{"protocolSection":{"identificationModule":{"nctId":"NCT00006170","orgStudyIdInfo":{"id":"NIDA-04174-1"},"secondaryIdInfos":[{"id":"R01DA004174","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01DA004174"}],"organization":{"fullName":"University of Pittsburgh","class":"OTHER"},"briefTitle":"Bupropion and Weight Control for Smoking Cessation - 1","officialTitle":"Bupropion and Weight Control for Smoking Cessation"},"statusModule":{"statusVerifiedDate":"2016-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2000-09"},"primaryCompletionDateStruct":{"date":"2009-12","type":"ACTUAL"},"completionDateStruct":{"date":"2010-09","type":"ACTUAL"},"studyFirstSubmitDate":"2000-08-09","studyFirstSubmitQcDate":"2000-08-09","studyFirstPostDateStruct":{"date":"2000-08-10","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-06-18","resultsFirstSubmitQcDate":"2013-09-06","resultsFirstPostDateStruct":{"date":"2013-11-14","type":"ESTIMATED"},"lastUpdateSubmitDate":"2016-06-22","lastUpdatePostDateStruct":{"date":"2016-07-21","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Marsha Marcus","investigatorTitle":"Professor of Psychiatry","investigatorAffiliation":"University of Pittsburgh"},"leadSponsor":{"name":"University of Pittsburgh","class":"OTHER"},"collaborators":[{"name":"National Institute on Drug Abuse (NIDA)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.","detailedDescription":"Although rates of smoking have declined, the decrease in prevalence has been much less pronounced in women than in men, and women are particularly vulnerable to ongoing smoking-related morbidity and mortality. One important reason for gender differences in smoking cessation is concern about cessation-related weight gain among women, which is associated with poorer cessation outcome. We previously documented that cognitive behavior therapy to minimize weight concerns (CBT) was effective in promoting cessation and controlling weight gain among weight concerned women smokers. The current study is a randomized, double-blind, controlled trial to determine whether the addition of bupropion (Zyban) to CBT (12 sessions over 14 weeks, with 6 booster sessions) will enhance longer-term abstinence. Bupropion was the clear medication of choice for this trial because it is efficacious in promoting smoking cessation, attenuates cessation-related weight gain (particularly in women), and relieves negative mood, which appears more common in weight-concerned women. Four hundred fifty weight concerned women smokers will be randomized to either CBT for weight concerns plus standard cessation or standard smoking cessation only and six months of either bupropion (Zyban) or placebo (2 x 2 design). Primary outcome will be rates of smoking abstinence at 1 year and time to relapse across the four treatment conditions. In addition, we will determine the effects of these treatments on tobacco withdrawal, mood, and weight. Results of this investigation will provide information on the relative efficacy of the CBT intervention and bupropion alone and in combination and the utility of drug and counseling strategies that are specifically tailored for a high-risk population."},"conditionsModule":{"conditions":["Tobacco Use Disorder"],"keywords":["smoking cessation","Women","bupropion","weight concerns","weight"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"FACTORIAL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":349,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Bupropion and Weight Concerns intervention","type":"EXPERIMENTAL","description":"Bupropion SR and a weight concerns psychosocial intervention","interventionNames":["Drug: Bupropion","Behavioral: weight concerns intervention"]},{"label":"Placebo and Weight Concerns","type":"ACTIVE_COMPARATOR","description":"A matched placebo administered on same schedule as bupriopion and a weight concerns psychosocial intervention for smoking cesstion","interventionNames":["Drug: Placebo","Behavioral: weight concerns intervention"]},{"label":"Bupropion and standard smoking cessation","type":"ACTIVE_COMPARATOR","description":"Bupropion SR and a time and attention controlled smoking cessation intervention","interventionNames":["Drug: Bupropion","Behavioral: smoking cessation intervention"]},{"label":"Placebo and standard smoking cessation","type":"PLACEBO_COMPARATOR","description":"A matched placebo administered on same schedule as bupriopion and a time and attention controlled smoking cessation intervention","interventionNames":["Drug: Placebo","Behavioral: smoking cessation intervention"]}],"interventions":[{"type":"DRUG","name":"Bupropion","description":"smoking cessation medication aid","armGroupLabels":["Bupropion and Weight Concerns intervention","Bupropion and standard smoking cessation"],"otherNames":["zyban"]},{"type":"DRUG","name":"Placebo","description":"A matched placebo pill","armGroupLabels":["Placebo and Weight Concerns","Placebo and standard smoking cessation"]},{"type":"BEHAVIORAL","name":"weight concerns intervention","description":"cognitive behavioral treatment to address weight concners","armGroupLabels":["Bupropion and Weight Concerns intervention","Placebo and Weight Concerns"]},{"type":"BEHAVIORAL","name":"smoking cessation intervention","description":"Cognitive behavioral intervention for smoking cessation","armGroupLabels":["Bupropion and standard smoking cessation","Placebo and standard smoking cessation"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Smoking Abstinence","description":"Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of \\>15 micrograms/L were used to confirm non-smoking.","timeFrame":"3 months"},{"measure":"Smoking Abstinence","description":"Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of \\>15 micrograms/L were used to confirm non-smoking.","timeFrame":"6 months"},{"measure":"Smoking Abstinence","description":"Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of \\>15 micrograms/L were used to confirm non-smoking.","timeFrame":"12 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Smoke at least 10 cigarettes per day\n* Report concern about cessation-related weight gain\n* Motivated to quit smoking\n\nExclusion Criteria:\n\n* Currently pregnant, lactating, or no medically approved method of contraception\n* Major medical problem\n* History of seizure disorder or head injury\n* Current or historical psychosis or bipolar disorder\n* History of alcohol or substance abuse within previous year\n* Current or historical eating disorder\n* Use of antidepressant medication, monoamine oxidase inhibitor or lithium with previous month\n* Multiple Drug Allergies\n* Current major depressive disorder","healthyVolunteers":false,"sex":"FEMALE","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Marsha Marcus, Ph.D.","affiliation":"Western Psychiatric Institute & Clinic","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Western Psychiatric Institute & Clinic","city":"Pittsburgh","state":"Pennsylvania","zip":"15213 2593","country":"United States","geoPoint":{"lat":40.44062,"lon":-79.99589}}]},"referencesModule":{"references":[{"pmid":"20308641","type":"RESULT","citation":"Levine MD, Perkins KA, Kalarchian MA, Cheng Y, Houck PR, Slane JD, Marcus MD. Bupropion and cognitive behavioral therapy for weight-concerned women smokers. Arch Intern Med. 2010 Mar 22;170(6):543-50. doi: 10.1001/archinternmed.2010.33."},{"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."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Potential participants were excluded for current MDD, suicidality, drug or alcohol dependence within the past year, psychotic disorders, conditions associated with lowered seizure threshold, use of medications contraindicated with bupropion, uncontrolled hypertension, recent use of bupropion, pregnancy or use of other smoking or weight treatments.","recruitmentDetails":"Women were recruited between September 1999 and October 2005.","groups":[{"id":"FG000","title":"Weight Concerns + Bupropion (WC+B)","description":"An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took bupropion, a widely used, efficacious smoking cessation agent."},{"id":"FG001","title":"Weight Concerns + Placebo (WC+P)","description":"An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took a placebo instead of the bupropion."},{"id":"FG002","title":"Social Support + Bupropion (SS+B)","description":"An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took bupropion, a widely used, efficacious smoking cessation agent."},{"id":"FG003","title":"Social Support + Placebo (SS+P)","description":"An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took a placebo instead of the bupropion."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"106"},{"groupId":"FG001","numSubjects":"87"},{"groupId":"FG002","numSubjects":"89"},{"groupId":"FG003","numSubjects":"67"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"57"},{"groupId":"FG001","numSubjects":"37"},{"groupId":"FG002","numSubjects":"46"},{"groupId":"FG003","numSubjects":"28"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"49"},{"groupId":"FG001","numSubjects":"50"},{"groupId":"FG002","numSubjects":"43"},{"groupId":"FG003","numSubjects":"39"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"WC+B","description":"An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took bupropion, a widely used, efficacious smoking cessation agent."},{"id":"BG001","title":"WC+P","description":"An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took a placebo instead of bupropion."},{"id":"BG002","title":"SS+B","description":"An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took bupropion, a widely used, efficacious smoking cessation agent."},{"id":"BG003","title":"SS+P","description":"An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took a placebo instead of the bupropion."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"106"},{"groupId":"BG001","value":"87"},{"groupId":"BG002","value":"89"},{"groupId":"BG003","value":"67"},{"groupId":"BG004","value":"349"}]}],"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":"106"},{"groupId":"BG001","value":"87"},{"groupId":"BG002","value":"89"},{"groupId":"BG003","value":"67"},{"groupId":"BG004","value":"349"}]},{"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":"42.1","spread":"9.2"},{"groupId":"BG001","value":"42.6","spread":"10.0"},{"groupId":"BG002","value":"41.0","spread":"11.2"},{"groupId":"BG003","value":"42.3","spread":"10.4"},{"groupId":"BG004","value":"42.0","spread":"10.1"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"106"},{"groupId":"BG001","value":"87"},{"groupId":"BG002","value":"89"},{"groupId":"BG003","value":"67"},{"groupId":"BG004","value":"349"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"106"},{"groupId":"BG001","value":"87"},{"groupId":"BG002","value":"89"},{"groupId":"BG003","value":"67"},{"groupId":"BG004","value":"349"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Smoking Abstinence","description":"Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of \\>15 micrograms/L were used to confirm non-smoking.","populationDescription":"Participants with available data at 3mo. All others were unable to provide data at this time point.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"3 months","groups":[{"id":"OG000","title":"WC+B"},{"id":"OG001","title":"WC+P"},{"id":"OG002","title":"SS+B"},{"id":"OG003","title":"SS+P"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"70"},{"groupId":"OG001","value":"39"},{"groupId":"OG002","value":"56"},{"groupId":"OG003","value":"37"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"41","spread":"1"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"33"},{"groupId":"OG003","value":"19"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.","pValue":"0.001","statisticalMethod":"Regression, Logistic","ciPctValue":"95","ciNumSides":"TWO_SIDED"},{"groupIds":["OG000","OG002"],"testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.","pValue":"0.25","statisticalMethod":"Regression, Logistic","ciPctValue":"95"},{"groupIds":["OG002","OG003"],"testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.","pValue":"0.07","statisticalMethod":"Regression, Logistic","ciPctValue":"95"}]},{"type":"PRIMARY","title":"Smoking Abstinence","description":"Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of \\>15 micrograms/L were used to confirm non-smoking.","populationDescription":"Participants with available data at 6mo. All others were unable to provide data at this time point.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"6 months","groups":[{"id":"OG000","title":"WC+B"},{"id":"OG001","title":"WC+P"},{"id":"OG002","title":"SS+B"},{"id":"OG003","title":"SS+P"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"47"},{"groupId":"OG003","value":"32"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"21"},{"groupId":"OG003","value":"10"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.","pValue":"<0.001","statisticalMethod":"Regression, Logistic","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.","pValue":"0.053","statisticalMethod":"Regression, Logistic","ciPctValue":"95"},{"groupIds":["OG002","OG003"],"testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.","pValue":"0.08","statisticalMethod":"Regression, Logistic","ciPctValue":"95"}]},{"type":"PRIMARY","title":"Smoking Abstinence","description":"Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of \\>15 micrograms/L were used to confirm non-smoking.","populationDescription":"Participants with available data at 12mo. All others were unable to provide data at this time point.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"12 months","groups":[{"id":"OG000","title":"WC+B"},{"id":"OG001","title":"WC+P"},{"id":"OG002","title":"SS+B"},{"id":"OG003","title":"SS+P"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"46"},{"groupId":"OG003","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"19"},{"groupId":"OG003","value":"7"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.","pValue":"0.006","statisticalMethod":"Regression, Logistic","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.","pValue":"0.45","statisticalMethod":"Regression, Logistic","ciPctValue":"95"},{"groupIds":["OG002","OG003"],"testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.","pValue":"0.046","statisticalMethod":"Regression, Logistic","ciPctValue":"95"}]}]},"adverseEventsModule":{"frequencyThreshold":"0","eventGroups":[{"id":"EG000","title":"WC+B","seriousNumAffected":0,"seriousNumAtRisk":106,"otherNumAffected":0,"otherNumAtRisk":106},{"id":"EG001","title":"WC+P","seriousNumAffected":0,"seriousNumAtRisk":87,"otherNumAffected":0,"otherNumAtRisk":87},{"id":"EG002","title":"SS+B","seriousNumAffected":0,"seriousNumAtRisk":89,"otherNumAffected":0,"otherNumAtRisk":89},{"id":"EG003","title":"SS+P","seriousNumAffected":0,"seriousNumAtRisk":67,"otherNumAffected":0,"otherNumAtRisk":67}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Michele Levine","organization":"University of Pittsburgh","email":"levinem@upmc.edu","phone":"412-647-0703"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D014029","term":"Tobacco Use Disorder"},{"id":"D016540","term":"Smoking Cessation"},{"id":"D001835","term":"Body Weight"}],"ancestors":[{"id":"D019966","term":"Substance-Related Disorders"},{"id":"D064419","term":"Chemically-Induced Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D015438","term":"Health Behavior"},{"id":"D001519","term":"Behavior"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]},"interventionBrowseModule":{"meshes":[{"id":"D016642","term":"Bupropion"}],"ancestors":[{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}