Varenicline and Placebo Groups for Completers of the Study.
Higher scores on the OCDS indicate increased craving. OCDS possible score range = 0 - 40. Difference in average OCDS scores from week 1 to week 12 were reported for the varenicline and placebo groups in subjects that completed the study. (NCT01011907)
Timeframe: Week 1 to Week 12
| Intervention | Scores on a scale (Mean) |
|---|
| Placebo | -3.07 |
| Varenicline | -4.36 |
Average Number of Alcoholic Drinks Consumed Between the Varenicline and Placebo Groups for Completers of the Study Through Week 12.
(NCT01011907)
Timeframe: Weeks 1-12
| Intervention | drinks (Mean) |
|---|
| Placebo | 277.5 |
| Varenicline | 177.04 |
Average Number of Cigarettes Smoked Between the Varenicline and Placebo Groups for Completers Through Week 12.
(NCT01011907)
Timeframe: Weeks 1-12
| Intervention | cigarettes (Mean) |
|---|
| Placebo | 788.94 |
| Varenicline | 403.24 |
CAR From Week 9 Through Week 24
The percentage of participants who, from Week 9 through Week 24, reported no smoking (Weeks 9 through 24) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 24), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO >10 ppm at any of these visits during this time frame. (NCT01244061)
Timeframe: Week 9 through Week 24
| Intervention | Percentage of participants (Number) |
|---|
| Varenicline | 28.9 |
| Placebo | 7.8 |
CAR From Week 9 Through Week 52
The percentage of participants who, from Week 9 through Week 52, reported no smoking (Weeks 9 through 52) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 52), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO >10 ppm at any of these visits during this time frame. (NCT01244061)
Timeframe: Week 9 through Week 52
| Intervention | Percentage of participants (Number) |
|---|
| Varenicline | 20.1 |
| Placebo | 3.3 |
Continuous Abstinence Rate (CAR) From Week 9 Through Week 12
The percentage of participants who, from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO)> 10ppm at any visits during this time frame. (NCT01244061)
Timeframe: Week 9 through Week 12
| Intervention | Percentage of participants (Number) |
|---|
| Varenicline | 45.0 |
| Placebo | 11.8 |
7-day Point Prevalence (PP) of Abstinence at Weeks 12, 24, and 52
"The secondary endpoint of 7-day point prevalence of smoking cessation was determined by evaluating a participant's cigarette smoking status, and other nicotine (and/or other tobacco) use, based on the last 7 days questions in the Nicotine Use Inventory. Additionally, a participant was not considered a responder if the expired CO was >10 ppm at the time point being summarized. Participants were considered responders independently at each visit." (NCT01244061)
Timeframe: Weeks 12, 24 and 52
| Intervention | Percentage of participants (Number) |
|---|
| Week 12 | Week 24 | Week 52 |
|---|
| Placebo | 14.7 | 15.5 | 12.2 |
,| Varenicline | 53.0 | 32.9 | 28.9 |
Number of Responders to Varenicline Treatment
Number of participants who succeeded in smoking cessation from 12 weeks through 24 weeks of the observation period. (NCT01061710)
Timeframe: 24 weeks
| Intervention | Participants (Number) |
|---|
| Varenicline (Champix®) | 2 |
Effectiveness of CTQ vs UC
We will measure abstinence of CTQ smokers vs those in Usual Care (UC). We will biochemically-validate (defined as salivary cotinine <10ng/ml) self reported abstinence (30 day point-prevalence) at the end of 2 years. (NCT01299896)
Timeframe: Two (2) year period
| Intervention | percentage of participants per arm (Number) |
|---|
| Usual Care | 7.5 |
| Coordinated Care | 6.1 |
Number of Participants Exceeding Thresholds for the Social Dysfunction and Aggression Scale (SDAS): Total Score
SDAS total scores ranged from 0 (not present) to 44 (extremely severe). Participants exceeding the threshold had a SDAS total score of more than 6 out of 44. (NCT00749944)
Timeframe: Baseline B (Week 2) to Week 4 (Period BC)
| Intervention | participants (Number) |
|---|
| Varenicline | 2 |
| Placebo | 1 |
Number of Participants With Carbon Monoxide Confirmed Daily Smoking Cessation
Participants who reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory, which was used to collect the information of cigarette or other nicotine use during the study) and who did not have carbon monoxide of more than 10 parts per million at any time from Week 9 to Week 12 (NCT00749944)
Timeframe: Week 9 to Week 12
| Intervention | participants (Number) |
|---|
| Varenicline | 16 |
| Placebo | 10 |
Change From Baseline in the Barratt Impulsiveness Scale - Version 11 (BIS-11): Total Score
The BIS-11 is a 30-item self-report questionnaire designed to assess general impulsiveness taking into account the multifactorial nature of the construct. Possible responses to each item were: 1=rarely/never, 2=occasionally, 3=often, and 4=almost always/always. Scores of Items 1, 7, 8, 9, 10, 12, 13, 15, 20, 29 and 30 were reversed when calculating the total score. Total score ranged from 30 (less impulsive) to 120 (more impulsive). (NCT00749944)
Timeframe: Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| Period AB (n=54, 54) | Period AC (n=54, 54) | Period AD (n=54, 54) | Period AE (n=55, 54) | Period BC (n=53, 54) | Period BD (n=53, 54) | Period BE (n=53, 54) |
|---|
| Placebo | -0.07 | 0.37 | 1.28 | 0.90 | 0.97 | 1.81 | 1.28 |
,| Varenicline | 0.34 | 0.45 | 1.34 | 1.19 | 0.04 | 1.07 | 0.85 |
Change From Baseline in the Hamilton Anxiety Scale (HAM-A): Total Score
HAM-A measures treatment-related changes in generalized anxiety symptoms and is a 14-item questionnaire. Each item was scored from 0 (not present) to 4 (very severe) and a lower score indicated less affected. Total scores ranged from 0 (not affected) to 56 (very severely affected). (NCT00749944)
Timeframe: Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| Period AB (n=54, 54) | Period AC (n=54, 54) | Period AD (n=54, 54) | Period AE (n=55, 54) | Period BC (n=53, 54) | Period BD (n=53, 54) | Period BE (n=53, 54) |
|---|
| Placebo | 0.75 | 2.16 | 1.86 | 1.61 | 2.65 | 0.77 | 0.81 |
,| Varenicline | 1.01 | 2.69 | 1.95 | 1.75 | 3.15 | 0.74 | 0.73 |
Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Increased Appetite Subscale
The MNWS increased appetite subscale contains 1 item (increased appetite) rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores ranged from 0 (no increased appetite) to 4 (extreme increased appetite). (NCT00749944)
Timeframe: Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| Period AB (n=54, 54) | Period AC (n=54, 54) | Period AD (n=54, 54) | Period AE (n=55, 54) | Period BC (n=53, 54) | Period BD (n=53, 54) | Period BE (n=53, 54) |
|---|
| Placebo | 0.02 | 0.12 | 0.15 | 0.04 | 0.16 | 0.15 | -0.03 |
,| Varenicline | 0.14 | 0.10 | 0.11 | -0.00 | -0.03 | -0.01 | -0.10 |
Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Insomnia Domain Subscale
The MNWS insomnia domain subscale contains 2 items (difficulty going to sleep; difficulty staying asleep). Each item was rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores were the average of the 2 items and ranged from 0 (no insomnia) to 4 (extreme insomnia). (NCT00749944)
Timeframe: Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| Period AB (n=54, 54) | Period AC (n=54, 54) | Period AD (n=54, 54) | Period AE (n=55, 54) | Period BC (n=53, 54) | Period BD (n=53, 54) | Period BE (n=53, 54) |
|---|
| Placebo | 0.12 | 0.17 | 0.10 | 0.13 | 0.09 | 0.01 | -0.01 |
,| Varenicline | 0.07 | 0.15 | 0.04 | 0.06 | 0.14 | -0.04 | -0.06 |
Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Negative Affect Domain Subscale
The MNWS negative affect domain subscale contains 4 items (depressed mood; irritability, frustration, or anger; anxiety; difficulty concentrating). Each item was rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores were the average from all 4 items and ranged from 0 (no negative affect) to 4 (extreme negative affect). (NCT00749944)
Timeframe: Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| Period AB (n=54, 54) | Period AC (n=54, 54) | Period AD (n=54, 54) | Period AE (n=55, 54) | Period BC (n=53, 54) | Period BD (n=53, 54) | Period BE (n=53, 54) |
|---|
| Placebo | 0.01 | 0.09 | 0.03 | 0.07 | 0.15 | 0.02 | 0.03 |
,| Varenicline | 0.06 | 0.10 | 0.07 | 0.05 | 0.07 | -0.01 | -0.02 |
Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Restlessness Subscale
The MNWS restlessness subscale contains 1 item (restlessness) rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores ranged from 0 (no restlessness) to 4 (extreme restlessness). (NCT00749944)
Timeframe: Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| Period AB (n=54, 54) | Period AC (n=54, 54) | Period AD (n=54, 54) | Period AE (n=55, 54) | Period BC (n=53, 54) | Period BD (n=53, 54) | Period BE (n=53, 54) |
|---|
| Placebo | 0.08 | 0.11 | 0.04 | 0.05 | 0.08 | -0.03 | -0.03 |
,| Varenicline | 0.06 | 0.10 | 0.09 | 0.03 | 0.07 | 0.03 | -0.04 |
Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Total Score
The MNWS total score contains 9 items (urge to smoke; depressed mood; irritability, frustration, or anger; anxiety; difficulty concentrating; restlessness; increased appetite; difficulty going to sleep; difficulty staying asleep). Each item was rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Total scores were the average score for all 9 items and ranged from 0 (no withdrawal symptoms) to 4 (extreme withdrawal symptoms). (NCT00749944)
Timeframe: Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| Period AB (n=54, 54) | Period AC (n=54, 54) | Period AD (n=54, 54) | Period AE (n=55, 54) | Period BC (n=53, 54) | Period BD (n=53, 54) | Period BE (n=53, 54) |
|---|
| Placebo | 0.05 | 0.11 | 0.05 | 0.04 | 0.10 | 0.02 | -0.05 |
,| Varenicline | 0.13 | 0.10 | 0.07 | -0.01 | -0.04 | -0.08 | -0.15 |
Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Urge to Smoke Subscale
The MNWS urge to smoke subscale contains 1 item (urge to smoke) rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores ranged from 0 (no urge to smoke) to 4 (extreme urge to smoke). (NCT00749944)
Timeframe: Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| Period AB (n=54, 54) | Period AC (n=54, 54) | Period AD (n=54, 54) | Period AE (n=55, 54) | Period BC (n=53, 54) | Period BD (n=53, 54) | Period BE (n=53, 54) |
|---|
| Placebo | -0.29 | -0.97 | -2.03 | -1.55 | -1.14 | -1.58 | -1.29 |
,| Varenicline | -0.60 | -1.40 | -2.17 | -1.90 | -1.59 | -1.66 | -1.56 |
Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS): Total Score
The MADRS measures the overall severity of depressive symptoms and is a 10-item checklist. Each item was rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). (NCT00749944)
Timeframe: Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| Period AB (n=54, 54) | Period AC (n=54, 54) | Period AD (n=54, 54) | Period AE (n=55, 54) | Period BC (n=53, 54) | Period BD (n=53, 54) | Period BE (n=53, 54) |
|---|
| Placebo | 0.83 | 1.84 | 1.41 | 1.50 | 1.69 | 0.33 | 0.49 |
,| Varenicline | 1.05 | 2.28 | 1.19 | 1.52 | 2.27 | -0.10 | 0.40 |
Change From Baseline in the Number of Cigarettes Smoked Per Day
(NCT00749944)
Timeframe: Baseline (Week 0) to Week 2
| Intervention | cigarettes smoked per day (Mean) |
|---|
| Day 2 (n=55, 54) | Day 3 (n=55, 54) | Day 4 (n=55, 54) | Day 5 (n=55, 54) | Day 6 (n=54, 54) | Day 7 (n=54, 54) | Day 8 (n=54, 54) | Day 9 (n=52, 54) | Day 10 (n=52, 54) | Day 11 (n=53, 54) | Day 12 (n=53, 54) | Day 13 (n=53, 54) | Day 14 (n=36, 38) |
|---|
| Placebo | -0.2 | 0.0 | -0.3 | -0.4 | 0.1 | -0.3 | 0.4 | 0.1 | -0.4 | -0.4 | -0.2 | -0.1 | -15.7 |
,| Varenicline | -0.1 | -0.6 | -1.8 | -1.0 | -1.3 | -1.8 | -1.7 | -1.0 | -1.7 | -1.8 | -0.7 | -1.4 | -17.2 |
Change From Baseline in the Overt Aggression Scale (Modified) (OAS-m): Aggression Total Score
The OAS-m contains 3 scales: Aggression (Questions [Q]1 to 4), Irritability (Q5 to 6), and Suicidality (Q7 to 7b). Aggression total score was calculated by summing the weighted scores in Q1 to 4. Scores for each question ranged from 0 (no events) to 5 (very severe events). Total scores ranged from 0 (no aggression) to any number with no upper limit depending on the frequency of agressive behaviour in a week. (NCT00749944)
Timeframe: Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| Period AB (n=54, 54) | Period AC (n=54, 54) | Period AD (n=54, 54) | Period AE (n=55, 54) | Period BC (n=53, 54) | Period BD (n=53, 54) | Period BE (n=53, 54) |
|---|
| Placebo | 0.48 | 0.72 | 0.75 | 0.77 | 0.22 | -0.15 | -0.13 |
,| Varenicline | 0.13 | 0.82 | 2.24 | 1.27 | 0.83 | 1.94 | 1.00 |
Change From Baseline in the Overt Aggression Scale (Modified) (OAS-m): Irritability Total Score
The OAS-m contains 3 scales: Aggression (Questions [Q]1 to 4), Irritability (Q5 to 6), and Suicidality (Q7 to 7b). Irritability total score was calculated by summing the items in Q5 to 6. Scores for each question ranged from 0 (not at all) to 5 (extreme). Total scores ranged from 0 (no irritability) to 10 (extreme irritability). (NCT00749944)
Timeframe: Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| Period AB (n=54, 54) | Period AC (n=54, 54) | Period AD (n=54, 54) | Period AE (n=55, 54) | Period BC (n=53, 54) | Period BD (n=53, 54) | Period BE (n=53, 54) |
|---|
| Placebo | 0.01 | 0.41 | 0.35 | 0.24 | 0.78 | 0.35 | 0.25 |
,| Varenicline | 0.01 | 0.43 | 0.46 | 0.32 | 0.82 | 0.53 | 0.38 |
Change From Baseline in the Profile of Mood States (POMS): Anger-Hostility Subscale
POMS Anger-Hostility subscale data were responses to 12 items regarding 'How you feel right now?' on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance). (NCT00749944)
Timeframe: Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| Period AB (n=55, 55) | Period AC (n=55, 55) | Period AD (n=55, 55) | Period AE (n=55, 55) | Period BC (n=53, 54) | Period BD (n=53, 54) | Period BE (n=54, 54) |
|---|
| Placebo | -0.69 | -0.89 | -1.00 | -0.68 | -0.52 | -0.65 | -0.43 |
,| Varenicline | 0.16 | -0.04 | 0.24 | 0.15 | -0.00 | 0.22 | -0.05 |
Change From Baseline in the Profile of Mood States (POMS): Confusion Subscale
POMS Confusion subscale data were responses to 7 items regarding 'How you feel right now?' on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. All items were rated in the same direction except for Efficient. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance). (NCT00749944)
Timeframe: Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| Period AB (n=55, 55) | Period AC (n=55, 55) | Period AD (n=55, 55) | Period AE (n=55, 55) | Period BC (n=53, 54) | Period BD (n=53, 54) | Period BE (n=54, 54) |
|---|
| Placebo | -0.09 | -0.18 | -0.11 | -0.03 | -0.07 | -0.02 | -0.02 |
,| Varenicline | 0.14 | 0.03 | 0.10 | -0.01 | 0.02 | 0.07 | -0.14 |
Change From Baseline in the Profile of Mood States (POMS): Depression-Dejection Subscale
POMS Depression-Dejection subscale data responses to 15 items regarding 'How you feel right now?' on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance). (NCT00749944)
Timeframe: Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| Period AB (n=55, 55) | Period AC (n=55, 55) | Period AD (n=55, 55) | Period AE (n=55, 55) | Period BC (n=53, 54) | Period BD (n=53, 54) | Period BE (n=54, 54) |
|---|
| Placebo | -0.24 | -0.24 | -0.10 | 0.00 | 0.03 | 0.10 | 0.23 |
,| Varenicline | 0.38 | 0.50 | 0.56 | 0.44 | 0.51 | 0.49 | 0.32 |
Change From Baseline in the Profile of Mood States (POMS): Fatigue Subscale
POMS Fatigue subscale data were responses to 7 items regarding 'How you feel right now?' on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. All items were rated in the same direction. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance). (NCT00749944)
Timeframe: Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| Period AB (n=55, 55) | Period AC (n=55, 55) | Period AD (n=55, 55) | Period AE (n=55, 55) | Period BC (n=53, 54) | Period BD (n=53, 54) | Period BE (n=54, 54) |
|---|
| Placebo | -0.65 | -0.83 | -0.76 | -0.59 | -0.22 | -0.13 | -0.26 |
,| Varenicline | -0.14 | -0.29 | -0.58 | -0.32 | 0.37 | -0.20 | -0.16 |
Change From Baseline in the Profile of Mood States (POMS): Tension-Anxiety Subscale
POMS Tension-Anxiety subscale data were responses to 9 items regarding 'How you feel right now?' on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. All items were rated in the same direction except for Relaxed. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance). (NCT00749944)
Timeframe: Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| Period AB (n=55, 55) | Period AC (n=55, 55) | Period AD (n=55, 55) | Period AE (n=55, 55) | Period BC (n=53, 54) | Period BD (n=53, 54) | Period BE (n=54, 54) |
|---|
| Placebo | -0.31 | -0.26 | -0.18 | -0.43 | -0.10 | -0.16 | -0.58 |
,| Varenicline | 0.30 | 0.15 | 0.31 | 0.01 | -0.01 | 0.06 | -0.35 |
Change From Baseline in the Profile of Mood States (POMS): Total Mood Disturbance (TMD)
POMS TMD were responses to 65 items in 6 subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor, Fatigue, and Confusion), on 'How you feel right now?' (scale:0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely). All items were rated in the same direction except for Relaxed and Efficient in the Tension-Anxiety and Confusion subscales. TMD was the sum of the scores of all 6 subscales but weighting Vigor negatively. Summary results (TMD scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance). (NCT00749944)
Timeframe: Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| Period AB (n=55, 55) | Period AC (n=55, 55) | Period AD (n=55, 55) | Period AE (n=55, 55) | Period BC (n=53, 54) | Period BD (n=53, 54) | Period BE (n=54, 54) |
|---|
| Placebo | -0.66 | -0.17 | 0.03 | 0.22 | 0.91 | 1.04 | 0.96 |
,| Varenicline | 0.06 | 0.30 | 0.95 | 0.72 | 0.48 | 1.07 | 0.59 |
Change From Baseline in the Profile of Mood States (POMS): Vigor Subscale
POMS Vigor subscale data were responses to 8 items regarding 'How you feel right now?' on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance). (NCT00749944)
Timeframe: Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| Period AB (n=55, 55) | Period AC (n=55, 55) | Period AD (n=55, 55) | Period AE (n=55, 55) | Period BC (n=53, 54) | Period BD (n=53, 54) | Period BE (n=54, 54) |
|---|
| Placebo | 0.98 | -1.15 | -1.14 | -1.82 | -3.44 | -3.22 | -3.37 |
,| Varenicline | 0.16 | -1.34 | -3.30 | -2.80 | -1.49 | -3.22 | -2.28 |
Number of Participants Exceeding Thresholds for the Barratt Impulsiveness Scale - Version 11 (BIS-11): Total Score
The BIS-11 is designed to assess general impulsiveness taking into account the multifactorial nature of the construct. Total score ranged from 30 (less impulsive) to 120 (more impulsive). Participants exceeding the threshold had a BIS-11 total score more than or equal to 70 out of 120. BIS-11 total scores of more than or equal to 70 could reflect clinically important and potentially pathological impulsivity. (NCT00749944)
Timeframe: Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).
| Intervention | participants (Number) |
|---|
| Period AB (n=54, 54) | Period AC (n=54, 54) | Period AD (n=54, 54) | Period AE (n=55, 54) | Period BC (n=53, 54) | Period BD (n=53, 54) | Period BE (n=54, 54) |
|---|
| Placebo | 0 | 2 | 2 | 5 | 2 | 2 | 5 |
,| Varenicline | 1 | 1 | 1 | 5 | 1 | 1 | 5 |
Number of Participants Exceeding Thresholds for the Hamilton Anxiety Scale (HAM-A): Total Score
HAM-A measures treatment-related changes in generalized anxiety symptoms. Total scores ranged from 0 (not affected) to 56 (very severely affected). Participants exceeding the threshold had a HAM-A total score of more than or equal to 14 out of 56. HAM-A total scores of more than or equal to 14 may reflect clinically noteworthy levels of anxiety. (NCT00749944)
Timeframe: Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).
| Intervention | participants (Number) |
|---|
| Period AB (n=54, 54) | Period AC (n=54, 54) | Period AD (n=54, 54) | Period AE (n=55, 54) | Period BC (n=53, 54) | Period BD (n=53, 54) | Period BE (n=54, 54) |
|---|
| Placebo | 2 | 7 | 7 | 10 | 6 | 6 | 9 |
,| Varenicline | 0 | 9 | 12 | 16 | 9 | 12 | 16 |
Number of Participants Exceeding Thresholds for the Montgomery-Asberg Depression Rating Scale (MADRS): Total Score
The MADRS measures the overall severity of depressive symptoms. Total score ranged from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Participants exceeding the threshold had a MADRS total score of more than 14 out of 60. MADRS total scores exceeding 14 may represent clinically notable effective symptomatology. (NCT00749944)
Timeframe: Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).
| Intervention | participants (Number) |
|---|
| Period AB (n=54, 54) | Period AC (n=54, 54) | Period AD (n=54, 54) | Period AE (n=55, 54) | Period BC (n=53, 54) | Period BD (n=53, 54) | Period BE (n=54, 54) |
|---|
| Placebo | 0 | 3 | 3 | 8 | 3 | 3 | 8 |
,| Varenicline | 2 | 7 | 8 | 11 | 5 | 6 | 9 |
Number of Participants Exceeding Thresholds for the Overt Aggression Scale (Modified) (OAS-m): Agression Total Score
The OAS-m contains 3 scales: Aggression, Irritability, and Suicidality. Aggression total score ranged from 0 (no aggression) to any number with no upper limit depending on the frequency of agressive behaviour in a week. Participants exceeding the threshold had an OAS-m Aggression total score of more than or equal to 3 out of any number with no upper limit depending on the frequency of agressive behaviour in a week. OAS-m Aggression total scores of more than or equal to 3 reflect clinically important aggression. (NCT00749944)
Timeframe: Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).
| Intervention | participants (Number) |
|---|
| Period AB (n=54, 54) | Period AC (n=54, 54) | Period AD (n=54, 54) | Period AE (n=55, 54) | Period BC (n=53, 54) | Period BD (n=53, 54) | Period BE (n=54, 54) |
|---|
| Placebo | 6 | 21 | 23 | 31 | 19 | 21 | 30 |
,| Varenicline | 9 | 20 | 21 | 28 | 15 | 18 | 27 |
Number of Participants Exceeding Thresholds for the Overt Aggression Scale (Modified) (OAS-m): Irritability Total Score
The OAS-m contains 3 scales: Aggression, Irritability, and Suicidality. Irritability total score ranged from 0 (no irritability) to 10 (extreme irritability). Participants exceeding the threshold had an OAS-m Irritability total score of more than or equal to 2 out of 10. OAS-m Irritability total scores of more than or equal to 2 reflect clinically important irritability. (NCT00749944)
Timeframe: Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).
| Intervention | participants (Number) |
|---|
| Period AB (n=54, 54) | Period AC (n=54, 54) | Period AD (n=54, 54) | Period AE (n=55, 54) | Period BC (n=53, 54) | Period BD (n=53, 54) | Period BE (n=54, 54) |
|---|
| Placebo | 11 | 34 | 36 | 39 | 31 | 33 | 38 |
,| Varenicline | 10 | 32 | 36 | 41 | 31 | 35 | 40 |
Number of Participants Exceeding Thresholds for the Profile of Mood States (POMS): Total Score
POMS total mood disturbance (TMD) summary results were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance). Participants exceeding the threshold had an increase from baseline of 1 standard deviation of the TMD baseline T-score plus 1 or more. (NCT00749944)
Timeframe: Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).
| Intervention | participants (Number) |
|---|
| Period AB (n=55, 55) | Period AC (n=55, 55) | Period AD (n=55, 55) | Period AE (n=55, 55) | Period BC (n=53, 54) | Period BD (n=53, 54) | Period BE (n=54, 54) |
|---|
| Placebo | 11 | 35 | 38 | 38 | 33 | 36 | 38 |
,| Varenicline | 14 | 32 | 37 | 38 | 27 | 30 | 32 |
Number of Participants With 7-day Point Prevalence of Abstinence (Smoking Cessation)
Participants who reported no smoking and no use of other nicotine-containing products since the last study visit (during treatment) in the previous 7 days and who did not have carbon monoxide of more than 10 parts per million for that observation (if measured). (NCT00749944)
Timeframe: Week 5 to Week 13
| Intervention | participants (Number) |
|---|
| Week 5 (n=55, 55) | Week 6 (n=55, 55) | Week 7 (n=55, 55) | Week 8 (n=55, 55) | Week 9 (n=55, 55) | Week 10 (n=55, 55) | Week 11 (n=55, 55) | Week 12 (n=55, 55) | Week 13 (n=55, 55) |
|---|
| Placebo | 16 | 12 | 17 | 15 | 14 | 17 | 18 | 15 | 15 |
,| Varenicline | 19 | 23 | 20 | 21 | 25 | 17 | 20 | 19 | 23 |
7-day Point Prevalence of Abstinence
"7-day point prevalence of abstinence was assessed by the question Have you had a cigarette, even a puff, in the past 7 days?" (NCT01023659)
Timeframe: 6-month
| Intervention | Participants (Count of Participants) |
|---|
| Bupropion + Motivational Emails | 45 |
| Motivational Emails | 22 |
| Varenicline + Motivational Emails | 50 |
Proportion of Eligible Participants Who Were Able to Attend an Appointment With a Physician
Proportion of eligible participants who were able to attend an appointment with a physician to have the prescription signed (NCT01023659)
Timeframe: End of Treatment
| Intervention | Participants (Count of Participants) |
|---|
| All Eligible Participants | 588 |
Percentage of Participants With 4-week Continuous Abstinence (CA)
The percentage of participants who reported complete abstinence from cigarette smoking and other nicotine use (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) >10 parts per million (ppm) at any visits Week 9 through Week 12. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO >10 ppm. (NCT00691483)
Timeframe: Week 9 through Week 12
| Intervention | Percentage of participants (Number) |
|---|
| Varenicline | 53.9 |
| Placebo | 19.4 |
Percentage of Participants With 4-week Point Prevalence of Nonsmoking
Percentage of participants with complete abstinence from cigarette smoking or use of tobacco products for the 4 weeks prior to Week 24 who did not have CO >10 ppm at any visits. (NCT00691483)
Timeframe: Week 24
| Intervention | Percentage of participants (Number) |
|---|
| Varenicline | 42.0 |
| Placebo | 17.0 |
Percentage of Participants With Continuous Abstinence (CA) From Smoking Weeks 9-24
Percentage of participants with CA from cigarette smoking and other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use, who did not have CO >10 ppm at any visits Week 9 through Week 24. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO >10 ppm. (NCT00691483)
Timeframe: Week 9 through Week 24
| Intervention | Percentage of participants (Number) |
|---|
| Varenicline | 35.2 |
| Placebo | 12.7 |
Percentage of Participants With Long Term Quit Through Week 24
Responder for the primary endpoint of CA from Week 9 through Week 12 and who had no more than 6 days of smoking during the non-treatment phase of the study. For Weeks 13, 16, 20, and 24, long term quit was determined by CO-confirmed in-clinic visit. (NCT00691483)
Timeframe: Week 9 through Week 24
| Intervention | Percentage of participants (Number) |
|---|
| Varenicline | 40.7 |
| Placebo | 14.6 |
Change From Baseline in Fagerström Test for Nicotine Dependence (FTND) to Day of First Quit Attempt (FQA) Through Week 5 by Smoking Status at Weeks 9-12
Change in nicotine dependence from baseline to the date of the FQA within the first 5 weeks. FTND was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The FTND contains 4 yes-no and 2 multiple choice questions and can be used in a self-report format. The items on FTND are scored 0 to 3 for multiple choice items, the items are summed to yield a total score of 0-10 (0=minimum nicotine dependence; 10=maximum nicotine dependence). (NCT00691483)
Timeframe: Baseline through Week 5
| Intervention | Units on a scale (Mean) |
|---|
| Responders | Non-Responders |
|---|
| Placebo | -1.8 | -1.8 |
,| Varenicline | -2.3 | -2.5 |
Percentage of Participants With 7-day Point Prevalence of Nonsmoking (Smoking Cessation)
Percentage of participants with complete abstinence from cigarette smoking or other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use for the 7 days prior to Week 12 and Week 24, respectively, who did not have CO >10 ppm at any visits. CO-confirmed in-clinic visit. (NCT00691483)
Timeframe: Week 12 and Week 24
| Intervention | Percentage of participants (Number) |
|---|
| Week 12 | Week 24 |
|---|
| Placebo | 24.2 | 17.6 |
,| Varenicline | 59.5 | 43.0 |
Effects of Varenicline on Self-reported Smoking Reduction Prior to the Quit Date
"Previous research has shown that abstinence at the end of treatment is strongly predicted by the extent to which smokers spontaneously reduce ad libitum smoking in the initial weeks of pharmacotherapy that is initiated before the quit-smoking date.~This measure will assess the extent of smoking reduction in participants during the initial seven days of treatment (prior to their planned quit date) - assessed via a self-report number of cigarettes per day. Data is recorded as a mean change." (NCT04188106)
Timeframe: 7 Days
| Intervention | Cigs smoked per day (Mean) |
|---|
| Hydroxyzine and Varenicline -- Successful in Quitting Smoking | -9.14 |
| Hydroxyzine and Varenicline -- Unsuccessful in Quitting Smoking | -5.53 |
Effects of Varenicline on Self-reported Smoking Reduction Prior to the Quit Date
"Previous research has shown that abstinence at the end of treatment is strongly predicted by the extent to which smokers spontaneously reduce ad libitum smoking in the initial weeks of pharmacotherapy that is initiated before the quit-smoking date.~This measure will assess the extent of smoking reduction in participants during the initial seven days of treatment (prior to their planned quit date) - assessed via expired air carbon monoxide (CO). Data is recorded as a mean change." (NCT04188106)
Timeframe: 7 Days
| Intervention | CO in ppm (Mean) |
|---|
| Hydroxyzine and Varenicline -- Successful in Quitting Smoking | -11.00 |
| Hydroxyzine and Varenicline -- Unsuccessful in Quitting Smoking | -2.12 |
Change in 10-item Perceived Stress Scale (PSS-10) Following Smoking Cessation (While Taking Arenicline and Hydroxyzine).
"Stress levels in the last 30 days will be measured using the 10-item Perceived Stress Scale (PSS-10). The PSS-10 uses a 5-point scale (0 - never, 1 = almost never, 2 = once in a while, 3 = often, 4 = very often). Total scores range from 0 to 40.~Scores ranging from 0-13 would be considered low stress.~Scores ranging from 14-26 would be considered moderate stress.~Scores ranging from 27-40 would be considered high perceived stress." (NCT04188106)
Timeframe: Weeks 1, 2, 4, 8, 12
| Intervention | score on a scale (Mean) |
|---|
| Change in PPS-10 from BL to Week 1 | Change in PPS-10 from BL to Week 2 | Change in PPS-10 from BL to Week 4 | Change in PPS-10 from BL to Week 8 | Change in PPS-10 from BL to Week 12 |
|---|
| Hydroxyzine and Varenicline | -1.38 | -1.48 | -1.55 | -2.05 | -2.75 |
Changes in Anxiety Using the 6-item State-Trait Anxiety Inventory (STAI)
"Trait and state anxiety levels will be monitored for changes using the 6-item State-Trait Anxiety Inventory (STAI). All items are rated on a 4-point scale (1-Almost Never to 4-Almost Always). The range of scores is from 6 to 24. Higher scores indicate greater anxiety." (NCT04188106)
Timeframe: Weeks 1, 2, 4, 8, 12
| Intervention | score on a scale (Mean) |
|---|
| Change in STAI from BL to Week 1 | Change in STAI from BL to Week 2 | Change in STAI from BL to Week 4 | Change in STAI from BL to Week 8 | Change in STAI from BL to Week 12 |
|---|
| Hydroxyzine and Varenicline | -0.54 | -1.09 | -0.86 | -1.82 | -1.65 |
Changes in Depression Using the Patient Health Questionnaire (PHQ-9)
"Depression will be monitored for changes using the Patient Health Questionnaire (PHQ-9). The PHQ-9 uses a 4-point scale (Not at all = 0; Several days = 1;More than half the days = 2; Nearly every day = 3). The sum of the scores is calculated (Score range is 0 to 27):~1-4 Minimal depression~5-9 Mild depression~10-14 Moderate depression~15-19 Moderately severe depression~20-27 Severe depression" (NCT04188106)
Timeframe: Weeks 1, 2, 4, 8, 12
| Intervention | score on a scale (Mean) |
|---|
| Change in PHQ-9 from BL to Week 1 | Change in PHQ-9 from BL to Week 2 | Change in PHQ-9 from BL to Week 4 | Change in PHQ-9 from BL to Week 8 | Change in PHQ-9 from BL to Week 12 |
|---|
| Hydroxyzine and Varenicline | -0.15 | 0.63 | 0.43 | -0.27 | -0.41 |
"Number of Participants With Suicidal Behavior and / or Ideation (Yes Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Treatment Phase"
"C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a yes response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a yes response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent)." (NCT00644969)
Timeframe: Week 1 to Week 12 (Treatment phase)
| Intervention | participants (Number) |
|---|
| Varenicline | 9 |
| Placebo | 4 |
"Number of Participants With Suicidal Behavior or Suicical Ideation (Yes Response ) on the Columbia Suicide-Severity Rating Scale (C-SSRS) During the Post Treatment Phase"
"C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a yes response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a yes response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent)." (NCT00644969)
Timeframe: Week 13 to Week 24 (Post treatment phase)
| Intervention | participants (Number) |
|---|
| Varenicline | 6 |
| Placebo | 0 |
Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Negative symptoms (deficit features) associated with schizophrenia (blunted affect, emotional withdrawal, poor rapport, and passive / apathetic social withdrawal) are rated on a scale from 1 (absent) to 7 (extreme); total negative subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms. (NCT00644969)
Timeframe: Baseline to Week 24
| Intervention | scores on a scale (Mean) |
|---|
| Varenicline | -1.43 |
| Placebo | -0.68 |
Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Positive symptoms (productive symptoms) associated with schizophrenia (delusions, conceptual disorganization, and hallucinatory behavior) are rated on a scale from 1 (absent) to 7 (extreme); total positive subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms. (NCT00644969)
Timeframe: Baseline to Week 24
| Intervention | scores on a scale (Mean) |
|---|
| Varenicline | -1.49 |
| Placebo | -1.68 |
Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Total scores range from 30 to 210 with higher scores indicating more extreme symptoms. (NCT00644969)
Timeframe: Baseline to Week 24
| Intervention | scores on a scale (Mean) |
|---|
| Varenicline | -4.77 |
| Placebo | -3.27 |
Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS)
10-item rating scale to assess the severity of extrapyramidal symptoms rated on a 5-point scale 0 (normal) to 4 (highest severity). Items measured are gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella tap, tremor, and salivation. Global score calculated by summing individual item scores and dividing by the total number of items; range is 0 to 40 with higher scores indicating greater severity. (NCT00644969)
Timeframe: Baseline to Week 24
| Intervention | scores on a scale (Mean) |
|---|
| Varenicline | -0.37 |
| Placebo | -0.29 |
Number of Participants With 7-day Point Prevalence of Non-smoking at Week 12
7-day point prevalence of non-smoking measured as the number of participants who maintained complete abstinence from cigarette smoking or other nicotine use in the previous 7 days before the Week 12 visit and had an end-expiratory carbon monoxide (CO) measurement of ≤10 parts per million (ppm). (NCT00644969)
Timeframe: Week 12
| Intervention | participants (Number) |
|---|
| Varenicline | 16 |
| Placebo | 2 |
Number of Participants With 7-day Point Prevalence of Non-smoking at Week 24
7-day point prevalence of non-smoking measured as the number of participants who maintained complete abstinence from cigarette smoking or other nicotine use in the previous 7 days before the Week 24 visit and had an end-expiratory carbon monoxide (CO) measurement of ≤10 parts per million (ppm). (NCT00644969)
Timeframe: Week 24
| Intervention | participants (Number) |
|---|
| Varenicline | 10 |
| Placebo | 1 |
Change From Baseline to Week 12 and Week 24 in the Number of Cigarettes Smoked Per Day
Measured as mean number of cigarettes smoked per day averaged over the past 7 days at Week 12 and Week 24. (NCT00644969)
Timeframe: Baseline, Week 12, Week 24
| Intervention | cigarettes per day (Least Squares Mean) |
|---|
| Week 12 (n=68, 39) | Week 24 (n=61, 37) |
|---|
| Placebo | -10.58 | -9.32 |
,| Varenicline | -14.23 | -9.55 |
Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Negative symptoms (deficit features) associated with schizophrenia (blunted affect, emotional withdrawal, poor rapport, and passive / apathetic social withdrawal) are rated on a scale from 1 (absent) to 7 (extreme); total negative subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms. (NCT00644969)
Timeframe: Baseline to Week 12
| Intervention | scores on a scale (Mean) |
|---|
| Baseline mean | Mean change at Week 12 (n=68, 39) |
|---|
| Placebo | 14.79 | -1.33 |
,| Varenicline | 14.75 | -1 |
Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Positive symptoms (productive symptoms) associated with schizophrenia (delusions, conceptual disorganization, and hallucinatory behavior) are rated on a scale from 1 (absent) to 7 (extreme); total positive subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms. (NCT00644969)
Timeframe: Baseline to Week 12
| Intervention | scores on a scale (Mean) |
|---|
| Baseline mean | Mean change at Week 12 (n=68, 39) |
|---|
| Placebo | 13.53 | -1.33 |
,| Varenicline | 13.43 | -1.87 |
Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Total scores range from 30 to 210 with higher scores indicating more extreme symptoms. (NCT00644969)
Timeframe: Baseline to Week 12
| Intervention | scores on a scale (Mean) |
|---|
| Baseline mean | Mean change at Week 12 (n=68, 39) |
|---|
| Placebo | 54.47 | -3.46 |
,| Varenicline | 55.88 | -5.19 |
Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS)
10-item rating scale to assess the severity of extrapyramidal symptoms rated on a 5-point scale 0 (normal) to 4 (highest severity). Items measured are gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella tap, tremor, and salivation. Global score calculated by summing individual item scores and dividing by the total number of items; range is 0 to 40 with higher scores indicating greater severity. (NCT00644969)
Timeframe: Baseline to Week 12
| Intervention | scores on a scale (Mean) |
|---|
| Baseline mean | Mean change at Week 12 (n=68, 39) |
|---|
| Placebo | 1.139 | 0.102 |
,| Varenicline | 1.452 | -0.42 |
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs are any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The event does not need to be causally related to the study treatment or usage. SAEs include any untoward medical occurrence that results in death, are life threatening, requires hospitalization or prolongation of hospitalization, results in disability or incapacity or are a congenital anomaly or birth defect in the offspring of a study participant. Lack of efficacy was to be reported as an AE when it was associated with an SAE. (NCT00644969)
Timeframe: Baseline up to 30 days after last dose of study treatment or up to Week 16
| Intervention | participants (Number) |
|---|
| Serious Adverse Events | Adverse Events |
|---|
| Placebo | 4 | 35 |
,| Varenicline | 5 | 70 |
Number of Participants With at Least a 50 Percent (%) Reduction From Baseline to Week 12 and Week 24 in the Number of Cigarettes Smoked Per Day
Measured as at least a 50% reduction from baseline in cigarettes smoked per day averaged over the past 7 days at Week 12 and Week 24. (NCT00644969)
Timeframe: Baseline, Week 12, Week 24
| Intervention | participants (Number) |
|---|
| Week 12 | Week 24 |
|---|
| Placebo | 22 | 18 |
,| Varenicline | 54 | 34 |
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1
CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline. (NCT00644969)
Timeframe: Baseline, Week 1
| Intervention | participants (Number) |
|---|
| Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse |
|---|
| Placebo | 0 | 0 | 3 | 37 | 3 | 0 | 0 |
,| Varenicline | 0 | 3 | 4 | 67 | 5 | 0 | 0 |
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12
CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline. (NCT00644969)
Timeframe: Baseline, Week 12
| Intervention | participants (Number) |
|---|
| Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse |
|---|
| Placebo | 0 | 0 | 4 | 35 | 0 | 0 | 0 |
,| Varenicline | 1 | 1 | 5 | 55 | 6 | 0 | 0 |
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24
CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline. (NCT00644969)
Timeframe: Baseline, Week 24
| Intervention | participants (Number) |
|---|
| Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse |
|---|
| Placebo | 0 | 1 | 5 | 31 | 0 | 0 | 0 |
,| Varenicline | 2 | 2 | 8 | 46 | 2 | 1 | 0 |
Number of Participants With Psychiatric Adverse Events
Psychiatric Adverse Event symptoms included, but were not restricted to, depression, anxiety, hostility, perceptual / thinking disturbance, suicidal ideation, or suicidal behavior based on clinical judgment and use of the Positive and Negative Syndrome Scale and Columbia Classification Algorithm of Suicide assessments. (NCT00644969)
Timeframe: Baseline up to Week 24
| Intervention | participants (Number) |
|---|
| Abnormal dreams | Aggression | Agitation | Anxiety | Depressed mood | Depression | Hallucination auditory | Hallucination visual | Initial insomnia | Insomnia | Nervousness | Nightmare | Panic reaction | Paranoia | Psychiatric symptom | Restlessness | Sleep disorder | Suicidal ideation | Suicide attempt | Tension |
|---|
| Placebo | 4 | 1 | 1 | 4 | 1 | 3 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 0 | 0 |
,| Varenicline | 6 | 0 | 0 | 4 | 2 | 4 | 4 | 1 | 1 | 8 | 1 | 1 | 1 | 2 | 1 | 1 | 1 | 5 | 1 | 1 |
Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states. (NCT00644969)
Timeframe: Baseline (Bsl) to Week 12
| Intervention | participants (Number) |
|---|
| Mildly ill Bsl to Borderline ill Week 12 | Mildly ill Bsl to Moderately ill Week 12 | Moderately ill Bsl to Borderline ill Week 12 | Moderately ill Bsl to Mildly ill Week 12 | Markedly ill Bsl to Moderately ill Week 12 |
|---|
| Placebo | 0 | 1 | 0 | 1 | 0 |
,| Varenicline | 1 | 1 | 1 | 4 | 1 |
Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states. (NCT00644969)
Timeframe: Baseline to Week 24
| Intervention | participants (Number) |
|---|
| Mildly ill Bsl to Borderline ill Week 24 | Mildly ill Bsl to Moderately ill Week 24 | Mildly ill Bsl to Markedly ill Week 24 | Moderately ill Bsl to Borderline ill Week 24 | Moderately ill Bsl to Mildly ill Week 24 | Markedly ill Bsl to Moderately ill Week 24 |
|---|
| Placebo | 0 | 1 | 0 | 0 | 1 | 0 |
,| Varenicline | 1 | 1 | 1 | 1 | 5 | 1 |
Smoking Topography: Total Puff Volume
Total puff volume was created by summing all of the puffs from the cigarette smoked in the lab at each time point (each lab visit). This value represents the total volume of smoke extracted from a single cigarette and it a standard measure of smoking behavior. A total puff volume represents the total smoking volume from a cigarette. Values are reported in milliliters. Value of interest is the average puff volume across all sessions for all participants in a group and is reported as a key measure of smoking behavior. Analyses were repeated measures analysis of variance where individual, time and drug were within factors. (NCT00948155)
Timeframe: Days 1-21 of each of 2 study periods
| Intervention | milliliters (Mean) |
|---|
| Placebo Then Varenicline | 523.4 |
| Varenicline Before Placebo | 684.6 |
The Number of Choices of a Nicotine Containing Cigarette Compared to a Non-nicotine Cigarette.
Participants were given 4 puff choices (between a nicotine containing and de-nicotinized cigarette) on 6 study visits, for a total of 24 choices. Number of puffs reported is average across both study periods. (NCT00948155)
Timeframe: Days 1, 7, 21 of each of two 21 day study periods
| Intervention | number of puffs chosen of a maximum 24 (Mean) |
|---|
| Placebo Then Varenicline | 12 |
| Varenicline Before Placebo | 11.5 |
Carbon Monoxide Levels
Exhaled breath carbon monoxide levels collected at Day 1 and Day 21 sessions. Alveolar carbon monoxide is a validated assessment of smoke exposure. (NCT00948155)
Timeframe: Samples from Day 1 and Day 21 of two 21 day Periods
| Intervention | parts per million (Mean) |
|---|
| Day 1 | Day 21 |
|---|
| Placebo | 30 | 25 |
,| Varenicline | 23.2 | 22 |
Cotinine Levels From Urine Samples
Cotinine levels from urine samples collected at Day 1 and Day 21. (NCT00948155)
Timeframe: Samples from Day 1 and Day 21 of two 21 day Periods
| Intervention | micromolar (Mean) |
|---|
| Day 1 | Day 21 |
|---|
| Placebo | 19.0 | 12.0 |
,| Varenicline | 16.9 | 14.0 |
Daily Cigarette Consumption
Average of the number of cigarettes smoked per day (NCT00948155)
Timeframe: Two 21 day study periods
| Intervention | number of cigarettes smoked per day (Mean) |
|---|
| Start of 21 day period | End of 21 day period |
|---|
| Placebo | 16.2 | 14.4 |
,| Varenicline | 16.1 | 12.8 |
Nicotine Levels From Urine Samples
Nicotine levels from urine samples collected at Day 1 and Day 21. (NCT00948155)
Timeframe: Samples from Day 1 and Day 21 of two 21 day Periods
| Intervention | micromolar (Mean) |
|---|
| Day 1 | Day 21 |
|---|
| Placebo | 20.0 | 18.0 |
,| Varenicline | 24.0 | 13.8 |
Subjective Measures to Assess Smoking Urges
Craving for cigarettes was assessed with the 32-item Questionnaire of Smoking Urges (QSU) during each study visit. In order to calculate the QSU measure, each item is rated on a Likert-type scale from 1 (strongly disagree) to 7 (strongly agree). The values are then summed to create a single total score. Well validated 2 factor subscale scores were also created by summing the item scores for the 2 factors: Factor 1 reflects the desire to smoke for pleasure and Factor 2 reflects urges to smoke to relieve withdrawal-related negative affect. Internal consistency for each scale across all time points was high (Cronbach's α > 0.95, 0.85, and 0.95 for Factor 1, Factor 2, and QSU total, respectively). Scale range is 1-7 where 1 is low urge to smoke and 7 represents high urge to smoke. Data was collected at each time point but outcome measure of interest is end of period. (NCT00948155)
Timeframe: Days 21 of each of the two 21-day study periods, range 1(low)-7(high)
| Intervention | units on a scale (Mean) |
|---|
| Factor 1 Day 1 | Factor 1 Day 21 | Factor 2 Day 1 | Factor 2 Day 21 |
|---|
| Placebo | 4.2 | 3.9 | 2.5 | 2.4 |
,| Varenicline | 4.3 | 3.7 | 2.8 | 2.6 |
Carbon Monoxide (CO)-Confirmed 7-day Abstinence
Number of participants reporting 7-day abstinence at 6-months, confirmed with CO measurement. (NCT00790569)
Timeframe: 6-Months
| Intervention | participants (Number) |
|---|
| Arm I | 5 |
| Arm II | 1 |
| Arm III | 11 |
Change in Cigarettes Per Day
Change in mean cigarettes per day (NCT00790569)
Timeframe: 6-Months
| Intervention | cigarettes/day (Mean) |
|---|
| Arm I | -8.7 |
| Arm II | -8.5 |
| Arm III | -7.8 |
Change in Smoking Urges
Smoking urges was measured on a 0 (not at all) - 100 (strongest feeling possible) scale. Higher values represent greater urge to smoke. Change in smoking urges was calculated as Follow-up score (6 month) - Baseline Score. (NCT00790569)
Timeframe: 6 months
| Intervention | units on a scale (Mean) |
|---|
| Arm I | -29.971 |
| Arm II | -25.015 |
| Arm III | -24.177 |
CO-confirmed 7-day Abstinence
Number of participants reporting 7-day abstinence at 12-months, confirmed with CO measurement. (NCT00790569)
Timeframe: 12 Months
| Intervention | participants (Number) |
|---|
| Arm I | 4 |
| Arm II | 1 |
| Arm III | 8 |
Rates of Smoking Cessation Continuous From First Quit Day to 6 Months
Number of participants who self-reported continuous abstinence from their initial quit day (study day 14) to 6 Months (NCT00790569)
Timeframe: 6-Months
| Intervention | participants (Number) |
|---|
| Arm I | 2 |
| Arm II | 0 |
| Arm III | 2 |
Reinforcing Effects of Smoking
Reinforcing effects of smoking was measured using the modified version of the Cigarette Evaluation Questionnaire. Participants were asked to indicate on a 12-item scale how smoking made them feel in the prior 30 days on a scale from 1 (Not at all) to 7 (Extremely). Higher values indicated that smoking was a more positive experience for 10 of 12 items. Two items were reverse coded. Change in reinforcing effects of smoking was calculated as Follow-up score (6 month) - Baseline Score. (NCT00790569)
Timeframe: 6 months
| Intervention | units on a scale (Mean) |
|---|
| Arm I | -1.005 |
| Arm II | -.683 |
| Arm III | -.761 |
Self- Reported 7-day Abstinence
Number of participants with self-reported, 7-day abstinence at 6-months (NCT00790569)
Timeframe: 6 Months
| Intervention | participants (Number) |
|---|
| Arm I | 11 |
| Arm II | 3 |
| Arm III | 16 |
Self-reported 7-day Abstinence
Number of participants with self-reported 7-day abstinence at 12-months (NCT00790569)
Timeframe: 12 Months
| Intervention | participants (Number) |
|---|
| Arm I | 4 |
| Arm II | 3 |
| Arm III | 11 |
Withdrawal Symptoms
Withdrawal Symptoms were measured using a modified version of the Minnesota Behavior Rating Scale. The scale asked subjects to rate their smoking withdrawal symptoms over the previous 24 hours on a scale from 0 (none) to 4 (severe). Higher values indicate more severe withdrawal symptoms. Change in withdrawal symptoms was calculated as Follow-up score (6 month) - Baseline Score. (NCT00790569)
Timeframe: 6 months
| Intervention | units on a scale (Mean) |
|---|
| Arm I | -.222 |
| Arm II | -.163 |
| Arm III | -.113 |
Carbon Monoxide-verified Abstinence
Carbon monoxide-verified abstinence determined as a measure of <10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers. (NCT00781599)
Timeframe: Month 1
| Intervention | participants (Number) |
|---|
| Chantix for 3 Months, Standard Counseling | 7 |
| Chantix for 3 Months and Adherence Counseling | 6 |
Carbon Monoxide-verified Abstinence
Carbon monoxide-verified abstinence determined as a measure of <10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers. (NCT00781599)
Timeframe: Month 2
| Intervention | participants (Number) |
|---|
| Chantix for 3 Months, Standard Counseling | 6 |
| Chantix for 3 Months and Adherence Counseling | 5 |
Cotinine Verified 7 Day Point Prevalence Smoking Abstinence
Smoking cessation verified by salivary cotinine (COT). A COT of <20 ng/ml indicated smoking abstinence. (NCT00781599)
Timeframe: Month 3
| Intervention | participants (Number) |
|---|
| Chantix for 3 Months, Standard Counseling | 9 |
| Chantix for 3 Months and Adherence Counseling | 8 |
Percent Compliance With Chantix
Compliance with Chantix calculated as the total doses taken over the total number of doses prescribed. Adherence was measured by pill counts. Measurements taken during monthly medication refill visits. There was no specific predetermined cutoff number on the scale which determined non-compliance. All results from compliance calculations are included in the table. (NCT00781599)
Timeframe: Months 1, 2, 3
| Intervention | Percentage of Participants (Mean) |
|---|
| Month 1 | Month 2 | Month 3 |
|---|
| Chantix for 3 Months and Adherence Counseling | 85.8 | 91.7 | 82.1 |
,| Chantix for 3 Months, Standard Counseling | 90.7 | 87.1 | 89.2 |
Number of Participants With Continuous Abstinence Situation by 52 Weeks.
Number of participants with dependence on Varenicline by 52 weeks. Varenicline-dependent Treatment Related Adverse Events are Feeling abnormal, Feeling drunk, Feeling jittery, Disturbance in attention, Dizziness, Memory impairment, Mental impairment, Psychomotor hyperactivity, Sedation, Somnolence, Confusional state, Depersonalisation, Disorientation, Dissociation, Euphoric mood, Mood variable, Mood swings, and Hallucination. (NCT00772941)
Timeframe: 52 weeks
| Intervention | participants (Number) |
|---|
| Varenicline | 38 |
Risk Factors for the Proportion of Responders - Antipsychotics as a Concomitant Drug.
"The primary analysis item was the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants." (NCT00772941)
Timeframe: 24 weeks
| Intervention | participants (Number) |
|---|
| Varenicline - With Antipsychotics as a Concomitant Drug | 85 |
| Varenicline - Without Antipsychotics as a Concomitant Drug | 2111 |
Risk Factors for the Proportion of Responders - Prolonged Administration After 12 Weeks.
"The primary analysis item was the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants." (NCT00772941)
Timeframe: 24 weeks
| Intervention | participants (Number) |
|---|
| Administration Prolonged After 12 Weeks | 39 |
| Administration Not Prolonged After 12 Weeks | 1993 |
Risk Factors for the Proportion of Responders - Tobacco Consumption Per Day.
"The primary analysis item was the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants." (NCT00772941)
Timeframe: 24 weeks
| Intervention | participants (Number) |
|---|
| <=20 Cigarettes Per Day | 1299 |
| >=21 and <=40 Cigarettes Per Day | 817 |
| >=41 Cigarettes Per Day | 66 |
Symptoms of Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D)
Symptoms of nicotine withdrawal measured using Center for Epidemiologic Studies Depression Scale (CES-D). Center of Epidemiologic Studies Depression Scale (CESD) a 20-item measure that asks caregivers to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. The average value was estimated from Baseline to 8 months (NCT00507728)
Timeframe: Baseline to 8 months
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Varenicline w/o DRD2 A1 Allele | 8.084 |
| Varenicline With DRD2 A1 Allele | 6.847 |
| Bupropion w/o DRD2 A1 Allele | 7.588 |
| Bupropion With DRD2 A1 Allele | 8.362 |
| Placebo w/o DRD2 A1 Allele | 8.65 |
| Placebo With DRD2 A1 Allele | 10.799 |
Abstinence at 6 Months by DRD2 A1 Allele
Values represent change in probability of abstinence for unit change in emotional reactivity. Abstinence data collected using a timeline follow-back (TLFB) procedure. Continuous Abstinence was defined as no smoking within the last 4 weeks of treatment. It is scored as 0 if the participant smoked during the specific interval, and 1 if the participant abstained from smoking. (NCT00507728)
Timeframe: Baseline to 6 Month ( the effects shown are the increase/decrease in probability of abstinence for 1 unit increase in the predictor)
| Intervention | probability (Least Squares Mean) |
|---|
| Emotional Reactivity (ORB) to Cigarette Stimuli | Emotional Reactivity (ORB) to Negative Stimuli | Emotional Reactivity (ORB) to Positive Stimuli | Emotional Reactivity (ORB) to Neutral Stimuli |
|---|
| Bupropion w/o DRD2 A1 Allele | 0.001 | 0.001 | 0 | 0.001 |
,| Bupropion With DRD2 A1 Allele | -0.001 | -0.002 | -0.001 | -0.001 |
,| Placebo w/o DRD2 A1 Allele | 0 | 0 | 0 | 0 |
,| Placebo With DRD2 A1 Allele | -0.005 | -0.004 | -0.004 | -0.004 |
,| Varenicline w/o DRD2 A1 Allele | 0.003 | 0.003 | 0.003 | 0.003 |
,| Varenicline With DRD2 A1 Allele | -0.001 | -0.001 | 0 | -0.001 |
Emotional Reactivity By Pharmacotherapy
Emotional reactivity measured by the peak eye blink electromyography (EMG) of the orbicularis oculi (ORB) muscle responses to acoustic startle probe delivered during the presentation of emotionally valent stimuli (pleasant, unpleasant, neutral, and smoking-related pictures). A single value was estimated by averaging within the specific time interval. (NCT00507728)
Timeframe: Baseline to 1 month
| Intervention | microvolts (Least Squares Mean) |
|---|
| Emotional Reactivity (ORB) to Cigarette Stimuli | Emotional Reactivity (ORB) to Negative Stimuli | Emotional Reactivity (ORB) to Positive Stimuli | Emotional Reactivity (ORB) to Neutral Stimuli |
|---|
| Bupropion | 64.7 | 73.1 | 65.4 | 64.9 |
,| Placebo | 65.6 | 65.6 | 64.7 | 72.5 |
,| Varenicline | 66.6 | 70.9 | 66.7 | 59.6 |
Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele
The emotional reactivity (ORB EMG) of smokers during cessation will be moderated by genotype. A single value was estimated by averaging within the specific time interval. During a quit attempt, smokers were evaluated on how they react to smoking related cues. An interaction term was then formed by the reactivity to smoking stimulus and genotype. (NCT00507728)
Timeframe: Baseline to 1 month
| Intervention | microvolts (Least Squares Mean) |
|---|
| Emotional Reactivity (ORB) to Cigarette Stimuli | Emotional Reactivity (ORB) to Negative Stimuli | Emotional Reactivity (ORB) to Positive Stimuli | Emotional Reactivity (ORB) to Neutral Stimuli |
|---|
| Bupropion w/o DRD2 A1 Allele | 66.2 | 78.6 | 71.3 | 73.9 |
,| Bupropion With DRD2 A1 Allele | 66 | 71.3 | 63.3 | 61.2 |
,| Placebo w/o DRD2 A1 Allele | 67.3 | 74 | 68.5 | 79.7 |
,| Placebo With DRD2 A1 Allele | 68.1 | 68.1 | 63.8 | 67.8 |
,| Varenicline w/o DRD2 A1 Allele | 66.5 | 70.5 | 65.5 | 55.3 |
,| Varenicline With DRD2 A1 Allele | 69.9 | 75.1 | 72 | 67.2 |
Heart Rate Response
Heart Rate Response. A single value was estimated by averaging within the specific time interval. During a quit attempt, smokers were evaluated on how they react to smoking related cues. An interaction term was then formed by the reactivity to smoking stimulus and genotype. (NCT00507728)
Timeframe: Baseline to 1 month
| Intervention | beats per minute (Least Squares Mean) |
|---|
| Heart Rate response to Cigarette Stimuli | Heart Rate response to Negative Stimuli | Heart Rate response to Positive Stimuli | Heart Rate response to Neutral Stimuli |
|---|
| Bupropion w/o DRD2 A1 Allele | 71.427 | 71.077 | 71.518 | 71.706 |
,| Bupropion With DRD2 A1 Allele | 69.836 | 69.595 | 70.404 | 70.234 |
,| Placebo w/o DRD2 A1 Allele | 65.966 | 65.768 | 65.787 | 65.237 |
,| Placebo With DRD2 A1 Allele | 65.276 | 65.569 | 65.927 | 66.04 |
,| Varenicline w/o DRD2 A1 Allele | 69.731 | 69.562 | 69.151 | 69.621 |
,| Varenicline With DRD2 A1 Allele | 68.652 | 68.078 | 68.711 | 68.969 |
Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales
Modified Cigarette Evaluation Questionnaire (mCEQ). mCEQ Smoking satisfaction: range (1-21); mCEQ Psychological Reward: range(1-35); mCEQ Aversion: range (1-14); mCEQ Enjoyment of Resp.Tract Sens: range (1-7); mCEQ Craving Reduction: range (1-7). For all scales of mCEQ higher scores indicate worse outcomes (greater intensity of smoking effect). Scores of mCEQ Smoking satisfaction, mCEQ psychological reward and mCEQ aversion were summed to create the subscales. mCEQ Enjoyment of Resp Tract Sens and mCEQ Craving Reduction were single items. (NCT00507728)
Timeframe: Baseline to 8 months
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Smoking Satisfaction | Psychological Reward | Aversion | Enjoyment of Respiratory Tract Sensation | Craving Reduction |
|---|
| Bupropion w/o DRD2 A1 Allele | 4.064 | 2.519 | 1.988 | 4.096 | 4.564 |
,| Bupropion With DRD2 A1 Allele | 3.369 | 2.723 | 1.79 | 1.955 | 6.628 |
,| Placebo w/o DRD2 A1 Allele | 3.025 | 3.575 | 1.808 | 3.711 | 4.486 |
,| Placebo With DRD2 A1 Allele | 3.515 | 3.246 | 1.69 | 2.783 | 4.673 |
,| Varenicline w/o DRD2 A1 Allele | 2.895 | 2.819 | 1.612 | 1.912 | 4.531 |
,| Varenicline With DRD2 A1 Allele | 2.591 | 2.155 | 1.694 | 1.703 | 3.952 |
Skin Conductance Response
Skin conductance response (SCR) amplitude measured by placing an electrodermal response transducer on the fore and ring fingers of the participants non-dominant hand, and heart rate (HR) was collected by placing a photoelectric pulse plethysmogram transducer on the middle finger of the participants non-dominant hand, during the presentation of emotionally valent stimuli (positive, negative, neutral, and smoking-related pictures). A single value was estimated by averaging within the specific time interval. (NCT00507728)
Timeframe: Baseline to 1 month
| Intervention | Microsiemens (Least Squares Mean) |
|---|
| Skin conductance to Cigarette Stimuli | Skin conductance to Negative Stimuli | Skin conductance to Positive Stimuli | Skin conductance to Neutral Stimuli |
|---|
| Bupropion w/o DRD2 A1 Allele | 2.275 | 2.31 | 2.299 | 2.369 |
,| Bupropion With DRD2 A1 Allele | 1.797 | 1.695 | 1.7 | 1.699 |
,| Placebo w/o DRD2 A1 Allele | 2.272 | 2.355 | 2.296 | 2.362 |
,| Placebo With DRD2 A1 Allele | 2.443 | 2.485 | 2.565 | 2.559 |
,| Varenicline w/o DRD2 A1 Allele | 2.301 | 2.295 | 2.256 | 2.261 |
,| Varenicline With DRD2 A1 Allele | 2.016 | 1.969 | 1.984 | 2.017 |
Smoking Abstinence at 3 Months
Values represent change in probability of abstinence for unit change in emotional reactivity. Abstinence data collected using a timeline follow-back (TLFB) procedure. Continuous Abstinence was defined as no smoking within the last 4 weeks of treatment. It is scored as 0 if the participant smoked during the specific interval, and 1 if the participant abstained from smoking. (NCT00507728)
Timeframe: Baseline to 3 months
| Intervention | probability (Least Squares Mean) |
|---|
| Emotional Reactivity (ORB) to Cigarette Stimuli | Emotional Reactivity (ORB) to Negative Stimuli | Emotional Reactivity (ORB) to Positive Stimuli | Emotional Reactivity (ORB) to Neutral Stimuli |
|---|
| Bupropion | -0.01 | -0.009 | -0.01 | -0.008 |
,| Placebo | -0.008 | -0.007 | -0.007 | -0.007 |
,| Varenicline | -0.003 | -0.004 | -0.003 | -0.004 |
Smoking Abstinence at 3 Months by DRD2 A1 Allele
Values represent change in probability of abstinence for unit change in emotional reactivity. Abstinence data collected using a timeline follow-back (TLFB) procedure. Continuous Abstinence was defined as no smoking within the last 4 weeks of treatment. It is scored as 0 if the participant smoked during the specific interval, and 1 if the participant abstained from smoking. (NCT00507728)
Timeframe: Baseline to 3 Month
| Intervention | probability (Least Squares Mean) |
|---|
| Emotional Reactivity (ORB) to Cigarette Stimuli | Emotional Reactivity (ORB) to Negative Stimuli | Emotional Reactivity (ORB) to Positive Stimuli | Emotional Reactivity (ORB) to Neutral Stimuli |
|---|
| Bupropion w/o DRD2 A1 Allele | 0 | 0 | 0 | 0.001 |
,| Bupropion With DRD2 A1 Allele | -0.003 | -0.004 | -0.003 | -0.002 |
,| Placebo w/o DRD2 A1 Allele | -0.001 | -0.001 | -0.001 | -0.001 |
,| Placebo With DRD2 A1 Allele | -0.004 | -0.004 | -0.004 | -0.003 |
,| Varenicline w/o DRD2 A1 Allele | 0.001 | 0.002 | 0.001 | 0.001 |
,| Varenicline With DRD2 A1 Allele | -0.004 | -0.005 | -0.005 | -0.005 |
Smoking Abstinence at 6 Months
Values represent change in probability of abstinence for unit change in emotional reactivity. Abstinence data collected using a timeline follow-back (TLFB) procedure. Continuous Abstinence was defined as no smoking within the last 4 weeks of treatment. It is scored as 0 if the participant smoked during the specific interval, and 1 if the participant abstained from smoking. (NCT00507728)
Timeframe: Abstinence at 6 Months ( the effects shown are the increase/decrease in probability of abstinence for 1 unit increase in the predictor)
| Intervention | probability (Least Squares Mean) |
|---|
| Emotional Reactivity (ORB) to Cigaretee Stimuli | Emotional Reactivity (ORB) to Negative Stimuli | Emotional Reactivity (ORB) to Positive Stimuli | Emotional Reactivity (ORB) to Neutral Stimuli |
|---|
| Bupropion | -0.002 | -0.003 | -0.003 | -0.001 |
,| Placebo | -0.006 | -0.005 | -0.005 | -0.005 |
,| Varenicline | 0.007 | 0.008 | 0.01 | 0.008 |
Symptoms of Nicotine Withdrawal and Negative Affect Using Positive and Negative Affect Scale (PANAS)
Symptoms of nicotine withdrawal and negative affect were measured using the Positive and Negative Affect Scale (PANAS). The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Scores can range from 10-50 for both the Positive and Negative Affect with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect. The average value was estimated from Baseline to 8 months (NCT00507728)
Timeframe: Baseline to 8 months
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Positive Affect | Negative Affect |
|---|
| Bupropion w/o DRD2 A1 Allele | 36.429 | 15.782 |
,| Bupropion With DRD2 A1 Allele | 35.281 | 16.385 |
,| Placebo w/o DRD2 A1 Allele | 33.672 | 18.017 |
,| Placebo With DRD2 A1 Allele | 33.984 | 18.902 |
,| Varenicline w/o DRD2 A1 Allele | 35.507 | 15.93 |
,| Varenicline With DRD2 A1 Allele | 37.315 | 14.98 |
Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS)
Symptoms of nicotine withdrawal measured using Wisconsin Smoking Withdrawal Scale (WSWS). The Wisconsin Withdrawal Scale (WSWS) contains 7 factors: Anger, Anxiety, Sadness, Concentration, Craving, Sleep, and Hunger. WSWS consists of 28 items that are scored on a 5-point Likert type scale (0 = strongly disagree, 4 = strongly agree). A single value was estimated by averaging within the specific time interval. Higher values represent worse outcome. The average value was estimated from Baseline to 8 months (NCT00507728)
Timeframe: Baseline to 8 months
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Anger | Anxiety | Concentration | Craving | Hunger | Sadness | Sleep |
|---|
| Bupropion w/o DRD2 A1 Allele | 4.28 | 6.587 | 4.238 | 6.814 | 9.79 | 4.005 | 9.672 |
,| Bupropion With DRD2 A1 Allele | 4.41 | 6.587 | 3.935 | 6.78 | 11.082 | 4.338 | 9.528 |
,| Placebo w/o DRD2 A1 Allele | 5.584 | 7.785 | 4.764 | 9.024 | 11.207 | 5.293 | 9.078 |
,| Placebo With DRD2 A1 Allele | 5.752 | 7.915 | 4.951 | 8.696 | 11.044 | 5.865 | 8.629 |
,| Varenicline w/o DRD2 A1 Allele | 4.394 | 6.218 | 3.743 | 6.646 | 11.016 | 4.246 | 7.721 |
,| Varenicline With DRD2 A1 Allele | 4.222 | 5.873 | 3.407 | 6.252 | 10.707 | 3.738 | 8.153 |
Percentage of Participants With 7-day Point Prevalence for at Least Week 11
Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No). (NCT00483002)
Timeframe: At least Week 11
| Intervention | Percentage of participants (Number) |
|---|
| Varenicline | 77.02 |
Percentage of Participants With 7-day Point Prevalence From Week 3 to Less Than Week 7
Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No). (NCT00483002)
Timeframe: Week 3 through Week 7
| Intervention | Percentage of participants (Number) |
|---|
| Varenicline | 59.55 |
Percentage of Participants With 7-day Point Prevalence From Week 7 to Less Than Week 11
Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No). (NCT00483002)
Timeframe: Week 7 through Week 11
| Intervention | Percentage of participants (Number) |
|---|
| Varenicline | 73.29 |
Carbon Monoxide Breath Level at 12 Weeks
Measured by expired breath in parts per million (ppm) (NCT00813800)
Timeframe: 12 weeks
| Intervention | ppm (Mean) |
|---|
| Varenicline | 6 |
Montgomery-Asberg Depression Rating Scale (MADRS) at 12 Weeks
MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item on the MADRS is scaled 0 through 6. Lowest score = 0, would indicate no depressive symptoms. Highest score = 60, indicating extreme depression. MADRS score > 20 is syndromal depression. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry 1979; 134:382-389. (NCT00813800)
Timeframe: 12 weeks
| Intervention | Units on a Scale (Mean) |
|---|
| Varenicline | 6 |
Young Mania Rating Scale (YMRS) at 12 Weeks
YMRS is an eleven-item, multiple choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes in patients already diagnosed with mania. Lowest score = 0, normal subject; Highest score = 60, highly manic subject. For this scale the following scores are associated with these grades of severity: mania (YMRS = 20), hypomania (YMRS = 12), under 5 is classified as non-manic. Young RC, Biggs JT, Ziegler Ve, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. BR J Psychiatry 1978; 133:429-435. (NCT00813800)
Timeframe: 12 weeks
| Intervention | Units on a Scale (Mean) |
|---|
| Varenicline | 4 |
Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions
Compares the mean percentage of heavy drinking days over the 3-week placebo-controlled pretreatment phase comparing participants in the extended varenicline pretreatment versus the short-term varenicline pretreatment conditions. Heavy drinking defined as consuming 4 or more drinks per occasion for women and 5 or more drinks per occasion for men. Drinking in the final week of pretreatment prior to the quit-date is not included because both groups were receiving active varenicline during this period. (NCT00860028)
Timeframe: First 3 weeks (pretreatment)
| Intervention | percentage of heavy drinking days (Mean) |
|---|
| Extended Varenicline Pretreatment | 22.7 |
| Short-term Varenicline Pretreatment | 38.0 |
Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions.
Compares the number of participants who reported no smoking, not even a puff, from the quit date through until the end of treatment (i.e., last 4 weeks of treatment) in the varenicline versus placebo pretreatment conditions. (NCT00860028)
Timeframe: Last 4 weeks of treatment
| Intervention | Participants (Number) |
|---|
| Extended Varenicline Pretreatment | 4 |
| Short-term Varenicline Pretreatment | 2 |
Number of Participants Who Reported an Adverse Event in the Varenicline Pretreatment Versus Placebo Pretreatment Conditions
Compares the number of participants who reported an adverse event in the extended varenicline pretreatment versus short-term varenicline pretreatment conditions during the 3-week placebo controlled pretreatment phase (NCT00860028)
Timeframe: First 3 weeks (pretreatment)
| Intervention | Number of participants (Number) |
|---|
| Extended Varenicline Pretreatment | 10 |
| Short-term Varenicline Pretreatment | 3 |
Percent Change BOLD Signal
We calculated the percent BOLD signal change while performing the N-back task between the varenicline vs. placebo session. We subtracted BOLD signal observed during the 0-back condition from the BOLD signal observed during the 3-back condition (3back minus 0-back)We controlled for relevant co-variates such as sex, nicotine dependence level and education. (NCT00602927)
Timeframe: Day 13
| Intervention | BOLD Signal Change (3-back minus 0-back) (Mean) |
|---|
| Placebo | 0.48 |
| Varenicline | 0.61 |
7-day Point Prevalence All Tobacco Abstinence
7-day point prevalence all tobacco abstinence at week 12 (end of treatment)confirmed by urine cotinine less than 50ng/ml (NCT00813917)
Timeframe: 12 weeks - end of treatment
| Intervention | participants (Number) |
|---|
| Varenicline | 21 |
| Placebo | 16 |
Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3
11-item scale designed to assess the severity of cognitive impairments in AD subjects. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, and remembering test instructions. Total score range from 0-70 with 70 indicating worse cognition. (NCT00744978)
Timeframe: Week 3
| Intervention | units on scale (Least Squares Mean) |
|---|
| Varenicline | 19.60 |
| Placebo | 19.01 |
Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 6
11-item scale designed to assess the severity of cognitive impairments in AD subjects. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, and remembering test instructions. Total score range from 0-70 with 70 indicating worse cognition. (NCT00744978)
Timeframe: Week 6
| Intervention | units on scale (Least Squares Mean) |
|---|
| Varenicline | 17.86 |
| Placebo | 18.23 |
Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 3
12-item scale to assess severity of cognitive impairment in AD. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, remembering test instructions, and concentration/distractibility. Total score range from 0-75 with 75 indicating worse cognition. (NCT00744978)
Timeframe: Week 3
| Intervention | units on scale (Least Squares Mean) |
|---|
| Varenicline | 19.87 |
| Placebo | 19.31 |
Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 6
12-item scale to assess severity of cognitive impairment in AD. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, remembering test instructions, and concentration/distractibility. Total score range from 0-75 with 75 indicating worse cognition. (NCT00744978)
Timeframe: Week 6
| Intervention | units on scale (Least Squares Mean) |
|---|
| Varenicline | 18.07 |
| Placebo | 18.49 |
Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 1
Assessment of the cognitive domain visual episodic memory (associate learning) through responses within 7 minutes to 4 targets x 4 rounds (mild AD) or 3 targets x 4 rounds (moderate AD); score range: 35 to 100. Performance variable: number of errors made in correctly placing each of the 4 patterns in their location four times. (NCT00744978)
Timeframe: Week 1
| Intervention | errors (Least Squares Mean) |
|---|
| Varenicline | 38.52 |
| Placebo | 40.05 |
Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 3
Assessment of the cognitive domain visual episodic memory (associate learning) through responses within 7 minutes to 4 targets x 4 rounds (mild AD) or 3 targets x 4 rounds (moderate AD); score range: 35 to 100. Performance variable: number of errors made in correctly placing each of the 4 patterns in their location four times. (NCT00744978)
Timeframe: Week 3
| Intervention | errors (Least Squares Mean) |
|---|
| Varenicline | 39.43 |
| Placebo | 43.57 |
Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 6
Assessment of the cognitive domain visual episodic memory (associate learning) through responses within 7 minutes to 4 targets x 4 rounds (mild AD) or 3 targets x 4 rounds (moderate AD); score range: 35 to 100. Performance variable: number of errors made in correctly placing each of the 4 patterns in their location four times. (NCT00744978)
Timeframe: Week 6
| Intervention | errors (Least Squares Mean) |
|---|
| Varenicline | 41.67 |
| Placebo | 42.98 |
Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 1
Assessment of the cognitive domain psychomotor function through yes or no responses within 5 minutes to 30 trials; score range: 0 to 3.69. Performance variable: speed of performance; average of the log10 t transformed reaction time for correct responses. Reaction times longer than 5 seconds (log10 [5000]) were excluded as reflecting responses that were abnormally slow. (NCT00744978)
Timeframe: Week 1
| Intervention | log10 millisecond (Least Squares Mean) |
|---|
| Varenicline | 2.65 |
| Placebo | 2.64 |
Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 3
Assessment of the cognitive domain psychomotor function through yes or no responses within 5 minutes to 30 trials; score range: 0 to 3.69. Performance variable: speed of performance; average of the log10 t transformed reaction time for correct responses. Reaction times longer than 5 seconds (log10 [5000]) were excluded as reflecting responses that were abnormally slow. (NCT00744978)
Timeframe: Week 3
| Intervention | log10 millisecond (Least Squares Mean) |
|---|
| Varenicline | 2.65 |
| Placebo | 2.63 |
Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 6
Assessment of the cognitive domain psychomotor function through yes or no responses within 5 minutes to 30 trials; score range: 0 to 3.69. Performance variable: speed of performance; average of the log10 t transformed reaction time for correct responses. Reaction times longer than 5 seconds (log10 [5000]) were excluded as reflecting responses that were abnormally slow. (NCT00744978)
Timeframe: Week 6
| Intervention | log10 millisecond (Least Squares Mean) |
|---|
| Varenicline | 2.64 |
| Placebo | 2.65 |
Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 1
Assessment of the cognitive domain visual attention through a yes or no response to 30 trials within 5 minutes; score range: 0 to 3.69. Performance variable: speed of performance; average log10 transformed reaction time for correct responses. Reaction times longer than 5 seconds ( log10 [5000]) were excluded as reflecting responses that were abnormally slow. (NCT00744978)
Timeframe: Week 1
| Intervention | log10 millisecond (Least Squares Mean) |
|---|
| Varenicline | 2.79 |
| Placebo | 2.80 |
Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 3
Assessment of the cognitive domain visual attention through a yes or no response to 30 trials within 5 minutes; score range: 0 to 3.69. Performance variable: speed of performance; average log10 transformed reaction time for correct responses. Reaction times longer than 5 seconds ( log10 [5000]) were excluded as reflecting responses that were abnormally slow. (NCT00744978)
Timeframe: Week 3
| Intervention | log10 millisecond (Least Squares Mean) |
|---|
| Varenicline | 2.79 |
| Placebo | 2.80 |
Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 6
Assessment of the cognitive domain visual attention through a yes or no response to 30 trials within 5 minutes; score range: 0 to 3.69. Performance variable: speed of performance; average log10 transformed reaction time for correct responses. Reaction times longer than 5 seconds ( log10 [5000]) were excluded as reflecting responses that were abnormally slow. (NCT00744978)
Timeframe: Week 6
| Intervention | log10 millisecond (Least Squares Mean) |
|---|
| Varenicline | 2.79 |
| Placebo | 2.79 |
Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 1
Assessment of the cognitive domain working memory through yes or no responses to 30 trials within 5 minutes; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses. (NCT00744978)
Timeframe: Week 1
| Intervention | arcsine proportion correct (Least Squares Mean) |
|---|
| Varenicline | 0.94 |
| Placebo | 0.94 |
Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 3
Assessment of the cognitive domain working memory through yes or no responses to 30 trials within 5 minutes; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses. (NCT00744978)
Timeframe: Week 3
| Intervention | arcsine proportion correct (Least Squares Mean) |
|---|
| Varenicline | 0.96 |
| Placebo | 0.97 |
Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 6
Assessment of the cognitive domain working memory through yes or no responses to 30 trials within 5 minutes; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses. (NCT00744978)
Timeframe: Week 6
| Intervention | arcsine proportion correct (Least Squares Mean) |
|---|
| Varenicline | 0.95 |
| Placebo | 0.96 |
Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 1
Assessment of the cognitive domain episodic memory through yes or no responses within 5 minutes to 4 targets repeated among 6 distractors on 4 rounds (mild Alzheimer's disease [AD], or 3 targets repeated among 4 distractors on 4 rounds (moderate AD) ; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses. (NCT00744978)
Timeframe: Week 1
| Intervention | arcsine proportion correct (Least Squares Mean) |
|---|
| Varenicline | 0.83 |
| Placebo | 0.81 |
Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 3
Assessment of the cognitive domain episodic memory through yes or no responses within 5 minutes to 4 targets repeated among 6 distractors on 4 rounds (mild Alzheimer's disease [AD], or 3 targets repeated among 4 distractors on 4 rounds (moderate AD) ; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses. (NCT00744978)
Timeframe: Week 3
| Intervention | arcsine proportion correct (Least Squares Mean) |
|---|
| Varenicline | 0.82 |
| Placebo | 0.82 |
Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 6
Assessment of the cognitive domain episodic memory through yes or no responses within 5 minutes to 4 targets repeated among 6 distractors on 4 rounds (mild Alzheimer's disease [AD], or 3 targets repeated among 4 distractors on 4 rounds (moderate AD) ; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses. (NCT00744978)
Timeframe: Week 6
| Intervention | arcsine proportion correct (Least Squares Mean) |
|---|
| Varenicline | 0.83 |
| Placebo | 0.84 |
Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 6
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. (NCT00744978)
Timeframe: Week 6
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Varenicline | 3.71 |
| Placebo | 3.70 |
Neuropsychiatric Inventory (NPI) Total Score at Week 3
Caregiver interview-based rating scale assessing 12 behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, appetite/eating, and sleep. Each symptom score derived by frequency of symptoms * severity of symptoms (range 0-12). Total score = sum of symptom scores; range: 0-144 with higher score indicating greater behavioral disturbances. (NCT00744978)
Timeframe: Week 3
| Intervention | scores on scale (Least Squares Mean) |
|---|
| Varenicline | 2.97 |
| Placebo | 2.29 |
Neuropsychiatric Inventory (NPI) Total Score at Week 6
Caregiver interview-based rating scale assessing 12 behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, appetite/eating, and sleep. Each symptom score derived by frequency of symptoms * severity of symptoms (range 0-12). Total score = sum of symptom scores; range: 0-144 with higher score indicating greater behavioral disturbances. (NCT00744978)
Timeframe: Week 6
| Intervention | scores on scale (Least Squares Mean) |
|---|
| Varenicline | 3.82 |
| Placebo | 2.55 |
Number of Infants Born Preterm
Preterm birth was defined as birth before the gestational age of 37 weeks. (NCT01290445)
Timeframe: At the time of birth
| Intervention | infants (Number) |
|---|
| Varenicline Exposed Cohort | 25 |
| Varenicline Unexposed Cohort | 6173 |
| Reference Cohort | 46732 |
Number of Infants Born Small for Gestational Age (SGA)
An infant was defined as SGA if birth weight was below the 10th percentile of its sex-specific national distribution at the respective gestational week. Data on birth weight and gestational age from the medical birth registries were used to calculate the 10th percentiles for each sex based on all Danish and Swedish births during the study observation period. (NCT01290445)
Timeframe: At the time of birth
| Intervention | infants (Number) |
|---|
| Varenicline Exposed Cohort | 42 |
| Varenicline Unexposed Cohort | 13433 |
| Reference Cohort | 73135 |
Number of Infants Born To Mothers Diagnosed With Premature Rupture of Membranes
(NCT01290445)
Timeframe: At the time of birth
| Intervention | infants (Number) |
|---|
| Varenicline Exposed Cohort | 12 |
| Varenicline Unexposed Cohort | 4246 |
| Reference Cohort | 30641 |
Number of Infants Diagnosed With Sudden Infant Death Syndrome (SIDS)
Sudden Infant Death Syndrome (SIDS) was defined as a sudden unexplained death of an infant less than one year of age. (NCT01290445)
Timeframe: For 12 months after birth
| Intervention | infants (Number) |
|---|
| Varenicline Exposed Cohort | 0 |
| Varenicline Unexposed Cohort | 51 |
| Reference Cohort | 58 |
Number of Infants With Stillbirths
Stillbirth was defined as death at a gestational age of greater than or equal to (>=) 22 weeks, with the exception that in Sweden prior to 2008 it was defined as death at a gestational age of >=28 weeks. (NCT01290445)
Timeframe: At the time of birth
| Intervention | infants (Number) |
|---|
| Varenicline Exposed Cohort | 1 |
| Varenicline Unexposed Cohort | 384 |
| Reference Cohort | 2418 |
Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco
"Number of subjects who reported no use of nicotine-containing products by answering No to the nicotine use inventory (NUI) question: Has the subject used any nicotine-containing products in the last 7 days (Week 9) or since last study visit (Week 10 through 12) and confirmed salivary cotinine <= 15 ng/mL." (NCT00717093)
Timeframe: Weeks 9 through 12
| Intervention | participants (Number) |
|---|
| Varenicline Tartrate | 125 |
| Placebo | 85 |
Number of Subjects With Long Term Quit Rate (LTQR) of Smokeless Tobacco
Number of subjects who were responders for the primary endpoint (4-week CQR for Weeks 9 through 12) and who had no more than 6 cumulative days of using nicotine containing products from Week 12 through Week 26. (NCT00717093)
Timeframe: Week 26
| Intervention | participants (Number) |
|---|
| Varenicline Tartrate | 102 |
| Placebo | 78 |
Number of Subjects With 7-day Point Prevalence (PP) of Abstinence at the End of Treatment (Week 12) and at the End of Study (Week 26)
Number of subjects at Week 12 and Week 26 reporting no use of nicotine-containing products in the last 7 days and confirmed salivary cotinine <= 15 ng/mL. (NCT00717093)
Timeframe: Week 12, Week 26
| Intervention | participants (Number) |
|---|
| Week 12 | Week 26 |
|---|
| Placebo | 85 | 88 |
,| Varenicline Tartrate | 123 | 102 |
Number of Subjects With Continuous Abstinence (CA) of Smokeless Tobacco Use
Number of subjects who remainded abstinent from the period defined as start of the primary endpoint (Week 9) through the end of follow up (Week 26) by reporting no use of nicotine-containing products and confirmed salivary cotinine <= 15 ng/mL. (NCT00717093)
Timeframe: Week 9 through 12, Week 26
| Intervention | participants (Number) |
|---|
| Week 9 | Week 10 | Week 11 | Week 12 | Week 26 |
|---|
| Placebo | 101 | 96 | 93 | 85 | 73 |
,| Varenicline Tartrate | 140 | 135 | 132 | 125 | 95 |
7-Day Point Prevalence Smoking Abstinence
7-day point prevalence abstinence at week 12, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm (NCT00794573)
Timeframe: 12 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 86 |
| Placebo | 55 |
7-Day Point Prevalence Smoking Abstinence
7-day point prevalence abstinence at week 24, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm (NCT00794573)
Timeframe: 24 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 70 |
| Placebo | 49 |
7-Day Point Prevalence Smoking Abstinence
7-day point prevalence abstinence at week 4, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm (NCT00794573)
Timeframe: 4 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 90 |
| Placebo | 57 |
7-Day Point Prevalence Smoking Abstinence
7-day point prevalence abstinence at week 52, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm (NCT00794573)
Timeframe: 52 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 59 |
| Placebo | 44 |
Continuous Smoking Abstinence
Continuous abstinence, defined as self-reported abstinence since baseline and exhaled carbon monoxide ≤10 ppm at all follow-up visits up to and including week 12. (NCT00794573)
Timeframe: 12 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 66 |
| Placebo | 45 |
Continuous Smoking Abstinence
Continuous abstinence, defined as self-reported abstinence since baseline and exhaled carbon monoxide ≤10 ppm at all follow-up visits up to and including week 24. (NCT00794573)
Timeframe: 24 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 53 |
| Placebo | 39 |
Continuous Smoking Abstinence
Continuous abstinence, defined as self-reported abstinence since baseline and exhaled carbon monoxide ≤10 ppm at all follow-up visits up to and including week 4. (NCT00794573)
Timeframe: 4 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 78 |
| Placebo | 49 |
Continuous Smoking Abstinence
Continuous abstinence, defined as self-reported abstinence since baseline and exhaled carbon monoxide ≤10 ppm at all follow-up visits up to and including week 52. (NCT00794573)
Timeframe: 52 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 46 |
| Placebo | 32 |
Reduction in Daily Cigarette Consumption by 50% or Greater
(NCT00794573)
Timeframe: 12 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 115 |
| Placebo | 93 |
Reduction in Daily Cigarette Consumption by 50% or Greater
(NCT00794573)
Timeframe: 24 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 99 |
| Placebo | 84 |
Reduction in Daily Cigarette Consumption by 50% or Greater
(NCT00794573)
Timeframe: 4 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 130 |
| Placebo | 113 |
Reduction in Daily Cigarette Consumption by 50% or Greater
(NCT00794573)
Timeframe: 52 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 85 |
| Placebo | 75 |
Point Prevalence Abstinence at 12 Months
Biochemically confirmed abstinence defined as no smoking, not even a puff, in the last 7 days (NCT00935818)
Timeframe: 12 months
| Intervention | participants (Number) |
|---|
| Varenicline and Buproprion SR | 91 |
| Varenicline and Placebo | 75 |
Point Prevalence Abstinence at 3 Months.
biochemically confirmed 7-day point prevalence abstinence defined as no smoking, not even a puff, in the previous 7 days. (NCT00935818)
Timeframe: 3 months
| Intervention | participants (Number) |
|---|
| Varenicline and Buproprion SR | 140 |
| Varenicline and Placebo | 125 |
Point Prevalence Abstinence at 6 Months.
Biochemically confirmed abstinence as no smoking, even a puff, for the prior 7 days. (NCT00935818)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| Varenicline and Buproprion SR | 95 |
| Varenicline and Placebo | 82 |
Prolonged Abstinence at 12 Months
(NCT00935818)
Timeframe: 12 months
| Intervention | participants (Number) |
|---|
| Varenicline and Buproprion SR | 77 |
| Varenicline and Placebo | 63 |
Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers.
"Prolonged smoking abstinence is defined as no smoking, not even a puff, in the last 7 days, and a negative response to the question Since 2 weeks after your target quit date, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?" (NCT00935818)
Timeframe: 3 months
| Intervention | participants (Number) |
|---|
| Varenicline and Buproprion SR | 132 |
| Varenicline and Placebo | 111 |
Prolonged Smoking Abstinence Rates at 26 Weeks in Cigarettes Smokers.
(NCT00935818)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| Varenicline and Buproprion SR | 91 |
| Varenicline and Placebo | 71 |
Weight Gain From Baseline to 3 Months
Weight change from baseline to three months in those who met criteria for prolonged abstinence at the 3 month visit (NCT00935818)
Timeframe: 3 months
| Intervention | kilograms (Mean) |
|---|
| Varenicline and Buproprion SR | 1.1 |
| Varenicline and Placebo | 2.5 |
Number of Participants With 7-day Point Prevalence Abstinence at 36 Weeks
7-day point-prevalence abstinence based onno self-reported tobacco use (not even a puff) during the 7 days preceding the assessment and a CO ≤10ppm as measured by Covita micro smokrlyzer at week 36. (NCT02460900)
Timeframe: 36 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline and Standard of Care | 5 |
| Placebo and Standard of Care | 4 |
| Positively Smoke Free and Placebo | 1 |
| Positively Smoke Free and Varenicline | 5 |
Abstinence (7 Days) at 6 Months.
(NCT00894166)
Timeframe: point abstinence (7 days) at 6 months post-quit date
| Intervention | percentage of subjects (Number) |
|---|
| NRT Responder | 21.7 |
| Pre-Quit Randomization to Bupropion + NRT | 17.2 |
| Pre-Quit Randomization to Varenicline | 16.5 |
| Pre-Quit Randomization to NRT | 6.6 |
| Post-Quit Randomization to Bupropion + NRT | 10.0 |
| Post-Quit Randomized to Varenicline | 20.0 |
| Post-Quit Randomized to NRT | 13.3 |
Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment)
A self report of no cigarettes smoked confirmed by expired air carbon monoxide of <=10ppm was the criterion for abstinence. (NCT00894166)
Timeframe: weeks 8-11 after quit date
| Intervention | percentage of subjects abstinent (Number) |
|---|
| NRT Responder | 59.2 |
| Pre-Quit Randomization to Bupropion + NRT | 28.3 |
| Pre-Quit Randomization to Varenicline | 23.3 |
| Pre-Quit Randomization to NRT | 16.0 |
| Post-Quit Randomization to Bupropion + NRT | 26.7 |
| Post-Quit Randomized to Varenicline | 37.1 |
| Post-Quit Randomized to NRT | 26.7 |
Continuous Abstinence From Smoking at 6 Months Post Quit.
(NCT00894166)
Timeframe: continuous abstinence at 6 months post quit day
| Intervention | percentage of subjects (Number) |
|---|
| NRT Responder | 20.0 |
| Pre-Quit Randomization to Bupropion + NRT | 13.1 |
| Pre-Quit Randomization to Varenicline | 5.8 |
| Pre-Quit Randomization to NRT | 5.8 |
| Post-Quit Randomization to Bupropion + NRT | 10.0 |
| Post-Quit Randomized to Varenicline | 14.3 |
| Post-Quit Randomized to NRT | 10.0 |
Cotinine Levels
Subject Cotinine Levels before each laboratory session. (NCT00606892)
Timeframe: Before each laboratory session on day 5
| Intervention | ng/mL (Mean) |
|---|
| Placebo | 202 |
| Varenicline (1 mg) | 185 |
Heart Rate
The average peak change (change score = maximum post dose score minus predose baseline) in heart rate was calculated. (NCT00606892)
Timeframe: 30 minutes after each nicotine infusion
| Intervention | beats per minute (Mean) |
|---|
| Placebo / Low Dose Nicotine | 7 |
| Placebo/ Medium Dose Nicotine | 13 |
| Placebo/High Dose Nicotine | 16 |
| Varenicline/ Low Dose Nicotine | 2 |
| Varenicline/ Medium Dose Nicotine | 5 |
| Varenicline / High Dose Nicotine | 5 |
Changes in Systolic and Diastolic Blood Pressure
The average peak change (change score = maximum post dose score minus predose baseline) in systolic and diastolic blood pressure after nicotine infusion. (NCT00606892)
Timeframe: 30 minutes after each nicotine infusion
| Intervention | mm Hg (Mean) |
|---|
| Systolic Blood Pressure | Diastolic Blood Pressure |
|---|
| Placebo / Low Dose Nicotine | 12 | 7 |
,| Placebo/ Medium Dose Nicotine | 16 | 6 |
,| Placebo/High Dose Nicotine | 8 | 5 |
,| Varenicline / High Dose Nicotine | 16 | 7 |
,| Varenicline/ Low Dose Nicotine | 7 | 5 |
,| Varenicline/ Medium Dose Nicotine | 13 | 6 |
Mean Reaction Time (RT) on Modified Stroop Task.
A Modified stroop task was used to assess attentional responses to smoking and negative affect cues. Cues were presented as blue, red or green text. Subjects completed 2 counterbalanced blocks (60 trials per block). One block contained smoking cues and neutral cues. The other block contained negative affect cues and a different set of matched neutral cues. The 2 blocks were administered twice during each experimental session - prior to nicotine infusion, and 30 mins after the last nicotine infusion (2 hrs and 45 mins after medication dosing). The Stroop effect is a differential RT when identifying the colors of words presented as neutral cues vs. emotional cues (i.e. smoking or negative affect cues). (NCT00606892)
Timeframe: pre-nicotine, and 30 min after last nicotine infusion (Post-Nicotine)
| Intervention | milliseconds (Mean) |
|---|
| Smoking Block | Neutral Block- Smoking Cue | Negative Affect block | Neutral Block- Negative Affect Cue |
|---|
| Placebo, Post-Nicotine | 693.1 | 686.7 | 641.3 | 661.5 |
,| Placebo, Pre-Nicotine | 722.3 | 702.3 | 679.0 | 692.5 |
,| Varenicline, Post-Nicotine | 624.2 | 618.6 | 631.7 | 618.6 |
,| Varenicline, Pre-Nicotine | 660.1 | 652.1 | 665.8 | 644.8 |
Subjective Responses to Intravenous Nicotine
"The Drug Effects Questionaire( DEQ) is a 7-item psychometric that measures the following subjective categories: 'drug strength',' high', 'feels stimulated', 'good effects', 'bad effects', 'head rush', and 'like the drug'. Smokers rated each item on a 100 millimeter scale from not at all (a score of 0) to extremely with a maximum score of 100." (NCT00606892)
Timeframe: 30 minutes after each nicotine infusion
| Intervention | millimeters (Mean) |
|---|
| High | Head Rush | Feels Stimulated | Drug Strength | Bad Effects | Good Effects | Like the Drug |
|---|
| Placebo/ Low Dose Nictoine | 23 | 24 | 25 | 24 | 7 | 19 | 18 |
,| Placebo/ Medium Dose Nicotine | 38 | 40 | 34 | 41 | 15 | 30 | 27 |
,| Placebo/High Dose Nicotine | 51 | 51 | 38 | 58 | 23 | 45 | 35 |
,| Varenicline/ High Dose Nicotine | 37 | 37 | 35 | 40 | 20 | 34 | 35 |
,| Varenicline/ Low Dose Nicotine | 14 | 11 | 11 | 16 | 8 | 22 | 14 |
,| Varenicline/ Medium Dose Nicotine | 27 | 28 | 24 | 32 | 8 | 25 | 25 |
Safety and Tolerability of Extended Duration Pharmacotherapy When Added to Antipsychotic Medications in Schizophrenia Patients Who Have Recently Quit Smoking as Assessed by the Brief Psychiatric Rating Scale
Brief Psychiatric Rating Scale is a 24 item scale that is designed to assess positive and negative symptoms, and general psychopathology in people with serious mental illness. Each item is rated on a 7-point scale from not present to extremely severe; higher scores in a range of 24 to 168, indicate more severe symptoms Ratings are based on observation and patient report. The validity of the BPRS is generally high when compared with other measures of general psychopathology. It was administered at baseline, study weeks 12, 18, 26, 38, 52 (NCT00621777)
Timeframe: at week 52
| Intervention | units on a scale (Mean) |
|---|
| Varenicline | 50.43 |
| Placebo | 47.88 |
Rate of 7-day Point Prevalence Abstinence at the End of the Relapse Prevention Phase (Study Week 53) in the Extended Duration Pharmacotherapy Group vs. the Placebo Group
(NCT00621777)
Timeframe: 76 weeks
| Intervention | participants (Number) |
|---|
| 7-day, point-prevalence abstinence at week 52 | Continuous abstinence, weeks 12-64 | Continuous abstinence, weeks 12-76 |
|---|
| Placebo | 9 | 7 | 5 |
,| Varenicline | 24 | 18 | 12 |
7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment.
(NCT01098305)
Timeframe: At the end of treatment (12 weeks)
| Intervention | participants (Number) |
|---|
| Varenicline | 30 |
| Placebo | 23 |
Nicotine Withdrawal and Craving, Negative Affect, Positive Affect, and Side Effects.
Side Effects (NCT01098305)
Timeframe: Ongoing throughout the treatment period (Baseline to the end of treatment, 12 weeks)
| Intervention | participants (Number) |
|---|
| sleep problems | gastrointestinal problems |
|---|
| Placebo | 11 | 9 |
,| Varenicline | 8 | 8 |
Average Weekly Number of Cigarettes Smoked at Last Observed Study Visit
The average number of cigarettes smoked per day over the last 7 days was collected as a part of nicotine use inventory assessment through consent record form module which included a questionnaire: Did the participant smoke any cigarettes (even a puff) in last 7 days (Yes/No) and Did the participant use any other tobacco products (example- pipe, cigars, chew, snuff) in last 7 days (Yes/No). (NCT00808015)
Timeframe: Last observed study visit (Week 12 or ET)
| Intervention | cigarettes (Median) |
|---|
| Varenicline | 10.0 |
CO Level at Last Observed Study Visit
The CO level was measured from exhaled air of the participant using CO analyzer at the last observed study visit which was the last available CO level recorded after baseline. The CO level was only measured if it was a part of the usual practice at the site. (NCT00808015)
Timeframe: Last observed study visit (Week 12 or ET)
| Intervention | ppm (Mean) |
|---|
| Varenicline | 4.1 |
Percentage of Participants With Smoking Abstinence at Week 12
Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4. (NCT00808015)
Timeframe: Week 12
| Intervention | percentage of participants (Number) |
|---|
| Varenicline | 46.40 |
Percentage of Participants With Smoking Abstinence Before Last Observed Study Visit
Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4. (NCT00808015)
Timeframe: Last observed study visit (Week 12 or early termination [ET])
| Intervention | percentage of participants (Number) |
|---|
| Varenicline | 50.30 |
Average Daily Dose of Varenicline
(NCT00808015)
Timeframe: Days 1-3, Days 4-7, Day 8 through last observed study visit (Week 12 or ET)
| Intervention | mg (Median) |
|---|
| Days 1-3 | Days 4-7 (n=1347) | Day 8 - Last observed study visit (n=1284) |
|---|
| Varenicline | 0.5 | 1.0 | 2.0 |
Concomitant Drug Treatments
(NCT00808015)
Timeframe: Baseline through Last observed study visit (Week 12 or ET)
| Intervention | Participants (Number) |
|---|
| Acamprosate | Acarbose | Aceclofenac | Acetylcarnitine | Acetylcysteine | Acetylsalicylic acid | Acetylsalicylic acid/atorvastatin/ramipril | Acetylsalicylic acid/clopidogrel | Adenine/biphenyldimethyldicarboxylate/vitamins | Albumin human | Alfuzosin | All other therapeutic products | Allopurinol | Almagate | Almagel | Alprazolam | Aluminum hydroxide/magnesium carbonate | Amantadine hydrochloride / paracetamol | Ambroxol | Ambroxol acefyllinate | Ambroxol hydrochloride | Amikacin | Amino acids | Amino acids NOS/carbohydrates NOS/electrolytes NOS | Aminophylline | Amisulpride | Amitriptyline hydrochloride | Amlodipine | Amlodipine besilate | Amlodipine besilate/atorvastatin calcium | Amlodipine besilate/valsartan | Amlodipine camsilate | Amlodipine maleate | Amlodipine orotate | Amlodipine/valsartan | Ammonium Cl/chlorpheniramine maleate | Amoxicillin | Amoxicillin sodium | Anisodamine | Antacids | Antidiarrhoeal microorganisms | Antisterone | Aripiprazole | Aronamin gold | Arotinolol hydrochloride | Artemisia asiatica | Artemisia asiatica/ethanol | Asasantin | Asmeton | Atenolol | Atorvastatin | Atorvastatin calcium | Atorvastatin/fenofibrate | Azathioprine | Azelastine | Azelastine hydrochloride | Azithromycin | Aztreonam | "B-komplex leciva" | Bambuterol hydrochloride | Becosules syrup | Becosym forte | Becotal | Benazepril | Benazepril hydrochloride | Benexate hydrochloride | Benproperine | Benproperine phosphate | Benzodiazepine derivatives | Bepotastine besilate | Beraprost | Beraprost sodium | Berberine | Beszyme | Betahistine | Bevantolol | Biselect | Bismuth subcitrate tripotassium | Bismuth subcitrate tripotassium/ranitidine HCl | Bisoprolol | Bisoprolol fumarate | Borneol/notoginseng/salvia miltiorrhiza | Bromelains/dehydrocholic/pancreatin/simeticone | Bromhexine | Broncho-vaxom | Budesonide | Bufferin | Bupropion | Bupropion hydrochloride | Buspiron | Buspirone | Calcitriol / calcium citrate | Calcium citrate/colecalciferol | Calcium lactate | Candesartan | Candesartan cilexetil | Carbazochrome | Cardiovascular system drugs | Carvedilol | Cefaclor | Cefalexin | Cefcapene pivoxil hydrochloride | Cefixime | Cefoperazone sodium | Cefpodoxime | Cefpodoxime proxetil | Cefradine | Ceftriaxone | Ceftriaxone sodium | Cefuroxime | Cefuroxime axetil | Cefuroxime sodium | Celecoxib | Cephalosporins and related substances | Cetirizine | Chlordiazepoxide/clidinium bromide/dicycloverine | Chlormadinone acetate | Chlorphenamine maleate | Chlorphenesin carbamate | Choline alfoscerate | Chondroitin/glucosamine | Cilazapril | Cilnidipine | Cilostazol | Cimetidine | Cimetropium bromide | Cinnarizine | Ciprofloxacin | Ciprofloxacin hydrochloride | Citalopram | Citicoline | Clarithromycin | Clavulin | Clobazam | Clonazepam | Clopidogrel | Clopidogrel sulfate | Co-diovan | Colchicine | Cordalin/old form/ | Cotylenol | Cough syrup | Cyproterone acetate | Desmopressin | Desonide | Dexamethasone | Dexamethasone/neomycin sulfate/polymyxin B sulfate | Diazepam | Diclofenac | Digoxin | Dihydrocodeine bitartrate | Diloxanide furoate/metronidazole | Diltiazem | Diltiazem hydrochloride | Dimenhydrinate | Disulfiram | Docetaxel | Domperidone | Domperidone maleate | Domperidone/pantoprazole | Domperidone/rabeprazole | Domperidone/rabeprazole sodium | Donepezil | Doxazosin | Doxazosin mesilate | Doxofylline | Drotaverine | Drug, unspecified | Duloxetine | Duloxetine hydrochloride | Ebastine | Ecabet monosodium | Efavirenz/emtricitabine/tenofovir | Efonidipine | Enalapril | Enalapril maleate | Epoprostenol | Eprosartan | Eprosartan mesilate | Eprosartan mesilate/hydrochlorothiazide | Erdosteine | Ergenyl chrono | Erlotinib hydrochloride | Erythromycin ethylsuccinate | Escitalopram | Esomeprazole | Esomeprazole magnesium | Estazolam | Etizolam | Etoposide | Etoricoxib | Ezetimibe | Ezetimibe/simvastatin | Famotidine | Felodipine | Fenofibrate | Ferric hydroxide polymaltose complex | Ferrous sulfate | Fexofenadine | Fexofenadine hydrochloride | Fish oil | Flunarizine | Fluoxetine | Fluoxetine hydrochloride | Fluticasone propionate | Fluvastatin | Folic acid | Folic acid/mecobalamin/pyridoxine hydrochloride | Foraseq | Formoterol | Formoterol fumarate | Fosinopril | Fosinopril sodium | Furosemide | Gabapentin | Galenic /fluticasone/salmeterol | Galenic /salbutamol/guaifenesin | General nutrients/minerals/vitamins | Ginkgo biloba | Ginkgo biloba extract | Glibenclamide | Gliclazide | Glimepiride | Glimepiride/metformin | Glimepiride/metformin hydrochloride | Glipizide | Gliquidone | Glucose | Glyceryl trinitrate | Guaifenesin | Hedera helix | Heparin-fraction | Hepatitis B vaccine | Herbal preparation | Homeopatic preparation | Hyaluronate sodium | Hydrochlorothiazide | Hydrotalcite | Hydroxychloroquine | Hydroxyzine | Hydroxyzine hydrochloride | Hyoscine butylbromide | Hyzaar | I.v. solutions | Ibuprofen | Indapamide | Indometacin | Infliximab | Inosine | Insulin | Insulin aspart | Insulin glargine | Insulin glulisine | Insulin human | Insulin human injection, isophane | Ipratropium | Ipratropium bromide | Irbesartan | Isoconazole nitrate | Isosorbide dinitrate | Isosorbide mononitrate | Isotretinoin | Ispaghula | Ispaghula husk | Itavastatin | Itopride | Itopride hydrochloride | Itraconazole | Karvea hct | Kombipak II | Lacidipine | Lactitol | Lactulose | Lamivudine | Lansoprazole | Lekovit Ca | Lenograstim | Lercanidipine | Lercanidipine hydrochloride | Levamlodipine besylate | Levocarnitine | Levocetirizine | Levocetirizine dihydrochloride | Levocetirizine dihydrochloride/montelukast sodium | Levocloperastine fendizoate | Levodropropizine | Levofloxacin | Levofloxacin hydrochloride | Levosalbutamol hydrochloride | Levosulpiride | Levothyroxine sodium | Lipase | Lisinopril | Lithium carbonate | Loperamide | Loratadine | Lorazepam | Losartan | Losartan potassium | Magnesium hydroxide | Magnesium oxide | Mecobalamin | Medilac-S | Mefloquine | Megestrol acetate | Meprobamate | Meropenem | Mesalazine | Metformin | Metformin hydrochloride | Metformin hydrochloride/rosiglitazone | Metformin hydrochloride/sitagliptin | Methoxyphenamine | Methylprednisolone | Metoclopramide | Metoclopramide hydrochloride | Metoprolol | Metoprolol succinate | Metoprolol tartrate | Metronidazole | Milnacipran | Milnacipran hydrochloride | Mirtazapine | Mobizox | Molsidomine | Mometasone | Mometasone furoate | Montelukast | Montelukast sodium | Mosapride | Mosapride citrate | Moxifloxacin | Moxifloxacin hydrochloride | Mucaine | Multivitamins with minerals | Multivitamins, plain | "Myprodol rio ethicals" | Myrin plus | Myrtol | Naltrexone | Naproxen | Nateglinide | Nebivolol | Nicorandil | Nicotine | Nicotinic acid | Nifedipine | Nimesulide/paracetamol | Nimodipine | Nisoldipine | Nitrendipine | Nizatidine | Ofloxacin | Olanzapine | Olmesartan | Olmesartan medoxomil | Omega-3 marine triglycerides | Omega-3 triglycerides | Omeprazole | Ondansetron | Ondansetron hydrochloride | Orlistat | Oxazepam | Oxcarbazepine | Oxycodone | Oxycodone hydrochloride | Palonosetron hydrochloride | Pantoprazole | Pantoprazole sodium | Paracetamol | Paroxetine | Paroxetine hydrochloride | Pentamycin | Perindopril | Phenylephrine/triprolidine | Phenytoin sodium | Phosphatidyl choline | Phytomenadione | Pinaverium bromide | Pioglitazone | Pioglitazone hydrochloride | Platelets, human blood | Pneumococcal vaccine | Polycarbophil calcium | Pramipexole | Pranlukast hydrate | Pravastatin | Pravastatin sodium | Prednicarbate | Prednisolone | Pregabalin | Procaterol | Promethazine | Pronase | Propranolol | Propranolol hydrochloride | Propylthiouracil | Pseudoephedrine hydrochloride | Pyridostigmine bromide | Pyridoxine hydrochloride | Quetiapine fumarate | Rabeprazole | Rabeprazole sodium | Raloxifene | Ramipril | Ranitidine | Ranitidine hydrochloride | Rebamipide | Repaglinide | Rino ebastel | Riopan plus | Risedronic acid | Risperidone | Rosiglitazone maleate | Rosuvastatin | Rosuvastatin calcium | Roxithromycin | Salbutamol | Salbutamol sulfate | Salmeterol | Salmeterol xinafoate | Salvia miltiorrhiza | Sarpogrelate | Sarpogrelate hydrochloride | Selective beta-2-adrenoreceptor agonists | Selegiline hydrochloride | "Seretide allen & hanburys ltd" | Seretide mite | Sertraline | Sibutramine | Sibutramine hydrochloride | Sildenafil citrate | Silymarin | Simeco | Simvastatin | Sinemet | Sirolin retard | Sitagliptin | Sodium chloride | Sotalol hydrochloride | Spedifen | Spirapril hydrochloride | Spironolactone | Spironolactone / torasemide | Streptomycin | Sucralfate | Sulglicotide | Sulodexide | "Symbicort turbuhaler draco" | Tadalafil | Tamsulosin | Tamsulosin hydrochloride | Tazobactam sodium | Telmisartan | Terazosin | Terazosin hydrochloride | Terbinafine hydrochloride | Terbutaline | Terbutaline sulfate | Testosterone undecanoate | Theophylline | Thiamazole | Thioctic acid | Throat preparations | Tianeptine | Ticlopidine | Tiotropium | Tiotropium bromide | Tiotropium bromide/formoterol fumarate | Tiropramide hydrochloride | Tocopherol | Tolterodine | Tramadol | Tramadol hydrochloride | Tranexamic acid | Trazodone | Triaprin | Triazolam | Triflusal | Trihexyphenidyl | Trimebutine | Trimebutine maleate | Trimetazidine | Trimetazidine hydrochloride | Tromcardin | Udenafil | Ultracet | Ursodeoxycholic acid | Valproate semisodium | Valsartan | Varidase | Verapamil | Vildagliptin | Vitamin B | Vitamins | Vitamins with minerals | Vitamins, other combinations | Voglibose | Warfarin | Yeast | Zevit | Zinc | Zoledronic acid | Zolpidem | Zolpidem tartrate |
|---|
| Varenicline | 5 | 17 | 1 | 2 | 14 | 110 | 1 | 1 | 1 | 1 | 1 | 11 | 2 | 8 | 1 | 8 | 1 | 1 | 3 | 3 | 4 | 1 | 2 | 1 | 1 | 2 | 2 | 18 | 21 | 3 | 2 | 2 | 2 | 2 | 3 | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 8 | 4 | 54 | 7 | 2 | 2 | 2 | 5 | 6 | 1 | 1 | 1 | 2 | 1 | 1 | 1 | 2 | 1 | 1 | 3 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 6 | 13 | 1 | 1 | 3 | 2 | 4 | 1 | 3 | 1 | 1 | 1 | 1 | 1 | 1 | 7 | 2 | 1 | 1 | 7 | 3 | 1 | 2 | 5 | 1 | 3 | 1 | 1 | 1 | 2 | 1 | 1 | 3 | 1 | 2 | 1 | 4 | 1 | 2 | 1 | 7 | 1 | 2 | 7 | 5 | 3 | 1 | 1 | 2 | 1 | 1 | 1 | 4 | 2 | 1 | 7 | 21 | 16 | 2 | 3 | 1 | 1 | 1 | 1 | 1 | 1 | 3 | 1 | 4 | 1 | 3 | 3 | 1 | 6 | 1 | 1 | 1 | 1 | 7 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 21 | 1 | 5 | 1 | 1 | 2 | 3 | 1 | 1 | 3 | 1 | 1 | 2 | 1 | 2 | 14 | 3 | 1 | 1 | 3 | 2 | 2 | 1 | 2 | 1 | 1 | 1 | 4 | 2 | 7 | 11 | 1 | 1 | 3 | 1 | 1 | 1 | 4 | 1 | 1 | 1 | 4 | 2 | 1 | 3 | 1 | 3 | 2 | 3 | 2 | 2 | 1 | 1 | 1 | 1 | 1 | 12 | 13 | 2 | 2 | 3 | 1 | 2 | 4 | 1 | 6 | 1 | 1 | 13 | 9 | 2 | 8 | 3 | 1 | 1 | 1 | 2 | 2 | 2 | 2 | 2 | 1 | 1 | 1 | 10 | 1 | 2 | 1 | 3 | 2 | 1 | 4 | 14 | 1 | 3 | 11 | 1 | 1 | 1 | 8 | 1 | 1 | 3 | 3 | 1 | 1 | 1 | 3 | 3 | 3 | 2 | 1 | 1 | 1 | 2 | 3 | 1 | 1 | 1 | 2 | 3 | 14 | 2 | 1 | 6 | 4 | 1 | 2 | 1 | 1 | 2 | 3 | 9 | 10 | 3 | 2 | 4 | 3 | 1 | 1 | 1 | 1 | 2 | 32 | 16 | 1 | 1 | 1 | 6 | 2 | 2 | 13 | 3 | 6 | 1 | 1 | 1 | 4 | 1 | 2 | 1 | 1 | 3 | 4 | 3 | 7 | 1 | 3 | 1 | 3 | 2 | 2 | 1 | 3 | 3 | 1 | 4 | 1 | 5 | 3 | 2 | 16 | 1 | 2 | 1 | 1 | 2 | 2 | 2 | 6 | 1 | 2 | 3 | 9 | 2 | 1 | 4 | 2 | 1 | 1 | 1 | 1 | 7 | 10 | 9 | 3 | 3 | 1 | 8 | 1 | 1 | 1 | 1 | 1 | 4 | 4 | 1 | 1 | 2 | 2 | 1 | 8 | 5 | 1 | 5 | 3 | 1 | 1 | 2 | 2 | 2 | 1 | 2 | 1 | 3 | 2 | 9 | 2 | 1 | 7 | 4 | 3 | 12 | 3 | 1 | 1 | 1 | 3 | 2 | 24 | 1 | 2 | 9 | 1 | 2 | 6 | 1 | 1 | 2 | 1 | 1 | 2 | 17 | 2 | 3 | 1 | 2 | 2 | 1 | 21 | 1 | 2 | 6 | 1 | 1 | 1 | 1 | 2 | 1 | 1 | 1 | 3 | 1 | 11 | 1 | 5 | 3 | 1 | 17 | 1 | 1 | 1 | 3 | 1 | 1 | 18 | 2 | 1 | 1 | 4 | 1 | 10 | 3 | 1 | 3 | 1 | 1 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 4 | 2 | 1 | 2 | 3 | 8 | 1 | 10 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 3 | 7 | 1 | 2 | 1 | 2 | 10 | 6 |
Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11
Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4. (NCT00808015)
Timeframe: Week 3 through Week 11
| Intervention | percentage of participants (Number) |
|---|
| Week 3 (n= 677) | Week 4 (n= 799) | Week 5 (n= 988) | Week 6 (n= 959) | Week 7 (n= 888) | Week 8 (n= 812) | Week 9 (n= 765) | Week 10 (n= 702) | Week 11 (n= 605) |
|---|
| Varenicline | 31.3 | 38.2 | 45.4 | 47.8 | 49.5 | 51.6 | 55.2 | 55.4 | 59.2 |
Varenicline Prescription Status
Prescribed status was assessed using the following question in consent record form: Would a maintenance period of the drug be prescribed to the participant after this study ends (Yes/No). Missing values were recorded as 'unknown'. (NCT00808015)
Timeframe: After last observed study visit (Week 12 or ET)
| Intervention | participants (Number) |
|---|
| Prescription status = Yes | Prescription status = No | Prescription status = Unknown |
|---|
| Varenicline | 145 | 962 | 266 |
AUC0-inf
AUC0-inf taken at predose (time 0), 0.083, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose. (NCT04072146)
Timeframe: Blood samples were taken predose (time 0), 0.083, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose.
| Intervention | h*ng/mL (Mean) |
|---|
| OC-01 (Varenicline) Nasal Spray 0.12 mg | 8.3 |
| Varenicline Oral Tablet 1 mg | 102.83 |
AUC0-t
Area under the curve from predose (time 0), 0.083, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose. (NCT04072146)
Timeframe: Blood samples were taken predose (time 0), 0.083, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose.
| Intervention | h*ng/ml (Mean) |
|---|
| Varenicline Oral Tablet 1 mg | 4.49 |
| OC-01 (Varenicline) Nasal Spray 0.12 mg | 98.74 |
Cmax
Cmax taken at predose (time 0), 0.083, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose. (NCT04072146)
Timeframe: Blood samples were taken predose (time 0), 0.083, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose.
| Intervention | ng/ml (Mean) |
|---|
| OC-01 (Varenicline) Nasal Spray 0.12 mg | 0.34 |
| Varenicline Oral Tablet 1 mg | 4.63 |
Creatine Shift From Normal at Baseline to Abnormal After 2 Hours Post-treatment
Creatine shift from baseline to 2 hours post treatment. Elevated creatinine may indicate impaired kidney function. (NCT04072146)
Timeframe: Baseline to 2 hours post treatment
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline Oral Tablet 1mg, Then OC-01 (Varenicline Solution) Nasal Spray 0.12 mg | 3 |
| OC-01 (Varenicline Solution) Nasal Spray 0.12 mg, Then Varenicline Oral Tablet 1 mg | 3 |
Tmax
Tmax taken at predose (time 0), 0.083, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose. (NCT04072146)
Timeframe: Blood samples were taken predose (time 0), 0.083, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose.
| Intervention | h (Median) |
|---|
| OC-01 (Varenicline) Nasal Spray 0.12 mg | 2.0 |
| Varenicline Oral Tablet 1 mg | 3 |
Number of Participants for Whom a Maintenance Period of Varenicline Was Prescribed at the End of Week 12
A maintenance period was an additional period of varenicline treatment that could be prescribed at Week 12 by the attending primary care physician in routine clinical practice (NCT00669240)
Timeframe: Week 12
| Intervention | participants (Number) |
|---|
| Varenicline | 60 |
Number of Treatment Responders at Week 12
"Responders are participants who answered no to both of the following 2 questions on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?" (NCT00669240)
Timeframe: Week 12
| Intervention | participants (Number) |
|---|
| Varenicline | 356 |
Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium
Self-administered rating of intensity of nicotine withdrawal symptoms over past 24 hours; consists of 9 questions (urge to smoke, depressed mood, irritability, anxiety, difficulty concentrating, restlessness, increased appetite, difficulty going to sleep, difficulty staying asleep), each rated 0-4 (0=not at all, 1=slight, 2=moderate, 3=quite a bit, 4=extreme). Subscales: Negative affect domain (average of items 2-5); Insomnia domain (average of items 8 and 9); Urge to smoke (item 1); Restlessness (item 6); Increased appetite (item 7). Range 0-4 (higher score=greater intensity of symptoms) (NCT00669240)
Timeframe: Week 7 and Week 13 or 14 (Week 13/14)
| Intervention | scores on a scale (Mean) |
|---|
| Week 7: Negative affect domain (n=137) | Week 13/14: Negative affect domain (n=137) | Week 7: Insomnia domain (n=137) | Week 13/14: Insomnia domain (n=137) | Week 7: Urge to smoke (n=137) | Week 13/14: Urge to smoke (n=137) | Week 7: Restlessness (n=137) | Week 13/14: Restlessness (n=137) | Week 7: Increased appetite (n=134) | Week 13/14: Increased appetite (n=134) |
|---|
| Varenicline | 0.7 | 0.6 | 0.8 | 0.5 | 1.1 | 0.8 | 0.8 | 0.6 | 1.1 | 0.9 |
Number of Participants in Belgium Whose Smoking Status Was Known at the End of 12 Weeks and 24 Weeks
"Number of participants in Belgium who were determined to be a responder or a non-responder at the specified time point. (Responders are participants who answered no to both of the following 2 questions, and non-responders are participants who answered yes to at least 1 of the following 2 questions, on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?)" (NCT00669240)
Timeframe: Week 12 and Week 24
| Intervention | participants (Number) |
|---|
| Week 12 Responders | Week 12 Non-responders | Week 24 Responders | Week 24 Non-responders |
|---|
| Varenicline | 138 | 41 | 103 | 34 |
Number of Participants Who Received Varenicline, by Duration of Treatment in Days
(NCT00669240)
Timeframe: Baseline through Week 12 or Week 24
| Intervention | participants (Number) |
|---|
| <=1 day | 2-7 days | 8-14 days | 15-28 days | 29-60 days | 61-90 days | >=91 days |
|---|
| Varenicline | 3 | 8 | 19 | 48 | 85 | 280 | 108 |
Number of Participants Who Registered With LifeREWARDS On-line Behavioral Support Program
"Number of participants who answered 'yes' to the question Did you register with LifeREWARDS? (LifeREWARDS not available in Greece.)" (NCT00669240)
Timeframe: Week 12
| Intervention | participants (Number) |
|---|
| Belgium (n=194) | Greece (n=98) | Hungary (n=107) | Slovenia (n=15) |
|---|
| Varenicline | 65 | 0 | 3 | 2 |
Number of Participants Whose Smoking Status Was Known at the End of 12 Weeks
"Number of participants who were determined to be a responder or a non-responder at the specified time point. (Responders are participants who answered no to both of the following 2 questions, and non-responders are participants who answered yes to at least 1 of the following 2 questions, on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?)" (NCT00669240)
Timeframe: Week 12
| Intervention | participants (Number) |
|---|
| Responders | Non-responders |
|---|
| Varenicline | 356 | 135 |
Number of Participants With Non-serious Adverse Events (AEs) or Serious Adverse Events (SAEs)
Non-serious AEs are any untoward medical occurrence in a clinical investigation (subject administered a product or medical device) observed or volunteered through 7 days after the last dose of study drug regardless of suspected causal relationship; SAEs are any untoward medical occurrence that results in death; is life-threatening; requires hospitalization or prolongation of hospitalization; results in disability or incapacity; congenital anomaly or birth defect observed or volunteered through 28 days after the last dose of study drug, regardless of suspected causal relationship. (NCT00669240)
Timeframe: Baseline through Week 12 or Week 24
| Intervention | participants (Number) |
|---|
| Non-serious AEs | SAEs |
|---|
| Varenicline | 131 | 7 |
Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11
Assessment of smoking cessation (ie, not a single puff) in previous 7 days, at time points of routine review of patients per local clinical practice. (NCT00669240)
Timeframe: Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11
| Intervention | participants (Number) |
|---|
| Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 |
|---|
| Varenicline | 105 | 129 | 84 | 65 | 50 | 45 | 38 | 18 | 23 |
Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11
"Responders are participants who answered no to the following 2 questions: 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days? Assessment conducted at specified time points only when usual for the local clinical practice." (NCT00669240)
Timeframe: Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11
| Intervention | participants (Number) |
|---|
| Week 3 (n=105) | Week 4 (n=129) | Week 5 (n=84) | Week 6 (n=65) | Week 7 (n=50) | Week 8 (n=45) | Week 9 (n=38) | Week 10 (n=18) | Week 11 (n=23) |
|---|
| Varenicline | 65 | 89 | 62 | 50 | 43 | 35 | 28 | 11 | 19 |
Number of Treatment Responders in Belgium at Week 12 and at Week 24
"Responders are participants who answered no to both of the following 2 questions on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?" (NCT00669240)
Timeframe: Week 12 and Week 24
| Intervention | participants (Number) |
|---|
| Week 12 | Week 24 |
|---|
| Varenicline | 138 | 103 |
Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 12
"Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?. Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study." (NCT00794365)
Timeframe: Week 12
| Intervention | percentage of participants (Number) |
|---|
| Varenicline | 57.58 |
Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 4
"Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?. Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study." (NCT00794365)
Timeframe: Week 4
| Intervention | percentage of participants (Number) |
|---|
| Varenicline | 58.79 |
Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 8
"Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?. Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study." (NCT00794365)
Timeframe: Week 8
| Intervention | percentage of participants (Number) |
|---|
| Varenicline | 61.52 |
A Measure of the Subjective Expected Value of a Cigarette
The cigarette choice procedure (Kidorf, Stitzer, and Griffiths, 1995) is a measure of the desire to smoke a cigarette. Participants are asked to hypothetically choose between smoking a cigarette now or receiving a small amount of money (from 10 cents up to $6 in increments of 10 cents). A crossover ($) value, at and above which participants prefer money, is obtained (Reid, Palmar, Raghavan, and Flammino, 2007). (NCT00747643)
Timeframe: 3 weeks per participant
| Intervention | Dollars (Mean) |
|---|
| Varenicline | 2.46 |
| Placebo | 3.72 |
Cue-provoked Cravings
"Strength of Craving 0 (lowest) to 20 (highest). One item 0 - 20 Likert scale How strong was your craving to smoke a cigarette?" (NCT00747643)
Timeframe: 3 weeks per participant
| Intervention | Scores on a scale (Mean) |
|---|
| Varenicline | 11.18 |
| Placebo | 14.61 |
Smoking Topography - Number of Puffs on a Cigarette
# Puffs = total number of puffs taken at Assessment Session. (NCT00747643)
Timeframe: 3 weeks per participant
| Intervention | Puffs on a Cigarette (Mean) |
|---|
| Varenicline | 6.05 |
| Placebo | 9.86 |
Tonic Craving Score (QSU) Based on Self Reports
Tonic Craving 1 (lowest) to 7 (highest). The Questionnaire of Smoking Urges (QSU), our primary measure of tonic craving, is a 32-item instrument, including 2 separate factor scales that roughly correspond to the desire to smoke for its pleasurable effects (positive reinforcement) or to remove unpleasant feelings of negative affect or withdrawal (negative reinforcement) (Tiffany and Drobes 1991). Following overnight abstinence, each session included assessment of tonic craving, reactivity (including craving) to smoking cues. (NCT00747643)
Timeframe: 3 weeks per participant
| Intervention | Scores on a scale (Mean) |
|---|
| Varenicline | 3.53 |
| Placebo | 4.93 |
Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.
(NCT01027754)
Timeframe: Week 12
| Intervention | participants (Number) |
|---|
| Varenicline | 6 |
| Placebo | 0 |
Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.
(NCT01027754)
Timeframe: Week 24
| Intervention | participants (Number) |
|---|
| Varenicline | 3 |
| Placebo | 0 |
Number of Counseling Visits Completed
Participants were offered 5 counseling visits at weeks 0, 2, 4, 8, 12. (NCT01027754)
Timeframe: End of 12 week intervention period
| Intervention | visits completed (Mean) |
|---|
| Varenicline | 1.96 |
| Placebo | 1.85 |
Number of Study Visits Completed
Mean number of study visit completed out of a possible total of 6 study visits at weeks 0, 2, 4, 8, 12 and 24. (NCT01027754)
Timeframe: 24 weeks
| Intervention | visits completed (Mean) |
|---|
| Varenicline | 5.72 |
| Placebo | 5.36 |
Adverse Medication Effects
(NCT01027754)
Timeframe: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
| Intervention | participants (Number) |
|---|
| Change in taste | Dry Mouth | Change in appetite | Nausea | Vomiting | Gas | Constipation | Change in concentration | Headache | Fatigue | Insomnia | Dizziness | Irritability | Vivid/more frequent dreams |
|---|
| Placebo | 14 | 23 | 18 | 14 | 8 | 15 | 9 | 6 | 18 | 13 | 13 | 8 | 8 | 22 |
,| Varenicline | 18 | 27 | 29 | 29 | 11 | 19 | 23 | 6 | 11 | 15 | 15 | 9 | 10 | 18 |
Confidence in Quitting Smoking (1-10 Scale)
Confidence of quitting smoking measure on a scale of 1-10 (10= high levels of quit confidence). (NCT01027754)
Timeframe: Weeks 2, 4, 8, 12, and 24
| Intervention | units on a scale (Median) |
|---|
| At week 2 | At week 4 | At week 8 | At week 12 | At week 24 |
|---|
| Placebo | 8 | 8 | 9 | 8 | 8 |
,| Varenicline | 8 | 9 | 9 | 9 | 8 |
Importance of Quitting Smoking (1-10 Scale)
Importance of quitting smoking measured on a scale of 1-10 (10=high levels of quit importance). (NCT01027754)
Timeframe: Weeks 2, 4, 8, 12, and 24
| Intervention | units on a scale (Median) |
|---|
| At week 2 | At week 4 | At week 8 | At week 12 | At week 24 |
|---|
| Placebo | 10 | 10 | 10 | 10 | 10 |
,| Varenicline | 10 | 10 | 10 | 10 | 10 |
Number of Cigarettes Smoked Per Day
(NCT01027754)
Timeframe: Weeks 2, 4, 8, 12, and 24
| Intervention | cigarettes/day (Median) |
|---|
| At week 2 | At week 4 | At week 8 | At week 12 | At week 24 |
|---|
| Placebo | 6 | 5 | 5 | 5 | 5 |
,| Varenicline | 3 | 2 | 3 | 2 | 4 |
Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours
(NCT01027754)
Timeframe: Weeks 2, 4, 8, 12, and 24
| Intervention | participants (Number) |
|---|
| At week 2 | At week 4 | At week 8 | At week 12 | At week 24 |
|---|
| Placebo | 25 | 27 | 32 | 25 | 30 |
,| Varenicline | 33 | 35 | 37 | 37 | 41 |
Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview
(NCT01027754)
Timeframe: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
| Intervention | participants (Number) |
|---|
| Week 2 | Week 4 | Week 8 | Week 12 | Week 24 |
|---|
| Placebo | 0 | 0 | 0 | 1 | 2 |
,| Varenicline | 0 | 0 | 2 | 0 | 2 |
Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview
(NCT01027754)
Timeframe: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
| Intervention | participants (Number) |
|---|
| Week 2 | Week 4 | Week 8 | Week 12 | Week 24 |
|---|
| Placebo | 0 | 0 | 0 | 0 | 0 |
,| Varenicline | 0 | 0 | 0 | 0 | 0 |
Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview
(NCT01027754)
Timeframe: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
| Intervention | participants (Number) |
|---|
| Week 2 | Week 4 | Week 8 | Week 12 | Week 24 |
|---|
| Placebo | 2 | 0 | 0 | 1 | 1 |
,| Varenicline | 0 | 0 | 1 | 1 | 2 |
Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory
(NCT01027754)
Timeframe: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
| Intervention | participants (Number) |
|---|
| Week 2 | Week 4 | Week 8 | Week 12 | Week 24 |
|---|
| Placebo | 11 | 7 | 7 | 5 | 5 |
,| Varenicline | 9 | 4 | 6 | 8 | 5 |
Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale
(NCT01027754)
Timeframe: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
| Intervention | participants (Number) |
|---|
| Week 2 | Week 4 | Week 8 | Week 12 | Week 24 |
|---|
| Placebo | 1 | 0 | 1 | 2 | 1 |
,| Varenicline | 1 | 1 | 1 | 1 | 1 |
7-day Point-prevalence Smoking Abstinence
7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml. (NCT00756275)
Timeframe: 3 month follow up
| Intervention | participants (Number) |
|---|
| Nicotine Replacement + PLA Pill | 2 |
| Varenicline + PLA Patch | 10 |
7-day Point-prevalence Smoking Abstinence
7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml. (NCT00756275)
Timeframe: 6 month follow up
| Intervention | participants (Number) |
|---|
| Nicotine Replacement + PLA Pill | 2 |
| Varenicline + PLA Patch | 7 |
Beck Depression Inventory
0-10 = These ups and downs are considered normal 11-16 = Mild mood disturbance 17-20 = Borderline clinical depression 21-30 = Moderate depression 31-40 = Severe depression over 40 = Extreme depression (NCT00756275)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| Nicotine Replacement + PLA Pill | 5.19 |
| Varenicline + PLA Patch | 5.75 |
Length of Longest Continuous Abstinence
(NCT00756275)
Timeframe: Weeks 9 to 12
| Intervention | Days (Mean) |
|---|
| Nicotine Replacement + PLA Pill | 6.25 |
| Varenicline + PLA Patch | 7.84 |
Percent Relapsed to Any Heavy Drinking
6 or more drinks for men; 5 or more drinks for women (NCT00756275)
Timeframe: 3 month follow up
| Intervention | percentage of participants (Number) |
|---|
| Nicotine Replacement + PLA Pill | 7 |
| Varenicline + PLA Patch | 9 |
Percent Relapsed to Any Heavy Drinking
6 or more drinks for men; 5 or more drinks for women (NCT00756275)
Timeframe: 6 month follow up
| Intervention | percentage of particpiants (Number) |
|---|
| Nicotine Replacement + PLA Pill | 9 |
| Varenicline + PLA Patch | 8 |
Percent Relapsed to Drug Use
(NCT00756275)
Timeframe: 3 month follow up
| Intervention | percentage of participants (Number) |
|---|
| Nicotine Replacement + PLA Pill | 12 |
| Varenicline + PLA Patch | 14 |
Percent Relapsed to Drug Use
(NCT00756275)
Timeframe: 6 month follow up
| Intervention | percentage of participants (Number) |
|---|
| Nicotine Replacement + PLA Pill | 8 |
| Varenicline + PLA Patch | 18 |
Percent Smoking Days
(NCT00756275)
Timeframe: 3 month follow up
| Intervention | percentage of days (Mean) |
|---|
| Nicotine Replacement + PLA Pill | 62.39 |
| Varenicline + PLA Patch | 70.37 |
Percent Smoking Days
(NCT00756275)
Timeframe: 6 month follow up
| Intervention | percentage of days (Mean) |
|---|
| Nicotine Replacement + PLA Pill | 84.52 |
| Varenicline + PLA Patch | 77.12 |
7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks
To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence (NCT01010204)
Timeframe: 24 weeks
| Intervention | participants (Number) |
|---|
| Varenicline | 6 |
| Placebo | 2 |
7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks
To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence at 12 weeks (NCT01010204)
Timeframe: 12 weeks
| Intervention | participants (Number) |
|---|
| Varenicline | 15 |
| Placebo | 3 |
Participants Experiencing Neuropsychiatric Events
Evaluate the safety of varenicline in treatment-emergent hypomania, mania, mixed or depressed episodes or being associated suicidal or aggressive behavior or psychotic symptoms when used as adjunctive treatment in participants with bipolar disorder. (NCT01010204)
Timeframe: 24 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 7 |
| Placebo | 2 |
Mean Change in Schirmer's Test Score From Baseline to 28 Days (Visit 4) - Fellow Eye
The Schirmer's test measures the amount of tears produced by numbing the eye and placing a paper strip in the eye for 5 minutes and distance of wetting was recorded following treatment with OC-01 or placebo. Schirmer's test scores range from 0-35 mm where a higher score is indicative of a better outcome. (NCT03873246)
Timeframe: Visit 1 (baseline) to Visit 4 (28 Days)
| Intervention | mm (Least Squares Mean) |
|---|
| OC-01 0.1%, 0.6 mg/ml | 5.4 |
| OC-01 0.2%. 1.2 mg/ml | 9.2 |
| Placebo | 6.7 |
Mean Change in Schirmer's Test Score From Baseline to 28 Days (Visit 4) - Study Eye
The Schirmer's test measures the amount of tears produced by numbing the eye and placing a paper strip in the eye for 5 minutes and distance of wetting was recorded following treatment of OC-01 or placebo. Schirmer's test scores range from 0-35 mm where a higher score is indicative of a better outcome. (NCT03873246)
Timeframe: Visit 1 (baseline) to Visit 4 (28 days)]
| Intervention | mm (Least Squares Mean) |
|---|
| OC-01 0.1%, 0.6 mg/ml | 10.2 |
| OC-01 0.2%. 1.2 mg/ml | 11.4 |
| Placebo | 6.9 |
Mean Change in Schirmer's Test Score From Baseline to 84 Days
The Schirmer's test measures the amount of tears produced by numbing the eye and placing a paper strip in the eye for 5 minutes and distance of wetting was recorded following treatment with OC-01 or placebo. Schirmer's test scores range from 0-35 mm where a higher score is indicative of a better outcome. (NCT03873246)
Timeframe: Visit 1 (baseline) and Visit 6 (84 days)
| Intervention | mm (Least Squares Mean) |
|---|
| OC-01 0.1%, 0.6 mg/ml | 10.8 |
| OC-01 0.2%. 1.2 mg/ml | 11.0 |
| Placebo | 6.0 |
Mean Change in Schirmer's Test Score From Baseline to 84 Days (Visit 6) - Fellow Eye
The Schirmer's test measures the amount of tears produced by numbing the eye and placing a paper strip in the eye for 5 minutes and distance of wetting was recorded following treatment with OC-01 or placebo. Schirmer's test scores range from 0-35 mm where a higher score is indicative of a better outcome. (NCT03873246)
Timeframe: Visit 1 (baseline) to Visit 6 (84 Days)
| Intervention | mm (Least Squares Mean) |
|---|
| OC-01 0.1%, 0.6 mg/ml | 7.9 |
| OC-01 0.2%. 1.2 mg/ml | 8.7 |
| Placebo | 4.8 |
Mean Change in Total Corneal Fluorescein Staining
A standardized grading system of 0-3 is used for each of the five areas of the cornea (inferior, superior, nasal, temporal, central). Grade 0 will be specified when no staining is present. The total score ranges from 0-15. Lower scores indicate improvement. (NCT03873246)
Timeframe: Visit 1 (baseline) and Visit 5 (56 days)
| Intervention | units on a scale (Least Squares Mean) |
|---|
| OC-01 0.1%, 0.6 mg/ml | -3.3 |
| OC-01 0.2%, 1.2 mg/ml | -3.7 |
| Placebo | -3.2 |
Percent of Subjects Who Achieve ≥10 mm Improvement in Schirmer's Test Score From Baseline at Visit 4 (Day 28)
The Schirmer's test measures the amount of tears produced by placing a paper strip in the eye for 5 minutes and the distance of wetting was recorded following treatment with OC-01 or placebo. Schirmer's test scores range from 0-35 mm where a higher score is indicative of a better outcome. (NCT03873246)
Timeframe: Visit 1 (baseline) and Visit 4 (28 Days)
| Intervention | Participants (Count of Participants) |
|---|
| OC-01 0.1%, 0.6 mg/ml | 18 |
| OC-01 0.2%. 1.2 mg/ml | 17 |
| Placebo | 12 |
Percent of Subjects Who Achieve ≥10 mm Improvement in Schirmer's Test Score From Baseline at Visit 6 (Day 84)
The Schirmer's test measures the amount of tears produced by numbing the eye and placing a paper strip in the eye for 5 minutes and distance of wetting was recorded following treatment with OC-01 or placebo. Schirmer's test scores range from 0-35 mm where a higher score is indicative of a better outcome. (NCT03873246)
Timeframe: Visit 1 (baseline) and Visit 6 (84 days)
| Intervention | Participants (Count of Participants) |
|---|
| OC-01 0.1%, 0.6 mg/ml | 15 |
| OC-01 0.2%, 1.2 mg/ml | 20 |
| Placebo | 10 |
Alcohol Craving
alcohol craving during the alcohol priming dose period using a visual analog scale of alcohol craving (1-100; higher scores = higher craving) (NCT00580645)
Timeframe: during laboratory session (Day 8) at baseline
| Intervention | units on a visual analog scale (Mean) |
|---|
| Placebo | 37.24 |
| 1 mg/Day Varenicline | 34.11 |
| 2 mg/Day Varenicline | 24.04 |
Number of Drinks Consumed
number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session (NCT00580645)
Timeframe: 2 hour ad-lib drinking period, during the laboratory session (Day 8)
| Intervention | number of drinks (Mean) |
|---|
| hour 1 | hour 2 |
|---|
| 1 mg/Day Varenicline | 2.05 | 2.05 |
,| 2 mg/Day Varenicline | 1.5 | 1.5 |
,| Placebo | 2.1 | 1.7 |
Change From Baseline in Body Weight
Change from baseline calculated as mean at observation minus baseline value; body weight measured in kilograms (kg). (NCT00285012)
Timeframe: Baseline, Week 52
| Intervention | kg (Mean) |
|---|
| Varenicline | 2.4 |
| Placebo | 1.5 |
Number of Subjects With 4-Week Point Prevalence of Abstinence
Number of subjects at Week 52 visit reporting no smoking and no use of other tobacco products in the last 4 weeks and with end-expiratory exhaled CO measurement less than or equal to 10 ppm. (NCT00285012)
Timeframe: Week 52
| Intervention | particpants (Number) |
|---|
| Varenicline | 65 |
| Placebo | 33 |
Number of Subjects With Four Week Continuous Quit Rate (CQR)
Number of subjects who reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory [NUI]) and with end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm) for weeks 9 through 12 (inclusive). (NCT00285012)
Timeframe: Week 9 through Week 12
| Intervention | participants (Number) |
|---|
| Varenicline | 105 |
| Placebo | 22 |
Change From Baseline in Clinical COPD Questionnaire (CCQ)
Change from baseline: mean at observation minus baseline value. Subject-administered 10-item instrument to systematically assess COPD symptoms (items 1, 2, 5, and 6), functional states (items 7, 8, 9, and 10) and mental states (items 3 and 4); For each domain score = sum of items divided by the number of items; total score = sum of scores divided by 10; range from 0 (very good health) to 6 (extremely poor health). Assessed at each visit based on subject's experience during the week prior to visit. (NCT00285012)
Timeframe: Baseline, Week, 12, Week 24, Week 52
| Intervention | scores on scale (Mean) |
|---|
| Week 12 Mental State (n=214, 193) | Week 24 Mental State (n=191, 161) | Week 52 Mental State (n=174, 155) | Week 12 Functional State (n=214, 192) | Week 24 Functional State (n=191, 160) | Week 52 Functional State (n=175, 154) | Week 12 Respiratory Symptoms (n=213, 193) | Week 24 Respiratory Symptoms (n=191, 161) | Week 52 Respiratory Symptoms (n=175, 155) | Week 12 Total Score (n=213, 192) | Week 24 Total Score (n=191, 160) | Week 52 Total Score (n=174, 154) |
|---|
| Placebo | -0.64 | -0.49 | -0.46 | -0.35 | -0.25 | -0.12 | -0.88 | -0.82 | -0.63 | -0.62 | -0.52 | -0.39 |
,| Varenicline | -0.81 | -0.72 | -0.58 | -0.41 | -0.40 | -0.35 | -1.16 | -0.98 | -0.90 | -0.79 | -0.70 | -0.62 |
Change From Baseline in Inflammatory Biomarkers: C-Reactive Protein (CRP) and Fibrinogen Antigen
Change from baseline in CRP and Fibrinogen antigen (blood markers of inflammation) calculated as mean at observation minus baseline value; measured as milligrams per deciliter (mg/dl). (NCT00285012)
Timeframe: Baseline, Week 12, Week 52
| Intervention | mg/dl (Mean) |
|---|
| Week 12 CRP (n=210, 197) | Week 52 CRP (n=162, 146) | Week 12 Fibrinogen (n=183, 174) | Week 52 Fibrinogen (n=150, 130) |
|---|
| Placebo | -0.0 | 0.1 | -1.4 | 14.9 |
,| Varenicline | -0.0 | 0.0 | -25.2 | -8.2 |
Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in First Second (FEV1)
Change from baseline in mean FEV1 (forced expiratory volume in the first second of forced exhalation) measured in millimeters (ml) as mean at observation minus baseline value. Directly after pre-bronchodilator measurement, subject inhaled albuterol or salbutamol delivered by metered-dose inhaler (MDI); post-bronchodilator lung function repeated 30 to 45 minutes following administration of albuterol or salbutamol. (NCT00285012)
Timeframe: Baseline, Week 12, Week 52
| Intervention | ml (Mean) |
|---|
| Week 12 [LOCF] Pre-bronchodilator (n= 244, 248) | Week 12 [LOCF] Post-bronchodilator (n=237, 246) | Week 52 [LOCF] Pre-bronchodilator (n=244, 248) | Week 52 [LOCF] Post-bronchodilator (n=237, 246) |
|---|
| Placebo | 1.77 | 15.61 | -37.90 | -9.51 |
,| Varenicline | 33.69 | 73.84 | -29.59 | -8.10 |
Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period
Number of cigarettes smoked daily collected during the first 3 weeks of study after randomization using patient smoking diaries. (NCT00285012)
Timeframe: Day 1 through Day 21
| Intervention | cigarettes per day (Mean) |
|---|
| Day 1 (n=226, 231) | Day 2 (n=232, 230) | Day 3 (n=233, 233) | Day 4 (n=230, 232) | Day 5 (n=224, 228) | Day 6 (n=222, 230) | Day 7 (n=214, 228) | Day 8 (n=176, 201) | Day 9 (n=168, 193) | Day 10 (155, 187) | Day 11 (n=151, 190) | Day 12 (n=145, 188) | Day 13 (n=144, 184) | Day 14 (n=134, 183) | Day 15 (n=131, 180) | Day 16 (n=132, 179) | Day 17 (n=128, 176) | Day 18 (n=123, 176) | Day 19 (n=120, 176) | Day 20 (n=121, 162) | Day 21 (n=100, 132) |
|---|
| Placebo | 18.7 | 18.4 | 17.4 | 17.1 | 16.9 | 16.0 | 15.3 | 13.4 | 12.7 | 12.6 | 12.1 | 11.9 | 11.9 | 12.9 | 11.5 | 11.9 | 11.9 | 11.9 | 11.6 | 11.3 | 10.4 |
,| Varenicline | 19.9 | 18.8 | 17.7 | 17.1 | 16.5 | 16.4 | 15.9 | 13.9 | 12.2 | 12.1 | 11.6 | 11.4 | 11.1 | 11.1 | 11.1 | 10.8 | 10.5 | 10.7 | 10.1 | 9.7 | 9.8 |
Number of Subjects With 7-Day Point Prevalence of Abstinence
Number of subjects at given visit (Week 12, Week 24, Week 52) or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and with end-expiratory exhaled CO measurement less than or equal to 10 ppm. CO confirmed in-clinic visit. (NCT00285012)
Timeframe: Week 12, Week 24, Week 52
| Intervention | participants (Number) |
|---|
| Week 12 | Week 24 | Week 52 |
|---|
| Placebo | 31 | 34 | 36 |
,| Varenicline | 119 | 74 | 65 |
Number of Subjects With Continuous Abstinence (CA)
Number of subjects who reported no smoking and no use of other nicotine-containing products (treatment phase = through week 12) or tobacco products (non-treatment phase = after treatment phase; follow up through week 52) at each contact (on the NUI) and with end-expiratory exhaled CO measurement less than or equal to 10 ppm from week 9 through week 24 and week 52. CO confirmed in-clinic visit. (NCT00285012)
Timeframe: Week 9 through Week 24 and Week 52
| Intervention | participants (Number) |
|---|
| Week 9 | Week 24 | Week 52 |
|---|
| Placebo | 28 | 18 | 14 |
,| Varenicline | 125 | 64 | 46 |
Number of Subjects With Long Term Quit Rate (LTQR)
"Number of subjects who were responders for the primary endpoint (4-week CQR for Weeks 9 through 12) and who had no more than 6 cumulative days of smoking from Week 12 through the given visit (Week 24 and Week 52).~CO confirmed in-clinic visit." (NCT00285012)
Timeframe: Week 24, Week 52
| Intervention | participants (Number) |
|---|
| Week 24 | Week 52 |
|---|
| Placebo | 19 | 17 |
,| Varenicline | 70 | 53 |
Number of Participants With a 4 Week Point Prevalence of Smoking Cessation
Responders: participants with abstinence during the last 4 weeks of non-treatment based on answering 'no' to both of the two 'last 4 week' questions in the Nicotine Use Inventory (NUI). NUI collected information of cigarette or other nicotine use during the study. (NCT00282984)
Timeframe: Week 48 through Week 52 (final 4 weeks of non-treatment period [pd])
| Intervention | participants (Number) |
|---|
| Varenicline (Var) | 99 |
| Placebo (Pbo) | 57 |
Number of Responders With Continuous Abstinence (CA) Through Week 24
"Responders: participants who remained abstinent based on 'since the last contact' question in Nicotine Use Inventory 1) Has participant smoked any cigarettes (even a puff) since the last contact? = No AND 2) Has participant used any other tobacco products… since the last contact? = No. Non- responder if the expired CO > 10 ppm at any given timepoint." (NCT00282984)
Timeframe: Week 9 through Week 24
| Intervention | participants (Number) |
|---|
| Varenicline (Var) | 100 |
| Placebo (Pbo) | 34 |
Cigarettes Smoked Per Day
Cigarettes smoked each day during the first 3 weeks of the treatment phase. (NCT00282984)
Timeframe: Day 21
| Intervention | cigarettes per day (Mean) |
|---|
| Baseline | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 11 | Day 12 | Day 13 | Day 14 | Day 15 | Day 16 | Day 17 | Day 18 | Day 19 | Day 20 | Day 21 |
|---|
| Placebo (Pbo) | 22.9 | 19.1 | 18.4 | 18.0 | 17.1 | 16.3 | 16.0 | 15.1 | 12.3 | 10.9 | 10.6 | 10.4 | 10.5 | 10.3 | 10.7 | 11.2 | 11.0 | 10.6 | 10.3 | 10.3 | 10.6 | 9.3 |
,| Varenicline (Var) | 22.2 | 17.6 | 16.8 | 15.8 | 15.7 | 15.1 | 14.4 | 13.8 | 11.7 | 9.5 | 8.9 | 8.9 | 8.7 | 8.8 | 9.3 | 8.9 | 8.8 | 8.3 | 8.2 | 7.8 | 7.9 | 7.2 |
Number of Long-Term Quit Responders
Responders: participants were considered Long Term Quit responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit. (NCT00282984)
Timeframe: Week 9 through Week 52
| Intervention | participants (Number) |
|---|
| responders | non-responders |
|---|
| Placebo (Pbo) | 34 | 316 |
,| Varenicline (Var) | 80 | 273 |
Number of Long-Term Quit Responders From Week 9 Through Week 24
Responders: participants were considered Long Term Quit Responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit. (NCT00282984)
Timeframe: Week 9 through Week 24
| Intervention | participants (Number) |
|---|
| responders | non-responders |
|---|
| Placebo (Pbo) | 42 | 308 |
,| Varenicline (Var) | 117 | 236 |
Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12
"Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) Has the participant smoked any cigarettes in the last 7 days? = No AND 2) Has the participant used any other tobacco products in the last 7 days? = No. Participant a non-responder if expired CO > 10 ppm." (NCT00282984)
Timeframe: Week 12
| Intervention | participants (Number) |
|---|
| responders | non-responders |
|---|
| Placebo (Pbo) | 65 | 285 |
,| Varenicline (Var) | 192 | 161 |
Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24
"Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) Has the participant smoked any cigarettes in the last 7 days? = No AND 2) Has the participant used any other tobacco products in the last 7 days? = No. Participant a non-responder if expired CO > 10 ppm." (NCT00282984)
Timeframe: Week 24
| Intervention | participants (Number) |
|---|
| responders | non-responders |
|---|
| Placebo (Pbo) | 57 | 293 |
,| Varenicline (Var) | 124 | 229 |
Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52
"Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) Has the participant smoked any cigarettes in the last 7 days? = No AND 2) Has the participant used any other tobacco products in the last 7 days? = No. Participant a non-responder if expired CO > 10 ppm." (NCT00282984)
Timeframe: Week 52
| Intervention | participants (Number) |
|---|
| responders | non-responders |
|---|
| Placebo (Pbo) | 62 | 288 |
,| Varenicline (Var) | 102 | 251 |
Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt)
Participants considered Responders (4-week CQR <=10 parts per million ) through reports of cigarette or other nicotine use since last study visit, confirmed by measurement of end-expiratory exhaled carbon monoxide (CO). If any CO measurement at a particular timepoint was >10 ppm, subject was considered to be Non-Responder at that timepoint. (NCT00282984)
Timeframe: weeks 9 through 12
| Intervention | participants (Number) |
|---|
| responders | non-responders |
|---|
| Placebo (Pbo) | 50 | 300 |
,| Varenicline (Var) | 167 | 186 |
Number of Responders With Continuous Abstinence (CA) Through Week 52
"Responders: participants who remained abstinent based on 'since the last contact' question in Nicotine Use Inventory 1) Has participant smoked any cigarettes (even a puff) since last contact? = No AND 2) Has participant used any other tobacco products… since last contact? = No. Participant a non-responder if expired CO > 10 ppm." (NCT00282984)
Timeframe: Week 9 through Week 52
| Intervention | participants (Number) |
|---|
| responders | non-responders |
|---|
| Placebo (Pbo) | 26 | 324 |
,| Varenicline (Var) | 70 | 283 |
Weekly Percentage of Heavy Drinking Days
Protocol: The primary outcome measure examines the hypothesis that varenicline will decrease the weekly proportion of heavy drinking days during Study Weeks 2 through 13 as compared to placebo. (NCT01146613)
Timeframe: Weeks 2-13*
| Intervention | percentage of heavy drinking days (Mean) |
|---|
| Varenicline | 37.9 |
| Sugar Pill | 48.4 |
Number of Participants With 4-week Continuous Abstinence
The number of participants who, at each visit from Week 9 through 12 (inclusive), reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) > 10 parts per milion (ppm) at any of these visits (NCT00594204)
Timeframe: Weeks 9 through 12
| Intervention | participants (Number) |
|---|
| Varenicline | 209 |
| Placebo | 37 |
Number of Participants With Continuous Abstinence
The number of participants who, at each contact from Week 9 through the given timepoint, reported no smoking and no use of other nicotine-containing products (Treatment Phase) or tobacco products (Nontreatment Phase) since the last study contact(on the Nicotine Use Inventory) and who did not have CO > 10 ppm (NCT00594204)
Timeframe: Weeks 9 through 24
| Intervention | participants (Number) |
|---|
| Varenicline | 155 |
| Placebo | 26 |
Number of Participants With Seven-day Point Prevalence of Abstinence
Number of participants who, at the given visit or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and who did not have CO >10 ppm on that day (NCT00594204)
Timeframe: Week 12 and 24
| Intervention | participants (Number) |
|---|
| Week 12 | Week 24 |
|---|
| Placebo | 45 | 38 |
,| Varenicline | 220 | 185 |
7 Day Point Prevalent Abstinence Verified by Breath Carbon Monoxide of Less Than 10 Parts Per Million
7 day point prevalent abstinence 6 months after enrolling in the study was determined by two steps: (1) A report of no days of smoking for the 7 days prior to the 6 month on the Time Line Follow Back obtained at a telephone call 6 months after enrollment; (2) Those who reported no smoking for the prior 7 days came to our lab for breath carbon monoxide (CO) measurement to confirm abstinence. Breath CO had to be less than 10 parts per million for the participant to be classified as abstinent. (NCT00595868)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| Varenicline | 15 |
| Placebo | 8 |
Number of Participants With a Quit Attempt
A quit attempt was defined as a self-reported attempt to quit smoking on a given day reported on a Time Line Follow Back (TLFB) obtained at each visit for the first 2 months and via monthly phone calls during months 3-6. The TLFB collected information for each day since the previous visit/call on number of cigarettes smoked that day, whether medication (varenicline or placebo) was used that day, and whether a quit attempt occured that day. (NCT00595868)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| Varenicline | 55 |
| Placebo | 36 |
Number of Participants With 7 Day Point Prevalence (PP) for Abstinence in the Week Preceding Week 26
"Responder defined as participant who answered No to question on Nicotine Use Inventory (NUI), Has the subject smoked any cigarettes or cigarillos or used any other nicotine containing products in the last 7 days? Additionally, responder status confirmed by measurement of end-expiratory exhaled carbon monoxide concentration <10 parts per million (ppm)." (NCT00889720)
Timeframe: Week 26
| Intervention | participants (Number) |
|---|
| Varenicline | 7 |
Number of Participants With 7 Day Point Prevalence (PP) for Smoking Abstinence Prior to Hospital Admission.
"Responder defined as participant who answered No to question on Nicotine Use Inventory (NUI), Has the subject smoked any cigarettes or cigarillos or used any other nicotine containing products in the last 7 days? Additionally, responder status confirmed by measurement of end-expiratory exhaled carbon monoxide concentration <10 parts per million (ppm)." (NCT00889720)
Timeframe: 7 days prior to hospital admission to day of hospital admission (after Week 8 of treatment)
| Intervention | participants (Number) |
|---|
| Varenicline | 9 |
Number of Participants With 7-day Point Prevalence (PP) for Abstinence From Cigarette Smoking and Other Nicotine Use at the End of Treatment (Week 12)
"Responder defined as participant who answered No to question on Nicotine Use Inventory (NUI), Has the subject smoked any cigarettes or cigarillos or used any other nicotine containing products in the last 7 days? Additionally, responder status confirmed by measurement of end-expiratory exhaled carbon monoxide concentration <10 parts per million (ppm)." (NCT00889720)
Timeframe: Week 12
| Intervention | participants (Number) |
|---|
| Varenicline | 9 |
Percentage of Fully Compliant Participants
Compliance defined as completed 12 weeks of varenicline therapy, underwent surgery 8 weeks +-10 days after start of varenicline treatment, and had evaluations of wound infection 1 to 3 days and 6 to 10 days after surgery. (NCT00889720)
Timeframe: Baseline through Week 12
| Intervention | percentage of participants (Number) |
|---|
| Varenicline | 0 |
Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System
Grade 0: no post-operative (post-op) complications (comp), Grade 1: any deviation from normal post-op course without need for pharmacological treatment (PT) other than allowed interventions (INT), or surgical, endoscopic or radiological INT; Grade II: required PT with drugs other than those allowed for grade I comp; Grade III required surgical, endoscopic or radiological INT, IIIa: not under general anaesthesia (GA), IIIb: under GA; Grade IV: life-threatening comp requiring IC/ICU management, IVa: single organ dysfunction (DSF), IVb: multiorgan DSF; Grade V: death. Not done = not assessed. (NCT00889720)
Timeframe: Baseline through Week 26
| Intervention | participants (Number) |
|---|
| 1-3 days PS: No post-operative complications | 1-3 days PS: Grade II | 1-3 days PS: Not done | 6-10 days PS: No post-operative complications | 6-10 days PS: Grade I | 6-10 days PS: Grade II | 6-10 days PS: Not done | Week 12: No post-operative complications | Week 12: Grade II | Week 12: Grade IIIb | Week 12: Not done | Week 26: No post-operative complications | Week 26: Grade IIIb |
|---|
| Varenicline | 10 | 1 | 1 | 7 | 3 | 1 | 1 | 7 | 1 | 1 | 2 | 8 | 1 |
Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 12: Southampton Wound Assessment Scale
Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm, c: large volume, D: prolonged > 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed. (NCT00889720)
Timeframe: Week 12
| Intervention | participants (Number) |
|---|
| Grade 0 | Grade Ia | Not done |
|---|
| Varenicline | 8 | 1 | 2 |
Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 26: Southampton Wound Assessment Scale
Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm, c: large volume, D: prolonged > 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed. (NCT00889720)
Timeframe: Week 26
| Intervention | participants (Number) |
|---|
| Grade 0 | Not done |
|---|
| Varenicline | 8 | 1 |
Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 1 to 3: Southampton Wound Assessment Scale
Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm, c: large volume, D: prolonged > 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed. (NCT00889720)
Timeframe: Post-surgery Days 1-3
| Intervention | participants (Number) |
|---|
| Grade 0 | Grade Ia | Not done |
|---|
| Varenicline | 10 | 1 | 1 |
Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 6 to 10: Southampton Wound Assessment Scale
Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm, c: large volume, D: prolonged > 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed. (NCT00889720)
Timeframe: Post-surgery Days 6-10
| Intervention | participants (Number) |
|---|
| Grade 0 | Grade Ia | Grade IIa | Grade IIb | Not done |
|---|
| Varenicline | 8 | 1 | 1 | 1 | 1 |
Number of Participants With Surgical Site Infection at Week 12: Center for Disease Control (CDC) Definition
Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed. (NCT00889720)
Timeframe: Week 12
| Intervention | participants (Number) |
|---|
| Category 0: no surgical wound complications | Not done |
|---|
| Varenicline | 9 | 2 |
Number of Participants With Surgical Site Infection at Week 26: Center for Disease Control (CDC) Definition
Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed. (NCT00889720)
Timeframe: Week 26
| Intervention | participants (Number) |
|---|
| Category 0: no surgical wound complications | Not done |
|---|
| Varenicline | 9 | 0 |
Number of Participants With Surgical Site Infection Post-surgery Days 1 to 3: Center for Disease Control (CDC) Definition
Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed. (NCT00889720)
Timeframe: Post-surgery Days 1-3
| Intervention | participants (Number) |
|---|
| Category 0: no surgical wound complications | Not done |
|---|
| Varenicline | 11 | 1 |
Number of Participants With Surgical Site Infection Post-surgery Days 6 to 10: Center for Disease Control (CDC) Definition
Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed. (NCT00889720)
Timeframe: Post-surgery Days 6-10
| Intervention | participants (Number) |
|---|
| Category 0: no surgical wound complications | Not Done |
|---|
| Varenicline | 11 | 1 |
Number of Treatment Emergent Adverse Events by Severity
Mild: did not interfere with usual function; Moderate: interfered to some extent with usual function; Severe: interfered significantly with usual function. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the most severe occurrence was taken. Missing baseline severities were imputed as mild. (NCT00889720)
Timeframe: Baseline through Week 26 (within 30 days of last dose)
| Intervention | events (Number) |
|---|
| Mild | Moderate | Severe |
|---|
| Varenicline | 13 | 11 | 4 |
Wound Healing Grade by ASEPSIS Criteria at Week 12
Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (>40). Surgical site complication defined as total score >10; wound infection defined as total score >20. Not done = not assessed. (NCT00889720)
Timeframe: Week 12
| Intervention | participants (Number) |
|---|
| Satisfactory healing | Not done |
|---|
| Varenicline | 6 | 1 |
Wound Healing Grade by ASEPSIS Criteria at Week 26
Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (>40). Surgical site complication defined as total score >10; wound infection defined as total score >20. Not done = not assessed. (NCT00889720)
Timeframe: Week 26
| Intervention | participants (Number) |
|---|
| Satisfactory healing | Not done |
|---|
| Varenicline | 6 | 0 |
Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 1 to 3
Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (>40). Surgical site complication defined as total score >10; wound infection defined as total score >20. Not done = not assessed. (NCT00889720)
Timeframe: Post-surgery Days 1-3
| Intervention | participants (Number) |
|---|
| Satisfactory healing | Not done |
|---|
| Varenicline | 7 | 1 |
Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 6 to 10
Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (>40). Surgical site complication defined as total score >10; wound infection defined as total score >20. Not done = not assessed. (NCT00889720)
Timeframe: Post-surgery Days 6-10
| Intervention | participants (Number) |
|---|
| Satisfactory healing | Not done |
|---|
| Varenicline | 7 | 1 |
Level of Nicotine Dependence Measured by the Fagerstrom Test
Fagerstrom Test for Nicotine Dependence (FTND) was designed to provide measure of nicotine dependence related to cigarette smoking. It contains 4 yes-no and 2 multiple choice questions. Items are scored 0-3 for multiple choice items, items are summed to yield total score of 0-10 (0=minimum to 10=maximum nicotine dependence). (NCT01104636)
Timeframe: Baseline
| Intervention | Scores on a scale (Median) |
|---|
| Varenicline | 5.30 |
Percentage of Participants Who Abstained From Smoking at Week 12
The use of nicotine was recorded using Nicotine Use Inventory (NUI) to determine the participants who abstained from smoking for the previous 7 days. A responder for the 7-day point prevalence was defined as those with 'no' answers to the following two questions: Did the participant smoke any cigarettes (even a puff) in the last 7 days; and did participant use any other tobacco products (example pipe, cigars, snuff, chewing tobacco) in the last 7 days. (NCT01104636)
Timeframe: Week 12
| Intervention | percentage of participants (Number) |
|---|
| Varenicline | 71.1 |
Depression
Beck Depression Inventory (BDI), a self-report rating inventory measuring characteristic attitudes and symptoms of depression consisting of 21 items with each item rated on a four point scale (0=not present to 3=severe). The accepted ranges are as follows: 0 to 9 indicates no depression, 10 to 18 indicates mild to moderate depression, 19 to 29 indicates moderate to severe depression and 30 to 63 indicates severe depression. (NCT01111149)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| Sugar Pill | 3.71 |
| Varenicline | 8.6 |
| Bupropion HCl | 5.4 |
Response Style Indicator (Beta) for CPT
Beta represents an individual's response tendency: Some individuals are cautious and choose not to respond very often. Conceptually, such individuals want to make sure they are correct when they give a response. Higher values of Beta reflect this response style. The emphasis is on avoiding commission errors. Other individuals respond more freely to make sure they respond to most or all targets, and they tend to be less concerned about mistakenly responding to a non-target. Lower values of Beta are produced by this response style. Values shown below were obtained at week 12. (NCT01111149)
Timeframe: Week 12
| Intervention | Beta (Mean) |
|---|
| Sugar Pill | 0.95 |
| Varenicline | 1.41 |
| Bupropion HCl | 2.92 |
Smoking Abstinence - Exhaled Carbon Monoxide
Exhaled carbon monoxide as a biochemical verification of smoking abstinence. Values below are for week 12. (NCT01111149)
Timeframe: Week 12
| Intervention | parts per million (Mean) |
|---|
| Sugar Pill | 21.14 |
| Varenicline | 17 |
| Bupropion HCl | 22.6 |
Smoking Abstinence - Number of Cigarettes Smoked
Number of cigarettes smoked at week 12 of the study by self-report. (NCT01111149)
Timeframe: Week 12
| Intervention | number of cigarettes smoked (Mean) |
|---|
| Sugar Pill | 19.71 |
| Varenicline | 9.4 |
| Bupropion HCl | 17.1 |
Variability of Standard Error - CPT
"Variability of Standard Error (VSE) is a measure of response speed consistency. VSE measures within respondent variability. That is, the amount of variability the individual shows in 18 separate segments of the Continuous Performance Test in relation to his or her own overall standard error. Although VSE is a different measure than Overall Standard Error, typically the two measures produce comparable results. The higher the VSE, the greater the inconsistency in the response speed. The values shown below are the VSE for Week 12." (NCT01111149)
Timeframe: Week 12
| Intervention | milliseconds (Mean) |
|---|
| Sugar Pill | 11.05 |
| Varenicline | 11.38 |
| Bupropion HCl | 11.8 |
Vital Signs - Pulse
Pulse will be measured. The values below were measured at week 12 of the study. (NCT01111149)
Timeframe: Week 12
| Intervention | heart beats per minute (Mean) |
|---|
| Sugar Pill | 82.57 |
| Varenicline | 87 |
| Bupropion HCl | 89.2 |
Vital Signs - Weight
Weight will be measured for each participant. Values listed below are for week 12. (NCT01111149)
Timeframe: Week 12
| Intervention | lbs (Mean) |
|---|
| Sugar Pill | 218.39 |
| Varenicline | 213.47 |
| Bupropion HCl | 254.78 |
Abnormal Movements - AIMS
Abnormal Involuntary Movement Scale (AIMS), to assess abnormal involuntary movements associated with antipsychotic drugs. There are 10 questions, based on a five-point scale ranging from 0 (none) to 4 (severe). Items 11-14 are yes/no questions that have no impact on the score. The Total Score is the sum of questions 1-7 (minimum = 0; maximum = 28). The severity index consists of one question (item 8; rated 0=none to 4=severe) based on the rater's observation of abnormal movements The AIMS Global Score is the sum of three questions (each item rated 0=none to 4=severe) regarding abnormal movements overall (minimum score 0, maximum score 12). For the total score and subscores, the higher the score, the greater the severity of abnormal movements. Scoring is based on the chapter: Guy W (2000), Abnormal Involuntary Movement Scale (AIMS), in: Handbook of Psychiatric Measures (Rush AJ Jr, et al., eds). APA Publishing: Washington DC: pp. 166-167. (NCT01111149)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| AIMS Total (Week 12) | AIMS Severity Index (Week 12) | AIMS Global Score (Week 12) |
|---|
| Bupropion HCl | 1.40 | 0.4 | 0.6 |
,| Sugar Pill | 0.71 | 0 | 0 |
,| Varenicline | 1 | 0.2 | 0.2 |
Abnormal Movements - BAS and SAS
"Barnes Akathisia Scale (BAS), a widely-used measurement of drug-induced akathisia. It consists of 4 questions with questions 1-3 scored on a scale of 0-3 with 0=normal and 3=severe (minimum score 0, maximum score 9; while item 4 is a global clinical assessment of akathisia rated on a scale of 0 (normal) to 5 (severe). The higher the score on each subsclae, the greater the severity of akathisia.~Simpson-Angus Scale (SAS), a 10-item instrument used to evaluate patients experiencing neuroleptic-induced parkinsonism and other extrapyramidal side effects. Items are rated for severity on a 0-4 scale, with 0 being normal and 4 being severe. Minimum = 0; Maximum = 40. The higher the score, the greater the severity." (NCT01111149)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| SAS (Week 12) | BAS Items 1-3 (Week 12) | BAS Item 4 (Week 12) |
|---|
| Bupropion HCl | 0.42 | 0.4 | 0.2 |
,| Sugar Pill | 0.2 | 0.57 | 0.29 |
,| Varenicline | 0.76 | 0.6 | 0.4 |
General Psychopathology
Brief Psychiatric Rating Scale (BPRS), an 24-item scale measuring positive symptoms, general psychopathology, and affective symptoms commonly used for schizophrenia with each item rated on a scale of 1-7 with 1=not present and 7=severe. The minimum score is 24 and the maximum score is 168. We have used five subscales as recommended by Dingemans et al., 1995: Positive subscale (minimum score 6; maximum score 42); Negative subscale (minimum score 5; maximum score 35); Depressed subscale (minimum score 5; maximum score 35); Mania subscale (minimum score 6; maximum score 42); and Disorientation subscale (minimum score 2; maximum score 14) . For both the total score and the subscale scores, the higher the score, the greater the symptom severity. We used the BPRS version 4.0. Dingemans PMAJ, Linszen DH, Lenoir ME, Smeets RMW, 1995. Component structure of the expanded Brief Psychiatric Rating Scale (BPRS-E). Psychopharmacology 122:263-267. (NCT01111149)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| BPRS Total - Week 12 | BPRS Positive Subscale - Week 12 | BPRS Negative Subscale - Week 12 | BPRS Mania Subscale - Week 12 | BPRS Disorientation Subscale - Week 12 | BPRS Depression Subscale - Week 12 |
|---|
| Bupropion HCl | 31.6 | 8 | 7.4 | 8 | 2 | 6.2 |
,| Sugar Pill | 30 | 8.14 | 6 | 6.43 | 2 | 7.43 |
,| Varenicline | 34.2 | 9 | 6.4 | 6.4 | 2 | 10.4 |
Hit Reaction Time - CPT
The hit reaction time is the average speed of correct responses for the entire test given in milliseconds. The higher the score, the slower the speed. The standard error is a measure of response speed consistency. The higher the overall standard error, the greater inconsistency in the response speed. The values below were measured at week 12. (NCT01111149)
Timeframe: Week 12
| Intervention | milliseconds (Mean) |
|---|
| Hit Reaction Time (week 12) | Hit Reaction Time Standard Error (Week 12) |
|---|
| Bupropion HCl | 63.81 | 8.79 |
,| Sugar Pill | 42.44 | 7.20 |
,| Varenicline | 67.61 | 6.96 |
Impulsivity and Inattention
Impulsivity and inattention will be measured using the continuous performance test. Individuals were tasked with 359 items divided six blocks (59 in block 1, 60 in blocks 2-6). Omissions result from the failure to respond to target letters. CPT% Omissions measures the percentage of responses that qualify as omissions made during the test. Higher scores indicate increased inattention. Commissions result from responses given to non-targets. CPT% Commissions measures the percentage of responses that qualify as commissions made during the test. Higher scores indicate increased inattention. Perseverations result from reaction time less than 100 ms. CPT% Perseveration % measures the percentage of responses that qualify as perseverations made during the test. The higher the score, the greater impulsivity. (NCT01111149)
Timeframe: Week 12
| Intervention | Percentage of responses (Mean) |
|---|
| CPT % Omissions (Week 12) | CPT % Commissions (Week 12) | Perseveration % (Week 12) |
|---|
| Bupropion HCl | 2.42 | 28.33 | 0.12 |
,| Sugar Pill | 5.62 | 36.11 | 0.57 |
,| Varenicline | 0.68 | 25 | 1.05 |
Negative Symptoms of Schizophrenia - SANS
Scale for the Assessment of Negative Symptoms (SANS) a well-established test, used to assess the presence of psychosis or negative symptoms of schizophrenia. It consists of 25 questions rated on a scale of 0 (none) to 5 (severe). With a total score range of 0 to 125 points. There are 6 subscales: Affective Flattening or Blunting - (minimum, 0; maximum 35); Inappropriate Affect (minimum, 0; maximum 5); Alogia (minimum 0; maximum 25); Avolition-Apathy (minimum 0; maximum 20); Anhedonia-Asociality (minimum 0; maximum 25); Attention (minimum 0; maximum 15). Each subscale (except for Inappropriate Affect) contains one additional question as a Global Rating - or overall measure for that particular subscale. The sum of these questions constitutes the Total Global Score (minimum 0, maximum 25). The global questions are included within the Total Composite score. In each case, the larger the score, the more severe the symptoms. (NCT01111149)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| SANS Total Composite (Week 12) | SANS Total Global (Week 12) | SANS Affective Flattening (Week 12) | SANS Alogia (Week 12) | SANS Avolition (Week 12) | SANS Anhedonia (Week 12) | SANS Attention (Week 12) | Inappropriate Affect (Week 12) |
|---|
| Bupropion HCl | 6.20 | 1.6 | 0.8 | 0 | 3.6 | 1.4 | 0 | 0.40 |
,| Sugar Pill | 5.86 | 1.71 | 1.57 | 0.71 | 2 | 1.57 | 0 | 0 |
,| Varenicline | 17.2 | 3.8 | 7 | 0.6 | 3 | 5.8 | 0.2 | 0.60 |
Positive Symptoms of Schizophrenia (SAPS)
Scale for the Assessment of Positive Symptoms (SAPS), a well-established test, used to assess the presence of psychotic symptoms of schizophrenia. There are 34 items rated on a scale of 0-5 with 0=none and 5=severe for a minimum score of 0 and a maximum score of 170. There are 4 subscales: Hallucinations (minimum score 0; maximum score 35); Delusions (minimum score 0; maximum score 65); Bizarre Behavior (minimum score 0; maximum score 25); Positive Formal Thought Disorder (minimum score 0; maximum score 45). Each subscale contains one additional question as a Global Rating - or overall measure for that particular subscale. The sum of these questions constitutes the Total Global Score (minimum 0, maximum 20). The values for the Global items are included in the Total Composite score. In each case, the higher the score, the greater the severity of symptoms. (NCT01111149)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| SAPS Total Composite Score - Week 12 | SAPS Total Global - Week 12 | SAPS Hallucinations - Week 12 | SAPS Delusions - Week 12 | SAPS Bizarre Behavior - Week 12 | SAPS Thought Disorder - Week 12 |
|---|
| Bupropion HCl | 10.6 | 1.8 | 3 | 3.8 | 0.4 | 3.4 |
,| Sugar Pill | 3.43 | 1.29 | 2 | 1.43 | 0 | 0 |
,| Varenicline | 7 | 1.2 | 2.2 | 4.2 | 0 | 0.6 |
Reduction in Smoking
Successful outcome will be defined as a 50% or greater reduction in self-reported cigarettes per day and a 30% greater reduction in carbon monoxide and cotinine levels. Measured at week 12 (NCT01111149)
Timeframe: Week 12
| Intervention | participants (Number) |
|---|
| 50% Reduction in Number of Cigarettes Smoked | 30% Reduction in Carbon Monoxide (Week 12) | 30% Reduction in Serum Cotinine (Week 12) | 30% Reduction in Urine Cotinine (Week 12) |
|---|
| Bupropion HCl | 1 | 1 | 1 | 1 |
,| Sugar Pill | 2 | 2 | 2 | 2 |
,| Varenicline | 2 | 2 | 4 | 4 |
Side Effects
Side effects will be monitored by a physician and/or assistant and recorded (SEP). All patients withdrawn from the study because of emerging side effects will be followed until the side effects are resolved. Each item is scored based on a scale of 0=none; 1=mild; 2=moderate; and 3=severe. Below, the data are shown for participants experiencing symptoms on week 12 of the study. (NCT01111149)
Timeframe: Week 12
| Intervention | participants (Number) |
|---|
| Anxiety | Dizziness | Mania | Abnormal Dreams | Abdominal Pain | Headache | Insomnia | Nausea | Psychosis | Dry Mouth | Chest Pain | Irregular Heart Beat | Weakness/Fainting | Diarrhea | Vomiting | Constipation | Confusion | Irritability | Drooling | Cold Sweats | Blurred Vision | Leg Pain/Cramps |
|---|
| Bupropion HCl | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 1 | 0 |
,| Sugar Pill | 3 | 0 | 0 | 3 | 0 | 3 | 1 | 0 | 0 | 2 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 |
,| Varenicline | 3 | 0 | 0 | 1 | 1 | 3 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 1 | 0 | 1 | 1 |
Smoking Abstinence - Serum/Urine Measurements
Measured by blood/urine tests for nicotine and its break-down product cotinine. (NCT01111149)
Timeframe: Week 12
| Intervention | ng/mL (Mean) |
|---|
| Serum Cotinine (Week 12) | Serum Nicotine (Week 12) | Urine Cotinine (Week 12) | Urine Nicotine (Week 12) |
|---|
| Bupropion HCl | 213.8 | 15.4 | 614.75 | 412.75 |
,| Sugar Pill | 198.67 | 22.57 | 772 | 820 |
,| Varenicline | 207 | 6 | 699.6 | 613.25 |
Suicidality
The Columbia-Suicide Severity Rating Scale (C-SSRS), is a survey intended to quantify the severity of suicidal ideation and behavior. The questionaire for suicidal ideation consists of 5 questions with yes (1) /no (0) answers. If answers to questions 1 and 2 are no, questions 3-5 are skipped. Minimum of 0; Maximum of 5. The questionaire for suicidal behavior consists of seven questions rated 0 for no and 1 for yes. The minimum score is 0 and the maximum score is 7. In each case, the higher the score, the greater the severity. (NCT01111149)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| Lifetime Suicidal Ideation (week 12) | Lifetime Suicide Attempts (week 12) |
|---|
| Bupropion HCl | 0.4 | 0.4 |
,| Sugar Pill | 1.71 | 1.29 |
,| Varenicline | 0.8 | 1.2 |
Urge to Smoke - MNWS
The Minnesota Nicotine Withdrawal Scale (MNWS) includes two items where individuals are asked to 1) declare the percentage of time they had an urge to smoke (MNWS % Urge to Smoke); and 2) declare the percentage of time they had a strong urge to smoke (MNWS % Strong Urge). For each case, percentages range from 0% to 100% - the higher the percentage, the greater urge to smoke. (NCT01111149)
Timeframe: Week 12
| Intervention | percentage of time (Mean) |
|---|
| MNWS % Urge to Smoke (Week 12) | MNWS % Strong Urge (Week 12) |
|---|
| Bupropion HCl | 47 | 32.4 |
,| Sugar Pill | 36.43 | 26.43 |
,| Varenicline | 47 | 33 |
Vital Signs
blood pressure will be measured. (NCT01111149)
Timeframe: Week 12
| Intervention | mm Hg (Mean) |
|---|
| Systolic Blood Pressure (Week 12) | Diastolic Blood Pressure (Week 12) |
|---|
| Bupropion HCl | 128.4 | 74.8 |
,| Sugar Pill | 116.29 | 76.71 |
,| Varenicline | 122 | 78.4 |
Cigarettes Per Smoking Day
"The number of cigarettes smoked were assessed only on a smoking day, i.e., when a participant smoked at least 1 cigarette. Data was recorded each day for up to 36 weeks." (NCT01228175)
Timeframe: up to 36 weeks
| Intervention | Cigarettes per smoking day (Mean) |
|---|
| Varenicline | 4.9256 |
| Microcrystal Cellulose | 8.4989 |
Number of Participants With 4-Week Point Prevalence (PP) of Abstinence
Number of participants at Week 52 visit reporting no smoking and no use of other tobacco products in the last 4 weeks confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm. (NCT01078298)
Timeframe: Week 52
| Intervention | participants (Number) |
|---|
| Varenicline | 70 |
| Placebo | 45 |
Number of Participants With Adverse Events (Including Solicited Neuropsychiatric Adverse Events)
Adverse Event (AE):any untoward medical occurrence attributed to study drug in participant who received study drug.SAE:AE causing:death;initial/prolonged inpatient hospitalization;life-threatening experience(immediate risk of dying);persistent/significant disability/incapacity;congenital anomaly.Solicited AEs collected by semi-structured neuropsychiatric AEs interview inquiring about AEs:delusions,hallucinations,paranoia,psychosis,mania,panic,agitation,hostility,aggression,homicidal ideation. If participant had positive response,investigator determined if it met AE criteria. (NCT01078298)
Timeframe: Baseline up to Week 16
| Intervention | participants (Number) |
|---|
| Varenicline | 185 |
| Placebo | 180 |
Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)
"Percentage of participants who reported no use of nicotine-containing products by answering No to the nicotine use inventory (NUI) questions: 'Has the participant smoked cigarettes' and 'Has the participant used other nicotine-containing products' in the last 7 days (Week 9) or since last study visit (Week 9 through 12) confirmed by a measurement of an end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm)." (NCT01078298)
Timeframe: Week 9 through Week 12
| Intervention | Percentage of participants (Number) |
|---|
| Varenicline | 35.9 |
| Placebo | 15.6 |
Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score
The BIS-11 is a self-administered 30 items questionnaire to assess measure of impulsivity. Items are scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). Total score range from 30 to 120. Barratt suggested that a total score of greater than or equal to 75 could indicate an impulse-control disorder, whereas a total score in the range of 70 to 75 could indicate pathological impulsivity. (NCT01078298)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
| Intervention | Units on a scale (Mean) |
|---|
| Baseline(n=256,269) | Change at Week 1(n=250,265) | Change at Week 2(n= 244, 255) | Change at Week 3(n= 241, 249) | Change at Week 4(n= 230, 246) | Change at Week 5(n=228, 234) | Change at Week 6(n=224, 226) | Change at Week 7(n=226, 227) | Change at Week 8(n=219, 216) | Change at Week 9(n=218, 215) | Change at Week 10(n=214, 211) | Change at Week 11(n= 211, 205) | Change at Week 12(n= 210, 204) | Change at Week 13(n= 211, 201) | Change at Week 16(n= 202, 196) |
|---|
| Placebo | 64.2 | -0.8 | -1.1 | -1.3 | -1.2 | -1.1 | -1.2 | -1.3 | -1.2 | -1.4 | -1.7 | -1.5 | -1.4 | -1.1 | -1.3 |
,| Varenicline | 65.1 | -0.5 | -0.8 | -1.0 | -1.0 | -1.1 | -1.4 | -1.6 | -1.3 | -1.5 | -1.5 | -1.6 | -1.0 | -1.4 | -1.4 |
Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected. Change: mean score at observation minus mean score at baseline. (NCT01078298)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
| Intervention | Units on a scale (Mean) |
|---|
| Baseline(n=256,269) | Change at Week 1(n=250,265) | Change at Week 2(n= 245, 255) | Change at Week 3(n= 241, 249) | Change at Week 4(n= 230, 246) | Change at Week 5(n=228, 235) | Change at Week 6(n=224, 227) | Change at Week 7(n=226, 227) | Change at Week 8(n=221, 218) | Change at Week 9(n=218, 216) | Change at Week 10(n=214, 212) | Change at Week 11(n= 211, 206) | Change at Week 12(n= 210, 205) | Change at Week 13(n= 211, 201) | Change at Week 16(n= 202, 197) |
|---|
| Placebo | 6.4 | -0.7 | -0.5 | -1.2 | -1.2 | -1.6 | -1.6 | -1.8 | -1.9 | -1.9 | -2.0 | -2.1 | -2.4 | -2.7 | -2.5 |
,| Varenicline | 6.1 | -0.5 | -0.7 | -1.3 | -1.6 | -1.6 | -1.7 | -2.0 | -1.9 | -2.0 | -2.2 | -2.3 | -2.3 | -2.4 | -2.7 |
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score
Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Change: mean score at observation minus mean score at baseline. (NCT01078298)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
| Intervention | Units on a scale (Mean) |
|---|
| Baseline(n=256,269) | Change at Week 1(n=250,265) | Change at Week 2(n= 245, 255) | Change at Week 3(n= 241, 249) | Change at Week 4(n= 230, 246) | Change at Week 5(n=228, 235) | Change at Week 6(n=224, 227) | Change at Week 7(n=226, 227) | Change at Week 8(n=221, 218) | Change at Week 9(n=218, 216) | Change at Week 10(n=214, 212) | Change at Week 11(n= 211, 206) | Change at Week 12(n= 210, 205) | Change at Week 13(n= 211, 201) | Change at Week 16(n= 202, 197) |
|---|
| Placebo | 7.9 | -0.6 | -1.1 | -1.8 | -1.5 | -2.3 | -2.3 | -2.4 | -2.6 | -2.5 | -2.8 | -2.9 | -3.2 | -3.6 | -3.2 |
,| Varenicline | 7.6 | -1.2 | -1.0 | -1.9 | -2.2 | -2.1 | -2.2 | -2.3 | -2.7 | -2.9 | -2.9 | -3.2 | -3.4 | -3.0 | -3.1 |
Number of Participants With 7-day Point Prevalence (PP) of Abstinence
Number of participants reporting no use of nicotine-containing products in the last 7 days confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm. (NCT01078298)
Timeframe: Weeks 12, 24, 52
| Intervention | participants (Number) |
|---|
| Week 12 | Week 24 | Week 52 |
|---|
| Placebo | 54 | 49 | 47 |
,| Varenicline | 118 | 80 | 73 |
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement from baseline is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected (NCT01078298)
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52
| Intervention | participants (Number) |
|---|
| Week 1: very much improved(n=250,263) | Week 1: much improved(n=250,263) | Week 1: minimally improved(n=250,263) | Week 1: no change(n=250,263) | Week 1: minimally worse(n=250,263) | Week 1: much worse(n=250,263) | Week 2: very much improved(n=244,255) | Week 2: much improved(n=244,255) | Week 2: minimally improved(n=244,255) | Week 2: no change(n=244,255) | Week 2: minimally worse(n=244,255) | Week 2: much worse(n=244,255) | Week 3: very much improved(n=241,248) | Week 3: much improved(n=241,248) | Week 3: minimally improved(n=241,248) | Week 3: no change(n=241,248) | Week 3: minimally worse(n=241,248) | Week 3: much worse(n=241,248) | Week 4: very much improved(n=230,245) | Week 4: much improved(n=230,245) | Week 4: minimally improved(n=230,245) | Week 4: no change(n=230,245) | Week 4: minimally worse(n=230,245) | Week 4: much worse(n=230,245) | Week 5: very much improved(n=227,233) | Week 5: much improved(n=227,233) | Week 5: minimally improved(n=227,233) | Week 5: no change(n=227,233) | Week 5: minimally worse(n=227,233) | Week 5: much worse(n=227,233) | Week 6: very much improved(n=224,226) | Week 6: much improved(n=224,226) | Week 6: minimally improved(n=224,226) | Week 6: no change(n=224,226) | Week 6: minimally worse(n=224,226) | Week 6: much worse(n=224,226) | Week 7: very much improved(n=226,226) | Week 7: much improved(n=226,226) | Week 7: minimally improved(n=226,226) | Week 7: no change(n=226,226) | Week 7: minimally worse(n=226,226) | Week 7: much worse(n=226,226) | Week 8: very much improved(n=221,217) | Week 8: much improved(n=221,217) | Week 8: minimally improved(n=221,217) | Week 8: no change(n=221,217) | Week 8: minimally worse(n=221,217) | Week 8: much worse(n=221,217) | Week 8: very much worse(n=221,217) | Week 9: very much improved(n=218,214) | Week 9: much improved(n=218,214) | Week 9: minimally improved(n=218,214) | Week 9: no change(n=218,214) | Week 9: minimally worse(n=218,214) | Week 10: very much improved(n=212,211) | Week 10: much improved(n=212,211) | Week 10: minimally improved(n=212,211) | Week 10: no change(n=212,211) | Week 10: minimally worse(n=212,211) | Week 10: much worse(n=212,211) | Week 11: very much improved(n=211,205) | Week 11: much improved(n=211,205) | Week 11: minimally improved(n=211,205) | Week 11: no change(n=211,205) | Week 11: minimally worse(n=211,205) | Week 11: much worse(n=211,205) | Week 12: very much improved(n=210,204) | Week 12: much improved(n=210,204) | Week 12: minimally improved(n=210,204) | Week 12: no change(n=210,204) | Week 12: minimally worse(n=210,204) | Week 13: very much improved(n=211,200) | Week 13: much improved(n=211,200) | Week 13: minimally improved(n=211,200) | Week 13: no change(n=211,200) | Week 13: minimally worse(n=211,200) | Week 13: much worse(n=211,200) | Week 16: very much improved(n=203,199) | Week 16: much improved(n=203,199) | Week 16: minimally improved(n=203,199) | Week 16: no change(n=203,199) | Week 16: minimally worse(n=203,199) | Week 16: much worse(n=203,199) | Week 24: very much improved(n=196,193) | Week 24: much improved(n=196,193) | Week 24: minimally improved(n=196,193) | Week 24: no change(n=196,193) | Week 24: minimally worse(n=196,193) | Week 24: much worse(n=196,193) | Week 32: very much improved(n=188,188) | Week 32: much improved(n=188,188) | Week 32: minimally improved(n=188,188) | Week 32: no change(n=188,188) | Week 32: minimally worse(n=188,188) | Week 32: much worse(n=188,188) | Week 40: very much improved(n=180,182) | Week 40: much improved(n=180,182) | Week 40: minimally improved(n=180,182) | Week 40: no change(n=180,182) | Week 40: minimally worse(n=180,182) | Week 40: much worse(n=180,182) | Week 40: very much worse(n=180,182) | Week 52: very much improved(n=178,180) | Week 52: much improved(n=178,180) | Week 52: minimally improved(n=178,180) | Week 52: no change(n=178,180) | Week 52: minimally worse(n=178,180) |
|---|
| Placebo | 2 | 6 | 21 | 222 | 11 | 1 | 1 | 12 | 38 | 181 | 21 | 2 | 4 | 14 | 45 | 165 | 17 | 3 | 6 | 12 | 51 | 154 | 19 | 3 | 9 | 11 | 46 | 151 | 14 | 2 | 6 | 14 | 41 | 148 | 17 | 0 | 9 | 18 | 34 | 150 | 13 | 2 | 12 | 15 | 40 | 139 | 10 | 1 | 0 | 13 | 16 | 31 | 141 | 13 | 13 | 18 | 35 | 133 | 11 | 1 | 15 | 14 | 35 | 129 | 10 | 2 | 17 | 13 | 39 | 124 | 11 | 16 | 13 | 40 | 121 | 10 | 0 | 15 | 16 | 33 | 119 | 12 | 4 | 13 | 18 | 31 | 125 | 6 | 0 | 19 | 21 | 31 | 113 | 3 | 1 | 17 | 15 | 32 | 109 | 7 | 2 | 0 | 22 | 13 | 26 | 112 | 7 |
,| Varenicline | 1 | 12 | 31 | 189 | 16 | 1 | 2 | 18 | 33 | 159 | 27 | 5 | 10 | 17 | 42 | 146 | 26 | 0 | 8 | 18 | 35 | 152 | 15 | 2 | 13 | 14 | 34 | 146 | 19 | 1 | 11 | 20 | 39 | 139 | 13 | 2 | 19 | 23 | 32 | 136 | 14 | 2 | 19 | 18 | 37 | 131 | 15 | 0 | 1 | 19 | 19 | 36 | 129 | 15 | 20 | 21 | 30 | 124 | 16 | 1 | 23 | 17 | 38 | 120 | 13 | 0 | 19 | 19 | 34 | 127 | 11 | 18 | 19 | 34 | 127 | 12 | 1 | 17 | 27 | 26 | 119 | 14 | 0 | 17 | 17 | 24 | 127 | 10 | 1 | 15 | 19 | 27 | 118 | 9 | 0 | 10 | 23 | 23 | 117 | 6 | 0 | 1 | 20 | 20 | 25 | 110 | 3 |
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
"C-SSRS assessed if participant experienced following: completed suicide (1), suicide attempt (2)(response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (3)(Yes on preparatory acts or behavior), suicidal ideation (4)(Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(Yes on Has participant engaged in non-suicidal self-injurious behavior)." (NCT01078298)
Timeframe: Baseline, Week 1 up to 30 days after Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (follow-up [FU])
| Intervention | participants (Number) |
|---|
| Baseline,Suicidal Behavior or/and Ideation | Baseline,4 | Baseline,4: wish to be dead | TE,Suicidal Behavior or/and Ideation | TE,2 | TE,4 | TE,4: wish to be dead | TE,4: non-specific active suicidal thoughts | TE,4: with any methods,without intent to act | TE,4: with some intent,without specific plan. | TE,4: with specific plan and intent | FU,Suicidal Behavior or/and Ideation | FU,1 | FU,4 | FU,4: wish to be dead | FU,4: non-specific active suicidal thoughts | FU,4: with any methods,without intent to act | FU,4: with some intent,without specific plan | FU,7 |
|---|
| Placebo | 1 | 1 | 1 | 20 | 1 | 19 | 18 | 7 | 5 | 3 | 1 | 12 | 0 | 12 | 12 | 3 | 2 | 1 | 1 |
,| Varenicline | 6 | 6 | 6 | 15 | 0 | 15 | 15 | 4 | 2 | 0 | 0 | 13 | 1 | 12 | 11 | 5 | 2 | 1 | 1 |
Number of Participants With Clinical Global Impression - Severity (CGI-S) Score
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected (NCT01078298)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52
| Intervention | participants (Number) |
|---|
| Baseline:Normal; Week 1:Normal (n=250,263) | Baseline:Borderline; Week 1:Normal (n=250,263) | Baseline:Mildly; Week 1:Normal (n=250,263) | Baseline:Moderately; Week 1:Normal (n=250,263) | Baseline:Normal; Week 1:Borderline (n=250,263) | Baseline:Borderline; Week 1:Borderline (n=250,263) | Baseline:Mildly; Week 1:Borderline (n=250,263) | Baseline:Moderately; Week 1:Borderline (n=250,263) | Baseline:Normal; Week 1:Mildly (n=250,263) | Baseline:Borderline; Week 1:Mildly (n=250,263) | Baseline:Mildly; Week 1:Mildly (n=250,263) | Baseline:Moderately; Week 1:Mildly (n=250,263) | Baseline:Borderline; Week 1:Moderately (n=250,263) | Baseline:Mildly; Week 1:Moderately (n=250,263) | Baseline:Moderately; Week 1:Moderately (n=250,263) | Baseline:Markedly; Week 1:Moderately (n=250,263) | Baseline:Markedly; Week 1:Markedly (n=250,263) | Baseline:Normal; Week 2:Normal (n=244,254) | Baseline:Borderline; Week 2:Normal (n=244,254) | Baseline:Mildly; Week 2:Normal (n=244,254) | Baseline: Moderately; Week 2:Normal (n=244,254) | Baseline:Normal; Week 2:Borderline (n=244,254) | Baseline:Borderline; Week 2:Borderline (n=244,254) | Baseline:Mildly; Week 2:Borderline (n=244,254) | Baseline:Moderately; Week 2:Borderline (n=244,254) | Baseline:Normal; Week 2:Mildly (n=244,254) | Baseline:Borderline; Week 2:Mildly (n=244,254) | Baseline:Mildly; Week 2:Mildly (n=244,254) | Baseline:Moderately; Week 2:Mildly (n=244,254) | Baseline:Markedly; Week 2:Mildly (n=244,254) | Baseline:Normal; Week 2:Moderately (n=244,254) | Baseline:Borderline; Week 2:Moderately (n=244,254) | Baseline:Mildly; Week 2:Moderately (n=244,254) | Baseline:Moderately; Week 2:Moderately (n=244,254) | Baseline:Markedly; Week 2:Moderately (n=244,254) | Baseline: Moderately; Week 2:Markedly (n=244,254) | Baseline:Markedly; Week 2:Markedly (n=244,254) | Baseline:Normal; Week 3:Normal (n=241,247) | Baseline:Borderline; Week 3:Normal (n=241,247) | Baseline:Mildly; Week 3:Normal (n=241,247) | Baseline:Moderately; Week 3:Normal (n=241,247) | Baseline:Normal; Week 3:Borderline (n=241,247) | Baseline:Borderline; Week 3:Borderline (n=241,247) | Baseline:Mildly; Week 3:Borderline (n=241,247) | Baseline:Moderately; Week 3:Borderline (n=241,247) | Baseline:Normal; Week 3:Mildly (n=241,247) | Baseline:Borderline; Week 3:Mildly (n=241,247) | Baseline:Mildly; Week 3:Mildly (n=241,247) | Baseline:Moderately; Week 3:Mildly (n=241,247) | Baseline:Markedly; Week 3:Mildly (n=241,247) | Baseline:Normal; Week 3:Moderately (n=241,247) | Baseline:Mildly; Week 3:Moderately (n=241,247) | Baseline:Moderately; Week 3:Moderately (n=241,247) | Baseline:Markedly; Week 3:Moderately (n=241,247) | Baseline:Moderately; Week 3:Markedly (n=241,247) | Baseline:Markedly; Week 3:Markedly (n=241,247) | Baseline:Normal; Week 4:Normal (n=230,244) | Baseline:Borderline; Week 4:Normal (n=230,244) | Baseline:Mildly; Week 4:Normal (n=230,244) | Baseline:Moderately; Week 4:Normal (n=230,244) | Baseline:Normal; Week 4:Borderline (n=230,244) | Baseline:Borderline; Week 4:Borderline (n=230,244) | Baseline:Mildly; Week 4:Borderline (n=230,244) | Baseline:Moderately; Week 4:Borderline (n=230,244) | Baseline:Normal; Week 4:Mildly (n=230,244) | Baseline:Borderline; Week 4:Mildly (n=230,244) | Baseline:Mildly; Week 4:Mildly (n=230,244) | Baseline:Moderately; Week 4:Mildly (n=230,244) | Baseline:Markedly; Week 4:Mildly (n=230,244) | Baseline:Borderline; Week 4:Moderately (n=230,244) | Baseline:Mildly; Week 4:Moderately (n=230,244) | Baseline:Moderately; Week 4:Moderately (n=230,244) | Baseline:Markedly; Week 4:Moderately (n=230,244) | Baseline:Borderline; Week 4:Markedly (n=230,244) | Baseline:Moderately; Week 4:Markedly (n=230,244) | Baseline:Markedly; Week 4:Markedly (n=230,244) | Baseline:Normal; Week 5:Normal (n=227,232) | Baseline:Borderline; Week 5:Normal (n=227,232) | Baseline:Mildly; Week 5:Normal (n=227,232) | Baseline:Moderately; Week 5:Normal (n=227,232) | Baseline:Normal; Week 5:Borderline (n=227,232) | Baseline:Borderline; Week 5:Borderline (n=227,232) | Baseline:Mildly; Week 5:Borderline (n=227,232) | Baseline:Moderately; Week 5:Borderline (n=227,232) | Baseline:Normal; Week 5:Mildly (n=227,232) | Baseline:Borderline; Week 5:Mildly (n=227,232) | Baseline:Mildly; Week 5:Mildly (n=227,232) | Baseline:Moderately; Week 5:Mildly (n=227,232) | Baseline:Markedly; Week 5:Mildly (n=227,232) | Baseline:Normal; Week 5:Moderately (n=227,232) | Baseline:Borderline; Week 5:Moderately (n=227,232) | Baseline:Mildly; Week 5:Moderately (n=227,232) | Baseline:Moderately; Week 5:Moderately (n=227,232) | Baseline:Markedly; Week 5:Moderately (n=227,232) | Baseline:Moderately; Week 5:Markedly (n=227,232) | Baseline:Normal; Week 6:Normal (n=224,225) | Baseline:Borderline; Week 6:Normal (n=224,225) | Baseline:Mildly; Week 6:Normal (n=224,225) | Baseline:Moderately; Week 6:Normal (n=224,225) | Baseline:Normal; Week 6:Borderline (n=224,225) | Baseline:Borderline; Week 6:Borderline (n=224,225) | Baseline:Mildly; Week 6:Borderline (n=224,225) | Baseline:Moderately; Week 6:Borderline (n=224,225) | Baseline:Normal; Week 6:Mildly (n=224,225) | Baseline:Borderline; Week 6:Mildly (n=224,225) | Baseline:Mildly; Week 6:Mildly (n=224,225) | Baseline:Moderately; Week 6:Mildly (n=224,225) | Baseline:Markedly; Week 6:Mildly (n=224,225) | Baseline:Normal; Week 6:Moderately (n=224,225) | Baseline:Borderline; Week 6:Moderately (n=224,225) | Baseline:Mildly; Week 6:Moderately (n=224,225) | Baseline:Moderately; Week 6:Moderately (n=224,225) | Baseline:Moderately; Week 6:Markedly (n=224,225) | Baseline:Markedly; Week 6:Markedly (n=224,225) | Baseline:Normal; Week 7:Normal (n=226,225) | Baseline:Borderline; Week 7:Normal (n=226,225) | Baseline:Mildly; Week 7:Normal (n=226,225) | Baseline:Moderately; Week 7:Normal (n=226,225) | Baseline:Normal; Week 7:Borderline (n=226,225) | Baseline:Borderline; Week 7:Borderline (n=226,225) | Baseline:Mildly; Week 7:Borderline (n=226,225) | Baseline:Moderately; Week 7:Borderline (n=226,225) | Baseline:Markedly; Week 7:Borderline (n=226,225) | Baseline:Normal; Week 7:Mildly (n=226,225) | Baseline:Borderline; Week 7:Mildly (n=226,225) | Baseline:Mildly; Week 7:Mildly (n=226,225) | Baseline:Moderately; Week 7:Mildly (n=226,225) | Baseline:Markedly; Week 7:Mildly (n=226,225) | Baseline:Normal; Week 7:Moderately (n=226,225) | Baseline:Borderline; Week 7:Moderately (n=226,225) | Baseline:Mildly; Week 7:Moderately (n=226,225) | Baseline:Moderately; Week 7:Moderately (n=226,225) | Baseline:Markedly; Week 7:Moderately (n=226,225) | Baseline:Moderately; Week 7:Markedly (n=226,225) | Baseline:Normal; Week 8:Normal (n=221,216) | Baseline:Borderline; Week 8:Normal (n=221,216) | Baseline:Mildly; Week 8:Normal (n=221,216) | Baseline:Moderately; Week 8:Normal (n=221,216) | Baseline:Normal; Week 8:Borderline (n=221,216) | Baseline:Borderline; Week 8:Borderline (n=221,216) | Baseline:Mildly; Week 8:Borderline (n=221,216) | Baseline:Moderately; Week 8:Borderline (n=221,216) | Baseline:Markedly; Week 8:Borderline (n=221,216) | Baseline:Normal; Week 8:Mildly (n=221,216) | Baseline:Borderline; Week 8:Mildly (n=221,216) | Baseline:Mildly; Week 8:Mildly (n=221,216) | Baseline:Moderately; Week 8:Mildly (n=221,216) | Baseline:Markedly; Week 8:Mildly (n=221,216) | Baseline:Normal; Week 8:Moderately (n=221,216) | Baseline:Mildly; Week 8:Moderately (n=221,216) | Baseline:Moderately; Week 8:Moderately (n=221,216) | Baseline:Markedly; Week 8:Moderately (n=221,216) | Baseline:Mildly; Week 8:Markedly (n=221,216) | Baseline:Moderately; Week 8:Markedly (n=221,216) | Baseline:Normal; Week 9:Normal (n=218,213) | Baseline:Borderline; Week 9:Normal (n=218,213) | Baseline:Mildly; Week 9:Normal (n=218,213) | Baseline:Moderately; Week 9:Normal (n=218,213) | Baseline:Normal; Week 9:Borderline (n=218,213) | Baseline:Borderline; Week 9:Borderline (n=218,213) | Baseline:Mildly; Week 9:Borderline (n=218,213) | Baseline:Moderately; Week 9:Borderline (n=218,213) | Baseline:Markedly; Week 9:Borderline (n=218,213) | Baseline:Normal; Week 9:Mildly (n=218,213) | Baseline:Borderline; Week 9:Mildly (n=218,213) | Baseline:Mildly; Week 9:Mildly (n=218,213) | Baseline:Moderately; Week 9:Mildly (n=218,213) | Baseline:Mildly; Week 9:Moderately (n=218,213) | Baseline:Moderately; Week 9:Moderately (n=218,213) | Baseline:Markedly; Week 9:Moderately (n=218,213) | Baseline:Mildly; Week 9:Markedly (n=218,213) | Baseline:Moderately; Week 9:Markedly (n=218,213) | Baseline:Normal; Week 10:Normal (n=212,210) | Baseline:Borderline; Week 10:Normal (n=212,210) | Baseline:Mildly; Week 10:Normal (n=212,210) | Baseline:Moderately; Week 10:Normal (n=212,210) | Baseline:Normal; Week 10:Borderline (n=212,210) | Baseline:Borderline; Week 10:Borderline (n=212,210 | Baseline:Mildly; Week 10:Borderline (n=212,210) | Baseline:Moderately; Week 10:Borderline(n=212,210) | Baseline:Markedly; Week 10:Borderline(n=212,210) | Baseline:Normal; Week 10:Mildly (n=212,210) | Baseline:Borderline; Week 10:Mildly (n=212,210) | Baseline:Mildly; Week 10:Mildly (n=212,210) | Baseline:Moderately; Week 10:Mildly (n=212,210) | Baseline:Normal; Week 10:Moderately (n=212,210) | Baseline:Mildly; Week 10:Moderately (n=212,210) | Baseline:Moderately; Week 10:Moderately(n=212,210) | Baseline:Markedly; Week 10:Moderately (n=212,210) | Baseline:Moderately; Week 10:Markedly (n=212,210) | Baseline:Normal; Week 11:Normal (n=211,205) | Baseline:Borderline; Week 11:Normal (n=211,205) | Baseline:Mildly; Week 11:Normal (n=211,205) | Baseline:Moderately; Week 11:Normal (n=211,205) | Baseline:Markedly; Week 11:Normal (n=211,205) | Baseline:Normal; Week 11:Borderline (n=211,205) | Baseline:Borderline; Week 11:Borderline(n=211,205) | Baseline:Mildly; Week 11:Borderline (n=211,205) | Baseline:Moderately; Week 11:Borderline(n=211,205) | Baseline:Markedly; Week 11:Borderline (n=211,205) | Baseline:Normal; Week 11:Mildly (n=211,205) | Baseline:Borderline; Week 11:Mildly (n=211,205) | Baseline:Mildly; Week 11:Mildly (n=211,205) | Baseline:Moderately; Week 11:Mildly (n=211,205) | Baseline:Normal; Week 11:Moderately (n=211,205) | Baseline:Mildly; Week 11:Moderately (n=211,205) | Baseline:Moderately; Week 11:Moderately(n=211,205) | Baseline:Markedly; Week 11:Moderately (n=211,205) | Baseline:Mildly; Week 11:Markedly (n=211,205) | Baseline:Normal; Week 12:Normal (n=210,203) | Baseline:Borderline; Week 12:Normal (n=210,203) | Baseline:Mildly; Week 12:Normal (n=210,203) | Baseline:Moderately; Week 12:Normal (n=210,203) | Baseline:Markedly; Week 12:Normal (n=210,203) | Baseline:Normal; Week 12:Borderline (n=210,203) | Baseline:Borderline; Week 12:Borderline(n=210,203) | Baseline:Mildly; Week 12:Borderline (n=210,203) | Baseline:Moderately; Week 12:Borderline(n=210,203) | Baseline:Markedly; Week 12:Borderline (n=210,203) | Baseline:Normal; Week 12:Mildly (n=210,203) | Baseline:Borderline; Week 12:Mildly (n=210,203) | Baseline:Mildly; Week 12:Mildly (n=210,203) | Baseline:Moderately; Week 12:Mildly (n=210,203) | Baseline:Borderline; Week 12:Moderately(n=210,203) | Baseline:Mildly; Week 12:Moderately (n=210,203) | Baseline:Moderately; Week 12:Moderately(n=210,203) | Baseline:Markedly; Week 12:Moderately(n=210,203) | Baseline:Moderately; Week 12:Markedly(n=210,203) | Baseline:Normal; Week 13:Normal (n=211,199) | Baseline:Borderline; Week 13:Normal (n=211,199) | Baseline:Mildly; Week 13:Normal (n=211,199) | Baseline:Moderately; Week 13:Normal (n=211,199) | Baseline:Markedly; Week 13:Normal (n=211,199) | Baseline:Normal; Week 13:Borderline (n=211,199) | Baseline:Borderline; Week 13:Borderline(n=211,199) | Baseline:Mildly; Week 13:Borderline (n=211,199) | Baseline:Moderately; Week 13:Borderline(n=211,199) | Baseline:Markedly; Week 13:Borderline(n=211,199) | Baseline:Borderline; Week 13:Mildly (n=211,199) | Baseline:Mildly; Week 13:Mildly (n=211,199) | Baseline:Moderately; Week 13:Mildly (n=211,199) | Baseline:Mildly; Week 13:Moderately (n=211,199) | Baseline:Moderately; Week 13:Moderately(n=211,199) | Baseline:Markedly; Week 13:Moderately(n=211,199) | Baseline:Moderately; Week 13:Markedly (n=211,199) | Baseline:Normal; Week 16:Normal (n=203,198) | Baseline:Borderline; Week 16:Normal (n=203,198) | Baseline:Mildly; Week 16:Normal (n=203,198) | Baseline:Moderately; Week 16:Normal (n=203,198) | Baseline:Markedly; Week 16:Normal (n=203,198) | Baseline:Normal; Week 16:Borderline (n=203,198) | Baseline:Borderline; Week 16:Borderline(n=203,198) | Baseline:Mildly; Week 16:Borderline (n=203,198) | Baseline:Moderately; Week 16:Borderline(n=203,198) | Baseline:Markedly; Week 16:Borderline (n=203,198) | Baseline:Normal; Week 16:Mildly (n=203,198) | Baseline:Borderline; Week 16:Mildly (n=203,198) | Baseline:Mildly; Week 16:Mildly (n=203,198) | Baseline:Moderately; Week 16:Mildly (n=203,198) | Baseline:Borderline; Week 16:Moderately(n=203,198) | Baseline:Mildly; Week 16:Moderately (n=203,198) | Baseline:Moderately; Week 16:Moderately(n=203,198) | Baseline:Markedly; Week 16:Moderately (n=203,198) | Baseline:Moderately; Week 16:Markedly (n=203,198) | Baseline:Normal; Week 24:Normal (n=196,192) | Baseline:Borderline; Week 24:Normal (n=196,192) | Baseline:Mildly; Week 24:Normal (n=196,192) | Baseline:Moderately; Week 24:Normal (n=196,192) | Baseline:Markedly; Week 24:Normal (n=196,192) | Baseline:Normal; Week 24:Borderline (n=196,192) | Baseline:Borderline; Week 24:Borderline(n=196,192) | Baseline:Mildly; Week 24:Borderline (n=196,192) | Baseline:Moderately; Week 24:Borderline(n=196,192) | Baseline:Markedly; Week 24:Borderline (n=196,192) | Baseline:Normal; Week 24:Mildly (n=196,192) | Baseline:Borderline; Week 24:Mildly (n=196,192) | Baseline:Mildly; Week 24:Mildly (n=196,192) | Baseline:Moderately; Week 24:Mildly (n=196,192) | Baseline:Mildly; Week 24:Moderately (n=196,192) | Baseline:Moderately; Week 24:Moderately(n=196,192) | Baseline:Markedly; Week 24:Moderately (n=196,192) | Baseline:Moderately; Week 24:Markedly (n=196,192) | Baseline:Normal; Week 32:Normal (n=188,187) | Baseline:Borderline; Week 32:Normal (n=188,187) | Baseline:Mildly; Week 32:Normal (n=188,187) | Baseline:Moderately; Week 32:Normal (n=188,187) | Baseline:Markedly; Week 32:Normal (n=188,187) | Baseline:Normal; Week 32:Borderline (n=188,187) | Baseline:Borderline; Week 32:Borderline(n=188,187) | Baseline:Mildly; Week 32:Borderline (n=188,187) | Baseline:Moderately; Week 32:Borderline(n=188,187) | Baseline:Markedly; Week 32:Borderline (n=188,187) | Baseline:Normal; Week 32:Mildly (n=188,187) | Baseline:Borderline; Week 32:Mildly (n=188,187) | Baseline:Mildly; Week 32:Mildly (n=188,187) | Baseline:Moderately; Week 32:Mildly (n=188,187) | Baseline:Markedly; Week 32:Mildly (n=188,187) | Baseline:Mildly; Week 32:Moderately (n=188,187) | Baseline:Moderately; Week 32:Moderately(n=188,187) | Baseline:Borderline; Week 32:Markedly (n=188,187) | Baseline:Moderately; Week 32:Markedly (n=188,187) | Baseline:Normal; Week 40:Normal (n=180,181) | Baseline:Borderline; Week 40:Normal (n=180,181) | Baseline:Mildly; Week 40:Normal (n=180,181) | Baseline:Moderately; Week 40:Normal (n=180,181) | Baseline:Markedly; Week 40:Normal (n=180,181) | Baseline:Normal; Week 40:Borderline (n=180,181) | Baseline:Borderline; Week 40:Borderline(n=180,181) | Baseline:Mildly; Week 40:Borderline (n=180,181) | Baseline:Moderately; Week 40:Borderline(n=180,181) | Baseline:Markedly; Week 40:Borderline (n=180,181) | Baseline:Normal; Week 40:Mildly (n=180,181) | Baseline:Borderline; Week 40:Mildly (n=180,181) | Baseline:Mildly; Week 40:Mildly (n=180,181) | Baseline:Moderately; Week 40:Mildly (n=180,181) | Baseline:Markedly; Week 40:Mildly (n=180,181) | Baseline:Normal; Week 40:Moderately (n=180,181) | Baseline:Mildly; Week 40:Moderately (n=180,181) | Baseline:Moderately; Week 40:Moderately(n=180,181) | Baseline:Moderately; Week 40:Markedly (n=180,181) | Baseline:Normal; Week 52:Normal (n=178,179) | Baseline:Borderline; Week 52:Normal (n=178,179) | Baseline:Mildly; Week 52:Normal (n=178,179) | Baseline:Moderately; Week 52:Normal (n=178,179) | Baseline:Markedly; Week 52:Normal (n=178,179) | Baseline:Normal; Week 52:Borderline (n=178,179) | Baseline:Borderline; Week 52:Borderline(n=178,179) | Baseline:Mildly; Week 52:Borderline (n=178,179) | Baseline:Moderately; Week 52:Borderline(n=178,179) | Baseline:Markedly; Week 52:Borderline (n=178,179) | Baseline:Normal; Week 52:Mildly (n=178,179) | Baseline:Borderline; Week 52:Mildly (n=178,179) | Baseline:Mildly; Week 52:Mildly (n=178,179) | Baseline:Moderately; Week 52:Mildly (n=178,179) | Baseline:Mildly; Week 52:Moderately (n=178,179) | Baseline:Moderately; Week 52:Moderately(n=178,179) | Baseline:Markedly; Week 52:Moderately (n=178,179) | Baseline:Moderately; Week 52:Markedly (n=178,179) |
|---|
| Placebo | 100 | 8 | 1 | 0 | 3 | 42 | 3 | 3 | 2 | 1 | 56 | 9 | 2 | 0 | 30 | 0 | 3 | 96 | 12 | 0 | 1 | 5 | 37 | 7 | 4 | 2 | 0 | 48 | 12 | 0 | 0 | 1 | 2 | 24 | 1 | 0 | 2 | 95 | 16 | 4 | 0 | 2 | 34 | 7 | 2 | 0 | 2 | 42 | 17 | 0 | 2 | 1 | 20 | 1 | 1 | 1 | 92 | 17 | 5 | 1 | 5 | 27 | 7 | 3 | 2 | 2 | 43 | 15 | 1 | 0 | 2 | 2 | 18 | 0 | 0 | 2 | 88 | 16 | 6 | 4 | 1 | 30 | 4 | 3 | 1 | 2 | 39 | 15 | 1 | 1 | 0 | 4 | 15 | 1 | 1 | 84 | 18 | 4 | 1 | 3 | 24 | 7 | 4 | 2 | 2 | 37 | 15 | 1 | 3 | 1 | 3 | 14 | 1 | 1 | 88 | 20 | 5 | 1 | 2 | 23 | 6 | 8 | 0 | 0 | 2 | 37 | 10 | 1 | 1 | 1 | 4 | 14 | 1 | 1 | 87 | 19 | 6 | 3 | 2 | 19 | 7 | 5 | 0 | 0 | 2 | 35 | 13 | 1 | 0 | 3 | 12 | 1 | 1 | 0 | 87 | 18 | 5 | 4 | 2 | 19 | 3 | 8 | 1 | 0 | 4 | 38 | 9 | 0 | 12 | 1 | 1 | 1 | 85 | 21 | 5 | 5 | 1 | 18 | 6 | 7 | 1 | 1 | 2 | 35 | 11 | 0 | 1 | 9 | 1 | 1 | 81 | 22 | 6 | 5 | 0 | 2 | 15 | 3 | 6 | 1 | 0 | 3 | 34 | 13 | 1 | 1 | 10 | 1 | 1 | 79 | 22 | 6 | 8 | 0 | 2 | 16 | 4 | 3 | 1 | 2 | 1 | 34 | 14 | 1 | 3 | 6 | 1 | 0 | 78 | 21 | 5 | 9 | 0 | 3 | 17 | 6 | 4 | 1 | 3 | 32 | 11 | 1 | 7 | 1 | 0 | 78 | 20 | 6 | 11 | 0 | 2 | 16 | 5 | 2 | 1 | 2 | 3 | 30 | 8 | 2 | 2 | 8 | 1 | 1 | 78 | 19 | 6 | 8 | 0 | 3 | 14 | 6 | 2 | 1 | 1 | 3 | 31 | 12 | 0 | 7 | 1 | 0 | 77 | 20 | 8 | 9 | 0 | 1 | 15 | 7 | 1 | 1 | 0 | 1 | 29 | 11 | 1 | 0 | 5 | 1 | 0 | 71 | 20 | 7 | 7 | 0 | 2 | 15 | 6 | 2 | 1 | 0 | 2 | 28 | 12 | 1 | 1 | 1 | 3 | 2 | 69 | 20 | 7 | 7 | 0 | 4 | 14 | 8 | 4 | 1 | 0 | 2 | 26 | 11 | 1 | 4 | 1 | 0 |
,| Varenicline | 105 | 7 | 4 | 1 | 3 | 31 | 9 | 2 | 0 | 4 | 46 | 6 | 1 | 1 | 28 | 1 | 1 | 102 | 13 | 5 | 0 | 1 | 22 | 10 | 4 | 3 | 4 | 40 | 10 | 1 | 2 | 1 | 2 | 20 | 0 | 3 | 1 | 101 | 18 | 6 | 2 | 3 | 16 | 8 | 4 | 2 | 6 | 42 | 10 | 1 | 0 | 2 | 19 | 0 | 0 | 1 | 101 | 17 | 7 | 4 | 2 | 17 | 8 | 1 | 0 | 3 | 39 | 11 | 1 | 2 | 2 | 12 | 1 | 1 | 1 | 0 | 98 | 19 | 8 | 4 | 2 | 13 | 8 | 2 | 2 | 6 | 36 | 11 | 2 | 0 | 1 | 2 | 12 | 0 | 1 | 96 | 22 | 10 | 3 | 3 | 11 | 6 | 5 | 2 | 5 | 38 | 8 | 2 | 0 | 1 | 1 | 10 | 1 | 0 | 93 | 23 | 14 | 3 | 5 | 13 | 4 | 5 | 1 | 2 | 2 | 36 | 10 | 1 | 0 | 1 | 2 | 10 | 0 | 1 | 92 | 21 | 12 | 3 | 4 | 14 | 6 | 7 | 2 | 2 | 3 | 32 | 9 | 0 | 1 | 3 | 9 | 0 | 0 | 1 | 91 | 22 | 11 | 4 | 3 | 13 | 6 | 6 | 2 | 3 | 2 | 34 | 10 | 1 | 8 | 0 | 1 | 1 | 88 | 20 | 13 | 7 | 5 | 14 | 6 | 4 | 2 | 1 | 1 | 29 | 8 | 1 | 3 | 9 | 0 | 1 | 90 | 23 | 13 | 7 | 1 | 3 | 10 | 6 | 3 | 1 | 1 | 2 | 30 | 9 | 0 | 3 | 8 | 0 | 0 | 89 | 23 | 13 | 6 | 1 | 4 | 12 | 6 | 4 | 1 | 0 | 0 | 30 | 9 | 0 | 3 | 8 | 0 | 1 | 92 | 22 | 13 | 6 | 2 | 3 | 11 | 7 | 5 | 0 | 0 | 30 | 9 | 3 | 7 | 0 | 1 | 91 | 19 | 14 | 7 | 2 | 2 | 11 | 4 | 2 | 0 | 1 | 0 | 30 | 11 | 0 | 3 | 4 | 0 | 2 | 88 | 18 | 15 | 5 | 2 | 0 | 13 | 4 | 2 | 0 | 2 | 0 | 27 | 8 | 4 | 7 | 0 | 1 | 82 | 16 | 10 | 4 | 2 | 0 | 12 | 9 | 4 | 0 | 2 | 0 | 28 | 8 | 0 | 3 | 7 | 0 | 1 | 81 | 17 | 11 | 2 | 2 | 0 | 9 | 8 | 4 | 0 | 1 | 2 | 25 | 11 | 0 | 0 | 2 | 4 | 1 | 81 | 19 | 12 | 4 | 2 | 1 | 8 | 8 | 4 | 0 | 1 | 0 | 24 | 8 | 1 | 4 | 0 | 1 |
Percentage of Participants With Continuous Abstinence Rate (CAR)
Percentage of participants who remained abstinent from the period defined as start of the primary endpoint (Week 9) through Week 24 and the end of follow-up (Week 52) by reporting no use of nicotine-containing products confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm. (NCT01078298)
Timeframe: Week 9 through Week 24, Week 9 through Week 52
| Intervention | Percentage of participants (Number) |
|---|
| Week 9 through Week 24 | Week 9 through Week 52 |
|---|
| Placebo | 12.3 | 10.4 |
,| Varenicline | 25.0 | 20.3 |
Change From Baseline in Eye Dryness Score From Baseline to Day 28
Change in Eye Dryness Score from baseline to 28 days. Eye Dryness (EDS) on a Visual Analogue Scale (VAS) from 0 (no discomfort) to 100 (maximum discomfort) millimeters where a lower score is indicative of a better outcome. (NCT03636061)
Timeframe: 28 days [Visit 1 (baseline and Visit 5 (28 days)]
| Intervention | score on a scale, mm (Least Squares Mean) |
|---|
| OC-01 Low Dose, 0.12 mg/ml | -11.6 |
| OC-01 Mid Dose, 0.6 mg/ml | -18.9 |
| OC-01 High Dose, 1.2 mg/ml | -15.6 |
| Placebo | -5.4 |
Change From Baseline to Day 21 in Eye Dryness Score at 5 Minutes Post Treatment in the CAE.
Change from baseline to Day 21 in Eye Dryness Score at 5 minutes post treatment in the CAE. Eye Dryness (EDS) on a Visual Analogue Scale (VAS) from 0 (no discomfort) to 100 (maximum discomfort) millimeters where a lower score is indicative of a better outcome. (NCT03636061)
Timeframe: 21 days [Visit 1 (baseline) and Visit 4 (21 days)]
| Intervention | score on a scale, mm (Least Squares Mean) |
|---|
| OC-01 Low Dose, 0.12 mg/ml | -8.1 |
| OC-01 Mid Dose, 0.6 mg/ml | -16.0 |
| OC-01 High Dose, 1.2 mg/ml | -18.4 |
| Placebo | -4.4 |
Mean Change in Schirmer's Test Score From Baseline to 28 Days
The primary end point was the change in anesthetized Schirmer's Test Score (STS) from baseline to 28 days in the study eye following treatment with OC-01. Schirmer's test score from 0-35 mm where a higher score is indicative of a better outcome. (NCT03636061)
Timeframe: 28 Days [Visit 1 (baseline) and Visit 5 (28 days)]
| Intervention | score on a scale, mm (Least Squares Mean) |
|---|
| OC-01 Low Dose, 0.12 mg/mL | 10.1 |
| OC-01 Mid Dose, 0.6 mg/ML | 11.7 |
| OC-01 High Dose, 1.2 mg/mL | 11.0 |
| Placebo | 3.2 |
7-day Point Prevalence Quit Rate at 6-month Follow up Survey
The percentage of ITT subjects who were verified as abstinent at the 6-month follow up survey. Abstinence was defined as no self-reported smoking (not even a puff) for at least 7 days before the telephone assessment, with in-person verification for those self-reporting abstinence. In-person verification consisted of breath carbon monoxide analysis, with a reading of 8 parts-per-million or less confirming abstinence. Subjects who were lost to follow-up were considered smokers. (NCT01314001)
Timeframe: Week 24
| Intervention | percentage of ITT subjects (Number) |
|---|
| Placebo (Slow Metabolizers) | 14.4 |
| Placebo (Normal Metabolizers) | 12.9 |
| Nicotine Patch (Slow Metabolizers) | 21.6 |
| Nicotine Patch (Normal Metabolizers) | 13.6 |
| Varenicline (Slow Metabolizers) | 19.1 |
| Varenicline (Normal Metabolizers) | 22.0 |
7-day Point Prevalence Quit Rate at End-of-Treatment (EOT)
The percentage of ITT subjects who were verified as abstinent. Abstinence was defined as no self-reported smoking (not even a puff) for at least 7 days before the telephone assessment, with in-person verification for those self-reporting abstinence. In-person verification consisted of breath carbon monoxide analysis, with a reading of 8 parts-per-million or less confirming abstinence. Subjects who were lost to follow-up were considered smokers. (NCT01314001)
Timeframe: Week 11
| Intervention | percentage of ITT subjects (Number) |
|---|
| Placebo (Slow Metabolizers) | 17.2 |
| Placebo (Normal Metabolizers) | 18.6 |
| Nicotine Patch (Slow Metabolizers) | 27.7 |
| Nicotine Patch (Normal Metabolizers) | 22.5 |
| Varenicline (Slow Metabolizers) | 30.4 |
| Varenicline (Normal Metabolizers) | 38.5 |
Total Side-Effect Severity Index at Pre-Quit
"The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers).~Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects." (NCT01314001)
Timeframe: Pre-Quit (Week -1/Baseline)
| Intervention | units on a scale (Mean) |
|---|
| Placebo (Slow Metabolizers) | 3.95 |
| Placebo (Normal Metabolizers) | 3.40 |
| Nicotine Patch (Slow Metabolizers) | 3.26 |
| Nicotine Patch (Normal Metabolizers) | 3.97 |
| Varenicline (Slow Metabolizers) | 3.05 |
| Varenicline (Normal Metabolizers) | 3.57 |
Total Side-Effect Severity Index at Target Quit Date
"The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers).~Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects." (NCT01314001)
Timeframe: Target Quit Date (Week 0)
| Intervention | units on a scale (Mean) |
|---|
| Placebo (Slow Metabolizers) | 4.22 |
| Placebo (Normal Metabolizers) | 4.27 |
| Nicotine Patch (Slow Metabolizers) | 3.98 |
| Nicotine Patch (Normal Metabolizers) | 4.28 |
| Varenicline (Slow Metabolizers) | 4.68 |
| Varenicline (Normal Metabolizers) | 4.06 |
Total Side-Effect Severity Index at Week 1
"The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers).~Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects." (NCT01314001)
Timeframe: Week 1
| Intervention | units on a scale (Mean) |
|---|
| Placebo (Slow Metabolizers) | 5.58 |
| Placebo (Normal Metabolizers) | 5.46 |
| Nicotine Patch (Slow Metabolizers) | 5.44 |
| Nicotine Patch (Normal Metabolizers) | 5.58 |
| Varenicline (Slow Metabolizers) | 6.04 |
| Varenicline (Normal Metabolizers) | 5.26 |
Total Side-Effect Severity Index at Week 4
"The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers).~Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects." (NCT01314001)
Timeframe: Week 4
| Intervention | units on a scale (Mean) |
|---|
| Placebo (Slow Metabolizers) | 5.33 |
| Placebo (Normal Metabolizers) | 4.93 |
| Nicotine Patch (Slow Metabolizers) | 4.24 |
| Nicotine Patch (Normal Metabolizers) | 4.52 |
| Varenicline (Slow Metabolizers) | 4.97 |
| Varenicline (Normal Metabolizers) | 4.39 |
Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score
"The anxiety/depression score is calculated by adding the scores for scales #2 Anxiety and #9 Depressive Mood. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum anxiety/depression score is 2 and the maximum psychosis score is 14. A higher score indicates a more severe anxiety/depression rating." (NCT00554840)
Timeframe: Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Treatment Week 1 | Treatment Week 2 | Treatment Week 4 | Treatment Week 8 | Treatment Week 12 |
|---|
| Placebo | 6.75 | 8 | 7.25 | 8 | 3.37 | 7.5 |
,| Varenicline | 5.5 | 3.25 | 7.25 | 6.25 | 7.25 | 7 |
Brief Psychiatric Rating Scale (BPRS) - Psychosis Score
"The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating." (NCT00554840)
Timeframe: Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Treatment Week 1 | Treatment Week 2 | Treatment Week 4 | Treatment Week 8 | Treatment Week 12 |
|---|
| Placebo | 10 | 11.5 | 8.5 | 8.5 | 7.67 | 10.5 |
,| Varenicline | 11.25 | 8.5 | 9.25 | 8.25 | 10.75 | 8.75 |
Brief Psychiatric Rating Scale (BPRS) - Total Score
"The total BPRS score is calculated by adding the scores for subscales #1-#18. Each scale ranges from 1=Not Present to 7=Very Severe. Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating." (NCT00554840)
Timeframe: Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Treatment Week 1 | Treatment Week 2 | Treatment Week 4 | Treatment Week 8 | Treatment Week 12 |
|---|
| Placebo | 30.25 | 32.75 | 30.25 | 30.25 | 28 | 32 |
,| Varenicline | 35.75 | 33.75 | 35.5 | 31.75 | 36.25 | 34.75 |
Change of ExpiredCO Level From Baseline
End expired carbon monoxide (CO) level change from baseline to determine participants' level of smoking reduction by treatment assignment. Larger negative values represent a greater level of smoking reduction. (NCT00554840)
Timeframe: Weekly for 12 weeks
| Intervention | ppm (Mean) |
|---|
| Treatment Week 1 | Treatment Week 2 | Treatment Week 3 | Treatment Week 4 | Treatment Week 5 | Treatment Week 6 | Treatment Week 7 | Treatment Week 8 | Treatment Week 9 | Treatment Week 10 | Treatment Week 11 | Treatment Week 12 |
|---|
| Placebo | 9.5 | -11.5 | -5.75 | 2.5 | -4.5 | -3.83 | -2.83 | -4.83 | -0.17 | -2.83 | 8.17 | -0.75 |
,| Varenicline | -2.88 | -17.38 | -17.13 | -18.63 | -20.63 | -20.38 | -20.13 | -20.88 | -20.88 | -21.13 | -19.63 | -19.875 |
Level of Nicotine Dependence by Treatment Assignment
Nicotine dependence was measured using the total score from the Fagerstrom Test for Nicotine Dependence (FTND) assessment. The total score is computed by adding the scores from the five subscales. Total scores range from 1-10, with lower scores representing a smaller degree of nicotine dependence. (NCT00554840)
Timeframe: Weekly for 12 weeks
| Intervention | units on a scale (Mean) |
|---|
| Treatment Week 0 | Treatment Week 1 | Treatment Week 2 | Treatment Week 3 | Treatment Week 4 | Treatment Week 5 | Treatment Week 6 | Treatment Week 7 | Treatment Week 8 | Treatment Week 9 | Treatment Week 10 | Treatment Week 11 | Treatment Week 12 |
|---|
| Placebo | 5.75 | 5.25 | 4.75 | 4.5 | 5 | 5.25 | 4.33 | 4.67 | 4 | 3.67 | 3.67 | 4.33 | 4.25 |
,| Varenicline | 5.88 | 4.5 | 4.33 | 3 | 3 | 2.75 | 4.25 | 4.5 | 4.75 | 5 | 5 | 6 | 3.5 |
Side Effects
Side effects (33 items) were measured using a Side Effects Checklist (SEC). The percentage of participants endorsing each side effect were reported regardless of the severity or relation to study drug. (NCT00554840)
Timeframe: Weekly for 12 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Abdominal pain | Anorexia | Bruising | Constipation | Diarrhea | Dizziness | Dry mouth | Enuresis | Fever | Headache | Insomnia | Malaise | Mucosal ulceration | Nausea | Rash | Restlessness | Hypersalivation | Sedation | Stiffness | Sore throat | Tremor | Uticaria | Vomiting | Weight loss | Tinnitus |
|---|
| Placebo | 4 | 1 | 0 | 0 | 0 | 2 | 2 | 2 | 0 | 1 | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 0 | 0 |
,| Varenicline | 1 | 0 | 0 | 2 | 1 | 1 | 0 | 0 | 0 | 1 | 3 | 2 | 0 | 3 | 1 | 0 | 3 | 2 | 0 | 1 | 0 | 1 | 0 | 1 | 0 |
Point Prevalence Smoking Outcome at 12 Weeks (End of Treatment)
To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers. Point prevalence is defined as no smoking in the past 7 days. (NCT01639560)
Timeframe: 12 weeks
| Intervention | participants (Number) |
|---|
| Varenicline | 24 |
| Placebo | 7 |
Point Prevalence Smoking Outcome at 24 Weeks (End of Study)
To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates at 6 months in light smokers. Point prevalence is defined as no smoking in the past 7 days. (NCT01639560)
Timeframe: 24 weeks
| Intervention | participants (Number) |
|---|
| Varenicline | 18 |
| Placebo | 10 |
Prolonged Smoking Outcome at 12 Weeks (End of Treatment)
To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers. Prolonged abstinence is defined as no smoking since 2 weeks after the target quit date. (NCT01639560)
Timeframe: 12 weeks
| Intervention | participants (Number) |
|---|
| Varenicline | 18 |
| Placebo | 4 |
Prolonged Smoking Outcome at 24 Weeks (End of Study)
To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates at 6 months in light smokers. Prolonged abstinence is defined as no smoking since 2 weeks after the target quit date. (NCT01639560)
Timeframe: 24 weeks
| Intervention | participants (Number) |
|---|
| Varenicline | 14 |
| Placebo | 4 |
Number of Days of Varenicline Use
Number of days varenicline was used (NCT02136498)
Timeframe: 5 mo follow-up
| Intervention | Mean number of days (Mean) |
|---|
| mHealth Self-help + Varenicline | 39 |
| Augmented mHealth Self-help + Varenicline | 46 |
Point Prevalence Abstinence
Self-report of no-smoking, even a puff during the last 7 days. (NCT02136498)
Timeframe: 5 month follow-up
| Intervention | Percentage of people not smoking (Number) |
|---|
| mHealth Self-help + Varenicline | 24 |
| Augmented mHealth Self-help + Varenicline | 36 |
7-day Point Prevalence Biochemically Confirmed Abstinence
Number of participants who self report complete smoking abstinence over the last 7 days and are also verified to be abstinent by carbon monoxide (CO) expired breath testing with CO < 7 parts per million. (NCT02501265)
Timeframe: 12 weeks post-TQD (Visit 4)
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline Standard Protocol | 6 |
| Nicotine Patch Standard Protocol | 3 |
| Varenicline Adaptive Protocol | 23 |
| Nicotine Patch Adaptive Protocol | 6 |
Biochemically-confirmed 30-day Continuous Smoking Abstinence
Number of participants who self report complete smoking abstinence over the last 30 days and are also verified to be abstinent by carbon monoxide (CO) expired breath testing with CO < 7 parts per million. (NCT02501265)
Timeframe: 12 weeks post-TQD (Visit 4)
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline Standard Protocol | 5 |
| Nicotine Patch Standard Protocol | 3 |
| Varenicline Adaptive Protocol | 18 |
| Nicotine Patch Adaptive Protocol | 5 |
Change in Cigarettes Smoked Per Day
The percentage of participants who decreased the number of daily cigarettes smoked by 50% or more from the baseline assessment visit to 12 weeks post target quit day assessment visit collected by self-report in participants who completed the 12-week post target quit day assessment visit (NCT02501265)
Timeframe: 12 weeks post-TQD (Visit 4)
| Intervention | percentage of participants (Number) |
|---|
| Varenicline Standard Protocol | 80.4 |
| Nicotine Patch Standard Protocol | 71.4 |
| Varenicline Adaptive Protocol | 89.4 |
| Nicotine Patch Adaptive Protocol | 82.6 |
Change in Cigarettes Smoked Per Day (Phone)
The percentage of participants who decreased the number of daily cigarettes smoked by 50% or more from the baseline assessment visit to 52 weeks post target quit day assessment visit collected by self-report in participants who completed the 52-week post target quit day phone assessment. (NCT02501265)
Timeframe: 52 weeks post-TQD
| Intervention | percentage of participants (Number) |
|---|
| Varenicline Standard Protocol | 67.6 |
| Nicotine Patch Standard Protocol | 57.1 |
| Varenicline Adaptive Protocol | 84.8 |
| Nicotine Patch Adaptive Protocol | 62.5 |
Phone-assessed Self-reported Abstinence
Number of participants who self reported smoking abstinence over the last 24 hours assessed via single-item question. (NCT02501265)
Timeframe: 52 weeks post-TQD
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline Standard Protocol | 16 |
| Nicotine Patch Standard Protocol | 5 |
| Varenicline Adaptive Protocol | 21 |
| Nicotine Patch Adaptive Protocol | 6 |
Biochemically-validated 7-day Point Prevalence Tobacco Abstinence
"7-day point prevalence abstinence (Have you smoked a cigarette, even a puff, in the past 7 days?) was assessed at 12-week follow-up. Self reported abstinence was confirmed only if a salivary cotinine level was < 15 ng/ml or an expired carbon monoxide measurement was <10 ppm." (NCT00580398)
Timeframe: 12 weeks
| Intervention | participants (Number) |
|---|
| Control | 2 |
| Intervention | 11 |
Determination of the Feasibility of a Cognitive Behavioral Smoking Cessation Intervention.
Number of participants who completed the 12-week follow-up survey and thus the study. (NCT00580398)
Timeframe: 12 weeks
| Intervention | participants (Number) |
|---|
| Control | 17 |
| Intervention | 32 |
Number of Participants With Continuous Abstinence at 6-Month Follow-Up as Assessed by Self-Report and Bio-verification
Number of participants with continuous abstinence at the 6-month follow-up (no self-reported smoking during weeks 12-28 AND cotinine level 15 ng/mL or less at EOT and 6 month follow-up) (NCT03262662)
Timeframe: Self-report Treatment Weeks 12-28; bio-verification ~Week 16 and ~Week 29
| Intervention | Participants (Count of Participants) |
|---|
| Extended Run-In | 37 |
| Standard Run-In | 29 |
Number of Participants With Continuous Abstinence at End-of-Treatment (EOT) as Assessed by Self-Report and Bio-verification
Number of participants with bio-verified (cotinine level of 15 ng/mL or less) self-reported continuous abstinence from smoking (not even a puff) during the final four weeks of treatment (NCT03262662)
Timeframe: Self-report Treatment Weeks 12-15; bio-verification ~Week 16
| Intervention | Participants (Count of Participants) |
|---|
| Extended Run-In | 64 |
| Standard Run-In | 57 |
Pre-quit Change in Cigarettes Smoked Per Day
Percent change in smoking behavior (self-reported cigarettes per day; CPD) from timeline follow-back (TLFB) interviews during the pre-quit phase of the study. (NCT03262662)
Timeframe: Treatment Week 1 vs. Treatment Week 4 (final week before TQD)
| Intervention | percent change in CPD (Mean) |
|---|
| Extended Run-In | -38.8 |
| Standard Run-In | -17.5 |
Comparison of Combined Extended vs Brief Treatment at Week 24
The three extended treatment programs were combined and compared to the Brief treatment, with extended treatments expected to produce significant higher CO corrected abstinence rates overall. Comparisons will be tested using Chi-Square analysis. (NCT01162239)
Timeframe: 24 weeks following treatment initiation
| Intervention | Participants (Count of Participants) |
|---|
| Extended Brief Contact | 20 |
| Combined Extended Treatments | 63 |
Comparison of Combined Extended vs Brief Treatment at Week 52
The three extended treatment programs were combined and compared to the Brief treatment, with extended treatments expected to produce significant higher CO corrected abstinence rates overall. Comparisons will be tested using Chi-Square analysis. (NCT01162239)
Timeframe: 52 weeks following treatment initiation
| Intervention | Participants (Count of Participants) |
|---|
| Extended Brief Contact | 19 |
| Combined Extended Treatments | 55 |
Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent. (NCT01162239)
Timeframe: 104 weeks following treatment initiation
| Intervention | Participants (Count of Participants) |
|---|
| Extended Brief Contact | 16 |
| Extended Health Education | 13 |
| Extended Relapse Prevention Plus Varenicline | 16 |
| Extended Relapse Prevention | 13 |
Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent. (NCT01162239)
Timeframe: 64 weeks following treatment initiation
| Intervention | Participants (Count of Participants) |
|---|
| Extended Brief Contact | 16 |
| Extended Health Education | 18 |
| Extended Relapse Prevention Plus Varenicline | 24 |
| Extended Relapse Prevention | 13 |
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 parts per million (ppm)) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent. (NCT01162239)
Timeframe: 12 weeks following treatment initiation
| Intervention | Participants (Count of Participants) |
|---|
| Extended Brief Contact | 22 |
| Extended Health Education | 20 |
| Extended Relapse Prevention Plus Varenicline | 29 |
| Extended Relapse Prevention | 20 |
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent. (NCT01162239)
Timeframe: 24 weeks following treatment initiation
| Intervention | Participants (Count of Participants) |
|---|
| Extended Brief Contact | 20 |
| Extended Health Education | 18 |
| Extended Relapse Prevention Plus Varenicline | 24 |
| Extended Relapse Prevention | 21 |
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent. (NCT01162239)
Timeframe: 52 weeks following treatment initiation
| Intervention | Participants (Count of Participants) |
|---|
| Extended Brief Contact | 19 |
| Extended Health Education | 15 |
| Extended Relapse Prevention Plus Varenicline | 23 |
| Extended Relapse Prevention | 17 |
4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12
The percentage of participants who, at each visit from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and at each of these visits were confirmed to have quit based on urine cotinine less than 200 nanograms/milliliter (ng/mL). (NCT01312909)
Timeframe: Week 9 through Week 12
| Intervention | percentage of participants (Number) |
|---|
| Varenicline High Dose | 20.2 |
| Varenicline Low Dose | 27.2 |
| Placebo | 18.0 |
Daily Number of Cigarettes Smoked at Baseline
The average number of cigarettes smoked per day in the past 7 days reported at the baseline visit. (NCT01312909)
Timeframe: Baseline
| Intervention | cigarettes smoked per day (Mean) |
|---|
| Varenicline High Dose | 10.68 |
| Varenicline Low Dose | 9.56 |
| Placebo | 9.57 |
Number of Participants With Laboratory Abnormalities
Criteria for laboratory abnormalities: Lymphocytes Absolute (Abs), Lymphocytes percentage (%), Total Neutrophils (Abs), Neutrophils %: <0.8*LLN or >1.2*ULN; Basophils (Abs), Basophils %Eosinophils (Abs), Eosinophils %, Monocytes (Abs), Monocytes %:> 1.2*ULN; Total Bilirubin milligram per deciliter (mg/dl) >1.5*ULN; alanine aminotransferase: >3.0*ULN; Blood urea nitrogen, Creatinine: >1.3*ULN; Uric acid :> 1.2*ULN. (NCT01312909)
Timeframe: Baseline up to Week 12
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline High Dose | 35 |
| Varenicline Low Dose | 33 |
| Placebo | 26 |
Number of Participants With Treatment-Emergent Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both non-serious AEs and SAEs. (NCT01312909)
Timeframe: First dose up to last dose (up-to Week 12) plus 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline High Dose | 65 |
| Varenicline Low Dose | 53 |
| Placebo | 52 |
Change From Baseline in Blood Pressure (BP) at Week 12
Measurement of BP included supine and sitting systolic BP, standing systolic BP, supine and sitting diastolic BP and standing diastolic BP. Blood pressure was taken after participants rested in a sitting position for 5 minutes. BP was recorded after participants had been supine for approximately 5 minutes, and then orthostatic blood pressure was recorded immediately when the participant stood. (NCT01312909)
Timeframe: Baseline, Week 12
| Intervention | millimeters of mercury (mmHg) (Median) |
|---|
| Supine Systolic BP:Baseline | Supine Systolic BP:Change at Week 12 | Sitting Systolic BP:Baseline | Sitting Systolic BP:Change at Week 12 | Standing Systolic BP:Baseline | Standing Systolic BP:Change at Week 12 | Supine Diastolic BP:Baseline | Supine Diastolic BP:Change at Week 12 | Sitting Diastolic BP:Baseline | Sitting Diastolic BP:Change at Week 12 | Standing Diastolic BP:Baseline | Standing Diastolic BP:Change at Week 12 |
|---|
| Placebo | 109.0 | 0.0 | 113.0 | 2.0 | 112.0 | 3.0 | 65.0 | 0.0 | 69.0 | 1.0 | 70.0 | 2.0 |
,| Varenicline High Dose | 115.0 | 0.0 | 117.0 | -1.0 | 116.0 | 0.0 | 69.0 | 0.0 | 72.0 | 0.0 | 73.0 | 0.0 |
,| Varenicline Low Dose | 114.0 | 0.0 | 115.0 | 0.0 | 115.0 | 0.0 | 66.0 | 0.0 | 70.0 | -1.0 | 72.0 | -1.0 |
Change From Baseline in Daily Number of Cigarettes Smoked at Weeks 12, 24, and 52
The reduction in the number of the cigarettes smoked was calculated by subtracting the reported average number of cigarettes smoked per day in the past 7 days at Weeks 12, 24 and 52 from the average number of cigarettes smoked per day in the past 7 days reported at the baseline visit. (NCT01312909)
Timeframe: Baseline, Weeks 12, 24, and 52
| Intervention | cigarettes smoked per day (Least Squares Mean) |
|---|
| Change at Week 12 | Change at Week 24 | Change at Week 52 |
|---|
| Placebo | -8.01 | -6.59 | -6.98 |
,| Varenicline High Dose | -8.56 | -6.93 | -6.80 |
,| Varenicline Low Dose | -8.20 | -7.31 | -7.74 |
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety (HADS-A) Total Scores at Specified Time-points
The HADS is a self-administered questionnaire measuring anxiety. Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A) consisted of 7 items that were assessed on a scale of 0 = no anxiety to 3 = severe feeling of anxiety. Total HADS-A subscale score range from 0 = no anxiety to 21 = severe anxiety; higher scores indicated more severe anxiety. (NCT01312909)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change at Week 1 | Change at Week 2 | Change at Week 3 | Change at Week 4 | Change at Week 5 | Change at Week 6 | Change at Week 7 | Change at Week 8 | Change at Week 9 | Change at Week 10 | Change at Week 11 | Change at Week 12 | Change at Week 13 | Change at Week 14 | Change at Week 15 | Change at Week 16 | Change at Week 20 | Change at Week 28 | Change at Week 36 | Change at Week 44 | Change at Week 52 |
|---|
| Placebo | 2.3 | -0.3 | -0.5 | -1.0 | -0.9 | -1.2 | -1.2 | -1.2 | -1.3 | -1.1 | -1.1 | -1.3 | -1.2 | -1.2 | -1.2 | -1.0 | -1.1 | -1.3 | -1.2 | -1.3 | -1.0 | -1.5 |
,| Varenicline High Dose | 2.4 | -0.6 | -1.1 | -1.2 | -1.5 | -1.3 | -1.5 | -1.6 | -1.5 | -1.4 | -1.4 | -1.4 | -1.4 | -1.5 | -1.4 | -1.7 | -1.6 | -1.5 | -1.5 | -1.4 | -1.8 | -1.6 |
,| Varenicline Low Dose | 1.9 | -0.5 | -0.7 | -0.8 | -0.9 | -1.0 | -1.0 | -1.1 | -1.1 | -1.2 | -1.2 | -1.2 | -1.3 | -1.2 | -1.2 | -1.3 | -1.2 | -1.2 | -1.2 | -1.2 | -1.2 | -1.1 |
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores - Depression Total Score at Specified Time-Points
Hospital Anxiety and Depression Scale Depression subscale (HADS-D) consists of 7 items that were assessed on a scale of 0 = no depression to 3 = severe feeling of depression. Total HADS-D subscale score range from 0 = no depression to 21 = severe feeling of depression; higher scores indicated a greater intensity of depression. (NCT01312909)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change at Week 1 | Change at Week 2 | Change at Week 3 | Change at Week 4 | Change at Week 5 | Change at Week 6 | Change at Week 7 | Change at Week 8 | Change at Week 9 | Change at Week 10 | Change at Week 11 | Change at Week 12 | Change at Week 13 | Change at Week 14 | Change at Week 15 | Change at Week 16 | Change at Week 20 | Change at Week 28 | Change at Week 36 | Change at Week 44 | Change at Week 52 |
|---|
| Placebo | 1.4 | 0.1 | -0.1 | -0.3 | -0.4 | -0.3 | -0.5 | -0.4 | -0.5 | -0.5 | -0.4 | -0.5 | -0.6 | -0.7 | -0.5 | -0.3 | -0.2 | -0.6 | -0.5 | -0.4 | -0.3 | -0.6 |
,| Varenicline High Dose | 1.5 | -0.4 | -0.5 | -0.5 | -0.7 | -0.6 | -0.6 | -0.7 | -0.8 | -0.8 | -0.9 | -0.7 | -0.7 | -0.6 | -0.8 | -0.8 | -0.6 | -0.8 | -0.9 | -0.7 | -0.9 | -0.7 |
,| Varenicline Low Dose | 1.4 | -0.2 | -0.2 | -0.3 | -0.3 | -0.3 | -0.4 | -0.5 | -0.5 | -0.5 | -0.7 | -0.9 | -0.7 | -0.7 | -0.6 | -0.8 | -0.6 | -0.8 | -0.8 | -0.8 | -0.9 | -0.8 |
Change From Baseline in Pulse Rate at Week 12
Measurement of pulse rate included supine, sitting and standing pulse rate. Pulse rate was taken after participants rested in a sitting position for 5 minutes. Pulse rate was recorded after participants had been supine for approximately 5 minutes and then immediately upon standing. (NCT01312909)
Timeframe: Baseline, Week 12
| Intervention | beats per minute (bpm) (Median) |
|---|
| Supine Pulse Rate:Baseline | Supine Pulse Rate:Change at Week 12 | Sitting Pulse Rate:Baseline | Sitting Pulse Rate:Change at Week 12 | Standing Pulse Rate:Baseline | Standing Pulse Rate:Change at Week 12 |
|---|
| Placebo | 72.0 | 3.0 | 77.0 | 1.0 | 85.0 | -3.0 |
,| Varenicline High Dose | 75.0 | 0.0 | 75.0 | -1.0 | 84.0 | 1.0 |
,| Varenicline Low Dose | 72.0 | 1.0 | 75.0 | 0.0 | 85.0 | -3.0 |
Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 24 and Week 52
The percentage of participants who, at each visit from Week 9 to 52 (inclusive), reported no smoking and no use of other nicotine-containing products (Weeks 9-12) or tobacco products (Weeks 13-52) since the last study visit/last contact (on the Nicotine Use Inventory) and at any of the study visits were confirmed to have quit based on urine cotinine less than 200 ng/mL. (NCT01312909)
Timeframe: Week 9 through Week 24; Week 9 through Week 52
| Intervention | percentage of participants (Number) |
|---|
| Week 9 through Week 24 | Week 9 through Week 52 |
|---|
| Placebo | 13.0 | 9.0 |
,| Varenicline High Dose | 10.1 | 8.3 |
,| Varenicline Low Dose | 24.3 | 20.4 |
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
"The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories);was an interview-based instrument to systematically assess suicidal ideation and suicidal behavior.C-SSRS assessed whether participant experienced any of the following:completed suicide;suicide attempt(response of Yes on actual attempt);preparatory acts toward imminent suicidal behavior (Yes on preparatory acts or behavior,aborted attempt or interrupted attempt),suicidal ideation (Yes on wish to be dead,non-specific active suicidal thoughts,active suicidal ideation with methods without intent to act or some intent to act,without specific plan or with specific plan and intent,any self-injurious behavior with no suicidal intent (Yes on Has participant engaged in non-suicidal self-injurious behavior).Here,number of participants with positive response (response of yes) to suicidal behavior or/and Ideation,any non-suicidal self-injurious behavior were reported." (NCT01312909)
Timeframe: Screening, Baseline, Week 1 up to Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (last follow-up [FU])
| Intervention | Participants (Count of Participants) |
|---|
| Screening:Suicidal Behavior or/and Ideation | Screening:Suicidal Ideation | Screening: Wish to be Dead | Screening: Non-Specific Active Suicidal Thoughts | Screen:Self Injurious Behavior, no Suicidal Intent | TE:Suicidal Behavior or/and Ideation | TE:Suicidal Ideation | TE: Wish to be Dead | TE: Non-Specific Active Suicidal Thoughts | TE:Self Injurious Behavior, no Suicidal Intent |
|---|
| Placebo | 2 | 2 | 2 | 2 | 2 | 1 | 1 | 1 | 1 | 1 |
,| Varenicline High Dose | 2 | 2 | 2 | 1 | 3 | 1 | 1 | 1 | 0 | 0 |
,| Varenicline Low Dose | 3 | 3 | 2 | 1 | 3 | 0 | 0 | 0 | 0 | 0 |
Number of Participants With Treatment-Emergent Neuropsychiatric Adverse Event Elicited by Neuropsychiatric Adverse Event Interview (NAEI)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE: AE causing: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent/significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Solicited AEs collected by semi-structured NAEI inquiring about AEs: depression, anxiety, delusions, hallucinations, paranoia, psychosis, mania, panic, agitation, dissociative states, feeling abnormal, hostility, aggression and homicidal ideation. If a participant had a positive response to any item on the NAEI, investigator determined if it met criteria AE criteria. (NCT01312909)
Timeframe: First dose up to last dose (up-to Week 12) plus 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Neuropsychiatric AEs | Neuropsychiatric SAEs |
|---|
| Placebo | 12 | 0 |
,| Varenicline High Dose | 18 | 0 |
,| Varenicline Low Dose | 11 | 0 |
Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52
The percentage of participants who reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) on the Nicotine Use Inventory in the 7 days prior to the study visits or telephone contacts at Week 12,24 and 52. (NCT01312909)
Timeframe: Weeks 12, 24 and 52
| Intervention | percentage of participants (Number) |
|---|
| Week 12 | Week 24 | Week 52 |
|---|
| Placebo | 23.0 | 23.0 | 20.0 |
,| Varenicline High Dose | 31.2 | 31.2 | 28.4 |
,| Varenicline Low Dose | 37.9 | 35.9 | 35.0 |
Cigarette Reduction
50% reduction in cigarettes per day as compared to baseline. Missing data are assumed to NOT have reduced. (NCT01308736)
Timeframe: At 6-month follow-up
| Intervention | participants (Number) |
|---|
| Varenicline | 10 |
| Placebo Pill | 11 |
Continuous Cigarette Abstinence From Quit Date
Secondary outcome will include continuous abstinence from quit date to end of treatment (week 11). (NCT01303861)
Timeframe: From Quit date to end of treatment (week 11)
| Intervention | participants (Number) |
|---|
| Varenicline | 9 |
| Nicotine Patches Only | 13 |
| Nicotine Patches With Nicotine Inhaler | 15 |
| Varenicline With Bupropion | 17 |
Four-week Continuous Abstinence From Cigarette Smoking
The primary dependent measures will be continuous four-week abstinence from weeks 8-11 post target quit date, defined as a self-report of no smoking confirmed by expired air carbon monoxide. (NCT01303861)
Timeframe: Study week 8 thru week 11
| Intervention | percentage of participants (Number) |
|---|
| Varenicline | 25.93 |
| Nicotine Patches Only | 46.94 |
| Nicotine Patches With Nicotine Inhaler | 43.64 |
| Varenicline With Bupropion | 39.82 |
Seven Day Point Abstinence From Cigarette Smoking
Secondary outcome will include point abstinence (no smoking in the previous 7-day) at 6 months post-quit. (NCT01303861)
Timeframe: Six months post quit date
| Intervention | participants (Number) |
|---|
| Varenicline | 18 |
| Nicotine Patches Only | 12 |
| Nicotine Patches With Nicotine Inhaler | 6 |
| Varenicline With Bupropion | 29 |
Quit Rate
The quit rate at 4 months will be compared between the 2 groups, using a logistic regression analysis with a 2-side 95% confidence interval. (NCT01771627)
Timeframe: 4 months
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (Varenicline) | 13 |
| Arm II (Nicotine Patch) | 23 |
Biochemically Confirmed Abstinence From Smoking
The primary endpoint of this trial is biochemically confirmed 7-day point prevalence smoking abstinence at the end of the medication phase (week 12). Self-reported abstinence from smoking (not even a puff) over the last 7-days will be considered biochemically confirmed by an expired air CO of <8 ppm. Subjects who discontinue the study or have a missed visit for any reason will be classified as smoking for that visit. (NCT01092702)
Timeframe: 12 weeks from start of medication
| Intervention | participants (Number) |
|---|
| Varenicline | 10 |
Cannabis Use Quantity
Cannabis use sessions per day measured by Timeline Followback (self-report) at twice weekly visits during Weeks 4, 5 and 6 of the active treatment phase. (NCT02892110)
Timeframe: 3 weeks (Week 4-6 of active treatment period)
| Intervention | sessions per day (Mean) |
|---|
| Week 4 | Week 5 | Week 6 |
|---|
| Placebo | 1.33 | 1.19 | 1.21 |
,| Varenicline | 0.93 | 0.89 | 0.89 |
Cannabis Withdrawal Symptoms During Active Treatment
"For this outcome, the negative affect subscale items of The Cannabis Withdrawal Scale (items 5 [I felt nervous], 6 [I had some angry outbursts], 7 [I had mood swings], 8 [I felt depressed], 9 [I was easily irritated], 15 [Life seemed an uphill struggle], 18 [I felt physically tense], restlessness (item 11, I felt restless), and/or urge to smoke (items 1 and 10, The only thing I could think about was smoking some cannabis and I had been imagining being stoned) were averaged at Weeks 4, 5, and 6 and for an overall 4-6 week value, with minimum score of the subscale being 0 and maximum score being 100 (higher score indicating worse outcome)." (NCT02892110)
Timeframe: 3 weeks (Week 4-6 of active treatment period)
| Intervention | score on a scale (Mean) |
|---|
| Overall Week 4-6 average | Week 4 | Week 5 | Week 6 |
|---|
| Placebo | 3.94 | 4.07 | 4.27 | 3.47 |
,| Varenicline | 2.23 | 2.59 | 2.15 | 1.96 |
Number of Participants With Cannabis Abstinence
Self reported abstinence from Timeline Followback, verified by urine cannabinoid measures (NCT02892110)
Timeframe: 3 weeks (Week 4-6 of active treatment period)
| Intervention | Participants (Count of Participants) |
|---|
| Week 4 | Week 5 | Week 6 |
|---|
| Placebo | 3 | 2 | 2 |
,| Varenicline | 5 | 4 | 6 |
Change From Baseline in Psychiatric Symptoms
The Positive and Negative Syndrome Scale (PANSS) was used to measure psychiatric symptoms. Item scores ranged from 1 (Absent) to 6 (Severe) for symptoms on the Positive Scale (total subscale range: 7-42), the Negative Scale (total subscale range: 7-42), and the General Psychopathology Scale (total subscale range:16-96). All three subscales were summed for the PANSS total score (total scale range: 30-180). Scores closer to 30 after baseline represented better outcomes. Here we report difference scores from post-treatment and baseline with negative difference scores representing better outcomes. (NCT00802919)
Timeframe: baseline, 4 weeks, 8 weeks
| Intervention | units on a scale (Mean) |
|---|
| PANSS Total wk4 -baseline diff | PANSS Total wk8-baseline diff | PANSS Depression Factor wk4-basline diff | PANSS depressor factor wk8-baseline diff |
|---|
| Matched Placebo | -0.86 | -0.97 | 0.23 | -0.10 |
,| Varenicline | -3.56 | -3.05 | -0.67 | -0.67 |
Change From Basellne in Calgary Depression Scale Score
The Calgary Depression Scale for Schizophrenia. The scale has 9 items with ratings of 0 to 3 on each item. Total score can vary from 0 to 27. Higher scores indicate more depression. Negative change scores indicate decreasing depression. (NCT00802919)
Timeframe: baseline, 4 weeks, 8 weeks
| Intervention | Scores on a scale (Mean) |
|---|
| Calgrapy Dep totl wk4-baseline diff | calgrapy dep wk8-baseline diff |
|---|
| Matched Placebo | -0.72 | -0.88 |
,| Varenicline | -0.63 | -0.79 |
Cotinine Level
plasma cotinine (NCT00802919)
Timeframe: Baseline, 4 weeks, 8 weeks
| Intervention | cotinine ng/ml (Mean) |
|---|
| baseline | week4 | week8 |
|---|
| Matched Placebo | 258.6 | 252.1 | 264.6 |
,| Varenicline | 257.9 | 176.0 | 147.0 |
Depression
Using the Beck Depression Index (BDI-II), depression was assessed on a daily basis. The daily mean score during the medication intervention period is presented, with a lower score indicating lower reported depression. The scores range from 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. (NCT00713479)
Timeframe: Daily
| Intervention | units on a scale (Mean) |
|---|
| Sugar Pill | 2.3 |
| Varenicline | 2.5 |
Diastolic Blood Pressure
Diastolic blood pressure is evaluated at 15 min intervals under placebo or varenicline in the presence of methamphetamine over 140 minutes post infusion. Data is pooled and the mean and standard deviation are presented. (NCT00713479)
Timeframe: 15 minute intervals
| Intervention | mm Hg (Mean) |
|---|
| Sugar Pill | 72.4 |
| Varenicline | 71.7 |
Heart Rate
Heart rate is evaluated at 15 min intervals under placebo or varenicline in the presence of methamphetamine over 140 minutes post infusion. Data is pooled and the mean and standard deviation are presented. (NCT00713479)
Timeframe: 15 minute intervals
| Intervention | bpm (Mean) |
|---|
| Sugar Pill | 80.4 |
| Varenicline | 84.4 |
Systolic Blood Pressure
Systolic blood pressure is evaluated at 15 min intervals under placebo or varenicline in the presence of methamphetamine over 140 minutes post infusion. Data is pooled and the mean and standard deviation are presented. (NCT00713479)
Timeframe: 15 minute intervals
| Intervention | mm Hg (Mean) |
|---|
| Sugar Pill | 126.4 |
| Varenicline | 127.4 |
Latency to Initiate Ad-lib Smoking Session
minutes to start smoking (range 0 to 50 minutes) (NCT00580853)
Timeframe: 0 to 50 minutes
| Intervention | minutes (Mean) |
|---|
| Varenicline | 38.138 |
| Bupropion | 39.416 |
| Placebo | 19.249 |
Number of Cigarettes Smoked During the 60 Minute Ad-lib Period
number of cigarettes smoked (range 0-8) during the 60 minute ad-lib period (NCT00580853)
Timeframe: 60 minutes
| Intervention | number of cigarettes (Mean) |
|---|
| Varenicline | .713 |
| Bupropion | 1.287 |
| Placebo | 2.085 |
Number of Participants With Smoking Abstinence at Month 6
Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Month 6 visit (NCT02360631)
Timeframe: Month 6
| Intervention | Participants (Count of Participants) |
|---|
| Chantix (Varenicline) | 47 |
| Placebo | 13 |
Number of Participants With Smoking Abstinence at Week 12
Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 12 visit (NCT02360631)
Timeframe: Week 12
| Intervention | Participants (Count of Participants) |
|---|
| Chantix (Varenicline) | 56 |
| Placebo | 14 |
Number of Participants With Smoking Abstinence at Week 26
Intent to treat Cotinine verified cessation for light and moderate to heavy smokers by treatment (NCT02360631)
Timeframe: Week 26
| Intervention | Participants (Count of Participants) |
|---|
| Light | Heavy |
|---|
| Chantix (Varenicline) | 33 | 14 |
,| Placebo | 9 | 4 |
Continuous Abstinence to Week 12
No smoking between the quit day and the follow-up (week 12). (NCT01710137)
Timeframe: Weeks 12
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 21 |
| Placebo | 9 |
Continuous Abstinence to Week 24
No smoking between the quit day and the follow-up (Week 24). (NCT01710137)
Timeframe: Weeks 24
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 9 |
| Placebo | 6 |
Point Prevalence Tobacco Abstinence
7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine. (NCT01710137)
Timeframe: Week 12
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 25 |
| Placebo | 11 |
Point Prevalence Tobacco Abstinence
7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine. (NCT01710137)
Timeframe: Week 18
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 19 |
| Placebo | 10 |
Point Prevalence Tobacco Abstinence
7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine. (NCT01710137)
Timeframe: Week 24
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 13 |
| Placebo | 9 |
Quality of Life at Week 12
The HIV/AIDS-Targeted Quality of Life scale measures overall functioning. Scale range from 7 - 35. Higher score indicates worse quality of life. (NCT01710137)
Timeframe: Week 12
| Intervention | score on a scale (Mean) |
|---|
| Varenicline | 26.83 |
| Placebo | 25.95 |
Time to 7-day Relapse
days to smoking regularly for 7 days (NCT01710137)
Timeframe: Week 24
| Intervention | days (Mean) |
|---|
| Varenicline | 58.86 |
| Placebo | 32.48 |
Drinks Per Drinking Day
Outcome for drinking reduction aim - Number of Drinks per Drinking Day (NCT02698215)
Timeframe: 26 weeks post-quit
| Intervention | drinks per drinking day (Mean) |
|---|
| Varenicline Plus Naltrexone | 3.1242 |
| Varenicline | 3.5121 |
Number of Participants With Expired Carbon Monoxide Level <=5ppm
Outcome for smoking cessation aim was Expired Carbon Monoxide level, which was used to determine whether a participant successfully abstained from cigarettes. 7 day point prevalence of nicotine abstinence was bioverified by Expired Carbon Monoxide reading of <= 5ppm at the 26-week follow-up visit. (NCT02698215)
Timeframe: 26 weeks post-quit
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline Plus Naltrexone | 22 |
| Varenicline | 37 |
Change in Smoking Status
Smoking abstinence is defined the change in number of self-reported cigarettes smoked per week (NCT02683161)
Timeframe: Assessed starting in week 2 of 12 weekly study visits
| Intervention | Mean cigarettes per/day (Mean) |
|---|
| Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 |
|---|
| Open-label Group | 7.4 | 5.9 | 6.0 | 4.9 | 0.8 | 0 | 0 | 0 | 0.3 | 0 | 0 |
HbA1c Change Between Baseline and 6 Months
The HbA1c change (in percentage of HbA1c) was calculated from values between baseline and 6 months. (NCT01926041)
Timeframe: Baseline and 6 months
| Intervention | percentage of HbA1c (Mean) |
|---|
| Intervention (FIT2 Program) | 0.11 |
| Usual Care | 0.12 |
Number of Participants With New-onset Type 2 Diabetes Mellitus (DM)
The primary outcome is type 2 DM, defined as having repeatedly at least one of the following criteria: 1) plasma glucose ≥126 mg/dL (7.0 mmol/L) in the fasting state; 2) plasma glucose ≥200 mg/dL (11.1 mmol/L) randomly with hyperglycemic symptoms or two hours after a 75-g oral glucose load; 3) A1C ≥6.5%;20 or under medications for physician-diagnosed type 2 DM. (NCT01926041)
Timeframe: Up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Intervention (FIT2 Program) | 83 |
| Usual Care | 134 |
Number of Participants With Regression to Normoglycemia
Participants who regress to normoglycemia should met all the following conditions for more than six months and maintained such status until the study end: 1) plasma glucose <5.6 mmol/L (100 mg/dL) in the fasting state; 2) plasma glucose <7.8 mmol/L (140 mg/dL) two hours after a 75-g oral glucose load; or 3) HbA1c<39 mmol/mol (5.7%), in the absence of antidiabetic drugs. (NCT01926041)
Timeframe: Up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Intervention (FIT2 Program) | 43 |
| Usual Care | 25 |
Number of Participants Who Participate in the Post-treatment Interview
Study primary outcomes are qualitative in nature. Participants will be asked to participate in a qualitative interview in which they will be interviewed regarding things they would change about the proposed treatment intervention. These results will be used to inform the treatment development for a randomized controlled trial. (NCT04135937)
Timeframe: Post-treatment follow-up visit (week 5)
| Intervention | Participants (Count of Participants) |
|---|
| MESH | 9 |
Change in MA Positive Urine Drug Screens Among Participants Randomly Assigned to Receive Varenicline Versus Placebo.
Urine samples, collected thrice weekly, were tested for metabolites of MA using radioimmunoassay. Each subject had a possible of 24 urine drug screens to provide during the 8 weeks of medication. An aggregate measure of urine drug screen results was calculated - the Treatment Effectiveness Score (TES) - which is the average of the sum of MA-free urine specimens provided during the treatment period by participants in each treatment condition. (NCT01011829)
Timeframe: 8-weeks
| Intervention | total MA-free urine drug screens (Mean) |
|---|
| Varenicline | 7.4 |
| Placebo (Sugar Pill) | 2.3 |
Retention (Completion)
Retention was determined by the proportion of participants retained for the entire trial and time until drop-out. (NCT01011829)
Timeframe: 8-weeks
| Intervention | participants (Number) |
|---|
| Varenicline | 6 |
| Placebo (Sugar Pill) | 1 |
Blood Serum Cotinine
Level of cotinine in blood (NCT00937235)
Timeframe: At end of 3-month follow-up
| Intervention | ng/mL (Mean) |
|---|
| Integrated Treatment | 156.0 |
| Varenicline | 149.2 |
Hamilton Depression Scale (HAM-D) Total Score at 3-Month Follow-Up
"Hamilton Depression scale (HAM-D) at 3-month followup assessment, which measures severity of depression symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 50.~Higher scores indicate higher/worse levels of depression." (NCT00937235)
Timeframe: 3-month follow-up
| Intervention | Scores on a scale (Mean) |
|---|
| Integrated Treatment | 6.95 |
| Varenicline | 11.45 |
Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment
"Hamilton Depression scale (HAM-D) at post-treatment assessment, which measures severity of depression symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 50.~Higher scores indicate higher/worse levels of depression." (NCT00937235)
Timeframe: Post-Treatment assessment, occurring 12 weeks after the start of treatment (week 0)
| Intervention | Scores on a scale (Mean) |
|---|
| Integrated Treatment | 6.34 |
| Varenicline | 11.84 |
Number of Participants With 7-day Point Prevalence Smoking Abstinence
Number of participants reporting seven-day point prevalence abstinence (PPA), which was defined as self-reported abstinence for 7 days prior to the assessment, serum cotinine level of <15ng/ml, and CO < 10 ppm. (NCT00937235)
Timeframe: At 3-month follow-up (6-month post-quit day)
| Intervention | Participants (Count of Participants) |
|---|
| Integrated Treatment | 8 |
| Varenicline | 11 |
Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment
"Posttraumatic Symptom Scale Interview at post-treatment assessment, which measures severity of post-traumatic stress disorder (PTSD) symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 51.~Higher scores indicate higher/worse levels of PTSD." (NCT00937235)
Timeframe: Post-treatment, occurring 12 weeks after the start of treatment (week 0)
| Intervention | Scores on a scale (Mean) |
|---|
| Integrated Treatment | 11.19 |
| Varenicline | 18.84 |
Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 3-Month Follow-Up
"Posttraumatic Symptom Scale Interview at 3-month follow-up assessment, which measures severity of post-traumatic stress disorder (PTSD) symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 51.~Higher scores indicate higher/worse levels of PTSD." (NCT00937235)
Timeframe: 3-month follow-up
| Intervention | scores on a scale (Mean) |
|---|
| Integrated Treatment | 10.35 |
| Varenicline | 16.74 |
TLFB - Cigarettes Smoked Week Before 3-Month Follow-up
Timeline followback - Number of cigarettes smoked the week before 3-month follow-up visit (NCT00937235)
Timeframe: 3-month follow-up
| Intervention | Number of Cigarettes Smoked (Mean) |
|---|
| Integrated Treatment | 32.92 |
| Varenicline | 25.85 |
TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment)
Timeline Followback - Total number of cigarettes smoked the week before Post-Treatment visit (NCT00937235)
Timeframe: Week before Post-Treatment visit occurring at week 12, i.e. number of cigarettes smoked for the week prior to this week 12 visit
| Intervention | Number of Cigarettes Smoked (Mean) |
|---|
| Integrated Treatment | 14.31 |
| Varenicline | 17.03 |
Cognitive Function as Measured by Omissions on the CPT
"Cognitive function was measured using the Continuous Performance Task (CPT). The CPT assess attention and response inhibition and the main outcome was number of omissions (the number of times the target was present, but the subject did not respond) errors in response to go and stop targets. Participants are presented with stop and go targets that appear on a computer screen. They are told to press the space bar (respond) to go targets and to avoid pressing the space bar when stop targets appear. Presented in the data table are the average number of omissions (the number of times the target was present, but the subject did not respond). Higher omission rates indicate a greater level of inattention (range 0-324)." (NCT01000987)
Timeframe: Following 3 weeks of medication. The CPT task was performed at 60 minutes following alcohol or placebo beverage consumption.
| Intervention | Number of Omissions (Mean) |
|---|
| Alcohol | Control Beverage |
|---|
| 1 mg/Day Varenicline | 1.78 | 0.98 |
,| 2 mg/Day Varenicline | 1.28 | 0.62 |
,| Placebo | 4.76 | 2.37 |
Brief Psychiatric Rating Scale
Sum of all items rated from 1 (not present) to 7 (extremely severe) (NCT03507127)
Timeframe: 72 hrs abstinence
| Intervention | score on a scale (Mean) |
|---|
| Varenicline | 1.33 |
| Placebo | 1.37 |
Latency to Smoking Relapse
hours until relapse during a smoking abstinence period, verified with breath carbon monoxide (CO) levels (NCT03507127)
Timeframe: 1 week
| Intervention | hours (Mean) |
|---|
| Varenicline | 8 |
| Placebo | 24 |
Minnesota Nicotine Withdrawal Scale - Negative Affect Scale
Average of responses to the anger, depression, anxiety and difficulty concentrating items, which are rated from 0 (not present) to 4 (severe). (NCT03507127)
Timeframe: 72 hrs abstinence
| Intervention | score on a scale (Mean) |
|---|
| Varenicline | 1.45 |
| Placebo | 0.85 |
Modified Cigarette Evaluation Questionnaire - Reward Scale
Average of the calm, feel more awake, less irritable, help to concentrate and reduce hunger items, which are rated from 1 (not at all) to 7 (extremely) (NCT03507127)
Timeframe: 72 hrs abstinence
| Intervention | score on a scale (Mean) |
|---|
| Varenicline | 4.00 |
| Placebo | 4.30 |
Modified Cigarette Evaluation Questionnaire - Satisfaction Scale
Average of the satisfaction, taste and enjoyment items, which are rated from 1 (not at all) to 7 (extremely) (NCT03507127)
Timeframe: 72 hrs abstinence
| Intervention | score on a scale (Mean) |
|---|
| Varenicline | 5.33 |
| Placebo | 3.43 |
Medication Adherence
Medication adherence is measured by composite self-reported diaries and daily text messaging responses. (NCT04089982)
Timeframe: Screening visit, Visit 4 (week 6)
| Intervention | Percent medication adherence (Mean) |
|---|
| Varenicline | 91.6 |
| Placebo | 90.3 |
Change in Self-Reported Craving Level Via Lab-Based Cue Reactivity
Participants were asked to self-report craving level to smoke on a scale of 1-10 with 1 corresponding to no craving and 10 corresponding to intense craving. Self-reported craving level was requested following presentation of multiple images on a screen over a 20 minute period. Four types of images were presented - neutral affect, negative affect, smoking and social images. (NCT04089982)
Timeframe: Baseline, Visit 4 (week 6)
| Intervention | score on a scale (Mean) |
|---|
| Baseline | Week 6 |
|---|
| Placebo | 4.2 | 2.4 |
,| Varenicline | 6.31 | 2.56 |
Change in Self-Reported Craving Level Via Real-World Cue Reactivity
"Craving level in real world situations was assessed through electronic momentary assessment (EMA). Participants were instructed to send a text to the study team each time they experienced craving to smoke a cigarette. Self-report craving level to smoke was reported on a scale of 1-10 with 1 corresponding to no craving and 10 corresponding to intense craving." (NCT04089982)
Timeframe: Baseline, Visit 4 (week 6)
| Intervention | score on a scale (Mean) |
|---|
| Baseline | Week 6 |
|---|
| Placebo | 6.7 | 8 |
,| Varenicline | 7.15 | 5.5 |
Changes in Smoking
7-day point prevalence smoking abstinence. This will be measured through self-reported daily smoking diaries and daily text messaging. (NCT04089982)
Timeframe: Screening visit, Visit 4 (week 6)
| Intervention | cigarettes per day (Mean) |
|---|
| Baseline | Week 6 |
|---|
| Placebo | 5.2 | 2.6 |
,| Varenicline | 3.6 | 0.5 |
Changes in Smoking Abstinence
7-day point prevalence smoking abstinence confirmed by CO <7ppm. This will be measured through biochemical confirmation (CO breath test). (NCT04089982)
Timeframe: Screening visit, Visit 4 (week 6)
| Intervention | ppm (Mean) |
|---|
| Baseline | Week 6 |
|---|
| Placebo | 10.2 | 7.8 |
,| Varenicline | 9.5 | 2.6 |
Medication Tolerance by Self-Reported Side Effects
Self-reported side effects (open ended survey questions) with a ranking scale of 1-2 (mild), 3-5 (moderate), and 6-7 (severe). Any side effect 3 or greater will be reviewed by a study medical provider. (NCT04089982)
Timeframe: Up to 12 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Abnormal/Vivid Dreams | Nausea/Vomiting | Constipation | Dizziness/Lightheadedness | Dry Mouth | Fatigue | Insomnia/Trouble Sleeping |
|---|
| Placebo | 2 | 1 | 0 | 0 | 0 | 2 | 1 |
,| Varenicline | 1 | 1 | 1 | 1 | 1 | 0 | 0 |
Change in Craving Score During Cue Exposure Task
Scores range from 0 (no craving) to 100 (extreme craving). (NCT02551692)
Timeframe: Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)
| Intervention | score on a scale (Mean) |
|---|
| Placebo (PLAC) | -11.17 |
| Transdermal Nicotine Patch (NRT) | -8.84 |
| Varenicline (VAR) | -14.29 |
Change in Latency to Smoke During Cue Exposure Task
The latency is the interval between smoking one cigarette and wanting, craving, or needing another. (NCT02551692)
Timeframe: Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)
| Intervention | seconds (Mean) |
|---|
| Placebo (PLAC) | 30.22 |
| Transdermal Nicotine Patch (NRT) | 48.04 |
| Varenicline (VAR) | 65.15 |
Change in Smoke Intake During Cue Exposure Task
Measured by number of puffs. (NCT02551692)
Timeframe: Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)
| Intervention | puffs (Mean) |
|---|
| Placebo (PLAC) | 14.42 |
| Transdermal Nicotine Patch (NRT) | 12.21 |
| Varenicline (VAR) | 12.98 |
Number of Cigarettes Smoked Per Day
Measure the effects of Varenicline and N-Acetylcysteine on smoking behavior over the course of the study (NCT02723162)
Timeframe: 28 Days
| Intervention | Cigarettes per day (Mean) |
|---|
| VRN+ NAC | 5.3 |
| NAC+ PBO | 4.0 |
| VRN+ PBO | 5.3 |
| PBO+PBO | 5.0 |
rZ Change Score in Resting State Functional Connectivity From Baseline
Measure the effects of Varenicline and N-Acetylcysteine on resting-state functional connectivity while participants undergo fMRI. Fisher transformed correlation (rZ) scores will be recorded between medial prefrontal cortex and ventral striatum during a resting state scan. The higher the rZ score, the better the outcome, meaning stronger functional connectivity. rZ scores range from -1 to 1. The rZ-score central value is analogous to a central value to of a Z-score of 0, representing the population mean. (NCT02723162)
Timeframe: Baseline to day 10
| Intervention | Fisher Z (Median) |
|---|
| VRN+ NAC | .297 |
| NAC+ PBO | .060 |
| VRN+ PBO | .181 |
| PBO+PBO | .191 |
Percent Change in Blood Oxygen Level Dependent (BOLD) Signal Response
Measure the Effects of Varenicline and N-Acetylcysteine (NAC) on brain activation to smoking images while participants undergo Functional Magnetic Resonance (fMRI) Imaging. Mean percent signal change of fMRI BOLD in the insula and nucleus accumbens will be recorded during smoking images. The lower the BOLD signal response, the better the outcome, meaning reduced reactivity to smoking images. (NCT02723162)
Timeframe: 10 Days
| Intervention | Percentage change (Median) |
|---|
| Insula | Nucleus Accumbens |
|---|
| NAC+ PBO | 1.07 | 0.91 |
,| PBO+PBO | 1.19 | 1.43 |
,| VRN+ NAC | -0.09 | 0.11 |
,| VRN+ PBO | 0.08 | 0.12 |
Conversion of Varenicline Use
Percent of participants in the sampling group using varenicline at 3-month follow up assessment. (NCT03742154)
Timeframe: At the end of the three-month follow up
| Intervention | Participants (Count of Participants) |
|---|
| Any use of varenicline | Daily use of varenicline |
|---|
| Varenicline Group | 12 | 5 |
Quit Attempts
Percent of participants with any self-defined and any self-defined 24-hr quit attempt (NCT03742154)
Timeframe: From study enrollment through end of three-month follow up
| Intervention | Participants (Count of Participants) |
|---|
| Any self defined quit attempt | Any 24 hour quit attempt |
|---|
| Control Group | 24 | 17 |
,| Varenicline Group | 30 | 26 |
Cigarette Choice
Over each of the four 6-hour experimental sessions, a participant was asked 9 times if they would take money or a cigarette. This outcome measure assesses the number of times a participant chose a cigarette. (NCT00731055)
Timeframe: During each of the four weekly 6-hour experimental sessions
| Intervention | number of cigarette choices (0-9) (Mean) |
|---|
| Placebo | 3.67 |
| Varenicline 0.5 mg | 3.17 |
| Varenicline 1.0 mg | 2.83 |
| Varenicline 2.0 mg | 2.83 |
End of Treatment Abstinence
The primary analysis will compare two weeks continuous MA abstinence at end of treatment during weeks 8 and 9 among participants randomly assigned to receive varenicline versus those randomly assigned to receive placebo. (NCT01365819)
Timeframe: 9 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Sugar Pill | 5 |
| Varenicline | 4 |
Prevalence of Relapse Following Initiation of Abstinence During Treatment
1) The number of participants who achieve MA abstinence and subsequently relapse to MA use during treatment by condition (varenicline, placebo) during the outpatient treatment period. (NCT01365819)
Timeframe: 7 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Sugar Pill | 6 |
| Varenicline | 8 |
Reduction in Cigarette Smoking
3) To determine whether varenicline reduces cigarette smoking more than placebo among cigarette smoking MA dependent participants. (NCT01365819)
Timeframe: 9 weeks
| Intervention | average number of cigarettes (Mean) |
|---|
| Sugar Pill | 19 |
| Varenicline | 1 |
Days to First Cigarette Following Quitting Smoking
Days to first cigarette (i.e. lapse) will be measured via self-report. (NCT01406223)
Timeframe: Up to 11 weeks post quit day.
| Intervention | days (Mean) |
|---|
| Varenicline | 9.15 |
| NRT (Nicotine Patches Only) | 15.21 |
| Varenicline + Bupropion | 9.90 |
| Post-quit NRT | 5.73 |
Mortality
Number of patients that died within 30 days of surgery (NCT02856581)
Timeframe: Up to 30 days post-surgery
| Intervention | Participants (Count of Participants) |
|---|
| Intervention Group (Varenicline and Behavioral Intervention) | 0 |
| Control Group (Placebo and Behavioral Intervention) | 0 |
Number of Participants With Incidence of Anastomotic Failure
Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, FTND, time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. A separate logistic model will be created including treatment arm instead of smoking status. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models. (NCT02856581)
Timeframe: Up to 24 weeks post-surgery
| Intervention | Participants (Count of Participants) |
|---|
| Intervention Group (Varenicline and Behavioral Intervention) | 0 |
| Control Group (Placebo and Behavioral Intervention) | 0 |
Number of Participants With Incidence of Intensive Care Unit Readmission
Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, FTND, time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. A separate logistic model will be created including treatment arm instead of smoking status. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models. (NCT02856581)
Timeframe: Up to 24 weeks post-surgery
| Intervention | Participants (Count of Participants) |
|---|
| Intervention Group (Varenicline and Behavioral Intervention) | 0 |
| Control Group (Placebo and Behavioral Intervention) | 0 |
Number of Participants With Incidence of Unspecified Wound Infection
Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, FTND, time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. A separate logistic model will be created including treatment arm instead of smoking status. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models. (NCT02856581)
Timeframe: Up to 24 weeks post-surgery
| Intervention | Participants (Count of Participants) |
|---|
| Intervention Group (Varenicline and Behavioral Intervention) | 0 |
| Control Group (Placebo and Behavioral Intervention) | 0 |
Number of Paticipants With Incidence of Pulmonary Complications
Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, Fagerström Test for Nicotine Dependence (FTND), time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models. (NCT02856581)
Timeframe: Up to 24 weeks post-surgery
| Intervention | Participants (Count of Participants) |
|---|
| Intervention Group (Varenicline and Behavioral Intervention) | 0 |
| Control Group (Placebo and Behavioral Intervention) | 0 |
Re-hospitalization
Number of patients re-hospitalized within 30 days of surgery (NCT02856581)
Timeframe: Up to 30 days post-surgery
| Intervention | Participants (Count of Participants) |
|---|
| Intervention Group (Varenicline and Behavioral Intervention) | 0 |
| Control Group (Placebo and Behavioral Intervention) | 0 |
BMI
Change in BMI from baseline to week 12 (NCT02393547)
Timeframe: 12 weeks
| Intervention | kg/m^2 (Mean) |
|---|
| Varenicline + Lorcaserin | 0.3 |
Post Cessation Weight Change
change in weight from baseline to week 12 (NCT02393547)
Timeframe: 12 weeks
| Intervention | kg (Mean) |
|---|
| Varenicline + Lorcaserin | 1.1 |
Smoking Abstinence Rates
prolonged smoking abstinence at week 12 (NCT02393547)
Timeframe: 12 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline + Lorcaserin | 10 |
Waist Circumference
Change in waist circumference from baseline to week 12 (NCT02393547)
Timeframe: 12 Weeks
| Intervention | cm (Mean) |
|---|
| Varenicline + Lorcaserin | 0.2 |
Medication Adherence
"Self-reported medication adherence measured through a single item assessing medication compliance. The item is answered as yes (scored as 1) or no (scored as 0). This measure combines all responses from Day 1 through Day 13 of this study to provide a total measure of medication adherence ranging from 0% (missed all doses) to 100% (took every dose as prescribed). Higher scores indicate better outcomes (i.e., better adherence to medication)." (NCT03538808)
Timeframe: Days 1 - 13
| Intervention | Percentage (Number) |
|---|
| Therapeutic Dose/Varenicline | 85.36 |
| Therapeutic Dose/Placebo | 86.79 |
| Low Dose/Varenicline | 81.93 |
| Low Dose/Placebo | 86.09 |
Medication Expectancies
Medication expectancies will be measured through the Beliefs and Attitudes about Varenicline (BAV) scale which is a 6-item questionnaire adapted to assess varenicline expectancies. This measure is rated on a scale from 1 (not at all) to 5 (extremely). The measure has a minimum score of 6 and a maximum score of 30. Higher scores indicating better outcomes (i.e., stronger positive beliefs about using varenicline). (NCT03538808)
Timeframe: Baseline and Day 14
| Intervention | units on a scale (Mean) |
|---|
| Therapeutic Dose/Varenicline | 3.56 |
| Therapeutic Dose/Placebo | 3.65 |
| Low Dose/Varenicline | 3.50 |
| Low Dose/Placebo | 3.44 |
Side Effects
"A 30-item self-report measure of the presence (or not) of symptoms commonly associated with varenicline side effects and nicotine withdrawal. Items are rated as No (scored as 0) or Yes (scored as 1). A total score was calculated to reflect the total number of reported side effects. This measure has a minimum score of 0 and a maximum score of 30. Higher scores indicate worse outcomes (i.e., greater frequency of experienced side effects)." (NCT03538808)
Timeframe: Day 14
| Intervention | Symptoms (Mean) |
|---|
| Therapeutic Dose/Varenicline | 1.50 |
| Therapeutic Dose/Placebo | 3.40 |
| Low Dose/Varenicline | 2.00 |
| Low Dose/Placebo | 1.89 |
BMI
BMI change from baseline to week 24 (NCT02412631)
Timeframe: 24 weeks
| Intervention | kg/m^2 (Mean) |
|---|
| Varenicline Plus Placebo | 0.5 |
| Varenicline Plus Lorcaserin | 0.8 |
Fat Mass
Body Fat difference from baseline to week 24. (NCT02412631)
Timeframe: 24 weeks
| Intervention | kg (Mean) |
|---|
| Varenicline Plus Placebo | 0.4 |
| Varenicline Plus Lorcaserin | 2.2 |
Post Cessation Weight Gain (kg)
weight (kg) change from baseline to week 24 among subjects who meet criteria for prolonged smoking abstinence at week 24 (NCT02412631)
Timeframe: 24 weeks
| Intervention | kg (Mean) |
|---|
| Varenicline Plus Placebo | 0.7 |
| Varenicline Plus Lorcaserin | 2.2 |
Smoking Abstinence
Lorcaserin combined with open label varenicline will be evaluated for improved smoking abstinence compared to placebo (NCT02412631)
Timeframe: 24 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline Plus Placebo | 13 |
| Varenicline Plus Lorcaserin | 8 |
Waist Circumference
Waist Circumference change from baseline to week 24 (NCT02412631)
Timeframe: 24 weeks
| Intervention | cm (Mean) |
|---|
| Varenicline Plus Placebo | 0.8 |
| Varenicline Plus Lorcaserin | -0.1 |
7-day CO-verified Tobacco Abstinence
Number of Participants with Verified 7 Day Tobacco Abstinence. (NCT01756885)
Timeframe: Weeks 24 & 52
| Intervention | participants (Number) |
|---|
| Week 24 | Week 52 |
|---|
| Extended Varenicline Treatment | 32 | 17 |
,| Standard Varenicline Treatment | 28 | 16 |
Number of Participants With Continuous Abstinence
No smoking from baseline to time-point, after a 2-week grace period. (NCT01756885)
Timeframe: Weeks 12, 24, and 52
| Intervention | participants (Number) |
|---|
| Week 24 | Week 52 |
|---|
| Extended Varenicline Treatment | 22 | 16 |
,| Standard Varenicline Treatment | 19 | 11 |
Quality of Life at Week 24 and 52
The Short-Form Health Survey (SF-12) assesses Quality of Life (QOL). Scale range from 12 - 47. Higher score indicates worse quality of life. (NCT01756885)
Timeframe: Weeks 24 & 52
| Intervention | score on a scale (Mean) |
|---|
| Week 24 | Week 52 |
|---|
| Extended Varenicline Treatment | 38.46 | 36.91 |
,| Standard Varenicline Treatment | 38.75 | 38.06 |
Number of Participants Who Quit Smoking at 2 Months
Smoking cessation is operationally defined as successfully quitting smoking at 2 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million). (NCT02562521)
Timeframe: Month 2
| Intervention | Participants (Count of Participants) |
|---|
| All Participants Enrolled in Treatment | 2 |
Number of Participants Who Quit Smoking at 3 Months
Smoking cessation is operationally defined as successfully quitting smoking at 3 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million). (NCT02562521)
Timeframe: Month 3
| Intervention | Participants (Count of Participants) |
|---|
| All Participants Enrolled in Treatment | 1 |
Number of Participants Who Quit Smoking for at Least 24 Hours in the Prior Six Weeks
A survey of dining hall employees will be used to determine the proportion of the dining hall employees who quit smoking for at least 24 hours in the prior six weeks in the treatment and delayed treatment control groups. Values present the number of individuals who report quitting successfully for at least 24 hours among individuals who reported smoking. (NCT02562521)
Timeframe: 6 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Smoking Cessation Treatment | 8 |
| Delayed Treatment Control | 1 |
Number of Participants With a Smoking Quit Attempt in the Prior Six Weeks
A survey of dining hall employees will be used to determine the proportion of the dining hall employees who made a quit attempt in the prior six weeks in the treatment and delayed treatment control groups. Values present the proportion of dining hall employees who smoke who reported making a quit attempt. (NCT02562521)
Timeframe: 6 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Smoking Cessation Treatment | 10 |
| Delayed Treatment Control | 1 |
Number of People Who Quit Smoking at 4 Months
Smoking cessation is operationally defined as successfully quitting smoking at 4 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million). (NCT02562521)
Timeframe: Month 4
| Intervention | Participants (Count of Participants) |
|---|
| All Participants Enrolled in Treatment | 4 |
Number of People Who Quit Smoking at 5 Months
Smoking cessation is operationally defined as successfully quitting smoking at 5 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million). (NCT02562521)
Timeframe: Month 5
| Intervention | Participants (Count of Participants) |
|---|
| All Participants Enrolled in Treatment | 2 |
Number of People Who Quit Smoking at 6 Months
Smoking cessation is operationally defined as successfully quitting smoking at 6 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million). (NCT02562521)
Timeframe: Month 6
| Intervention | Participants (Count of Participants) |
|---|
| All Participants Enrolled in Treatment | 1 |
Wisconsin Predicting Patient's Relapse Questionnaire
Items from the Wisconsin Predicting Patient's Relapse questionnaire (WI-PREPARE) will be administered. This is a brief scale comprised of 7 items that assesses proneness to smoking relapse. Items are summed to create a total score. Total range=1-13 with higher scores indicating greater likelihood of smoking relapse. (NCT02562521)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| All Participants Enrolled in Treatment | 5.64 |
Wisconsin Predicting Patient's Relapse Questionnaire
Items from the Wisconsin Predicting Patient's Relapse questionnaire (WI-PREPARE) will be administered. This is a brief scale comprised of 7 items that assesses proneness to smoking relapse. Items are summed to create a total score. Total range=1-13 with higher scores indicating greater likelihood of smoking relapse. (NCT02562521)
Timeframe: Month 6
| Intervention | units on a scale (Mean) |
|---|
| All Participants Enrolled in Treatment | 4.80 |
Bioverified Point-prevalence Abstinence at 14 Weeks (End of Treatment)
Participants were classified as abstinent if they reported abstinence, not even a puff of a cigarette, for >7 days prior to week 14 (11-weeks post-target quit date) and had an expired carbon monoxide reading of ≤ 6 parts per million at week 14. (NCT02378714)
Timeframe: 14 weeks (11-weeks post-target quit date)
| Intervention | Participants (Count of Participants) |
|---|
| Standard Treatment + Placebo Varenicline | 8 |
| BASC + Placebo Varenicline | 4 |
| Standard Treatment + Active Varenicline | 26 |
| BASC + Active Varenicline | 26 |
Bioverified Point-prevalence Abstinence at 27 Weeks
Participants were classified as abstinent if they reported abstinence, not even a puff of a cigarette, for >7 days prior to week 27 (24 weeks post-target quit date) and had an expired carbon monoxide reading of ≤ 6 parts per million at week 27. (NCT02378714)
Timeframe: 27 weeks (24-weeks post-target quit date)
| Intervention | Participants (Count of Participants) |
|---|
| Standard Treatment + Placebo Varenicline | 6 |
| BASC + Placebo Varenicline | 3 |
| Standard Treatment + Active Varenicline | 13 |
| BASC + Active Varenicline | 13 |
Continuous Abstinence
No smoking between target quit date (week 3) and week 27 (NCT02378714)
Timeframe: 27 weeks (24 weeks post target quit date)
| Intervention | Participants (Count of Participants) |
|---|
| Standard Treatment + Placebo Varenicline | 3 |
| BASC + Placebo Varenicline | 2 |
| Standard Treatment + Active Varenicline | 6 |
| BASC + Active Varenicline | 2 |
Prolonged Abstinence
<7 consecutive days of self-reported smoking after a 2-week grace period (NCT02378714)
Timeframe: 27 weeks (24 weeks post target quit date)
| Intervention | Participants (Count of Participants) |
|---|
| Standard Treatment + Placebo Varenicline | 13 |
| BASC + Placebo Varenicline | 11 |
| Standard Treatment + Active Varenicline | 26 |
| BASC + Active Varenicline | 26 |
Time to 7-day Relapse
Time to relapse as defined by 7 or more consecutive days of self-reported smoking (no grace period) (NCT02378714)
Timeframe: 27 weeks (24 weeks post target quit date)
| Intervention | median days to relapse (Median) |
|---|
| Standard Treatment + Placebo Varenicline | 15 |
| BASC + Placebo Varenicline | 15 |
| Standard Treatment + Active Varenicline | 57 |
| BASC + Active Varenicline | 24 |
Adverse Event and Serious Adverse Event Rates
"Adverse event and serious adverse event rates between varenicline and placebo arms. A previously developed algorithm was used to classify side effect reports as adverse events (AEs) or serious adverse events (SAEs) (Schnoll et al. 2019).~Reference: Schnoll, R., Leone, F., Weisbrot, J., Veluz-Wilkins, A., Miele, A., Hole, A., Jao, N.C., Wileyto, E.P., Carroll, A.J., Kalhan, R., Patel, J., Langer, C., & Hitsman, B. (2019). A randomized controlled trial of 24-weeks of varenicline for tobacco use among cancer patients: Efficacy, safety, and adherence. Psycho-Oncology, 28, 561-569." (NCT02378714)
Timeframe: Weeks 1 (1-week before starting medication), 6, and 14 (end of medication)
| Intervention | Participants (Count of Participants) |
|---|
| Any adverse event | Any serious adverse event |
|---|
| Placebo - Week 1 | 104 | 28 |
,| Placebo - Week 14 | 50 | 9 |
,| Placebo - Week 6 | 68 | 26 |
,| Varenicline - Week 1 | 136 | 34 |
,| Varenicline - Week 14 | 60 | 8 |
,| Varenicline - Week 6 | 81 | 22 |
Varenicline Occupancy of alpha4beta2* Nicotinic Acetylcholine Receptors
Varenicline occupancy of alpha4beta2* nicotinic acetylcholine receptors (nAChR) was assessed with ascending doses of varenicline and the selective alpha4beta2* nAChR positron emission tomography (PET) ligand [18F]Flubatine. Alpha4beta2* nAChR agonists may induce nAChR expression. Consequently, we imaged participants at the end of their drug exposure periods (Day 10) and again after 5 days (~5 half-lives) of washout from drug exposure (Day 15). We used the difference between the two PET scans, (Day 10 - Day 15)/Day 15 x 100%, to determine the receptor occupancy of alpha4beta2* nicotinic acetylcholine receptors (nAChR) by each dose of varenicline. (NCT02933372)
Timeframe: 15 days
| Intervention | percentage of VCN-alpha4beta2* nAChRs (Mean) |
|---|
| 0.25 mg once daily Varenicline | 0.25 mg twice daily Varenicline | 0.5 mg twice daily Varenicline |
|---|
| Healthy Controls | 67.9 | 70.6 | 69.6 |
Varenicline Occupancy of alpha4beta2* Nicotinic Acetylcholine Receptors
Varenicline occupancy of alpha4beta2* nicotinic acetylcholine receptors (nAChR) was assessed with ascending doses of varenicline and the selective alpha4beta2* nAChR positron emission tomography (PET) ligand [18F]Flubatine. Alpha4beta2* nAChR agonists may induce nAChR expression. Consequently, we imaged participants at the end of their drug exposure periods (Day 10) and again after 5 days (~5 half-lives) of washout from drug exposure (Day 15). We used the difference between the two PET scans, (Day 10 - Day 15)/Day 15 x 100%, to determine the receptor occupancy of alpha4beta2* nicotinic acetylcholine receptors (nAChR) by each dose of varenicline. (NCT02933372)
Timeframe: 15 days
| Intervention | percentage of VCN-alpha4beta2* nAChRs (Mean) |
|---|
| 0.25 mg once daily Varenicline | 0.25 mg twice daily Varenicline | 0.5 mg twice daily Varenicline | 1 mg twice daily Varenicline |
|---|
| Parkinson's Disease Patients | 67.0 | 65.7 | 66.3 | 71.5 |
Cigarettes Smoked Per Week
The number of cigarettes smoked per week during the last month of treatment (weeks 3-6) computed only among participants who were smokers at baseline (varenicline n=11; placebo n=11). Note: cigarettes smoked per week outcome data was missing for two of the varenicline participants resulting in n=9 available for analysis. (NCT03035708)
Timeframe: Weeks 3-6
| Intervention | cigarettes per week (Mean) |
|---|
| Varenicline - Smokers at Baseline | 47.0 |
| Placebo - Smokers at Baseline | 64.0 |
Cue-elicited Craving
The primary outcome is cue-elicited alcohol craving, operationalized as the difference in Visual Analog Scale (VAS) craving for alcohol when exposed to an alcohol cue minus the VAS craving for alcohol when exposed to a water cue. The VAS has a minimum value of 0 and maximum value of 20; higher scores indicate more craving (a worse outcome). (NCT03035708)
Timeframe: Study Week 3
| Intervention | units on a scale (Mean) |
|---|
| Varenicline | 2.1 |
| Placebo | 2.2 |
Penn Alcohol Craving Scale
Penn Alcohol Craving Scale (higher numbers are indicative of more craving for alcohol); min = 0, max = 30. The measure was assessed at Study Weeks 3, 4, 5, and 6. The reported outcome is the adjusted mean total score across weeks 3-6. (NCT03035708)
Timeframe: Study Weeks 3, 4, 5, 6 (assessed weekly during this period)
| Intervention | units on a scale (Mean) |
|---|
| Varenicline | 10.8 |
| Placebo | 10.9 |
Percent Heavy Drinking Days
The percentage of heavy drinking days during the last month of treatment (weeks 3-6). A heavy drinking day is defined as 4 or more drinks on a single day for females and 5 or more drinks on a single day for males. (NCT03035708)
Timeframe: Weeks 3-6
| Intervention | percentage of heavy drinking days (Mean) |
|---|
| Varenicline | 30.7 |
| Placebo | 21.0 |
The Percentage of Subjects Abstinent During the Last Month of Treatment (Weeks 3-6).
The percentage of subjects abstinent from alcohol during the last month of treatment (weeks 3-6). (NCT03035708)
Timeframe: Weeks 3-6
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 2 |
| Placebo | 4 |
Mean Change From Baseline in Eye Dryness Score From Baseline to Day 28
Change in Eye Dryness Score Eye from baseline to 28 days. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better outcome. (NCT04036292)
Timeframe: 28 Days [Visit 1 (baseline) and Visit 4b (28 days)]
| Intervention | mm (Least Squares Mean) |
|---|
| OC-01 Low Dose, 0.6 mg/mL | -19.8 |
| OC-01 High Dose, 1.2 mg/mL | -22.2 |
| Placebo | -15.4 |
Mean Change From Baseline in Eye Dryness Score in CAE at Week 4 at 5 Minutes
Change in Eye Dryness Score Eye from baseline in CAE at 4 Weeks at 5 minutes post treatment. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better outcome. (NCT04036292)
Timeframe: 28 Days [Visit 1 (baseline) and Visit 4a (28 days)]
| Intervention | mm (Least Squares Mean) |
|---|
| OC-01 Low Dose, 0.6 mg/mL | -10.3 |
| OC-01 High Dose, 1.2 mg/mL | -9.0 |
| Placebo | -7.4 |
Mean Change From Baseline in Eye Dryness Score in the Study Eye at Week 1
Change in Eye Dryness Score Eye from baseline to 28 days. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better outcome. (NCT04036292)
Timeframe: 7 Days [Visit 1 (baseline) and Visit 2 (7 days)]
| Intervention | mm (Least Squares Mean) |
|---|
| OC-01 Low Dose, 0.6 mg/mL | -15.7 |
| OC-01 High Dose, 1.2 mg/mL | -15.4 |
| Placebo | -13.3 |
Mean Change From Baseline in Eye Dryness Score in the Study Eye at Week 2
Chang in Eye Dryness Score Eye from baseline to 28 days. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better otucome. (NCT04036292)
Timeframe: 14 Days [Visit 1 (baseline) and Visit 3 (14 days)]
| Intervention | mm (Least Squares Mean) |
|---|
| OC-01 Low Dose, 0.6 mg/mL | -16.5 |
| OC-01 High Dose, 1.2 mg/mL | -17.9 |
| Placebo | -12.7 |
Percent of Subjects Who Achieve ≥10 mm Improvement in Schirmer's Test Score From Baseline at Visit 4 (Day 28)
The primary endpoint was the percentage of subjects who achieve ≥10 mm improvement in Schirmer's Test Score from baseline to 28 days in the study eye following treatment with OC-01. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome. (NCT04036292)
Timeframe: 28 Days [Visit 1 (baseline) and Visit 4b (28 days)]
| Intervention | Participants (Count of Participants) |
|---|
| OC-01 Low Dose, 0.6 mg/mL | 123 |
| OC-01 High Dose, 1.2 mg/mL | 121 |
| Placebo (Vehicle) Nasal Spray | 70 |
Number of Participants Achieving 7+ Days Abstinence at Any Point During Treatment
Number of participants achieving 7+ days of self-reported abstinence at any point during active treatment (NCT01509547)
Timeframe: 12 weeks of active treatment
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 31 |
| Placebo | 24 |
Number of Participants Experiencing Treatment-emergent Adverse Events
Clinician-collected adverse events (regardless of relatedness to medication) occurring at any point after randomization and initiation of treatment. (NCT01509547)
Timeframe: 26 weeks (12 weeks of treatment plus full post-treatment follow-up)
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 55 |
| Placebo | 60 |
Number of Participants With Cotinine-confirmed 7-day Point Prevalence Abstinence at the End of Treatment
Self-reported 7-day cigarette abstinence, confirmed by urine corinne ≤50 ng/mL at the end-of-treatment (week 12) visit (NCT01509547)
Timeframe: 7 days at end of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 4 |
| Placebo | 4 |
Percentage of Post-treatment Visits With Abstinence
Self-reported abstinence at post-treatment follow-up visits (reported as percentage of total possible post-treatment follow-up visits at which abstinence in the prior week was self-reported). Missing data were imputed to non-abstinence. (NCT01509547)
Timeframe: One week abstinence at the Week 16 and Week 26 post-treatment follow-up visits
| Intervention | percentage of visits with abstinence (Number) |
|---|
| Varenicline | 20.8 |
| Placebo | 10.6 |
Percentage of Visits With Abstinence During Treatment
Self-reported between-visit abstinence at weekly visits during treatment (reported as percentage of total possible visits across all participants at which participants self-reported abstinence). Missing data were imputed to non-abstinence. (NCT01509547)
Timeframe: 12 weeks (all of active treatment)
| Intervention | percentage of visits with abstinence (Number) |
|---|
| Varenicline | 14.2 |
| Placebo | 7.3 |
Feasibility of Combining ACT With 2 Different Varenicline-assisted Quitting Strategies
Demand for participating (# of participants recruited per month); practicality of study procedures (% participants completing study procedures); acceptability of study procedures (% participants adhering to making a quit attempt within the quit window) (NCT04011280)
Timeframe: Through completion of study, an average of 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Demand For Participating | Practicality of Study Procedures | Acceptability of Study Procedures |
|---|
| Low Dose Varenicline | 1 | 9 | 13 |
,| Standard Dose Varenicline | 1 | 12 | 12 |
Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks
Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day, confirmed with an exhaled carbon monoxide reading of <10 ppm.. (NCT01553084)
Timeframe: Assessed 26 weeks after the target quit day.
| Intervention | Participants (Count of Participants) |
|---|
| Effectiveness of Nicotine Patch Only | 63 |
| Effectiveness of Combination NRT | 124 |
| Effectiveness of Varenicline [Chantix] | 108 |
Number of Days to Relapse
The number of days to relapse is defined as the number of days from the target quit day until the first of seven consecutive days of smoking. (NCT01553084)
Timeframe: Assessed from the target quit day through 26 weeks.
| Intervention | Days (Mean) |
|---|
| Effectiveness of Nicotine Patch Only | 29.3 |
| Effectiveness of Combination NRT | 37.4 |
| Effectiveness of Varenicline [Chantix] | 31.7 |
Number of Participants With Initial Cessation in the First 7 Days Post-quit
Defined as at least 1 day of abstinence during the first 7 days after the target quit day. (NCT01553084)
Timeframe: Assessed for the first seven days after the target quit date.
| Intervention | Participants (Count of Participants) |
|---|
| Effectiveness of Nicotine Patch Only | 176 |
| Effectiveness of Combination NRT | 339 |
| Effectiveness of Varenicline [Chantix] | 289 |
Change in Quick Inventory of Depressive Symptoms, 16 Question Self-report
"this is a 16-item self report questionnaire that measures depressive symptoms.~Improvement is reported in change in depressive score~score ranges from 0-27, with higher numbers indicating more severe symptom reporting.~change is calculated by baseline plus/minus the value at the later time point" (NCT00525837)
Timeframe: Baseline and every 2 weeks until 8 weeks or study endpoint
| Intervention | Units on a scale (Mean) |
|---|
| Varenicline | 4.7 |
Improvement on Patient and Clinician Clinical Global Impression Rating Scale (CGI)
"Reference:~Guy W, editor. ECDEU Assessment Manual for Psychopharmacology. 1976. Rockville, MD, U.S. Department of Health, Education, and Welfare~The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients)." (NCT00525837)
Timeframe: 6-8 weeks
| Intervention | units on a scale (Mean) |
|---|
| Varenicline | 2.1 |
Improvement on Snaith-Hamilton Pleasure Scale (SHAPS)
"Snaith-Hamilton Pleasure Scale (SHAPS; Snaith et al, 1995). The SHAPS is a 14-item scale that measures anhedonia, the inability to experience pleasure. The items cover the domains of: social interaction, food and drink, sensory experience, and interest/pastimes. A score of 2 or less constitutes a normal score, while an abnormal score is defined as 3 or more. Each item has four possible responses: strongly disagree, disagree, agree, or strongly agree. Either of the disagree responses score one point, and either of the agree responses score 0 points. Thus, the final score ranges from 0 to 14. The SHAPS has adequate construct validity and satisfactory test-retest reliability (ICC=0.70) (Franken et al, 2007). High internal consistency has also been reported (Cronbach's alpha of 0.94) (Franken et al, 2007)" (NCT00525837)
Timeframe: 6-8 weeks
| Intervention | score on a scale (Mean) |
|---|
| Varenicline | 24.9 |
Point Prevalence Smoking Abstinence at 12 Weeks: the Number of Patients Who Refrained From Smoking at 12 Weeks
Smoking abstinence biochemically confirmed with exhaled carbon monoxide concentrations (NCT00587769)
Timeframe: 12 weeks
| Intervention | Participants (Number) |
|---|
| Medication Arm | 27 |
Point Prevalence Smoking Abstinence at 6 Months: the Number of Patients Who Refrained From Smoking at 6 Months
Smoking abstinence biochemically confirmed with exhaled carbon monoxide concentrations (NCT00587769)
Timeframe: 6 months
| Intervention | Participants (Number) |
|---|
| Medication Arm | 22 |
End-of-treatment Abstinence
Carbon monoxide (≤10 parts per million) verified abstinence during the last two weeks of treatment (NCT00664755)
Timeframe: 2 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 25 |
| Transdermal Nicotine Patch | 13 |
Visual Analog Scale Alcohol Craving
Visual Analog Scale specific to alcohol craving. The VAS has a 100 mm line anchored by 0 and 100. Participants mark the line to indicate how strong their craving is for alcohol. 0 indicates no craving 100 indicates strongest possible craving. (NCT01151813)
Timeframe: average value over one week
| Intervention | units on a scale (Mean) |
|---|
| Varenicline First, Then Placebo | 20 |
| Placebo First, Then Varenicline | 35 |
Visual Analog Scale Alcohol Craving 2
Visual Analog Scale specific to alcohol craving. The VAS has a 100 mm line anchored by 0 and 100. Participants mark the line to indicate how strong their craving is for alcohol. 0 indicated no craving, 100 represents the worst craving imaginable. The subject draws a hatch mark line along the line closer to where there current craving is rated. Closer to the 0 means less craving, closer to the 100 means more craving (NCT01151813)
Timeframe: average over one week
| Intervention | units on a scale (Mean) |
|---|
| Varenicline First, Then Placebo | 35 |
| Placebo First, Then Varenicline | 55 |
Visual Analog Scale Cocaine Craving
Visual Analog Scale specific to cocaine craving. The VAS has a 100 mm line anchored by 0 and 100. Participants mark the line to indicate how strong their craving is for cocaine. 0 indicated no craving, 100 represents the worst craving imaginable. The subject draws a hatch mark line along the line closer to where there current craving is rated. (NCT01151813)
Timeframe: average value over one week
| Intervention | units on a scale (Mean) |
|---|
| Varenicline First, Then Placebo | 25 |
| Placebo First, Then Varenicline | 65 |
Visual Analog Scale Cocaine Craving 2
Visual Analog Scale specific to cocaine craving. The VAS has a 100 mm line anchored by 0 and 100. Participants mark the line to indicate how strong their craving is for cocaine. 0 indicated no craving, 100 represents the worst craving imaginable. The subject draws a hatch mark line along the line closer to where there current craving is rated. Closer to the 0 means less craving, closer to the 100 means more craving (NCT01151813)
Timeframe: average over one week
| Intervention | units on a scale (Mean) |
|---|
| Varenicline First, Then Placebo | 65 |
| Placebo First, Then Varenicline | 80 |
Average Weekly Cocaine Craving Scores Varenicline Group Versus the Placebo Group Comparator
As measured by average weekly scores for cocaine craving on the brief substance craving scale combining cocaine craving frequency, intensity and duration. Minimum value 0 maximum value 12 higher scores indicate worse craving. (NCT01680887)
Timeframe: Once per week in weeks 2 through 13
| Intervention | score on a scale (Mean) |
|---|
| Varenicline | 1.12 |
| Placebo | 0.99 |
Number of Participants Who Report no Cocaine Use and Have no Cocaine Positive Urine Drug Screens in the Chantix Group Versus the Placebo Group Comparator During the Last Three Weeks of the Trial
Number of subjects with cocaine abstinence as measured through three-times-weekly urine benzoylecgonine (BE) levels in urine drug screen (UDS) and self-reports of use from the Time Line Follow Back. UDS results and TLFB reports combined to yield weekly use/no-use indicators for each week of treatment. (NCT01680887)
Timeframe: weeks 11,12,13 of the trial
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 6 |
| Placebo | 7 |
Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.
This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina. (NCT01574703)
Timeframe: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).
| Intervention | percentage of participants (Number) |
|---|
| Varenicline | 0.25 |
| Bupropion | 0.20 |
| NRT Patch | 0.10 |
| Placebo | 0.25 |
Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.
This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug). (NCT01574703)
Timeframe: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).
| Intervention | percentage of participants (Number) |
|---|
| Varenicline | 0.05 |
| Bupropion | 0.10 |
| NRT Patch | 0.05 |
| Placebo | 0.20 |
Incidence of MACE Assessed Until End of Study NCT01574703.
This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study. (NCT01574703)
Timeframe: Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).
| Intervention | percentage of participants (Number) |
|---|
| Varenicline | 0.15 |
| Bupropion | 0.45 |
| NRT Patch | 0.30 |
| Placebo | 0.40 |
Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.
This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up. (NCT01574703)
Timeframe: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.
| Intervention | percentage of participants (Number) |
|---|
| Varenicline | 0.05 |
| Bupropion | 0.10 |
| NRT Patch | 0.10 |
| Placebo | 0.20 |
Incidence of MACE+ Assessed Until End of Study NCT01574703.
This is an adjudicated endpoint. MACE+ is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina. (NCT01574703)
Timeframe: Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).
| Intervention | percentage of participants (Number) |
|---|
| Varenicline | 0.50 |
| Bupropion | 0.75 |
| NRT Patch | 0.49 |
| Placebo | 0.60 |
Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.
This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina. (NCT01574703)
Timeframe: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.
| Intervention | percentage of participants (Number) |
|---|
| Varenicline | 0.25 |
| Bupropion | 0.20 |
| NRT Patch | 0.15 |
| Placebo | 0.35 |
Time to MACE Until the End of Study NCT01574703.
This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study. The measure type mentioned in the outcome data table is Hazard Ratio. (NCT01574703)
Timeframe: Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).
| Intervention | Unitless (Number) |
|---|
| Varenicline | 0.39 |
| Bupropion | 1.09 |
| NRT Patch | 0.75 |
| Placebo | NA |
Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.
This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up. The measure type mentioned in the outcome data table is Hazard Ratio. (NCT01574703)
Timeframe: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days.
| Intervention | Unitless (Number) |
|---|
| Varenicline | 0.29 |
| Bupropion | 0.51 |
| NRT Patch | 0.50 |
| Placebo | NA |
Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.
This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug). The measure type mentioned in the outcome data table is Hazard Ratio relative to Placebo. (NCT01574703)
Timeframe: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).
| Intervention | Unitless (Number) |
|---|
| Varenicline | 0.29 |
| Bupropion | 0.50 |
| NRT Patch | 0.29 |
| Placebo | NA |
Cigarettes Per Day
Cigarettes per day at Baseline versus 8 weeks of treatment, placebo-controlled (NCT01524627)
Timeframe: last week of treatment (1-8 weeks)
| Intervention | cigarettes per day (Mean) |
|---|
| Baseline | Following Treatment |
|---|
| Placebo | 15.7 | 9.8 |
,| Varenicline | 14.3 | 5.3 |
Number of Participants Who Completed Treatment.
To assess feasibility/acceptability, the number of participants who completed treatment will be assessed. (NCT02151591)
Timeframe: 12 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Integrated Counseling for Tobacco and Alcohol (INT) | 7 |
| Standard Care for Primary Presenting Concern (SC) | 10 |
Number of Participants With Smoking Abstinence at 6 Months
Number of participants with point prevalence smoking abstinence (i.e., no smoking, not even a puff over the last 7 days) 6 months after treatment completion. (NCT02151591)
Timeframe: 6 months post treatment start
| Intervention | Participants (Count of Participants) |
|---|
| Integrated Counseling for Tobacco and Alcohol (INT) | 6 |
| Standard Care for Primary Presenting Concern (SC) | 3 |
Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Cognitive Interference as Assessed by The Three-card Stroop Task
"In the 3-card Stroop Task, 3 cards were presented; the 1st contained color names printed in black ink, the 2nd contained colored patches of ink, the 3rd contained color names printed in incongruously colored ink. Participants were asked to read or name as many items as possible in 45 seconds for each condition. Individuals are asked to identify the color of the ink of a word. They may be distracted by the presence of a word that states another color (i.e. the word blue written in green ink would require the answer green).The interference score was calculated by dividing the color-word score by the color score. There is only one outcome measure time point because cognitive outcomes were analyzed using crossover analyses of covariance (ANCOVA) with drug (mecamylamine vs varenicline vs pbo) as a within subject factor, diagnosis (schizophrenia vs. control) as a between subject factor as well as study period and drug administration sequence as between subject crossover design factors" (NCT00455650)
Timeframe: Baseline (week 1), week 2, week 3, week 4 analyzed as a single time point
| Intervention | score (Mean) |
|---|
| Schizophrenia: Mecamylamine | 50.2 |
| Schizophrenia: Varenicline | 52.8 |
| Schizophrenia: Placebo | 50.3 |
| Control: Mecamylamine | 54.4 |
| Control: Varenicline | 53.3 |
| Control: Placebo | 53.5 |
Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Prolonged Attention as Assessed With the CPT-IP Hit Reaction Time Variability
The Continuous Performance Test-Identical Pairs, CPT-IP, Version 4.0 was developed and normed for use in people with schizophrenia and normal controls. This task estimates attention by requiring an individual to push a response key when two identical pairs of shapes or numbers are presented in sequence. Stimuli were presented with increasing cognitive load: 2-, 3-, and 4-digit targets. Outcome variables measured included correct hits, hit reaction time (HRT), errors of commission: false alarms and random errors, and the primary outcome, variability, or standard deviation, of hit reaction time, HRT-SD. There is only one outcome measure time point because cognitive outcomes were analyzed using crossover analyses of covariance (ANCOVA) with drug (mecamylamine vs. varenicline vs. placebo) as a within subject factor, diagnosis (schizophrenia vs. control) as a between subject factor, as well as study period and drug administration sequence as between subject crossover design factors. (NCT00455650)
Timeframe: Baseline (week 0), week 1, week 2 and week 3 as one time point (see outcome measure description)
| Intervention | ms (Mean) |
|---|
| Schizophrenia: Mecamylamine | 141.6 |
| Schizophrenia: Varenicline | 120.5 |
| Schizophrenia: Placebo | 123.1 |
| Control: Mecamylamine | 91.2 |
| Control: Varenicline | 83.2 |
| Control: Placebo | 87.8 |
Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Sustained Attention as Assessed by The N-back Task
"The N-back task with 1- and 2-back parametric conditions was used. During the task, a letter was displayed for 1,500 ms every 2 s with a 500 ms isi. Participants were asked to press the 1 key for letters that corresponded to the letter 1 back for the 1-back condition, the 2 key for the 2-back condition, and the 3 key for nontarget letters. Outcome variable presented is hit reaction time There is only one outcome measure time point because this outcome was analyzed using crossover analyses of covariance (ANCOVA) with drug (mecamylamine vs. varenicline vs. placebo) as a within subject factor, diagnosis (schizophrenia vs. control) as a between subject factor, as well as study period and drug administration sequence as between subject crossover design factors." (NCT00455650)
Timeframe: Baseline (week 1), week 2, week 3, week 4 analyzed as a single time point
| Intervention | ms (Mean) |
|---|
| Schizophrenia: Mecamylamine | 909.2 |
| Schizophrenia: Varenicline | 931.2 |
| Schizophrenia: Placebo | 894.4 |
| Control: Mecamylamine | 864.6 |
| Control: Varenicline | 795.8 |
| Control: Placebo | 827.5 |
Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Working Memory as Assessed by The Visual Spatial Working Memory (VSWM) Task
In the Visual spatial working memory (VSWM), participants were asked to place the cursor where the symbol appeared immediately after its display. For 16 additional trials, participants were asked to identify the symbol location after a 30-second delay. During the delay, participants were distracted by being asked to read aloud words appearing on the screen at 2-second intervals. The outcome of interest in this task were the average distance from the target for immediate and delayed recall There is only one outcome measure time frame because this outcome was analyzed using crossover analyses of covariance (ANCOVA) with drug (mecamylamine vs. varenicline vs. placebo) as a within subject factor, diagnosis (schizophrenia vs. control) as a between subject factor, as well as study period and drug administration sequence as between subject crossover design factors. (NCT00455650)
Timeframe: Baseline (week 1), week 2, week 3, week 4 analyzed as a single time point
| Intervention | Distance (in) (Mean) |
|---|
| Schizophrenia: Mecamylamine | 2.83 |
| Schizophrenia: Varenicline | 2.72 |
| Schizophrenia: Placebo | 2.87 |
| Control: Mecamylamine | 2.29 |
| Control: Varenicline | 2.28 |
| Control: Placebo | 2.25 |
Tolerability of the Combination of 25 mg Naltrexone and 2 mg Varenicline
Tolerability was measured by tracking adverse events. These data are reported in detail in the adverse events section. Presented are an unduplicated count of participants that experienced at least 1 adverse event. (NCT00502216)
Timeframe: 11 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline + Naltrexone | 10 |
| Varenicline + Placebo | 4 |
Weight Gain in Participants Who Are Continuously Abstinent for the Last 4 Weeks of Treatment
(NCT00502216)
Timeframe: 4 weeks
| Intervention | pounds (Mean) |
|---|
| Varenicline + Naltrexone | 0 |
| Varenicline + Placebo | 7.67 |
Weight Gain in Treatment Completers
(NCT00502216)
Timeframe: baseline and 12 weeks
| Intervention | Pounds (Mean) |
|---|
| Varenicline + Naltrexone | 3.35 |
| Varenicline + Placebo | 4.14 |
Change From Baseline in Psychiatric Symptoms
The Positive and Negative Syndrome Scale (PANSS) was used to measure psychiatric symptoms. Item scores ranged from 1 (Absent) to 6 (Severe) for symptoms on the Positive Scale (total subscale range: 7-42), the Negative Scale (total subscale range: 7-42), and the General Psychopathology Scale (total subscale range:16-96). All three subscales were summed for the PANSS total score (total scale range: 30-180). Higher numbers indicate more psychopathology. Therefore, if scores are reduced at post-baseline ratings, this would indicate lower psychopathology. (NCT00548470)
Timeframe: Baseline and 2 months later
| Intervention | Units on the PANSS scale (Mean) |
|---|
| PANSS total baseline | PANSS total 2 months | PANSS Positive baseline | PANSS Positive 2 months |
|---|
| Varenciline | 56.57 | 55.58 | 12.58 | 12.00 |
CO (Carbon Monoxide) Breathalyzer Level
Carbon Monoxide in breath ,parts per million (NCT00548470)
Timeframe: baseline and during 2 months of treatment
| Intervention | ppm (carbon monoxide parts per million) (Mean) |
|---|
| CO level baseline | CO level month 1 | CO level month 2 |
|---|
| Varenciline | 8.97 | 5.7 | 4.85 |
Plasma Cotinine
cotinine level in plasma ng/ml. (NCT00548470)
Timeframe: baseline 1 month and 2 months
| Intervention | ng/ml (Mean) |
|---|
| baseline cotinine | 1 month cotinine | 2 month cotinine |
|---|
| Varenciline | 362.25 | 181.75 | 200.25 |
RBANS Neuropsychological Battery
The scale is Repeatable Battery for the Assessment to Neuropsychological Status (RBANS). This scale measures cognitive function in patients with schizophrenia. RBANS scores for list learning range from 0 to 40. RBANS Index scores for visual-spatial index, language index, and Total score range from 40-160. RBANS Total score is the sum of score of all the individual items ( items 1-12) on the RBANS scale. List Learning scores range from 0 to 40. Visual Spatial Construction index scores range from 0 to 30.. Higher scores on all these measures indicate better performance or better cognitive ability. (NCT00548470)
Timeframe: baseline and month 2 of treatment
| Intervention | RBANS scores (Mean) |
|---|
| RBANS total baseline | RBANS total 2 months | RBANS l;ist learning baseline | RBANS list learning 2 months | RBANS visuospatal index baseline | RBANS visuospatial index 2 months | RBANS language index baseline | RBANS language index 2 months |
|---|
| Varenciline | 59.00 | 59.17 | 15.75 | 19.50 | 73.58 | 63.50 | 70.17 | 83.50 |
Self Report of Smoking
Patients self-report of smoking cigarettes. Patients were interviewed weekly about the number of cigarettes smoked. Number of cigarettes smoked in the past week. (NCT00548470)
Timeframe: Baseline and during 2 months of treatment
| Intervention | Cigarettes (Mean) |
|---|
| Cigarettes smoked baseline | Cigarettes smoked month 1 | Cigarettes smoked month 2 |
|---|
| Varenciline | 36.45 | 17.25 | 12.52 |
Alcohol Consumption
Peak Breath Alcohol Concentration during IV alcohol self-administration (NCT00695500)
Timeframe: 2.5 hr session following 3 weeks of treatment
| Intervention | mg/% (Mean) |
|---|
| Varenicline | 92.0 |
| Placebo | 77.3 |
Alcohol Urges
"Peak Alcohol Urge Questionnaire Score during IV alcohol self-administration. Scale: Alcohol Urge Questionnaire. Contains 8 items, each item scored on a likert scale from 1 to 7.~Range: Total scores range between 8 and 64. Higher scores indicate higher urges for alcohol." (NCT00695500)
Timeframe: 2.5 hr session following 3 weeks of treatment
| Intervention | Units on a scale (Mean) |
|---|
| Varenicline | 23.65 |
| Placebo | 26.82 |
BOLD Response to Alcohol Cue
Percent BOLD signal change during Alcohol Food Incentive Delay Task (Alcohol - Neutral) (NCT00695500)
Timeframe: fMRI session following 2 weeks of treatment
| Intervention | Percent Signal Change (Mean) |
|---|
| Varenicline | -0.021 |
| Placebo | 0.194 |
To Determine the Efficacy of Varenicline for Smoking Cessation Among PLWH Who Smoke
To compare biochemically confirmed tobacco abstinence rates among smokers living with HIV treated with nicotine replacement vs varenicline (NCT00701896)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) |
|---|
| 3 month biochemically confirmed abstinence rate | 6 month biochemically confirmed abstinence rate | 12 month biochemically confirmed abstinence rate |
|---|
| Nicotine Replacement Plus Motivational Interviewing | 13 | 5 | 4 |
,| Varenicline Plus Motivational Interviewing | 30 | 19 | 18 |
To Determine the Safety of Varenicline in PLWH Who Smoke
To determine the safety and tolerability of varenicline compared to nicotine replacement (NCT00701896)
Timeframe: 3 months
| Intervention | Participants (Count of Participants) |
|---|
| Nausea | Vomiting | Insomnia | Vivid dreams | Suicidal ideation | Depressed mood | Skin rash |
|---|
| Nicotine Replacement Plus Motivational Interviewing | 13 | 3 | 11 | 11 | 0 | 0 | 17 |
,| Varenicline Plus Motivational Interviewing | 38 | 4 | 8 | 27 | 1 | 8 | 0 |
Nicotine Withdrawal Scale
Scale is equal to days subject did not smoke Scale is 0-5 0 being no days 5 being did not quit at all (NCT00709696)
Timeframe: 21 days
| Intervention | units on a scale (Mean) |
|---|
| Placebo Varenicline | 3.3 |
| Varenicline | 0.3 |
Latency to Initiate Ad-lib Smoking Session
Time to smoking during the smoking delay task. Smoking delay task occurred on day 8 of the study. Range of time delay is 0 minutes to 50 minutes. (NCT00773422)
Timeframe: day 8
| Intervention | minutes (Mean) |
|---|
| Naltrexone + Varenicline | 28.134 |
| Varenicline | 45.861 |
| Placebo | 21.737 |
Number of Cigarettes Smoked During the Ad-lib Period
Number of cigarettes smoked during the ad libitum phase of the smoking delay task. Task occurred on day 8 of the study. (NCT00773422)
Timeframe: day 8
| Intervention | cigarettes (Mean) |
|---|
| Naltrexone + Varenicline | 1.283 |
| Varenicline | 0.959 |
| Placebo | 2.23 |
Change in Smoking Behavior
Change in cigarettes per day from Week 2 to Week 5 (NCT00835900)
Timeframe: Change in cigarettes per day from Week 2 to Week 5
| Intervention | Change in Cigarettes Per Day (Mean) |
|---|
| Extended Run-In | -6.3 |
| Standard Run-In | -3.2 |
Rates of Smoking Cessation.
To parallel most clinical trials of varenicline, we focused on CO-verified (<11 parts per million) continuous abstinence (not even one puff) during the final 4 weeks of treatment (i.e., post-quit weeks 8 through 11). Participants lost to follow-up were coded as smokers. (NCT00835900)
Timeframe: 12 weeks after quit date.
| Intervention | Participants (Count of Participants) |
|---|
| Extended Run-In | 17 |
| Standard Run-In | 11 |
Alcohol Use
Alcohol use during the previous seven days will be assessed among those receiving the risky alcohol use treatment module and those in the quitline referral condition who would have been eligible for the intervention if assigned to the tailored treatment group. (NCT01592695)
Timeframe: Six-month follow-up
| Intervention | Drinks consumed per day (Mean) |
|---|
| Tailored Intervention Group | 9.5 |
| Enhanced Standard of Care Group | 2.8 |
Body Weight
Self-reported body weight. (NCT01592695)
Timeframe: Six-month follow-up
| Intervention | Pounds (Mean) |
|---|
| Tailored Intervention Group | 214.0 |
| Enhanced Standard of Care Group | 228.2 |
Depressive Symptoms
Depressive symptoms as measured using the Patient Health Questionnaire 9 (PHQ-9). Possible scores range from 0 to 27, with higher scores indicating greater levels of depressive symptoms. (NCT01592695)
Timeframe: Six-month follow-up
| Intervention | units on a scale (Mean) |
|---|
| Tailored Intervention Group | 7.0 |
| Enhanced Standard of Care Group | 3.9 |
Enrollment Rate
The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approached for the entire six-month recruitment period. (NCT01592695)
Timeframe: 6 months after study initiation
| Intervention | Participants (Count of Participants) |
|---|
| Tailored Intervention Group | 31 |
| Enhanced Standard of Care Group | 32 |
Number of Participants Abstinent From Tobacco Use
At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven days (point prevalence abstinence). (NCT01592695)
Timeframe: Six-month follow-up
| Intervention | Participants (Count of Participants) |
|---|
| Tailored Intervention Group | 9 |
| Enhanced Standard of Care Group | 9 |
Retention
The number of participants who remain in the study throughout the seven-week treatment period will be computed as an indicator of the feasibility of the treatment approach. (NCT01592695)
Timeframe: End of treatment (seven weeks after baseline)
| Intervention | Participants (Count of Participants) |
|---|
| Tailored Intervention Group | 16 |
Treatment Attendance
The number of treatment calls completed (out of six total) will be calculated for all participants in the Tailored Intervention group as an indicator of the feasibility of the treatment approach. (NCT01592695)
Timeframe: End of treatment (seven weeks after baseline)
| Intervention | Calls (Mean) |
|---|
| Tailored Intervention Group | 4.0 |
Treatment Satisfaction
Participants' impressions of and satisfaction with the intervention will be assessed by interview at the end of treatment. (NCT01592695)
Timeframe: End of treatment (seven weeks after baseline)
| Intervention | Participants (Count of Participants) |
|---|
| Found treatment very or extremely useful | Found medication to be very or extremely useful | Found treatment to be very or extremely convenient | Found treatment to be very or extremely difficult | Liked that treatment was delivered by phone |
|---|
| Enhanced Standard of Care Group | 6 | 7 | 9 | 5 | 10 |
,| Tailored Intervention Group | 17 | 16 | 16 | 5 | 21 |
Change in Post-Resist Craving
Change in Post-resist task craving between Scan 1, pre-medication, and Scan 2, post- medication, as measured on a 0-10 Likert scale. The Within Sessions Rating scale (Range 0-10) measures craving with 0 indicating Not at All and 10 indicating Extremely. Change scores were calculate by subtracting the craving score immediately following the pre-medication scan from the craving score immediately following the post-medication scan. (NCT00934024)
Timeframe: 5 weeks
| Intervention | units on a scale (Mean) |
|---|
| Abstinent | 6 |
| Non-abstinent | 3.6 |
Days to Relapse
Number of days following the programmed lapse exposure until relapse to smoking occurred (NCT00944554)
Timeframe: 4 weeks
| Intervention | days (Mean) |
|---|
| Placebo | 9.1 |
| Varenicline | 16.4 |
End-of-intervention Smoking Abstinence
number of participants who achieved smoking abstinence based on self-reported 7-day point prevalence smoking abstinence verified by a carbon monoxide (CO) < 8 ppm (NCT01898195)
Timeframe: 7 Days
| Intervention | participants (Number) |
|---|
| Standard Care | 3 |
| Standard Care + Text Message | 2 |
| Standard Care + Text Message + ABT | 8 |
End-of-intervention Varenicline Adherence
number of participants who took at least 80% prescribed dose since last interview, based on pill count (NCT01898195)
Timeframe: 4 Weeks
| Intervention | participants (Number) |
|---|
| Standard Care | 18 |
| Standard Care + Text Message | 16 |
| Standard Care + Text Message + ABT | 15 |
Evidence of Abstinence From Cocaine as Indicated by Qualitative Urinalysis for Benzoylecgonine.
Number of Participants that Tested Negative for Benzoylecgonine in Qualitative Urinalysis Assessment. (NCT00567008)
Timeframe: 8 weeks
| Intervention | participants (Number) |
|---|
| Varenicline | 2 |
| Placebo | 1 |
Proportion of Cocaine Positive Urine Tests Per Week
Urine samples were obtained thrice-weekly and analyzed for the presence of cocaine metabolites. Levels that exceeded 300 ng / ml on each individual urine test were considered positive. The primary outcome measure was the proportions of positive cocaine urine results per week that was calculated by using the total number of completed tests as the denominator and the total number of positive tests for that week as the numerator. This data was subjected to Hierarchical Linear Modeling (HLM) analysis using a total of 13 longitudinal results that included a baseline result (Week 0). (NCT00567320)
Timeframe: Weekly Measures over 12 weeks
| Intervention | Proportion of cocaine positive (Mean) |
|---|
| Varenicline | .57 |
| Placebo | .58 |
Change in MPSS Scores of Urges to Smoke and Cigarette Withdrawal Symptoms Throughout the First Four Weeks of Abstinence
"Change in the Mood and Physical Symptoms Scale (MPSS)*, scores of urges to smoke and cigarette withdrawal symptoms throughout the first four weeks of abstinence (measured weekly from weeks 4-8).~* The MPSS measures cigarette withdrawal symptoms. The scale is 1-5, 1 being not at all and 5 being extremely (depressed, irritable, restless, hungry, poor concentration, slept worse than usual)." (NCT00789074)
Timeframe: Week 4 - 8
| Intervention | Scores on a scale (Mean) |
|---|
| Varenicline Pre-treatment | 0.15 |
| Placebo | 0.15 |
Change in Pre-quit Cigarette Consumption
Participants reported average number of cigarettes smoked per day every week throughout the four week pre-quit period. (NCT00789074)
Timeframe: Baseline - week 4
| Intervention | Cigarettes consumed per day (Mean) |
|---|
| Varenicline Pre-treatment | -9.78 |
| Placebo | -5.68 |
Change in Pre-quit Cotinine Levels
Differences in baseline cotinine levels were compared with cotinine levels measured 4 weeks after taking the first medication dose. (NCT00789074)
Timeframe: Weeks 1-4 (the first 4-weeks after first medication dose)
| Intervention | ng/ml (Mean) |
|---|
| Varenicline Pre-treatmemt | -184.69 |
| Placebo | -44.73 |
Change in Pre-quit End-expired Carbon Monoxide Reading (CO)
"Carbon monoxide concentration is measured in particles per million. It indicates smoke intake.~CO was measured at each contact to monitor changes in smoke intake and differences between the study arms." (NCT00789074)
Timeframe: Baseline - week 8
| Intervention | ppm (Mean) |
|---|
| Varenicline | -14.85 |
| Placebo | -7.68 |
Change in Pre-quit Ratings of Cigarette Satisfaction
"Satisfaction measured on a scale of 1-5; Have you found your cigarettes more or less enjoyable than usual in the last week? 1= much more and 5 = much less" (NCT00789074)
Timeframe: Baseline - week 4
| Intervention | units on a scale (Mean) |
|---|
| Varenicline Pre-treatmemt | -1.48 |
| Placebo | -0.842 |
Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale
The scale measures tobacco withdrawal symptoms (depressed, irritable, restless, hungry, poor concentration, slept worse than usual) on 5-point scales from Not at all (rated as 1) to Extremely (rated as 5). It also asks 'How much of the time have you felt the urge to smoke in the last week? and 'How strong have these urges been?'; both rated on 6-point scales with higher numbers=higher craving. (NCT00789074)
Timeframe: 24 hours and 7 days after quit date (week 4)
| Intervention | units on a scale (Mean) |
|---|
| Varenicline | 2.47 |
| Placebo | 2.88 |
Expired-air CO Verified Point-prevalence Abstinence
Self-reported no smoking in last 7 days verified by CO<10 ppm (NCT01330043)
Timeframe: 104 weeks
| Intervention | participants (Number) |
|---|
| Maintenance Treatment | 39 |
| Extended Treatment | 33 |
Expired-air CO Verified Point-prevalence Abstinence
Self-reported no smoking in last 7 days verified by CO<10 ppm (NCT01330043)
Timeframe: 52 weeks
| Intervention | participants (Number) |
|---|
| Maintenance Treatment | 44 |
| Extended Treatment | 42 |
# of Drinks Per Drinking Day
The drinks per drinking day outcome is determined using the the Timeline Follow Back (TLFB). The TLFB was administered to assess quantity and frequency of alcohol use each day during the practice quit period (Day 8 - Day 14). Information obtained in this interview was recorded on the TLFB Calendar and transcribed to a database. The primary outcome variable was calculated as the number of drinks per drinking day during the practice quit period. (NCT04249882)
Timeframe: 6 days
| Intervention | number of drinks per drinking day (Least Squares Mean) |
|---|
| Placebo | 1.66 |
| Varenicline | 2.19 |
| Naltrexone | 2.73 |
Cue-induced Craving
Randomized participants completed a cue-exposure paradigm at two time points during the study, once on Day 1 prior to ingesting the first does of study medication, and again on Day 14. After every 3 minutes of exposure (water and alcohol), participants rated their urge to drink on the Alcohol Urge Questionnaire (AUQ). The AUQ is comprised of eight items rated on a 7-point Likert scale with items related to the subjective experience of alcohol craving, with higher total scores indicating higher craving and a minimum score of 8 and maximum score of 56. Alcohol urge questionnaire score (alcohol minus water) is the primary outcome for the cue-reactivity paradigm. The investigators are primarily interested in the difference in craving from post-treatment (day 14) to pre-treatment (randomization/day 1). (NCT04249882)
Timeframe: Cue reactivity paradigm takes place on Day 1 and on Day 14. Craving is measured 3 min after each cue exposure
| Intervention | units on a scale (Mean) |
|---|
| Placebo | -0.11 |
| Varenicline | 0.31 |
| Naltrexone | -0.32 |
Percentage of Days Abstinent
The percentage of days abstinent from alcohol is determined using the Timeline Follow Back (TLFB). The TLFB was administered to assess quantity and frequency of alcohol use each day during the practice quit period (Day 8 - Day 14). Information obtained in this interview was recorded on the TLFB Calendar and transcribed to a database. The primary outcome variable was calculated as the percent of days participants were abstinent during the practice quit period. (NCT04249882)
Timeframe: 6 days
| Intervention | percent days (Least Squares Mean) |
|---|
| Placebo | 80.59 |
| Varenicline | 75.62 |
| Naltrexone | 77.59 |
Number of Participants Completing Continuous Abstinence From Smoking Between Quit Day and 11-week Post Quit Day Visit
This will be determined by a composite of self-report of no smoking between study visits at the 1-week, 3-week, 7-week and 11-week post Quit Day study visits and expired air carbon monoxide (CO) <10 ppm (measured at those study visits). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent. (NCT01806779)
Timeframe: Quit Day to 11-week post Quit Day study visit
| Intervention | participants (Number) |
|---|
| Chantix | 21 |
| Chantix + Zyban | 15 |
Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits
This will be determined by a composite of self-report at the 11-week study visit of no smoking between the 8-week and 11-week visits and expired air carbon monoxide (CO) <10 ppm (measured at the 11-week study visit). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent. (NCT01806779)
Timeframe: Period between 8-week and 11-week visits post target Quit Day
| Intervention | participants (Number) |
|---|
| Chantix | 41 |
| Chantix + Zyban | 38 |
Number of Participants Completing Seven-day Point Abstinence From Smoking at 6 Months Post Quit Day
This will be determined by a self-report of no smoking for the previous seven days when called for 6-month follow-up confirmed by expired air CO. (NCT01806779)
Timeframe: 6 months post Quit Day
| Intervention | participants (Number) |
|---|
| Chantix | 21 |
| Chantix + Zyban | 19 |
Change in Smoking Withdrawal Symptoms
Withdrawal symptoms will be assessed by questionnaire on Quit Day, Week 1, Week 3, Week 7 and Week 11 post target quit date and 6 months post quit Follow-Up (if applicable) using the Shiffman-Jarvik questionnaire, which consists of 33-items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced. (NCT01806779)
Timeframe: Quit Day and 1 week, 3 weeks, 7 Weeks, 11 Weeks and 6 months post Quit Day
| Intervention | percentage of change (Mean) |
|---|
| Craving -- % change 1 week from Quit Day | Craving -- % change 3 weeks from Quit Day | Craving -- % change 7 weeks from Quit Day | Craving -- % change 11 weeks from Quit Day | Craving -- % change 6 months from Quit Day | Negative Affect -- % change 1 week from Quit Day | Negative Affect -- % change 3 weeks from Quit Day | Negative Affect -- % change 7 weeks from Quit Day | Negative Affect -- % change 11 weeks from Quit Day | Negative Affect -- % change 6 months from Quit Day | Appetite -- % change 1 week from Quit Day | Appetite -- % change 3 weeks from Quit Day | Appetite -- % change 7 weeks from Quit Day | Appetite -- % change 11 weeks from Quit Day | Appetite -- % change 6 months from Quit Day | Arousal -- % change 1 week from Quit Day | Arousal -- % change 3 weeks from Quit Day | Arousal -- % change 7 weeks from Quit Day | Arousal -- % change 11 weeks from Quit Day | Arousal -- % change 6 months from Quit Day | Anxiety -- % change 1 week from Quit Day | Anxiety -- % change 3 weeks from Quit Day | Anxiety -- % change 7 weeks from Quit Day | Anxiety -- % change 11 weeks from Quit Day | Anxiety -- % change 6 months from Quit Day | Gastrointestinal -- % change 1 week from Quit Day | Gastrointestinal -- % change 3 weeks from Quit Day | Gastrointestinal -- % change 7 weeks from Quit Day | Gastrointestinal - % change 11 weeks from Quit Day | Gastrointestinal - % change 6 months from Quit Day | Respiratory -- % change 1 week from Quit Day | Respiratory -- % change 3 weeks from Quit Day | Respiratory -- % change 7 weeks from Quit Day | Respiratory -- % change 11 weeks from Quit Day | Respiratory -- % change 6 months from Quit Day | Habit -- % change 1 week from Quit Day | Habit -- % change 3 weeks from Quit Day | Habit -- % change 7 weeks from Quit Day | Habit -- % change 11 weeks from Quit Day | Habit -- % change 6 months from Quit Day |
|---|
| Chantix | -18.15 | -27.06 | -30.94 | -26.97 | -42.96 | -11.45 | -9.74 | -10.16 | -15.06 | -8.55 | -10.53 | -11.04 | -9.30 | -16.20 | -33.88 | 8.03 | 5.87 | 6.94 | 7.33 | 19.80 | -8.22 | -8.66 | -11.82 | -9.34 | -66.77 | -0.69 | -5.14 | -7.67 | -8.05 | -67.72 | 1.41 | -1.12 | 0.92 | -4.36 | -65.87 | -5.15 | -17.67 | -14.46 | -16.61 | -56.97 |
,| Chantix + Zyban | -15.49 | -28.64 | -28.75 | -30.82 | -33.52 | -7.15 | -4.72 | -10.88 | -8.52 | 21.96 | -4.40 | -4.42 | -11.66 | -8.64 | -35.44 | 10.72 | -4.40 | -4.03 | -1.56 | 49.01 | -12.26 | -14.40 | -12.50 | -19.83 | -57.15 | -7.78 | -10.07 | -8.44 | -9.60 | -56.61 | -7.47 | -8.81 | -18.04 | -19.67 | -55.77 | 1.64 | -16.07 | -20.55 | -24.78 | -53.40 |
Number of Participants With the Left Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations
Number of Participants with the Left Nostril/Abnormal at 12 months as assessed by Intranasal Examinations (NCT03920215)
Timeframe: 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 12 months)
| Intervention | Participants (Count of Participants) |
|---|
| OC-01 Low Dose, 0.12 mg/mL | 0 |
| OC-01 Mid Dose, 0.6 mg/mL | 0 |
| OC-01 High Dose, 1.2 mg/mL | 0 |
| Placebo (Vehicle) Nasal Spray | 0 |
Number of Participants With the Left Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations
Number of Participants with the Left Nostril/Abnormal at 6 months as assessed by Intranasal Examinations (NCT03920215)
Timeframe: 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 6 months)
| Intervention | Participants (Count of Participants) |
|---|
| OC-01 Low Dose, 0.12 mg/mL | 0 |
| OC-01 Mid Dose, 0.6 mg/mL | 0 |
| OC-01 High Dose, 1.2 mg/mL | 0 |
| Placebo (Vehicle) Nasal Spray | 0 |
Number of Participants With the Right Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations
Number of Participants with the Right Nostril/Abnormal at 12 months as assessed by Intranasal Examinations (NCT03920215)
Timeframe: 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 12 months)
| Intervention | Participants (Count of Participants) |
|---|
| OC-01 Low Dose, 0.12 mg/mL | 0 |
| OC-01 Mid Dose, 0.6 mg/mL | 0 |
| OC-01 High Dose, 1.2 mg/mL | 1 |
| Placebo (Vehicle) Nasal Spray | 0 |
Number of Participants With the Right Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations
Number of Participants with the Right Nostril/Abnormal at 6 months as assessed by Intranasal Examinations (NCT03920215)
Timeframe: 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 6 months)
| Intervention | Participants (Count of Participants) |
|---|
| OC-01 Low Dose, 0.12 mg/mL | 0 |
| OC-01 Mid Dose, 0.6 mg/mL | 0 |
| OC-01 High Dose, 1.2 mg/mL | 1 |
| Placebo (Vehicle) Nasal Spray | 0 |
Number of Participants With Cotinine-verified 7-day Point Prevalence Smoking Abstinence at Week 26
Defined as having no cigarettes for the previous 7 days at the Week 26 visit. The recommended cut-off of 15ng/ml for salivary cotinine will be used to differentiate smokers from non-smokers. (NCT01836276)
Timeframe: Change from Baseline to Week 26
| Intervention | Participants (Count of Participants) |
|---|
| African American (AA) Smokers | 32 |
| White Smokers | 55 |
Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment
The percentage of days of heavy drinking will be examined over the final 8 weeks of the study averaged by month (weeks 9-12 and weeks 13-16). A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol. (NCT01553136)
Timeframe: weeks 13-16
| Intervention | log transformed percentage of days (Mean) |
|---|
| Varenicline | 1.99 |
| Placebo | 2.09 |
Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment
The percentage of days of heavy drinking will be examined over the final 8 weeks of the study averaged by month (weeks 9-12 and weeks 13-16). A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol. (NCT01553136)
Timeframe: weeks 9-12
| Intervention | log transformed percentage of days (Mean) |
|---|
| Varenicline | 2.07 |
| Placebo | 2.25 |
Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment
The percentage of days of heavy drinking will be examined over the final 8 weeks of the study. A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol. Presented here is the average of the 8 weeks (reported as week 17 originally). (NCT01553136)
Timeframe: 8 weeks
| Intervention | percentage of heavy drinking days (Least Squares Mean) |
|---|
| Varenicline | 2.40 |
| Placebo | 2.28 |
Smoking Abstinence
Smoking abstinence is defined by self-reported abstinence from smoking for the last four weeks of treatment (weeks 13-16) and a urine cotinine level less than 15ng/mL measured at week 17. (NCT01553136)
Timeframe: Weeks 13-16
| Intervention | Participants (Count of Participants) |
|---|
| Varenicline | 8 |
| Placebo | 0 |
Cigarettes Per Day
The Quitbit lighter will measure how many cigarettes are smoked per day. In addition to the Quitbit lighter measurement, the Timeline Follow Back (TLFB) form will be filled out for each subject to measure use, as well. (NCT02147132)
Timeframe: 7 weeks
| Intervention | cigarettes per day (Mean) |
|---|
| Nicotine Nasal Spray | 13.7 |
| Placebo Nasal Spray | 15.8 |
| Varenicline Tablets | 12.5 |
| Placebo Varenicline Tablets | 9.0 |
Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose
Subjects will be given a special electronic cigarette lighter called Quitbit.The electronic lighter will record a timestamp for each time the lighter is used to light a cigarette. Data will be collected from the lighter at each study visit. This will measure how many cigarettes are smoked and when. (NCT02147132)
Timeframe: 7 weeks
| Intervention | proportion of daily cigarettes (Mean) |
|---|
| Nicotine Nasal Spray | 0.294 |
| Placebo Nasal Spray | 0.177 |
| Varenicline Tablets | 0.196 |
| Placebo Varenicline Tablets | 0.325 |
Number of Participants With Carbon Monoxide Levels Less Than or Equal to 8 Parts-per-million
Carbon monoxide (CO) in each participant's breath will be tested. A CO level less than or equal to 8 parts-per-million will be used to verify reports of no smoking. (NCT02147132)
Timeframe: up to 8 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Participants with CO less than or equal to 8 ppm | Participants with CO greater than 8 ppm |
|---|
| Nicotine Nasal Spray | 2 | 5 |
,| Placebo Nasal Spray | 1 | 6 |
,| Placebo Varenicline Tablets | 2 | 4 |
,| Varenicline Tablets | 3 | 3 |
CO-Confirmed Continuous Abstinence for Weeks 9 Through 12 (Overall)
"A responder to this endpoint requires the answer no to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive)." (NCT01456936)
Timeframe: Week 9 through Week 12
| Intervention | percentage of participants (Number) |
|---|
| Varenicline 1.0 mg BID | 33.5 |
| Bupropion 150 mg BID | 22.6 |
| NRT Patch | 23.4 |
| Placebo | 12.5 |
CO-Confirmed Continuous Abstinence for Weeks 9 Through 12, Non-psychiatric History Cohort
"A responder to this endpoint requires the answer no to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive)." (NCT01456936)
Timeframe: Week 9 through Week 12
| Intervention | percentage of participants (Number) |
|---|
| Varenicline 1.0 mg BID | 38.0 |
| Bupropion 150 mg BID | 26.1 |
| NRT Patch | 26.4 |
| Placebo | 13.7 |
CO-Confirmed Continuous Abstinence for Weeks 9 Through 12, Psychiatric History Cohort
"A responder to this endpoint requires the answer no to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive)." (NCT01456936)
Timeframe: Week 9 through Week 12
| Intervention | percentage of participants (Number) |
|---|
| Varenicline 1.0 mg BID | 29.2 |
| Bupropion 150 mg BID | 19.3 |
| NRT Patch | 20.4 |
| Placebo | 11.4 |
CO-confirmed Continuous Abstinence From Week 9 Through Week 24 (Overall)
"A responder to this endpoint requires the answer no to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive)." (NCT01456936)
Timeframe: Week 9 through Week 24
| Intervention | percentage of participants (Number) |
|---|
| Varenicline 1.0 mg BID | 21.8 |
| Bupropion 150 mg BID | 16.2 |
| NRT Patch | 15.7 |
| Placebo | 9.4 |
CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Non-psychiatric History Cohort
"A responder to this endpoint requires the answer no to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive)." (NCT01456936)
Timeframe: Week 9 through Week 24
| Intervention | percentage of participants (Number) |
|---|
| Varenicline 1.0 mg BID | 25.5 |
| Bupropion 150 mg BID | 18.8 |
| NRT Patch | 18.5 |
| Placebo | 10.5 |
CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Psychiatric History Cohort
"A responder to this endpoint requires the answer no to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive)." (NCT01456936)
Timeframe: Week 9 through Week 24
| Intervention | percentage of participants (Number) |
|---|
| Varenicline 1.0 mg BID | 18.3 |
| Bupropion 150 mg BID | 13.7 |
| NRT Patch | 13.0 |
| Placebo | 8.3 |
"Clinical Global Impression of Improvement (CGI-I), No Change Rating by Visit"
"The CGI-I is a clinician rated instrument that measures change in participant's psychiatric condition (or lack thereof in the stratum without psychiatric disorders) on a 7 point scale ranging from 1 (very much improved) to 7 (very much worse), with 4 = no change. The ratings were applicable even to those without psychiatric diagnoses (eg, those with no psychiatric symptoms would be rated as normal, not at all ill on the CGI-S at baseline and assuming no psychiatric symptoms emerge during the trial, would be rated as no change on the CGI-I at follow-up visits). For those participants with a psychiatric diagnosis, the clinician should rate the severity of the mental illness with respect to the clinician's experience with the psychiatric population to which the participant belongs." (NCT01456936)
Timeframe: Baseline to Week 24
| Intervention | percentage of participants (Number) |
|---|
| Week 1 (N= 1986, 1974, 1986, 1982) | Week 2 (N= 1934, 1936, 1927, 1926) | Week 3 (N= 1880, 1892, 1880, 1863) | Week 4 (N= 1860, 1856, 1858, 1834) | Week 5 (N= 1828, 1816, 1822, 1802) | Week 6 (N= 1816, 1808, 1820, 1773) | Week 8 (N= 1758, 1756, 1755, 1738) | Week 10 (N= 1717, 1707, 1715, 1675) | Week 12 (N= 1558, 1572, 1540, 1492) | Week 13 (N= 1612, 16081602, 1575) | Week 16 (N= 1586, 1606, 1568, 1541) | Week 20 (N= 1563, 1573, 1523, 1510) | Week 24 (N= 1533, 1515, 1499, 1497) |
|---|
| Bupropion 150 mg BID | 93.2 | 90.8 | 89.8 | 88.0 | 86.5 | 86.5 | 83.6 | 81.7 | 75.1 | 76.7 | 76.7 | 75.0 | 72.3 |
,| NRT Patch | 94.6 | 90.5 | 88.7 | 87.1 | 85.5 | 85.1 | 82.8 | 80.4 | 72.2 | 75.2 | 73.9 | 72.2 | 71.1 |
,| Placebo | 95.1 | 91.2 | 87.9 | 86.3 | 85.4 | 84.1 | 81.9 | 79.2 | 71.3 | 74.9 | 73.4 | 71.7 | 71.1 |
,| Varenicline 1.0 mg BID | 94.2 | 90.8 | 88.3 | 86.6 | 85.7 | 85.2 | 82.4 | 80.6 | 72.9 | 75.9 | 74.2 | 73.4 | 71.8 |
7-Day Point Prevalence of Abstinence (Overall)
"A responder to this endpoint requires the answer no to both questions 3 and 6 on the nicotine use inventory at that specific visit.~NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?" (NCT01456936)
Timeframe: 24 Weeks
| Intervention | percentage of participants (Number) |
|---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 | Week 15 | Week 16 | Week 17 | Week 18 | Week 19 | Week 20 | Week 21 | Week 22 | Week 23 | Week 24 |
|---|
| Bupropion 150 mg BID | 1.1 | 17.9 | 22.3 | 24.4 | 25.7 | 26.9 | 30.2 | 26.5 | 30.4 | 27.6 | 30.7 | 27.1 | 26.5 | 29.2 | 29.2 | 25.1 | 27.9 | 27.8 | 27.9 | 23.9 | 26.7 | 26.4 | 27.0 | 23.2 |
,| NRT Patch | 0.9 | 14.2 | 20.0 | 23.5 | 25.1 | 26.8 | 31.3 | 28.0 | 32.1 | 28.0 | 32.1 | 27.6 | 26.9 | 29.4 | 29.2 | 24.9 | 28.1 | 28.2 | 28.1 | 23.7 | 26.5 | 26.3 | 25.3 | 23.6 |
,| Placebo | 1.0 | 10.3 | 12.1 | 13.1 | 13.6 | 14.6 | 17.9 | 15.9 | 18.1 | 15.5 | 18.8 | 16.0 | 16.0 | 19.1 | 19.8 | 16.1 | 18.8 | 19.5 | 19.2 | 16.3 | 18.8 | 18.4 | 18.3 | 15.7 |
,| Varenicline 1.0 mg BID | 1.3 | 18.8 | 26.3 | 30.4 | 33.4 | 35.8 | 39.5 | 37.4 | 41.6 | 38.7 | 42.5 | 39.6 | 36.8 | 39.5 | 38.5 | 33.1 | 36.4 | 36.2 | 35.7 | 30.8 | 33.9 | 33.8 | 33.0 | 29.8 |
7-Day Point Prevalence of Abstinence, Non-psychiatric History Cohort
"A responder to this endpoint requires the answer no to both questions 3 and 6 on the nicotine use inventory at that specific visit.~NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?" (NCT01456936)
Timeframe: 24 Weeks
| Intervention | percentage of participants (Number) |
|---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 | Week 15 | Week 16 | Week 17 | Week 18 | Week 19 | Week 20 | Week 21 | Week 22 | Week 23 | Week 24 |
|---|
| Bupropion 150 mg BID | 1.0 | 21.3 | 26.6 | 27.7 | 29.8 | 31.4 | 35.2 | 31.0 | 34.9 | 31.0 | 34.1 | 30.5 | 30.7 | 33.5 | 33.2 | 28.5 | 31.9 | 31.3 | 31.2 | 27.5 | 30.3 | 29.9 | 30.6 | 26.0 |
,| NRT Patch | 1.2 | 15.5 | 22.1 | 25.9 | 27.8 | 30.4 | 35.1 | 31.4 | 34.8 | 31.1 | 34.9 | 30.4 | 29.9 | 32.0 | 32.4 | 28.1 | 31.4 | 31.7 | 31.2 | 26.3 | 29.3 | 29.0 | 28.3 | 27.0 |
,| Placebo | 1.5 | 11.4 | 13.6 | 14.5 | 14.9 | 15.9 | 19.2 | 16.7 | 19.0 | 16.9 | 20.8 | 17.8 | 17.2 | 20.4 | 21.3 | 18.2 | 20.1 | 20.8 | 20.8 | 18.2 | 20.1 | 20.3 | 20.3 | 17.4 |
,| Varenicline 1.0 mg BID | 1.7 | 20.9 | 30.0 | 34.3 | 38.4 | 41.0 | 44.4 | 42.3 | 47.1 | 42.4 | 46.6 | 44.4 | 41.1 | 44.5 | 43.8 | 37.2 | 40.7 | 40.9 | 39.9 | 35.1 | 38.1 | 38.7 | 37.6 | 33.6 |
7-Day Point Prevalence of Abstinence, Psychiatric History Cohort
"A responder to this endpoint requires the answer no to both questions 3 and 6 on the nicotine use inventory at that specific visit.~NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?" (NCT01456936)
Timeframe: 24 Weeks
| Intervention | percentage of participants (Number) |
|---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 | Week 15 | Week 16 | Week 17 | Week 18 | Week 19 | Week 20 | Week 21 | Week 22 | Week 23 | Week 24 |
|---|
| Bupropion 150 mg BID | 1.2 | 14.6 | 18.1 | 21.3 | 21.8 | 22.7 | 25.4 | 22.1 | 26.0 | 24.3 | 27.4 | 23.9 | 22.6 | 25.0 | 25.3 | 21.9 | 24.0 | 24.5 | 24.7 | 20.4 | 23.2 | 22.9 | 23.5 | 20.4 |
,| NRT Patch | 0.7 | 13.0 | 17.9 | 21.1 | 22.4 | 23.3 | 27.5 | 24.6 | 29.4 | 25.0 | 29.4 | 24.9 | 24.0 | 26.8 | 26.0 | 21.8 | 24.8 | 24.7 | 25.1 | 25.1 | 23.7 | 23.6 | 22.2 | 20.1 |
,| Placebo | 0.5 | 9.2 | 10.7 | 11.8 | 12.4 | 13.4 | 16.6 | 15.0 | 17.2 | 14.0 | 17.2 | 14.2 | 14.8 | 17.8 | 18.3 | 13.9 | 17.4 | 18.2 | 17.6 | 17.6 | 17.5 | 16.5 | 16.4 | 14.0 |
,| Varenicline 1.0 mg BID | 1.0 | 16.8 | 22.7 | 26.6 | 28.5 | 30.8 | 34.8 | 32.7 | 36.2 | 35.1 | 38.6 | 35.0 | 32.7 | 34.7 | 33.4 | 29.1 | 32.3 | 31.7 | 31.6 | 26.6 | 29.7 | 29.1 | 28.5 | 26.1 |
Estimated NPS AE Rate (%), by Cohort
"The primary safety endpoint is the occurrence of at least one treatment emergent severe adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent moderate or severe adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Estimated NPS AE rate (%) was calculated based on least-squares means analysis." (NCT01456936)
Timeframe: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
| Intervention | percentage of participants (Least Squares Mean) |
|---|
| Non-psychiatric cohort (N=3984) | Psychiatric cohort (N= 4074) |
|---|
| Bupropion 150 mg BID | 2.44 | 6.62 |
,| NRT Patch | 2.31 | 5.20 |
,| Placebo | 2.52 | 4.83 |
,| Varenicline 1.0 mg BID | 1.25 | 6.42 |
HADS Total Score (Overall)
The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms. (NCT01456936)
Timeframe: Baseline to Week 24
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 (N= 1989, 1976, 1985, 1987) | Week 2 (N= 1938, 1937, 1931, 1929) | Week 3 (N= 1882, 1891, 1881, 1867) | Week 4 (N= 1858, 1854, 1863, 1831) | Week 5 (N= 1829, 1815, 1820, 1797) | Week 6 (N= 1816, 1807, 1821, 1771) | Week 8 (N= 1755, 1754, 1755, 1736) | Week 10 (N= 1717, 1709, 1716, 1669) | Week 12 (N= 1562, 1571, 1548, 1491) | Week 13 (N= 1610, 1608, 1603, 1570) | Week 16 (N= 1579, 1602, 1566, 1537) | Week 20 (N= 1555, 1569, 1525, 1509) | Week 24 (N= 1528, 1512, 1495, 1487) |
|---|
| Bupropion 150 mg BID | 5.61 | 5.06 | 4.60 | 4.39 | 4.16 | 4.05 | 4.10 | 3.86 | 3.79 | 3.66 | 3.77 | 3.73 | 3.80 |
,| NRT Patch | 4.95 | 4.74 | 4.48 | 4.31 | 4.08 | 4.01 | 3.96 | 4.00 | 3.78 | 3.71 | 3.78 | 3.72 | 3.82 |
,| Placebo | 5.05 | 4.80 | 4.38 | 4.39 | 4.14 | 4.09 | 4.12 | 4.04 | 3.95 | 3.70 | 3.82 | 3.75 | 3.62 |
,| Varenicline 1.0 mg BID | 5.03 | 4.68 | 4.31 | 4.15 | 3.94 | 3.82 | 3.82 | 3.85 | 3.64 | 3.60 | 3.67 | 3.65 | 3.62 |
HADS Total Score, Psychiatric History Cohort
The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms. (NCT01456936)
Timeframe: Baseline to Week 24
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 (N= 1026, 1017, 1015, 1015) | Week 2 (N= 1005, 1004, 996, 995) | Week 3 (N= 947, 961, 945, 926) | Week 4 (N= 935, 938, 929, 908) | Week 5 (N= 918, 918, 914, 895) | Week 6 (N= 917, 914, 912, 874) | Week 8 (N= 887, 893, 878, 859) | Week 10 (N= 864, 865, 864, 823) | Week 12 (N= 790, 803, 798, 749) | Week 13 (N= 813, 812, 814, 763) | Week 16 (N= 795, 805, 791, 748) | Week 20 (N= 784, 784, 763, 737) | Week 24 (N= 770, 764, 758, 729) |
|---|
| Bupropion 150 mg BID | 7.58 | 6.99 | 6.51 | 6.36 | 6.03 | 5.87 | 5.96 | 5.72 | 5.66 | 5.44 | 5.62 | 5.54 | 5.69 |
,| NRT Patch | 6.82 | 6.64 | 6.30 | 6.16 | 5.82 | 5.62 | 5.63 | 5.64 | 5.44 | 5.36 | 5.44 | 5.46 | 5.57 |
,| Placebo | 6.70 | 6.42 | 6.02 | 6.04 | 5.80 | 5.75 | 5.63 | 5.55 | 5.42 | 5.09 | 5.37 | 5.26 | 5.04 |
,| Varenicline 1.0 mg BID | 6.76 | 6.42 | 5.99 | 5.87 | 5.58 | 5.39 | 5.43 | 5.38 | 5.17 | 5.06 | 5.26 | 5.17 | 5.21 |
Hospital Anxiety and Depression Scale (HADS) Total Score, Non-psychiatric History Cohort
The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms. (NCT01456936)
Timeframe: Baseline to Week 24
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 (N= 984, 972, 989, 992) | Week 2 (N= 961, 954, 963, 970) | Week 3 (N= 935, 930, 936, 941) | Week 4 (N= 923, 916, 934, 923) | Week 5 (N= 911, 897, 906, 902) | Week 6 (N= 899, 893, 909, 897) | Week 8 (N= 868, 861, 877, 877) | Week 10 (N= 853, 844, 852, 846) | Week 12 (N= 772, 768, 750, 742) | Week 13 (N= 797, 796, 789, 807) | Week 16 (N= 784, 797, 775, 789) | Week 20 (N= 771, 785, 762, 772) | Week 24 (N= 758, 748, 737, 758) |
|---|
| Bupropion 150 mg BID | 3.58 | 3.07 | 2.64 | 2.36 | 2.24 | 2.18 | 2.16 | 1.96 | 1.83 | 1.85 | 1.90 | 1.93 | 1.87 |
,| NRT Patch | 3.06 | 2.84 | 2.63 | 2.46 | 2.32 | 2.40 | 2.28 | 2.33 | 2.01 | 2.01 | 2.09 | 1.97 | 2.01 |
,| Placebo | 3.38 | 3.20 | 2.77 | 2.77 | 2.48 | 2.48 | 2.64 | 2.57 | 2.46 | 2.38 | 2.34 | 2.31 | 2.25 |
,| Varenicline 1.0 mg BID | 3.26 | 2.91 | 2.61 | 2.40 | 2.29 | 2.23 | 2.17 | 2.29 | 2.07 | 2.11 | 2.05 | 2.10 | 2.01 |
Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint
"The primary safety endpoint is the occurrence of at least one treatment emergent severe adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent moderate or severe adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide." (NCT01456936)
Timeframe: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
| Intervention | percentage of participants (Number) |
|---|
| Non-psychiatric cohort (N= 990, 989, 1006, 999) | Psychiatric cohort (N= 1026, 1017, 1016, 1015) | Overall (N= 2016, 2006, 2022, 2014) |
|---|
| Bupropion 150 mg BID | 2.2 | 6.7 | 4.5 |
,| NRT Patch | 2.5 | 5.2 | 3.9 |
,| Placebo | 2.4 | 4.9 | 3.7 |
,| Varenicline 1.0 mg BID | 1.3 | 6.5 | 4.0 |
Occurrence of Severe-only NPS AEs in the Primary Endpoint, by Cohort
"The primary safety endpoint is the occurrence of at least one treatment emergent severe adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent moderate or severe adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint." (NCT01456936)
Timeframe: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
| Intervention | percentage of participants (Number) |
|---|
| Non-psychiatric cohort (N= 990, 989, 1006, 999) | Psychiatric cohort (N= 1026, 1017, 1016, 1015) | Overall (N= 2016, 2006, 2022, 2014) |
|---|
| Bupropion 150 mg BID | 0.4 | 1.4 | 0.9 |
,| NRT Patch | 0.3 | 1.4 | 0.8 |
,| Placebo | 0.5 | 1.3 | 0.9 |
,| Varenicline 1.0 mg BID | 0.1 | 1.4 | 0.7 |
Occurrence of the Components of NPS AE Primary Endpoint (Overall)
The NPS AE composite results (as previously described) are for the two cohorts combined and are presented below. (NCT01456936)
Timeframe: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
| Intervention | participants (Number) |
|---|
| Anxiety | Depression | Feeling Abnormal | Hostility | Agitation | Aggression | Delusions | Hallucination | Mania | Panic Disorder | Paranoia | Psychosis | Homicidal Ideation | Suicidal Behavior | Suicidal Ideation | Suicide |
|---|
| Bupropion 150 mg BID | 5 | 4 | 1 | 1 | 40 | 12 | 1 | 4 | 10 | 20 | 1 | 2 | 0 | 2 | 3 | 0 |
,| NRT Patch | 6 | 7 | 0 | 1 | 40 | 9 | 2 | 2 | 5 | 14 | 0 | 4 | 1 | 1 | 5 | 0 |
,| Placebo | 5 | 6 | 0 | 0 | 33 | 11 | 0 | 2 | 8 | 10 | 2 | 1 | 0 | 1 | 5 | 1 |
,| Varenicline 1.0 mg BID | 5 | 7 | 0 | 0 | 35 | 17 | 1 | 6 | 7 | 7 | 1 | 4 | 0 | 1 | 5 | 0 |
Occurrence of the Components of Severe-only NPS AE Endpoint (Overall)
"The NPS AE endpoint was the occurrence of at least 1 treatment-emergent severe AE of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least 1 treatment-emergent severe AE of agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint." (NCT01456936)
Timeframe: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
| Intervention | participants (Number) |
|---|
| Anxiety | Depression | Feeling Abnormal | Hostility | Agitation | Aggression | Delusions | Hallucination | Mania | Panic Disorder | Paranoia | Psychosis | Suicidal Behavior | Suicidal Ideation | Suicide | Homicidal Ideation |
|---|
| Bupropion 150 mg BID | 5 | 4 | 1 | 1 | 1 | 2 | 0 | 1 | 1 | 2 | 1 | 2 | 2 | 0 | 0 | 0 |
,| NRT Patch | 6 | 7 | 0 | 1 | 6 | 0 | 0 | 0 | 0 | 1 | 0 | 4 | 0 | 1 | 0 | 1 |
,| Placebo | 5 | 6 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 2 | 2 | 1 | 1 | 0 | 1 | 0 |
,| Varenicline 1.0 mg BID | 5 | 7 | 0 | 0 | 1 | 2 | 0 | 0 | 2 | 0 | 1 | 4 | 1 | 1 | 0 | 0 |
Occurrence of the Components of the NPS AE Primary Endpoint, Non-psychiatric History Cohort
"The safety endpoint is the occurrence of at least one treatment emergent severe adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent moderate or severe adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Each of these 16 components is reported below." (NCT01456936)
Timeframe: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
| Intervention | participants (Number) |
|---|
| Anxiety (severe) | Depression (severe) | Feeling abnormal (severe only) | Hostility (severe) | Agitation (moderate and severe) | Aggression (moderate and severe) | Delusions (moderate and severe) | Hallucinations (moderate and severe) | Mania (moderate and severe) | Panic (moderate and severe) | Paranoia (moderate and severe) | Psychosis (moderate and severe) | Homicidal ideation (moderate and severe) | Suicidal behavior (moderate and severe) | Suicidal ideation (moderate and severe) | Suicide (moderate and severe) |
|---|
| Bupropion 150 mg BID | 1 | 0 | 0 | 1 | 11 | 3 | 0 | 0 | 1 | 4 | 1 | 0 | 0 | 1 | 1 | 0 |
,| NRT Patch | 0 | 0 | 0 | 1 | 19 | 2 | 1 | 0 | 2 | 1 | 0 | 1 | 1 | 1 | 2 | 0 |
,| Placebo | 3 | 0 | 0 | 0 | 11 | 3 | 0 | 0 | 2 | 3 | 0 | 0 | 0 | 0 | 3 | 1 |
,| Varenicline 1.0 mg BID | 0 | 1 | 0 | 0 | 10 | 3 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Occurrence of the Components of the NPS AE Primary Endpoint, Psychiatric History Cohort
"The safety endpoint is the occurrence of at least one treatment emergent severe adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent moderate or severe adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Each of these 16 components is reported below." (NCT01456936)
Timeframe: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
| Intervention | participants (Number) |
|---|
| Anxiety (severe) | Depression (severe) | Feeling abnormal (severe only) | Hostility (severe) | Agitation (moderate and severe) | Aggression (moderate and severe) | Delusions (moderate and severe) | Hallucinations (moderate and severe) | Mania (moderate and severe) | Panic (moderate and severe) | Paranoia (moderate and severe) | Psychosis (moderate and severe) | Homicidal ideation (moderate and severe) | Suicidal behavior (moderate and severe) | Suicidal ideation (moderate and severe) | Suicide (moderate and severe) |
|---|
| Bupropion 150 mg BID | 4 | 4 | 1 | 0 | 29 | 9 | 1 | 4 | 9 | 16 | 0 | 2 | 0 | 1 | 2 | 0 |
,| NRT Patch | 6 | 7 | 0 | 0 | 21 | 7 | 1 | 2 | 3 | 13 | 0 | 3 | 0 | 0 | 3 | 0 |
,| Placebo | 2 | 6 | 0 | 0 | 22 | 8 | 0 | 2 | 6 | 7 | 2 | 1 | 0 | 1 | 2 | 0 |
,| Varenicline 1.0 mg BID | 5 | 6 | 0 | 0 | 25 | 14 | 1 | 5 | 7 | 7 | 1 | 4 | 0 | 1 | 5 | 0 |
Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Non-psychiatric History Cohort
"The safety endpoint is the occurrence of at least one treatment emergent severe adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent moderate or severe adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint." (NCT01456936)
Timeframe: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
| Intervention | participants (Number) |
|---|
| Anxiety | Depression | Feeling abnormal | Hostility | Agitation | Aggression | Delusions | Hallucinations | Mania | Panic | Paranoia | Psychosis | Homicidal ideation | Suicidal behavior | Suicidal ideation | Suicide |
|---|
| Bupropion 150 mg BID | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
,| NRT Patch | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Placebo | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 1 |
,| Varenicline 1.0 mg BID | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Psychiatric History Cohort
"The safety endpoint is the occurrence of at least one treatment emergent severe adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent moderate or severe adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint." (NCT01456936)
Timeframe: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
| Intervention | participants (Number) |
|---|
| Anxiety | Depression | Feeling abnormal | Hostility | Agitation | Aggression | Delusions | Hallucinations | Mania | Panic | Paranoia | Psychosis | Homicidal ideation | Suicidal behavior | Suicidal ideation | Suicide |
|---|
| Bupropion 150 mg BID | 4 | 4 | 1 | 0 | 1 | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 0 | 1 | 0 | 0 |
,| NRT Patch | 6 | 7 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
,| Placebo | 2 | 6 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
,| Varenicline 1.0 mg BID | 5 | 6 | 0 | 0 | 1 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Non-psychiatric History Cohort
"The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from wish to be dead to active suicidal ideation with specific plan and intent. Answers at screening are for lifetime history. Answers for all other visits are since last visit.The scale is also used to record any completed suicides." (NCT01456936)
Timeframe: Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
| Intervention | participants with positive responses (Number) |
|---|
| Suicidal Behavior (Screening lifetime) | Suicidal Ideation (Screening lifetime) | Suicidal Behavior (Baseline) | Suicidal Ideation (Baseline) | Suicidal Behavior (treatment emergent 12 weeks) | Suicidal Ideation (treatment emergent 12 weeks) |
|---|
| Bupropion 150 mg BID | 9 | 43 | 0 | 1 | 0 | 4 |
,| NRT Patch | 7 | 50 | 0 | 0 | 1 | 3 |
,| Placebo | 6 | 49 | 0 | 1 | 1 | 6 |
,| Varenicline 1.0 mg BID | 6 | 48 | 0 | 0 | 0 | 7 |
Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Overall
"The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from wish to be dead to active suicidal ideation with specific plan and intent. Answers at screening are for lifetime history. Answers for all other visits are since last visit. The scale is also used to record any completed suicides." (NCT01456936)
Timeframe: Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
| Intervention | participants with positive responses (Number) |
|---|
| Suicidal Behavior (Screening lifetime) | Suicidal Ideation (Screening lifetime) | Suicidal Behavior (Baseline) | Suicidal Ideation (Baseline) | Suicidal Behavior (treatment emergent 12 weeks) | Suicidal Ideation (treatment emergent 12 weeks) |
|---|
| Bupropion 150 mg BID | 152 | 400 | 0 | 6 | 1 | 19 |
,| NRT Patch | 118 | 383 | 0 | 2 | 1 | 23 |
,| Placebo | 129 | 398 | 1 | 4 | 3 | 31 |
,| Varenicline 1.0 mg BID | 143 | 386 | 0 | 6 | 0 | 34 |
Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Psychiatric History Cohort
"The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from wish to be dead to active suicidal ideation with specific plan and intent. Answers at screening are for lifetime history. Answers for all other visits are since last visit. The scale is also used to record any completed suicides." (NCT01456936)
Timeframe: Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
| Intervention | participants with positive responses (Number) |
|---|
| Suicidal Behavior (Screening lifetime) | Suicidal Ideation (Screening lifetime) | Suicidal Behavior (Baseline) | Suicidal Ideation (Baseline) | Suicidal Behavior (treatment emergent 12 weeks) | Suicidal Ideation (treatment emergent 12 weeks) |
|---|
| Bupropion 150 mg BID | 143 | 357 | 0 | 5 | 1 | 15 |
,| NRT Patch | 111 | 333 | 0 | 2 | 0 | 20 |
,| Placebo | 123 | 349 | 1 | 3 | 2 | 25 |
,| Varenicline 1.0 mg BID | 137 | 338 | 0 | 6 | 0 | 27 |
Addiction Severity Index (ASI) Alcohol Composite Score at End of Study.
The Addiction Severity Index (ASI) is a semistructured interview that measures the severity of addiction in 25 questions concerning seven problem areas: medical problems, employment problems, drug use, alcohol use, family and social problems, criminality, and psychiatric problems. Each problem area is measured as its own Compsite Score. Each Composite Score total ranges between 0 (no endorsement of any problems) and 1 (maximal endorsement of all problems). Higher scores (i.e., those closer to 1) on each Composite Score indicate more difficulty/lower functioning in that area, while lower scores (i.e., those closer to 0) indicate higher functioning/less difficulty in that area. As such, the Addiction Severity Index (ASI) Alcohol Composite Total Score must fall between 0 and 1, and scores closer to 1 suggest continued problem drinking. (NCT00705523)
Timeframe: 12 weeks of treatment, with a follow-up one month after treatment
| Intervention | alcohol composite score (Mean) |
|---|
| Varenicline | 0.12 |
| Placebo | 0.29 |
Rate of Heavy Drinking Days Per Week.
Rate of heavy drinking days per week (defined as five drinks per day for men, four drinks per day for women) as determined by self-report on the time-line follow-back (TLFB). (NCT00705523)
Timeframe: 12 weeks of treatment and one month follow-up
| Intervention | rate of heavy drinking days per week (Median) |
|---|
| Varenicline | .89 |
| Placebo | 1.21 |
7-day Point Prevalence Quit Rate
The definition of this measure requires: (a) no self-reported smoking (not even a puff of a cigarette) for at least the 7 days prior to the assessment, and (b) biochemical verification of abstinence. (NCT02351167)
Timeframe: Week 12
| Intervention | Participants (Count of Participants) |
|---|
| Combination NRT and Counseling | 55 |
| Varenicline (Chantix) and Counseling | 70 |
| Placebo Medicine and Counseling | 24 |
7-day Point Prevalence Quit Rate
The definition of this measure requires: (a) no self-reported smoking (not even a puff of a cigarette) for at least the 7 days prior to the assessment, and (b) biochemical verification of abstinence. (NCT02351167)
Timeframe: Week 24
| Intervention | Participants (Count of Participants) |
|---|
| Combination NRT and Counseling | 37 |
| Varenicline (Chantix) and Counseling | 56 |
| Placebo Medicine and Counseling | 25 |
Continuous Abstinence
The definition of this measure requires: Not taking even 1 cigarette puff from target quit date to end of treatment. (NCT02351167)
Timeframe: 12 weeks (with first 1 week initial grace period)
| Intervention | Participants (Count of Participants) |
|---|
| Combination NRT and Counseling | 43 |
| Varenicline (Chantix) and Counseling | 46 |
| Placebo Medicine and Counseling | 21 |
Initial Cessation
Defined as at least 1 day of abstinence during the first 7 days after the target quit day. (NCT02351167)
Timeframe: Assessed for the first seven days after the target quit date
| Intervention | Participants (Count of Participants) |
|---|
| Combination NRT and Counseling | 217 |
| Varenicline (Chantix) and Counseling | 186 |
| Placebo Medicine and Counseling | 172 |
Number of Days to Lapse
"The number of days to lapse is defined as the number of days from the target quit date until the participant reports smoking (even a single puff).~Participants who did not lapse by the end of the 52 weeks and participants who had missing information on lapse are not included in the overall number of participants analyzed" (NCT02351167)
Timeframe: Assessed from the target quit day through 52 weeks
| Intervention | days (Mean) |
|---|
| Combination NRT and Counseling | 16.78 |
| Varenicline (Chantix) and Counseling | 20.47 |
| Placebo Medicine and Counseling | 11.85 |
| 3 Arms Combined | 16.33 |
Number of Days to Relapse
"The number of days to relapse is defined as the number of days from the target quit day until the first of seven consecutive days of smoking.~Participants who did not relapse by the end of the 52 weeks and participants who had missing information on relapse are not included in the overall number of participants analyzed" (NCT02351167)
Timeframe: Assessed from the target quit day through 52 weeks
| Intervention | days (Mean) |
|---|
| Combination NRT and Counseling | 44.83 |
| Varenicline (Chantix) and Counseling | 45.01 |
| Placebo Medicine and Counseling | 28.87 |
| 3 Arms Combined | 39.22 |
Longitudinal Models of Abstinence Outcomes Across Multiple Time Points
-The definition of this measure requires; no self-reported smoking (not even a puff of a cigarette) for at least 7 days prior to the assessment. (NCT02351167)
Timeframe: 0-52 Weeks
| Intervention | Participants (Count of Participants) |
|---|
| 0 weeks - Abstinence | 1 week - Abstinence | 2 week - Abstinence | 4 week - Abstinence | 12 week - Abstinence | 26 week - Abstinence | 52 week - Abstinence |
|---|
| 3 Arms Combined | 8 | 255 | 294 | 300 | 218 | 206 | 188 |
,| Combination NRT and Counseling | 5 | 91 | 119 | 112 | 81 | 75 | 68 |
,| Placebo Medicine and Counseling | 0 | 70 | 70 | 74 | 49 | 49 | 43 |
,| Varenicline (Chantix) and Counseling | 3 | 94 | 105 | 114 | 88 | 82 | 77 |
Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points.
The definition of this measure requires self-reported cigarettes per day. (NCT02351167)
Timeframe: 0-52 Weeks
| Intervention | cigarettes per day (Mean) |
|---|
| 0 week | 1 week | 2 week | 4 week | 12 week | 26 week | 52 week |
|---|
| 3 Arms Combined | 3.06 | 3.56 | 3.83 | 4.49 | 3.50 | 8.03 | 8.12 |
,| Combination NRT and Counseling | 2.50 | 3.06 | 3.43 | 4.08 | 6.38 | 7.68 | 7.67 |
,| Placebo Medicine and Counseling | 3.74 | 4.46 | 5.00 | 5.79 | 8.33 | 9.38 | 8.98 |
,| Varenicline (Chantix) and Counseling | 2.95 | 3.18 | 3.08 | 3.63 | 5.75 | 7.09 | 7.76 |
Medication Adherence
Adherence is the proportion of expected medication (varenicline, patch, lozenge) taken as advised during pre-quit week to week 12 (NCT02351167)
Timeframe: Pre-quit week to Week 12
| Intervention | proportion of expected medication taken (Mean) |
|---|
| Varenicline (Chantix) |
|---|
| Varenicline (Chantix) and Counseling | 0.67 |
Medication Adherence
Adherence is the proportion of expected medication (varenicline, patch, lozenge) taken as advised during pre-quit week to week 12 (NCT02351167)
Timeframe: Pre-quit week to Week 12
| Intervention | proportion of expected medication taken (Mean) |
|---|
| Patch | Lozenge |
|---|
| Combination NRT and Counseling | 0.65 | 0.57 |
Medication Adherence
Adherence is the proportion of expected medication (varenicline, patch, lozenge) taken as advised during pre-quit week to week 12 (NCT02351167)
Timeframe: Pre-quit week to Week 12
| Intervention | proportion of expected medication taken (Mean) |
|---|
| Patch | Lozenge | Varenicline (Chantix) |
|---|
| Placebo Medicine and Counseling | 0.57 | 0.57 | 0.70 |
Side Effects
All reported side effects (occurring>4%) will be summarized and presented for the study. In addition, the investigators will further identify a pre-specified set of key side effects as being related to drug agonist effects (e.g., nausea, vomiting, racing heart, headache, and sleep disturbance). These will be analyzed as rate of occurrence during the period of medication use. (NCT02351167)
Timeframe: Pre-quit week to Week 12
| Intervention | Participants (Count of Participants) |
|---|
| Nausea | Vomiting | Racing Heart | Headache | Sleep Disturbance |
|---|
| Combination NRT and Counseling | 53 | 28 | 27 | 81 | 49 |
,| Placebo Medicine and Counseling | 59 | 27 | 17 | 71 | 42 |
,| Varenicline (Chantix) and Counseling | 92 | 36 | 24 | 81 | 55 |
Withdrawal
"Withdrawal severity is assessed by Wisconsin Smoking Withdrawal Scale (WSWS), there are 28 items.~Participants rate each item on a scale of 0-4 (0=Strongly disagree, 1=Disagree, 2=Feel neutral, 3=Agree, 4=Strongly agree). The subscale to each item is determined on how high they agree on the scale. For some items, the subscale is determined on how low they agreed. Each score is determined by the mean of each item that applies. Higher means indicate greater withdrawal.~The scores were calculated by averaging a mean score of each item for each participant with data from time point pre-quit, quit, week 1, week 2, and week 4. The mean score for each participant was averaged for each item and a mean score was taken for each treatment condition (cNRT, Varenicline, Placebo). These data are reported as mean withdrawal scores and not change in withdrawal scores." (NCT02351167)
Timeframe: Pre-quit, quit, week 1, week 2, and week 4
| Intervention | score on a scale (Mean) |
|---|
| Anger | Anxiety | Concentration | Craving | Hunger | Sadness | Sleep |
|---|
| Combination NRT and Counseling | 1.33 | 1.69 | 1.28 | 2.29 | 2.11 | 1.01 | 1.49 |
,| Placebo Medicine and Counseling | 1.47 | 1.82 | 1.42 | 2.50 | 2.17 | 1.11 | 1.54 |
,| Varenicline (Chantix) and Counseling | 1.49 | 1.81 | 1.48 | 2.20 | 2.28 | 1.11 | 1.70 |
Average Intervention Adherence - Cigarettes Per Day (CPD)
Average Cigarettes per Day across group, during last week of treatment. (NCT02202499)
Timeframe: During last week of treatment, week 16
| Intervention | cigarettes per day (Mean) |
|---|
| Extended Varenicline + Facilitated Extinction | 17.58 |
| Standard Varenicline | 14.95 |
| Extended Varenicline | 11.05 |
Client Satisfaction Questionnaire (CSQ) Results
Acceptability: Mean score of Client Satisfaction Questionnaire (CSQ) version 8 by Attkison & Greenfield. Questionnaire scores client satisfaction with a scale of 1-4 per question, 1 being very dissatisfied and 4 being very satisfied. Score total range is 8-32. A total score of 32 would be the highest possible Client Satisfaction Score. (NCT02202499)
Timeframe: One month post treatment - approximately 20 weeks
| Intervention | units on a scale (Mean) |
|---|
| Extended Varenicline + Facilitated Extinction | 30.33 |
| Standard Vareniclline | 30.80 |
| Extended Varenicline | 30.47 |
Mean Peak Craving Score Per Group
"Peak craving per day by treatment group, scored using an 11-point Likert scale 0-10. 0 was none, 5 medium and 10 very high/strong" (NCT02202499)
Timeframe: Across 4 pre-quit weeks
| Intervention | units on a scale (Mean) |
|---|
| Extended Varenicline + Facilitated Extinction | 4.64 |
| Standard Varenicline | 6.34 |
| Extended Varenicline | 4.56 |
Mean Smoking Satisfaction Score Per Group
"Smoking satisfaction per day by treatment group, using 11-point Likert scale, 0-10. 0 was none, 5 medium and 10 very high" (NCT02202499)
Timeframe: Across 4 pre-quit weeks
| Intervention | units on a scale (Mean) |
|---|
| Extended Varenicline + Facilitated Extinction | 3.37 |
| Standard Varenicline | 5.22 |
| Extended Varenicline | 2.59 |
Rate of Intervention Adherence - Medication
Percent of participants still using varenicline at time of analysis. (NCT02202499)
Timeframe: One month post treatment - approximately 20 weeks
| Intervention | percentage of participants (Number) |
|---|
| Extended Varenicline + Facilitated Extinction | 80 |
| Standard Varenicline | 80 |
| Extended Varenicline | 84 |
Rate of Participant Retention
Practicality: Number of participants completing 3 month post treatment follow-up. Feasibility: Ability to recruit and retain sufficient numbers of the target population, which would be essential in conducting a future randomized clinical trial (RCT). (NCT02202499)
Timeframe: End of post treatment follow-up period of 3 months - approximately 28 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Extended Varenicline + Facilitated Extinction | 15 |
| Standard Vareniclline | 16 |
| Extended Varenicline | 19 |