{"protocolSection":{"identificationModule":{"nctId":"NCT00304707","orgStudyIdInfo":{"id":"R01DA017370","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01DA017370"},"secondaryIdInfos":[{"id":"R01DA017370","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01DA017370"}],"organization":{"fullName":"National Institute on Drug Abuse (NIDA)","class":"NIH"},"briefTitle":"Effectiveness of Bupropion for Smokers Recovering From Alcohol Dependence","officialTitle":"Bupropion Treatment for Smokers in Recovery"},"statusModule":{"statusVerifiedDate":"2017-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2005-04"},"primaryCompletionDateStruct":{"date":"2010-02","type":"ACTUAL"},"completionDateStruct":{"date":"2011-02","type":"ACTUAL"},"studyFirstSubmitDate":"2006-03-17","studyFirstSubmitQcDate":"2006-03-17","studyFirstPostDateStruct":{"date":"2006-03-20","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-04-05","resultsFirstSubmitQcDate":"2017-05-04","resultsFirstPostDateStruct":{"date":"2017-05-15","type":"ACTUAL"},"lastUpdateSubmitDate":"2017-05-04","lastUpdatePostDateStruct":{"date":"2017-05-15","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"David Kalman","investigatorTitle":"Principal Investigatgor","investigatorAffiliation":"National Institute on Drug Abuse (NIDA)"},"leadSponsor":{"name":"National Institute on Drug Abuse (NIDA)","class":"NIH"}},"descriptionModule":{"briefSummary":"Smoking is often a problem for alcohol dependent individuals. Many people who seek treatment for alcohol dependence are unable to quit smoking. The purpose of this study is to evaluate the effectiveness of bupropion, an antidepressant medication, in treating smokers receiving treatment for alcohol dependence.","detailedDescription":"Past research suggests that over 75% of alcohol dependent individuals in early alcohol recovery smoke cigarettes; smoking-related mortality exceeds alcohol-related mortality in this population. Many alcohol dependent individuals in early recovery are interested in smoking cessation treatment; however, studies indicate that these smokers find it very difficult to quit smoking. More effective treatment methods are needed for smokers in early alcohol recovery. Bupropion is a dopaminergic antidepressant that may be effective in treating nicotine dependent individuals. The purpose of this study is to evaluate the effectiveness of bupropion in nicotine dependent individuals receiving treatment for alcohol dependence. In addition, this study will investigate the psychological mechanisms that may mediate the efficacy of bupropion in smoking cessation. We will also collect DNA from subjects in order to explore whether response to bupropion is mediated by particular genetic variants in the dopaminergic, metabolic and nicotinic receptor systems of smokers.\n\nParticipants will be randomly assigned to receive either 300 mg of bupropion or placebo, daily for 8 weeks. In addition, all participants will receive a nicotine patch for 7 weeks. This will consist of a 21-mg nicotine patch for 4 weeks, a 14-mg nicotine patch for 2 weeks, and a 7-mg nicotine patch for 1 week. All participants will undergo seven counseling sessions. Follow-up visits will occur at Weeks 7, 12, and 24. Pre-quit variables (e.g., smoking satisfaction) and three post-quit variables (craving, nicotine withdrawal, and negative effects) will be evaluated at all study visits."},"conditionsModule":{"conditions":["Smoking Cessation","Alcohol-Related Disorders"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"FACTORIAL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":143,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"2","type":"EXPERIMENTAL","description":"participants in this arm receive bupropion","interventionNames":["Drug: Bupropion"]},{"label":"1","type":"PLACEBO_COMPARATOR","description":"placebo","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"Bupropion","description":"300 mg QD","armGroupLabels":["2"]},{"type":"DRUG","name":"placebo","description":"placebo","armGroupLabels":["1"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Smoking Abstinence","description":"The number of subjects in each treatment group who were smoking abstinent (7-day point prevalence) at week 7 (end of treatment), week 11 and week 24.","timeFrame":"week 7, week 11 and week 24 after scheduled quit day"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Smokes a minimum of 10 cigarettes daily for at least 1 year prior to study entry\n* Abstinence from alcohol and other non-nicotine drugs for between 1 and 12 months at time of study entry\n* Meets criteria for alcohol dependence or abuse in the 12 months prior to study entry\n\nExclusion Criteria:\n\n* History of seizures, head trauma and/or severe hepatic cirrhosis\n* Current use of medications known to affect smoking behavior and/or cessation\n* Use of tricyclic antidepressant medication and monoamine oxidase inhibitors\n* Major depressive disorder within the month prior to study entry\n* Eating disorder within the year prior to study entry\n* History of bipolar or psychotic disorder\n* Pregnant or breastfeeding\n* Unstable serious medical disorder\n* History of migraines\n* Currently using smokeless tobacco, pipes, or cigars","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"David Kalman, PhD","affiliation":"Boston University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"ENRM Veterans Hospital","city":"Bedford","state":"Massachusetts","zip":"01730","country":"United States","geoPoint":{"lat":42.49065,"lon":-71.27617}}]},"referencesModule":{"references":[{"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":{"groups":[{"id":"FG000","title":"Bupropion 300-mg Capsules","description":"participants in this arm receive bupropion\n\nBupropion: 300 mg QD"},{"id":"FG001","title":"Placebo","description":"placebo\n\nplacebo: placebo"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"73"},{"groupId":"FG001","numSubjects":"70"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"66"},{"groupId":"FG001","numSubjects":"64"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"6"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Bupropion 300-mg Capsules","description":"participants in this arm receive bupropion\n\nBupropion: 300 mg QD"},{"id":"BG001","title":"Placebo","description":"placebo\n\nplacebo: placebo"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"73"},{"groupId":"BG001","value":"70"},{"groupId":"BG002","value":"143"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"49.2","spread":"7.5"},{"groupId":"BG001","value":"47.8","spread":"10.5"},{"groupId":"BG002","value":"48.6","spread":"9.0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"26"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"58"},{"groupId":"BG001","value":"59"},{"groupId":"BG002","value":"117"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"36"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"53"},{"groupId":"BG001","value":"54"},{"groupId":"BG002","value":"107"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"73"},{"groupId":"BG001","value":"70"},{"groupId":"BG002","value":"143"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Smoking Abstinence","description":"The number of subjects in each treatment group who were smoking abstinent (7-day point prevalence) at week 7 (end of treatment), week 11 and week 24.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"week 7, week 11 and week 24 after scheduled quit day","groups":[{"id":"OG000","title":"Bupropion 300-mg Capsules","description":"participants in this arm receive bupropion\n\nBupropion: 300 mg QD"},{"id":"OG001","title":"Placebo","description":"placebo\n\nplacebo: placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"70"}]}],"classes":[{"title":"week 7","categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"21"}]}]},{"title":"week 11","categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"9"}]}]},{"title":"week 24","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"11"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"1","eventGroups":[{"id":"EG000","title":"Bupropion 300-mg Capsules","description":"participants in this arm receive bupropion\n\nBupropion: 300 mg QD","seriousNumAffected":0,"seriousNumAtRisk":73,"otherNumAffected":7,"otherNumAtRisk":73},{"id":"EG001","title":"Placebo","description":"placebo\n\nplacebo: placebo","seriousNumAffected":0,"seriousNumAtRisk":70,"otherNumAffected":2,"otherNumAtRisk":70}],"otherEvents":[{"term":"insomnia","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":73},{"groupId":"EG001","numAffected":2,"numAtRisk":70}]},{"term":"Dry mouth","organSystem":"Endocrine disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":73},{"groupId":"EG001","numAffected":1,"numAtRisk":70}]},{"term":"Rise in systolic blood pressure","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":73},{"groupId":"EG001","numAffected":1,"numAtRisk":70}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"David Kalman, PhD","organization":"University of Massachusetts Medical School","email":"kalmand@comcast.net","phone":"9785782371"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D016540","term":"Smoking Cessation"},{"id":"D019973","term":"Alcohol-Related Disorders"}],"ancestors":[{"id":"D015438","term":"Health Behavior"},{"id":"D001519","term":"Behavior"},{"id":"D019966","term":"Substance-Related Disorders"},{"id":"D064419","term":"Chemically-Induced Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D016642","term":"Bupropion"}],"ancestors":[{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}