{"protocolSection":{"identificationModule":{"nctId":"NCT00935818","orgStudyIdInfo":{"id":"09-003598"},"secondaryIdInfos":[{"id":"09-002459","type":"OTHER","domain":"Mayo Clinic IRB number"},{"id":"1R01CA138417","type":"NIH","link":"https://reporter.nih.gov/quickSearch/1R01CA138417"}],"organization":{"fullName":"Mayo Clinic","class":"OTHER"},"briefTitle":"Varenicline and Bupropion for Smoking Cessation","officialTitle":"Combination Therapy With Varenicline and Bupropion for Smoking Cessation","acronym":"CHANBAN"},"statusModule":{"statusVerifiedDate":"2014-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-09"},"primaryCompletionDateStruct":{"date":"2013-04","type":"ACTUAL"},"completionDateStruct":{"date":"2013-04","type":"ACTUAL"},"studyFirstSubmitDate":"2009-07-06","studyFirstSubmitQcDate":"2009-07-07","studyFirstPostDateStruct":{"date":"2009-07-09","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-03-21","resultsFirstSubmitQcDate":"2014-03-21","resultsFirstPostDateStruct":{"date":"2014-04-24","type":"ESTIMATED"},"lastUpdateSubmitDate":"2014-04-25","lastUpdatePostDateStruct":{"date":"2014-05-09","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Jon Ebbert","investigatorTitle":"Principal Investigator","investigatorAffiliation":"Mayo Clinic"},"leadSponsor":{"name":"Mayo Clinic","class":"OTHER"},"collaborators":[{"name":"National Cancer Institute (NCI)","class":"NIH"},{"name":"University of Minnesota","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This study provides an opportunity to combine varenicline and bupropion SR and capitalize on the potential additive benefit. The investigators hypothesize that this will further increase long-term (≥ 6 months) smoking abstinence rates.","detailedDescription":"Cigarette smoking is the single most important preventable cause of morbidity, mortality and excess health care costs in the United States and accounts for 30% of U.S. cancer deaths. Varenicline and bupropion SR (sustained-release) are non nicotine pharmacotherapies FDA-indicated for the treatment of tobacco dependence in cigarette smokers. Although varenicline has proven greater efficacy than bupropion SR, both medications are associated with high end-of-treatment smoking abstinence rates. However, almost two-thirds of smokers treated with varenicline report smoking at 6 months. Because varenicline and bupropion SR have different mechanisms of action and different neuropharmacologic targets, combination pharmacotherapy with these agents may increase long-term smoking abstinence rates above what is observed with single-agent therapy. In our recent pilot study of combination therapy with varenicline and bupropion SR, we observed treatment to be well-tolerated with 7-day point prevalence smoking abstinence rates of 71% (95% CI: 54-85%) at 3 months and 58% (95% CI: 41-74%) at 6 months. Determining the efficacy of combination therapy compared to single-agent therapy has immediate and important clinical implications. In this study, we will conduct a randomized, multicenter, controlled clinical trial evaluating the efficacy of combination therapy with varenicline and bupropion SR compared to varenicline and placebo in 506 cigarette smokers at the Mayo Clinic in Rochester, MN, and the University of Minnesota in Minneapolis, MN."},"conditionsModule":{"conditions":["Smoking"],"keywords":["smoking","nicotine","tobacco","dependence","cessation","abstinence"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2","PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":506,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"varenicline and buproprion SR","type":"ACTIVE_COMPARATOR","description":"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.","interventionNames":["Drug: Varenicline","Drug: bupropion SR"]},{"label":"varenicline and placebo","type":"PLACEBO_COMPARATOR","description":"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.","interventionNames":["Drug: Varenicline","Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"Varenicline","description":"varenicline - 1 mg bid for 12 weeks","armGroupLabels":["varenicline and buproprion SR","varenicline and placebo"],"otherNames":["chantix"]},{"type":"DRUG","name":"placebo","description":"placebo for 12 weeks","armGroupLabels":["varenicline and placebo"],"otherNames":["sugar pill"]},{"type":"DRUG","name":"bupropion SR","description":"bupropion sr - 150 mg bid for 12 weeks","armGroupLabels":["varenicline and buproprion SR"],"otherNames":["wellbutrin SR","zyban"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers.","description":"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?\"","timeFrame":"3 months"},{"measure":"Point Prevalence Abstinence at 3 Months.","description":"biochemically confirmed 7-day point prevalence abstinence defined as no smoking, not even a puff, in the previous 7 days.","timeFrame":"3 months"}],"secondaryOutcomes":[{"measure":"Prolonged Smoking Abstinence Rates at 26 Weeks in Cigarettes Smokers.","timeFrame":"6 months"},{"measure":"Weight Gain From Baseline to 3 Months","description":"Weight change from baseline to three months in those who met criteria for prolonged abstinence at the 3 month visit","timeFrame":"3 months"},{"measure":"Point Prevalence Abstinence at 6 Months.","description":"Biochemically confirmed abstinence as no smoking, even a puff, for the prior 7 days.","timeFrame":"6 months"},{"measure":"Prolonged Abstinence at 12 Months","timeFrame":"12 months"},{"measure":"Point Prevalence Abstinence at 12 Months","description":"Biochemically confirmed abstinence defined as no smoking, not even a puff, in the last 7 days","timeFrame":"12 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. Subject is at least 18 years of age;\n2. Subject has provide written informed consent;\n3. Subject is smoking greater than or equal to 10 cigarettes per day for at least 6 months;\n\n3\\) Subject is able to complete all study visits 4) Subject is in good health as determined by the investigator 5) Subject has the ability to participate fully in all aspects of the study and keep scheduled appointments 6) Subject is motivated to stop smoking.\n\nExclusion Criteria:\n\nFemale and were pregnant, lactating or likely to become pregnant during the trial and not able nor willing to use contraception or had:\n\n1. an unstable medical condition;\n2. another household member participating in the study;\n3. bupropion or varenicline allergy;\n4. current use (previous 30 days) of a tobacco dependence treatment and unable or unwilling to discontinue use;\n5. an unstable medical condition or unstable angina, myocardial infarction, or coronary angioplasty (past 3 months) or an untreated cardiac dysrhythmia;\n6. a history of renal failure or were on renal dialysis;\n7. a history of seizures;\n8. as defined by the C-SSRS (Columbia-Suicide Severity Rating Scale), current non-specific suicidal thoughts or lifetime history of a suicidal attempt (defined as \"potentially self-injurious act committed with at least some wish to die, as a result of act\");\n9. a history of closed head trauma associated with \\> 30 minutes of loss of consciousness, amnesia, skull fracture, subdural hematoma, or brain contusion;\n10. a history or psychosis, bipolar disorder, bulimia or anorexia nervosa;\n11. current moderate or severe depression as assessed by a score of ≥ 20 on the Beck Depression Inventory, Second Edition (BDI-II) 10;\n12. active substance abuse other than nicotine;\n13. current (past 14 days) use of an antipsychotic, monoamine oxidase inhibitors, or drugs known to interact with bupropion SR;\n14. a recent dose change of their antidepressant (within last 3 months);\n15. untreated hypertension or baseline systolic blood pressure \\> 180 or diastolic \\> 100;\n16. current treatment with another investigational drug for tobacco dependence (previous 30 days); or\n17. current use of bupropion or varenicline (previous 30 days).","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Jon Ebbet, MD","affiliation":"Mayo Clinic","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Dorothy Hatsukami, PhD","affiliation":"University of Minnesota","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"University Of Minnesota","city":"Minneapolis","state":"Minnesota","zip":"55414","country":"United States","geoPoint":{"lat":44.97997,"lon":-93.26384}},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","zip":"55905","country":"United States","geoPoint":{"lat":44.02163,"lon":-92.4699}},{"facility":"Franciscan Skemp Hospital","city":"La Crosse","state":"Wisconsin","zip":"54601","country":"United States","geoPoint":{"lat":43.80136,"lon":-91.23958}}]},"referencesModule":{"references":[{"pmid":"24399554","type":"RESULT","citation":"Ebbert JO, Hatsukami DK, Croghan IT, Schroeder DR, Allen SS, Hays JT, Hurt RD. Combination varenicline and bupropion SR for tobacco-dependence treatment in cigarette smokers: a randomized trial. JAMA. 2014 Jan 8;311(2):155-63. doi: 10.1001/jama.2013.283185."},{"pmid":"37142273","type":"DERIVED","citation":"Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8."},{"pmid":"34611902","type":"DERIVED","citation":"Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Study subjects who consented, were screened for entry criteria, and asked to return for a physical exam and medical history. If eligible and still interested, the volunteer was asked to return to the baseline visit at which time they would receive the study medication assignment.","recruitmentDetails":"Recruitment was between October 2009 and April 2012. Volunteers from local communities of Rochester, MN, Minneapolis, MN and LaCrosse, WI, were recruited using newspaper classified ads, radio, TV, internet ads, print ads in magazines, word of mouth, and volunteer wait lists.","groups":[{"id":"FG000","title":"Varenicline and Buproprion SR","description":"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.\n\nvarenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"},{"id":"FG001","title":"Varenicline and Placebo","description":"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.\n\nvarenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"249"},{"groupId":"FG001","numSubjects":"257"}]},{"type":"End of Medication Phase","achievements":[{"groupId":"FG000","numSubjects":"182"},{"groupId":"FG001","numSubjects":"184"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"158"},{"groupId":"FG001","numSubjects":"157"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"91"},{"groupId":"FG001","numSubjects":"100"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"45"},{"groupId":"FG001","numSubjects":"50"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"40"},{"groupId":"FG001","numSubjects":"42"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Smokers from the local community who smoked 10 cigarettes or more per day for the 6 months prior to study entry.","groups":[{"id":"BG000","title":"Varenicline and Buproprion SR","description":"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.\n\nvarenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"},{"id":"BG001","title":"Varenicline and Placebo","description":"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.\n\nvarenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"249"},{"groupId":"BG001","value":"257"},{"groupId":"BG002","value":"506"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"3"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"234"},{"groupId":"BG001","value":"253"},{"groupId":"BG002","value":"487"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"16"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"42.2","spread":"12.2"},{"groupId":"BG001","value":"41.9","spread":"12.7"},{"groupId":"BG002","value":"42.1","spread":"12.4"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"113"},{"groupId":"BG001","value":"126"},{"groupId":"BG002","value":"239"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"136"},{"groupId":"BG001","value":"131"},{"groupId":"BG002","value":"267"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"White, non-hispanic","categories":[{"measurements":[{"groupId":"BG000","value":"234"},{"groupId":"BG001","value":"240"},{"groupId":"BG002","value":"474"}]}]},{"title":"other","categories":[{"measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"32"}]}]}]},{"title":"smoking rate","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"cigarettes per day","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"19.5","spread":"7.3"},{"groupId":"BG001","value":"19.7","spread":"7.9"},{"groupId":"BG002","value":"19.6","spread":"7.6"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers.","description":"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?\"","populationDescription":"intention-to-treat (all randomized subjects included)","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"3 months","groups":[{"id":"OG000","title":"Varenicline and Buproprion SR","description":"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.\n\nvarenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"},{"id":"OG001","title":"Varenicline and Placebo","description":"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.\n\nvarenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"249"},{"groupId":"OG001","value":"257"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"132"},{"groupId":"OG001","value":"111"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Logistic regression with covariate included for study site.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.03","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.49","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.05","ciUpperLimit":"2.12"}]},{"type":"SECONDARY","title":"Prolonged Smoking Abstinence Rates at 26 Weeks in Cigarettes Smokers.","populationDescription":"intention to treat - all subjects","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"6 months","groups":[{"id":"OG000","title":"Varenicline and Buproprion SR","description":"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.\n\nvarenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"},{"id":"OG001","title":"Varenicline and Placebo","description":"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.\n\nvarenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"249"},{"groupId":"OG001","value":"257"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"91"},{"groupId":"OG001","value":"71"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Logistic Regression - adjusting for study site","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.03","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.52","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.04","ciUpperLimit":"2.22"}]},{"type":"SECONDARY","title":"Weight Gain From Baseline to 3 Months","description":"Weight change from baseline to three months in those who met criteria for prolonged abstinence at the 3 month visit","populationDescription":"analysis was restricted to subjects who had weight measured at the 3 month visit and were classified as meeting criteria for prolonged abstinence","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kilograms","timeFrame":"3 months","groups":[{"id":"OG000","title":"Varenicline and Buproprion SR","description":"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.\n\nvarenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"},{"id":"OG001","title":"Varenicline and Placebo","description":"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.\n\nvarenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"111"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.1","spread":"3.4"},{"groupId":"OG001","value":"2.5","spread":"2.7"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"< 0.001","statisticalMethod":"t-test, 2 sided"}]},{"type":"PRIMARY","title":"Point Prevalence Abstinence at 3 Months.","description":"biochemically confirmed 7-day point prevalence abstinence defined as no smoking, not even a puff, in the previous 7 days.","populationDescription":"intent to treat - all subjects","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"3 months","groups":[{"id":"OG000","title":"Varenicline and Buproprion SR","description":"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.\n\nvarenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"},{"id":"OG001","title":"Varenicline and Placebo","description":"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.\n\nvarenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"249"},{"groupId":"OG001","value":"257"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"140"},{"groupId":"OG001","value":"125"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Logistic regression adjusted for study site","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.09","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.36","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.95","ciUpperLimit":"1.93"}]},{"type":"SECONDARY","title":"Point Prevalence Abstinence at 6 Months.","description":"Biochemically confirmed abstinence as no smoking, even a puff, for the prior 7 days.","populationDescription":"Intention to treat - all subjects","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"6 months","groups":[{"id":"OG000","title":"Varenicline and Buproprion SR","description":"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.\n\nvarenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"},{"id":"OG001","title":"Varenicline and Placebo","description":"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.\n\nvarenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"249"},{"groupId":"OG001","value":"257"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"82"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Logistic Regression adjusting for study site","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.14","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.32","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.91","ciUpperLimit":"1.91"}]},{"type":"SECONDARY","title":"Prolonged Abstinence at 12 Months","populationDescription":"intention to treat - all subjects","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"12 months","groups":[{"id":"OG000","title":"Varenicline and Buproprion SR","description":"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.\n\nvarenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"},{"id":"OG001","title":"Varenicline and Placebo","description":"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.\n\nvarenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"249"},{"groupId":"OG001","value":"257"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"63"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Logistic Regression - adjusting for study site","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.11","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.39","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.93","ciUpperLimit":"2.07"}]},{"type":"SECONDARY","title":"Point Prevalence Abstinence at 12 Months","description":"Biochemically confirmed abstinence defined as no smoking, not even a puff, in the last 7 days","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"12 months","groups":[{"id":"OG000","title":"Varenicline and Buproprion SR","description":"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.\n\nvarenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"},{"id":"OG001","title":"Varenicline and Placebo","description":"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.\n\nvarenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"249"},{"groupId":"OG001","value":"257"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"91"},{"groupId":"OG001","value":"75"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Logistic Regression - adjusting for site","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.08","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.40","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.96","ciUpperLimit":"2.05"}]}]},"adverseEventsModule":{"frequencyThreshold":"2","eventGroups":[{"id":"EG000","title":"Varenicline and Buproprion SR","description":"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. 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