{"protocolSection":{"identificationModule":{"nctId":"NCT01330030","nctIdAliases":["NCT00218647"],"orgStudyIdInfo":{"id":"SU-07232007-459"},"secondaryIdInfos":[{"id":"R01DA017457","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01DA017457"}],"organization":{"fullName":"Stanford University","class":"OTHER"},"briefTitle":"Selegiline Patch for Treatment of Nicotine Dependence","officialTitle":"Selegiline Patch for Treatment of Nicotine Dependence"},"statusModule":{"statusVerifiedDate":"2016-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2005-07"},"primaryCompletionDateStruct":{"date":"2008-08","type":"ACTUAL"},"completionDateStruct":{"date":"2011-07","type":"ACTUAL"},"studyFirstSubmitDate":"2010-11-08","studyFirstSubmitQcDate":"2011-04-05","studyFirstPostDateStruct":{"date":"2011-04-06","type":"ESTIMATED"},"resultsFirstSubmitDate":"2016-03-01","resultsFirstSubmitQcDate":"2016-03-03","resultsFirstPostDateStruct":{"date":"2016-04-04","type":"ESTIMATED"},"lastUpdateSubmitDate":"2016-06-29","lastUpdatePostDateStruct":{"date":"2016-08-10","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Joel D Killen","investigatorTitle":"Principle Investigator","investigatorAffiliation":"Stanford University"},"leadSponsor":{"name":"Stanford University","class":"OTHER"},"collaborators":[{"name":"National Institute on Drug Abuse (NIDA)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"Relapse to smoking is a common problem affecting smokers who seek treatment. The purpose of this study is examine whether selegiline, given in the form of a skin patch, is effective in stopping smoking.","detailedDescription":"Most smokers relapse following smoking cessation treatment. More effective smoking cessation therapies are needed to prevent the high rates of relapse. Selegiline is a selective inhibitor of monoamine oxidase B (MAO B) and has been used clinically in combination with levodopa to treat Parkinson's disease. Selegiline permits the stabilization of dopamine (DA) levels in the brain by preventing the rapid degradation of DA by means of MAO B and is used as an adjunct to levodopa therapy causing a dose-sparing effect and enhancing dopaminergic transmission. Selegiline's effect on MAO B and the resulting effect on brain DA has interesting implications for the treatment of nicotine dependence because brain DA systems may play a key role in the mediation of reward learning behavior. Previous research suggests that the brains of living smokers show a 40% decrease in the level of MAO B relative to nonsmokers or former smokers. The purpose of this study is examine whether selegiline, administered in the form of a skin patch, is effective for smoking cessation.\n\nParticipants will be randomly assigned to one of two treatments: 1) transdermal selegiline patch (STS) or 2) placebo. Treatment with STS or placebo will be given for a period of 8 weeks. Participants will be stratified by gender to evaluate the role that gender plays in moderating smoking cessation treatment. Study visits will take place once each week for 30 to 45 minutes, and will include adverse events monitoring, biochemical verification of smoking status, and a physical exam. Follow-up visits will occur at Weeks 24 and 52 to determine response to treatment."},"conditionsModule":{"conditions":["Tobacco Use Disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"FACTORIAL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":243,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Drug Selegiline","type":"EXPERIMENTAL","description":"6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks","interventionNames":["Drug: Selegiline"]},{"label":"Matching placebo","type":"PLACEBO_COMPARATOR","description":"matching placebo worn 24 hours for 8 weeks","interventionNames":["Other: matching placebo"]}],"interventions":[{"type":"DRUG","name":"Selegiline","description":"6mg/24 hrs for 8 weeks","armGroupLabels":["Drug Selegiline"],"otherNames":["EMSAM"]},{"type":"OTHER","name":"matching placebo","description":"placebo/24hrs for 8 weeks","armGroupLabels":["Matching placebo"],"otherNames":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Expired-air Carbon Monoxide Confirmed Smoking Abstinence","description":"expired-air carbon monoxide confirmed smoking abstinence at 52 weeks","timeFrame":"52 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Smokes greater than 20 cigarettes per day\n\nExclusion Criteria:\n\n* History of Parkinson's disease, high blood pressure, or severe liver or kidney disease\n* Current substance abuse\n* Mental illness\n* Skin conditions that could interfere with patch use\n* Using antidepressant medications (e.g., levodopa/carbidopa, methyldopa, or any MAO inhibitor)\n* Pregnant or breastfeeding","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Joel D Killen","affiliation":"Stanford University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Stanford University School of Medicine","city":"Stanford","state":"California","zip":"94305","country":"United States","geoPoint":{"lat":37.42411,"lon":-122.16608}}]},"referencesModule":{"references":[{"pmid":"20707784","type":"RESULT","citation":"Killen JD, Fortmann SP, Murphy GM Jr, Hayward C, Fong D, Lowenthal K, Bryson SW, Killen DT, Schatzberg AF. Failure to improve cigarette smoking abstinence with transdermal selegiline + cognitive behavior therapy. Addiction. 2010 Sep;105(9):1660-8. doi: 10.1111/j.1360-0443.2010.03020.x."},{"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":"The original target enrollment was 230. Over recruitment led to a study sample size =243","groups":[{"id":"FG000","title":"Drug Selegiline","description":"6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks"},{"id":"FG001","title":"Matching Placebo","description":"matching placebo worn 24 hours for 8 weeks"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"121"},{"groupId":"FG001","numSubjects":"122"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"number assessed at week 52 follow-up","numSubjects":"105"},{"groupId":"FG001","comment":"number assessed at week 52 follow-up","numSubjects":"105"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"17"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"17"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Drug Selegiline","description":"6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks\n\nSelegiline: 6mg/24 hrs for 8 weeks"},{"id":"BG001","title":"Matching Placebo","description":"matching placebo worn 24 hours for 8 weeks\n\nmatching placebo: placebo/24hrs for 8 weeks"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"121"},{"groupId":"BG001","value":"122"},{"groupId":"BG002","value":"243"}]}],"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"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"121"},{"groupId":"BG001","value":"122"},{"groupId":"BG002","value":"243"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"37"},{"groupId":"BG001","value":"37"},{"groupId":"BG002","value":"74"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"84"},{"groupId":"BG001","value":"85"},{"groupId":"BG002","value":"169"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"121"},{"groupId":"BG001","value":"122"},{"groupId":"BG002","value":"243"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Expired-air Carbon Monoxide Confirmed Smoking Abstinence","description":"expired-air carbon monoxide confirmed smoking abstinence at 52 weeks","populationDescription":"intention to treat","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants not smoking","timeFrame":"52 weeks","groups":[{"id":"OG000","title":"Drug Selegiline","description":"6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks\n\nSelegiline: 6mg/24 hrs for 8 weeks"},{"id":"OG001","title":"Matching Placebo","description":"matching placebo worn 24 hours for 8 weeks\n\nmatching placebo: placebo/24hrs for 8 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"122"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"25"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"Drug Selegiline","description":"6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks\n\nSelegiline: 6mg/24 hrs for 8 weeks","seriousNumAffected":0,"seriousNumAtRisk":121,"otherNumAffected":110,"otherNumAtRisk":121},{"id":"EG001","title":"Matching Placebo","description":"matching placebo worn 24 hours for 8 weeks\n\nmatching placebo: placebo/24hrs for 8 weeks","seriousNumAffected":0,"seriousNumAtRisk":122,"otherNumAffected":108,"otherNumAtRisk":122}],"otherEvents":[{"term":"Insomnia","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":57,"numAffected":57,"numAtRisk":121},{"groupId":"EG001","numEvents":53,"numAffected":53,"numAtRisk":122}]},{"term":"Headache","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":41,"numAffected":41,"numAtRisk":121},{"groupId":"EG001","numEvents":43,"numAffected":43,"numAtRisk":122}]},{"term":"skin rash","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":30,"numAffected":30,"numAtRisk":121},{"groupId":"EG001","numEvents":27,"numAffected":27,"numAtRisk":122}]},{"term":"racing thoughts","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":25,"numAffected":25,"numAtRisk":121},{"groupId":"EG001","numEvents":28,"numAffected":28,"numAtRisk":122}]},{"term":"Lightheaded","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":20,"numAffected":20,"numAtRisk":121},{"groupId":"EG001","numEvents":20,"numAffected":20,"numAtRisk":122}]},{"term":"Vivid dreams","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":13,"numAffected":13,"numAtRisk":121},{"groupId":"EG001","numEvents":12,"numAffected":12,"numAtRisk":122}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Dr Joel D Killen","organization":"Stanford University","email":"jkillen@stanford.edu","phone":"650-723-5895"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D014029","term":"Tobacco Use Disorder"}],"ancestors":[{"id":"D019966","term":"Substance-Related Disorders"},{"id":"D064419","term":"Chemically-Induced Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D012642","term":"Selegiline"}],"ancestors":[{"id":"D010627","term":"Phenethylamines"},{"id":"D005021","term":"Ethylamines"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}