{"protocolSection":{"identificationModule":{"nctId":"NCT00580853","orgStudyIdInfo":{"id":"0702002390"},"secondaryIdInfos":[{"id":"P50AA015632","type":"NIH","link":"https://reporter.nih.gov/quickSearch/P50AA015632"}],"organization":{"fullName":"Yale University","class":"OTHER"},"briefTitle":"The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior","officialTitle":"The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior"},"statusModule":{"statusVerifiedDate":"2018-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2007-04"},"primaryCompletionDateStruct":{"date":"2016-10","type":"ACTUAL"},"completionDateStruct":{"date":"2016-10","type":"ACTUAL"},"studyFirstSubmitDate":"2007-12-25","studyFirstSubmitQcDate":"2007-12-26","studyFirstPostDateStruct":{"date":"2007-12-27","type":"ESTIMATED"},"resultsFirstSubmitDate":"2016-10-21","resultsFirstSubmitQcDate":"2017-01-20","resultsFirstPostDateStruct":{"date":"2017-03-10","type":"ACTUAL"},"lastUpdateSubmitDate":"2018-01-12","lastUpdatePostDateStruct":{"date":"2018-02-08","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Yale University","class":"OTHER"},"collaborators":[{"name":"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purpose of this study is to examine how smoking cessation medications (varenicline, bupropion) affect the ability to resist smoking and also subsequent ad-lib smoking in non-treatment seeking daily smokers."},"conditionsModule":{"conditions":["Smoking Lapse Behavior"],"keywords":["smoking lapse behavior","smoking cessation","varenicline","bupropion","medication effect on smoking lapse behavior"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":62,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"varenicline","type":"EXPERIMENTAL","description":"varenicline 2mg/day","interventionNames":["Drug: varenicline"]},{"label":"Bupropion","type":"EXPERIMENTAL","description":"Bupropion 300mg/day","interventionNames":["Drug: bupropion"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo Control","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"varenicline","description":"2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8).","armGroupLabels":["varenicline"],"otherNames":["Chantix"]},{"type":"DRUG","name":"bupropion","description":"300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8).","armGroupLabels":["Bupropion"],"otherNames":["Zyban"]},{"type":"DRUG","name":"Placebo","description":"Placebo","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Latency to Initiate Ad-lib Smoking Session","description":"minutes to start smoking (range 0 to 50 minutes)","timeFrame":"0 to 50 minutes"}],"secondaryOutcomes":[{"measure":"Number of Cigarettes Smoked During the 60 Minute Ad-lib Period","description":"number of cigarettes smoked (range 0-8) during the 60 minute ad-lib period","timeFrame":"60 minutes"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* ages 18-55\n* able to read and write in English\n* Smokers\n\nExclusion Criteria:\n\n* any significant current medical or psychiatric conditions that would contraindicate smoking\n* current Diagnostic and Statistical Manual IV abuse or dependence of other substances, other than nicotine dependence or alcohol abuse\n* positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines\n* women who are pregnant or nursing\n* suicidal, homicidal, or evidence of current severe mental illness\n* participants prescribed any psychotropic drug in the 30 days prior to study enrollment\n* blood donation within the past 6 weeks\n* individuals seeking treatment for smoking cessation or have attempted to quit smoking within the past 3 months\n* specific exclusions for bupropion administration not already specified, including: have taken monoamine inhibitors in the past 6 weeks; history of anorexia or bulimia; previous hypersensitivity to bupropion; history of alcohol or drug dependence in the past year; history of seizure disorder of any etiology\n* known allergy to varenicline or taking H2blockers\n* participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current study","healthyVolunteers":false,"sex":"ALL","minimumAge":"21 Years","maximumAge":"55 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Sherry A McKee, PhD","affiliation":"Yale University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Yale Center for Clinical Investigation, Yale University","city":"New Haven","state":"Connecticut","zip":"06519","country":"United States","geoPoint":{"lat":41.30815,"lon":-72.92816}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Varenicline","description":"varenicline 2mg/day\n\nvarenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8)."},{"id":"FG001","title":"Bupropion","description":"Bupropion 300mg/day\n\nbupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8)."},{"id":"FG002","title":"Placebo","description":"Placebo Control\n\nPlacebo: Placebo"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"21"},{"groupId":"FG002","numSubjects":"21"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"21"},{"groupId":"FG002","numSubjects":"21"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Varenicline","description":"varenicline 2mg/day\n\nvarenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8)."},{"id":"BG001","title":"Bupropion","description":"Bupropion 300mg/day\n\nbupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8)."},{"id":"BG002","title":"Placebo","description":"Placebo Control\n\nPlacebo: Placebo"},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"21"},{"groupId":"BG003","value":"62"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"34.95","spread":"11.36"},{"groupId":"BG001","value":"34.95","spread":"9.70"},{"groupId":"BG002","value":"36.47","spread":"10.95"},{"groupId":"BG003","value":"35.47","spread":"6.95"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"26"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"12"},{"groupId":"BG003","value":"36"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Latency to Initiate Ad-lib Smoking Session","description":"minutes to start smoking (range 0 to 50 minutes)","populationDescription":"Subsample with high nicotine dependence","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"minutes","timeFrame":"0 to 50 minutes","groups":[{"id":"OG000","title":"Varenicline","description":"varenicline 2mg/day\n\nvarenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8)."},{"id":"OG001","title":"Bupropion","description":"Bupropion 300mg/day\n\nbupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8)."},{"id":"OG002","title":"Placebo","description":"Placebo Control\n\nPlacebo: Placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"38.138","spread":"6.268"},{"groupId":"OG001","value":"39.416","spread":"5.939"},{"groupId":"OG002","value":"19.249","spread":"6.196"}]}]}]},{"type":"SECONDARY","title":"Number of Cigarettes Smoked During the 60 Minute Ad-lib Period","description":"number of cigarettes smoked (range 0-8) during the 60 minute ad-lib period","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"number of cigarettes","timeFrame":"60 minutes","groups":[{"id":"OG000","title":"Varenicline","description":"varenicline 2mg/day\n\nvarenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8)."},{"id":"OG001","title":"Bupropion","description":"Bupropion 300mg/day\n\nbupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8)."},{"id":"OG002","title":"Placebo","description":"Placebo Control\n\nPlacebo: Placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"21"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":".713","spread":".351"},{"groupId":"OG001","value":"1.287","spread":".342"},{"groupId":"OG002","value":"2.085","spread":".396"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Titration period (7 days)","description":"All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.","eventGroups":[{"id":"EG000","title":"Varenicline","description":"varenicline 2mg/day\n\nvarenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8).","deathsNumAffected":0,"deathsNumAtRisk":20,"seriousNumAffected":0,"seriousNumAtRisk":20,"otherNumAffected":13,"otherNumAtRisk":20},{"id":"EG001","title":"Bupropion","description":"Bupropion 300mg/day\n\nbupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8).","deathsNumAffected":0,"deathsNumAtRisk":21,"seriousNumAffected":0,"seriousNumAtRisk":21,"otherNumAffected":13,"otherNumAtRisk":21},{"id":"EG002","title":"Placebo","description":"Placebo Control\n\nPlacebo: Placebo","deathsNumAffected":0,"deathsNumAtRisk":21,"seriousNumAffected":0,"seriousNumAtRisk":21,"otherNumAffected":13,"otherNumAtRisk":21}],"otherEvents":[{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20},{"groupId":"EG001","numAffected":3,"numAtRisk":21},{"groupId":"EG002","numAffected":0,"numAtRisk":21}]},{"term":"need to urinate","organSystem":"Renal and urinary disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":20},{"groupId":"EG001","numAffected":3,"numAtRisk":21},{"groupId":"EG002","numAffected":2,"numAtRisk":21}]},{"term":"Dry mouth","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":21},{"groupId":"EG002","numAffected":2,"numAtRisk":21}]},{"term":"Insomnia","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":21},{"groupId":"EG002","numAffected":1,"numAtRisk":21}]},{"term":"Flatulence","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20},{"groupId":"EG001","numAffected":4,"numAtRisk":21},{"groupId":"EG002","numAffected":3,"numAtRisk":21}]},{"term":"Abnormal dreams","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":21},{"groupId":"EG002","numAffected":1,"numAtRisk":21}]},{"term":"Discomfort","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":21},{"groupId":"EG002","numAffected":1,"numAtRisk":21}]},{"term":"Headache","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":3,"numAtRisk":21},{"groupId":"EG002","numAffected":4,"numAtRisk":21}]},{"term":"Change in taste","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":4,"numAtRisk":21},{"groupId":"EG002","numAffected":2,"numAtRisk":21}]},{"term":"Runny nose","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":21},{"groupId":"EG002","numAffected":3,"numAtRisk":21}]},{"term":"Change in appetite","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":4,"numAtRisk":21},{"groupId":"EG002","numAffected":4,"numAtRisk":21}]},{"term":"Trouble concentrating","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":21},{"groupId":"EG002","numAffected":2,"numAtRisk":21}]},{"term":"Sweating","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":4,"numAtRisk":21},{"groupId":"EG002","numAffected":1,"numAtRisk":21}]},{"term":"Heartburn","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":21},{"groupId":"EG002","numAffected":1,"numAtRisk":21}]},{"term":"Cough","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":21},{"groupId":"EG002","numAffected":2,"numAtRisk":21}]},{"term":"Drowsiness","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":3,"numAtRisk":21},{"groupId":"EG002","numAffected":2,"numAtRisk":21}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Sherry McKee PhD","organization":"Yale University","email":"sherry.mckee@yale.edu","phone":"203-737-3529"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D016540","term":"Smoking Cessation"}],"ancestors":[{"id":"D015438","term":"Health Behavior"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D000068580","term":"Varenicline"},{"id":"D016642","term":"Bupropion"}],"ancestors":[{"id":"D001552","term":"Benzazepines"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D011810","term":"Quinoxalines"},{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}