{"protocolSection":{"identificationModule":{"nctId":"NCT01621009","orgStudyIdInfo":{"id":"1998-369"},"secondaryIdInfos":[{"id":"P50CA084724","type":"NIH","link":"https://reporter.nih.gov/quickSearch/P50CA084724"},{"id":"P50DA019706","type":"NIH","link":"https://reporter.nih.gov/quickSearch/P50DA019706"}],"organization":{"fullName":"University of Wisconsin, Madison","class":"OTHER"},"briefTitle":"Bupropion SR Plus Counseling for Smoking Cessation","officialTitle":"A Randomized Controlled Clinical Trial of Bupropion SR and Individual Smoking Cessation Counseling"},"statusModule":{"statusVerifiedDate":"2015-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2001-01"},"primaryCompletionDateStruct":{"date":"2002-10","type":"ACTUAL"},"completionDateStruct":{"date":"2003-10","type":"ACTUAL"},"studyFirstSubmitDate":"2012-06-13","studyFirstSubmitQcDate":"2012-06-13","studyFirstPostDateStruct":{"date":"2012-06-15","type":"ESTIMATED"},"resultsFirstSubmitDate":"2015-05-27","resultsFirstSubmitQcDate":"2015-12-16","resultsFirstPostDateStruct":{"date":"2016-01-27","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-12-16","lastUpdatePostDateStruct":{"date":"2016-01-27","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University of Wisconsin, Madison","class":"OTHER"},"collaborators":[{"name":"National Cancer Institute (NCI)","class":"NIH"},{"name":"National Institute on Drug Abuse (NIDA)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study was to determine if bupropion plus counseling was more effective than bupropion alone or counseling alone in helping smokers quit smoking."},"conditionsModule":{"conditions":["Tobacco Dependence","Smoking"],"keywords":["smoking cessation medications","smoking cessation counseling"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","CARE_PROVIDER"]}},"enrollmentInfo":{"count":463,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Active bupropion + counseling","type":"ACTIVE_COMPARATOR","description":"Active bupropion SR plus eight 10-minute individual counseling sessions.","interventionNames":["Drug: Active bupropion + counseling"]},{"label":"Active bupropion , No counseling","type":"ACTIVE_COMPARATOR","description":"Active bupropion, No counseling, only medication checks","interventionNames":["Drug: Active bupropion, No counseling"]},{"label":"Placebo medication + counseling","type":"PLACEBO_COMPARATOR","description":"Placebo bupropion plus eight 10-minute individual counseling sessions","interventionNames":["Drug: Placebo medication + counseling"]},{"label":"Placebo medication, No counseling","type":"PLACEBO_COMPARATOR","description":"Placebo bupropion, No counseling, just medication checks","interventionNames":["Drug: Placebo medication, No counseling"]}],"interventions":[{"type":"DRUG","name":"Active bupropion + counseling","description":"Medications-Pre-quit: 150 mg bupropion per day 7 days before quit attempt, then 150 mg twice daily for 4 days before quit attempt; then 150 mg bupropion twice daily for eight weeks.\n\nCounseling-Pre-quit: two 10 minutes sessions before quit date; eight 10-minute sessions post quit date.","armGroupLabels":["Active bupropion + counseling"]},{"type":"DRUG","name":"Active bupropion, No counseling","description":"Medication - 150 mg bupropion per day starting week before quit day, then 150 mg twice daily 3 days before quit day, then 150 mg twice daily for eight weeks after quit day.\n\nCounseling: No cessation counseling, only medication checks","armGroupLabels":["Active bupropion , No counseling"]},{"type":"DRUG","name":"Placebo medication + counseling","description":"Placebo bupropion once daily 7 days before quit day, then twice daily 4 days before quit attempt, then twice daily for 8 weeks after quit day.\n\nCounseling: Two 10-minutes sessions before quit day, then eight 10-minutes sessions for eight weeks after quit day.","armGroupLabels":["Placebo medication + counseling"]},{"type":"DRUG","name":"Placebo medication, No counseling","description":"Pre-quit: Placebo medication once daily 7 days before quit day, then twice daily before quit day, then twice daily for 8 weeks after quit day.\n\nCounseling: No counseling, just medication checks","armGroupLabels":["Placebo medication, No counseling"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"7-day Point Prevalence Abstinence From Smoking at 6 Months","description":"No smoking, not even a puff, during the 7 days prior to the 6 month follow-up. Biochemically confirmed.","timeFrame":"6 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Smoke 10 or more cigarettes per day\n* Expired carbon monoxide (CO) level greater than 9 parts per million (ppm)\n* Motivated to quit smoking (score of 3 on 4-point self-report scale)\n* Willing to fulfill study requirements\n\nExclusion Criteria:\n\n* Carbon monoxide breath test score below 9 ppm\n* Serious psychopathology (bipolar disorder, psychosis)\n* Center for Epidemiologic Studies Depression Scale CES-D)score over 16\n* Contraindications for use of bupropion\n* History of seizure disorder\n* History of eating disorder\n* Current heavy drinking\n* Risk of pregnancy\n* Current breastfeeding","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Timothy B Baker, PhD","affiliation":"University of Wisconsin, Madison","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Timothy B Baker, PhD","affiliation":"University of Wisconsin, Madison","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"UW Center for Tobacco Research and Intervention","city":"Madison","state":"Wisconsin","zip":"53711","country":"United States","geoPoint":{"lat":43.07305,"lon":-89.40123}}]},"referencesModule":{"references":[{"pmid":"18418793","type":"RESULT","citation":"McCarthy DE, Piasecki TM, Lawrence DL, Jorenby DE, Shiffman S, Fiore MC, Baker TB. A randomized controlled clinical trial of bupropion SR and individual smoking cessation counseling. Nicotine Tob Res. 2008 Apr;10(4):717-29. doi: 10.1080/14622200801968343."},{"pmid":"37230961","type":"DERIVED","citation":"Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants were 1) phone screened, 2) invited to group orientation where signed consent was obtained, and 3) completed CO testing and office visit for physical exam. Participants were considered enrolled after passing all 3 steps and randomization occurred at enrollment.","recruitmentDetails":"Participants recruited from Madison, WI area through TV, radio, newspaper advertisements from January, 2001 to October 2002","groups":[{"id":"FG000","title":"Active Bupropion + Counseling","description":"Active bupropion SR plus eight 10-minute individual counseling sessions."},{"id":"FG001","title":"Active Bupropion , No Counseling","description":"Active bupropion, No counseling, only medication checks"},{"id":"FG002","title":"Placebo Medication + Counseling","description":"Placebo bupropion plus eight 10-minute individual counseling sessions"},{"id":"FG003","title":"Placebo Medication, No Counseling","description":"Placebo bupropion, No counseling, just medication checks"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"113"},{"groupId":"FG001","numSubjects":"116"},{"groupId":"FG002","numSubjects":"121"},{"groupId":"FG003","numSubjects":"113"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"70"},{"groupId":"FG001","numSubjects":"65"},{"groupId":"FG002","numSubjects":"58"},{"groupId":"FG003","numSubjects":"60"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"43"},{"groupId":"FG001","numSubjects":"51"},{"groupId":"FG002","numSubjects":"63"},{"groupId":"FG003","numSubjects":"53"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Active Bupropion + Counseling","description":"Active bupropion SR plus eight 10-minute individual counseling sessions."},{"id":"BG001","title":"Active Bupropion , No Counseling","description":"Active bupropion, No counseling, only medication checks"},{"id":"BG002","title":"Placebo Medication + Counseling","description":"Placebo bupropion plus eight 10-minute individual counseling sessions"},{"id":"BG003","title":"Placebo Medication, No Counseling","description":"Placebo bupropion, No counseling, just medication checks"},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"113"},{"groupId":"BG001","value":"116"},{"groupId":"BG002","value":"121"},{"groupId":"BG003","value":"113"},{"groupId":"BG004","value":"463"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"113"},{"groupId":"BG001","value":"116"},{"groupId":"BG002","value":"121"},{"groupId":"BG003","value":"113"},{"groupId":"BG004","value":"463"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"36.76","spread":"11.39"},{"groupId":"BG001","value":"41.03","spread":"12.64"},{"groupId":"BG002","value":"37.82","spread":"12.82"},{"groupId":"BG003","value":"39.42","spread":"11.34"},{"groupId":"BG004","value":"38.76","spread":"12.16"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"52"},{"groupId":"BG001","value":"57"},{"groupId":"BG002","value":"63"},{"groupId":"BG003","value":"61"},{"groupId":"BG004","value":"233"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"61"},{"groupId":"BG001","value":"59"},{"groupId":"BG002","value":"58"},{"groupId":"BG003","value":"52"},{"groupId":"BG004","value":"230"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"113"},{"groupId":"BG001","value":"116"},{"groupId":"BG002","value":"121"},{"groupId":"BG003","value":"113"},{"groupId":"BG004","value":"463"}]}]}]},{"title":"7-day point prevalence abstinence","description":"Participants provided breath samples for carbon monoxide(CO)testing at all visits and provided a blood sample to assess cotinine (the first metabolite of nicotine)levels at baseline and again at end of treatment.","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Abstinent","categories":[{"measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"15"},{"groupId":"BG003","value":"14"},{"groupId":"BG004","value":"66"}]}]},{"title":"Not Abstinent","categories":[{"measurements":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"100"},{"groupId":"BG002","value":"106"},{"groupId":"BG003","value":"99"},{"groupId":"BG004","value":"397"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"7-day Point Prevalence Abstinence From Smoking at 6 Months","description":"No smoking, not even a puff, during the 7 days prior to the 6 month follow-up. Biochemically confirmed.","populationDescription":"Full intent-to-treat sample","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Number of abstinent participants","timeFrame":"6 months","groups":[{"id":"OG000","title":"Bupropion + Counseling","description":"Active bupropion + 8 weeks counseling: Medications: Pre-quit - 150mg bupropion SR per day 3 days before quit day, then 150mg twice a day 4 days before quit day; 150mg bupropion SR twice daily for 8 weeks after the quit date.\n\nCounseling: Pre-quit - Two 10-minute sessions; Post-quit: Eight weekly 10-minute sessions"},{"id":"OG001","title":"Bupropion, No Counseling","description":"Active bupropion, No counseling: Medications: Medications: Pre-quit - 150mg bupropion SR per day 3 days before quit day, then 150mg twice a day 4 days before quit day; 150mg bupropion SR twice daily for 8 weeks after the quit date. No cessation counseling, medication management and assessment only."},{"id":"OG002","title":"Placebo + Counseling","description":": Medications: Pre-quit - Placebo bupropion one per day 3 days before quit day, then two per day 4 days before quit day; placebo bupropion twice daily for 8 weeks after the quit date.\n\nCounseling: Pre-quit - Two 10-minute sessions; Post-quit: Eight weekly 10-minute sessions"},{"id":"OG003","title":"Placebo, No Counseling","description":": Medications: Pre-quit - Placebo bupropion one per day 3 days before quit day, then two per day 4 days before quit day; placebo bupropion twice daily for 8 weeks after the quit date.\n\nNo cessation counseling, medication management and assessment only."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"113"},{"groupId":"OG001","value":"116"},{"groupId":"OG002","value":"121"},{"groupId":"OG003","value":"113"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"14"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.61","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":".78","ciUpperLimit":"3.36"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.13","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":".52","ciUpperLimit":"2.44"}]}]},"adverseEventsModule":{"frequencyThreshold":"4","timeFrame":"6 months","eventGroups":[{"id":"EG000","title":"Placebo Medication","description":"Medications: Pre-quit - one placebo pill for 3 days before quit day, then one placebo pill twice a day 4 days before quit day for 8 weeks after the quit date.","seriousNumAffected":0,"seriousNumAtRisk":234,"otherNumAffected":66,"otherNumAtRisk":234},{"id":"EG001","title":"Active Medication","description":"Pre-quit - 150mg bupropion SR per day 3 days before quit day, then 150mg twice a day 4 days before quit day; 150mg bupropion SR twice daily for 8 weeks after the quit date.","seriousNumAffected":0,"seriousNumAtRisk":229,"otherNumAffected":94,"otherNumAtRisk":229}],"otherEvents":[{"term":"upper respiratory infection","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":21,"numAffected":21,"numAtRisk":234},{"groupId":"EG001","numEvents":19,"numAffected":19,"numAtRisk":229}]},{"term":"depression","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":25,"numAffected":25,"numAtRisk":234},{"groupId":"EG001","numEvents":15,"numAffected":15,"numAtRisk":229}]},{"term":"insomnia","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":10,"numAffected":10,"numAtRisk":234},{"groupId":"EG001","numEvents":35,"numAffected":35,"numAtRisk":229}]},{"term":"Headache","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":234},{"groupId":"EG001","numEvents":14,"numAffected":14,"numAtRisk":229}]},{"term":"Feeling jittery","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":234},{"groupId":"EG001","numEvents":11,"numAffected":11,"numAtRisk":229}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"Lack of a no-treatment control condition; limited ability to generalize to broader population"},"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Timothy Baker, PhD, Director of Research","organization":"University of Wisconsin Center for Tobacco Research and Intervention","email":"tbb@ctri.wisc.edu","phone":"(608) 262-7568"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D014029","term":"Tobacco Use Disorder"},{"id":"D012907","term":"Smoking"}],"ancestors":[{"id":"D019966","term":"Substance-Related Disorders"},{"id":"D064419","term":"Chemically-Induced Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D003376","term":"Counseling"}],"ancestors":[{"id":"D008605","term":"Mental Health Services"},{"id":"D004191","term":"Behavioral Disciplines and Activities"},{"id":"D003153","term":"Community Health Services"},{"id":"D006296","term":"Health Services"},{"id":"D005159","term":"Health Care Facilities Workforce and Services"}]}},"hasResults":true}