{"protocolSection":{"identificationModule":{"nctId":"NCT00296647","nctIdAliases":["NCT00106873"],"orgStudyIdInfo":{"id":"H-2004-0462"},"secondaryIdInfos":[{"id":"P50DA019706","type":"NIH","link":"https://reporter.nih.gov/quickSearch/P50DA019706"}],"organization":{"fullName":"University of Wisconsin, Madison","class":"OTHER"},"briefTitle":"Smoking Cessation Intervention: Effectiveness in Primary Care","officialTitle":"Tobacco Dependence: Treatment and Outcomes; Pharmacotherapies: Effectiveness in Primary Care"},"statusModule":{"statusVerifiedDate":"2015-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2004-09"},"primaryCompletionDateStruct":{"date":"2009-07","type":"ACTUAL"},"completionDateStruct":{"date":"2010-12","type":"ACTUAL"},"studyFirstSubmitDate":"2006-02-24","studyFirstSubmitQcDate":"2006-02-24","studyFirstPostDateStruct":{"date":"2006-02-27","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-10-21","resultsFirstSubmitQcDate":"2011-10-21","resultsFirstPostDateStruct":{"date":"2011-11-30","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-10-09","lastUpdatePostDateStruct":{"date":"2015-10-14","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University of Wisconsin, Madison","class":"OTHER"},"collaborators":[{"name":"National Institute on Drug Abuse (NIDA)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The information gathered in this study may help to develop more effective ways to help people quit smoking and stay quit in the future.","detailedDescription":"Randomized clinical trials may not accurately reflect the public health benefit of tobacco dependence pharmacotherapies when used in real-world clinical settings due to differences in patient selection, motivation, and adherence. To have a positive public health impact, a treatment must be accessible and acceptable to a broad range of smokers and effective under normal use conditions. The proposed project will assess primary care patients willingness to use cessation treatment and will determine the relative effectiveness of five cessation pharmacotherapies. This research builds on a primary care clinic-based recruitment strategy that was highly successful in a previous study. In the proposed research, 1320 primary care patients presenting for a regular outpatient visit will be recruited by medical assistants to participate in a free smoking cessation program and will be randomly assigned to one of five active pharmacotherapies: patch, lozenge, bupropion, patch+lozenge, and bupropion+lozenge (n = 264/condition). Interested participants who pass medical screening will pick up their medications at clinic pharmacies and will receive proactive telephone counseling from the Wisconsin Tobacco Quit Line. Assessment will be limited to preserve the generalizability of the findings, but select individual differences will be assessed pre-quit to validate algorithms (from Project 1: Efficacy) designed to optimize pharmacotherapy selection for smokers based on gender, level of dependence, and other factors. Smoking behavior will be assessed at six months and one year post-quit so that abstinence rates across pharmacotherapy conditions can be compared. The cost of incorporating tobacco dependence treatment into primary care will also be estimated."},"conditionsModule":{"conditions":["Tobacco Dependence"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":1346,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"patch","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: nicotine patch"]},{"label":"nicotine lozenge","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: nicotine lozenge"]},{"label":"bupropion","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: bupropion"]},{"label":"patch + lozenge","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: patch + lozenge"]},{"label":"buproion + lozenge","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: bupropion + lozenge"]}],"interventions":[{"type":"DRUG","name":"nicotine patch","description":"Decreasing dosages from 21 to 7 mg over 12 week period","armGroupLabels":["patch"]},{"type":"DRUG","name":"nicotine patch","description":"Decreasing dosage from 21 to 7 mg over 12 weeks","armGroupLabels":["patch"]},{"type":"DRUG","name":"nicotine lozenge","description":"4 mg nicotine lozenge: dosage according to package directions for 16 weeks","armGroupLabels":["nicotine lozenge"]},{"type":"DRUG","name":"bupropion","description":"dosage according to prescription directions: 12 weeks","armGroupLabels":["bupropion"]},{"type":"DRUG","name":"patch + lozenge","description":"dosage of each according to package insert directions (12 weeks patch, 16 weeks lozenge)","armGroupLabels":["patch + lozenge"]},{"type":"DRUG","name":"bupropion + lozenge","description":"dosage of each according to prescription or package insert (12 weeks bupropion, 16 weeks lozenge)","armGroupLabels":["buproion + lozenge"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"6 Month Self-reported Abstinence From Smoking","description":"Primary postquit outcomes was 7-day point prevalence abstinence (0, abstinent; 1, smoking) at 6 months (based on the week 24 interview)","timeFrame":"6 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Smoke at least 10 cigarettes per day for the previous 6 months - Expired CO \\> 9 ppm - Motivated to quit smoking - Able to read and write English - Willing to complete required study assessments, Aurora participating clinic patient\n\nExclusion Criteria:\n\n* Uncontrolled hypertension (systolic \\>180mm Hg or diastolic \\>110mm Hg) - History of bipolar disorder or psychosis - Myocardial infarction or other serious cardiac problem in the previous 4 weeks - History of diagnosed anorexia and/or bulimia - Diagnosis of Alcohol Dependence in the previous 6 months by participant self-report or drinking 6 or more drinks on six or more days a week - History of seizure and/or serious head injury involving loss of consciousness - Use of contraindicated medications (MAO inhibitors, bupropion, lithium, anticonvulsants, antipsychotics) - Currently pregnant or breast-feeding - Unwilling to use effective contraception during the treatment phase - More than one participant from the same household - Allergic reactions to 3 or more classes of drugs","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Thomas C Jackson, MD","affiliation":"Wake Forest University Health Sciences","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"UW-CTRI Milwaukee Research site","city":"Milwaukee","state":"Wisconsin","zip":"53233","country":"United States","geoPoint":{"lat":43.0389,"lon":-87.90647}}]},"referencesModule":{"references":[{"pmid":"22608375","type":"DERIVED","citation":"Hockenberry JM, Curry SJ, Fishman PA, Baker TB, Fraser DL, Cisler RA, Jackson TC, Fiore MC. Healthcare costs around the time of smoking cessation. Am J Prev Med. 2012 Jun;42(6):596-601. doi: 10.1016/j.amepre.2012.02.019."},{"pmid":"20008701","type":"DERIVED","citation":"Smith SS, McCarthy DE, Japuntich SJ, Christiansen B, Piper ME, Jorenby DE, Fraser DL, Fiore MC, Baker TB, Jackson TC. Comparative effectiveness of 5 smoking cessation pharmacotherapies in primary care clinics. Arch Intern Med. 2009 Dec 14;169(22):2148-55. doi: 10.1001/archinternmed.2009.426."}],"seeAlsoLinks":[{"label":"web site of the study lead investigators","url":"http://www.ctri.wisc.edu"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Primary inclusion criteria included (1) 18 years or older; (2) 10 or more cigarettes per day (CPD) for the past 6 months; (3) motivated to quit smoking; and (4) if female, willing to use an acceptable contraception while using the study medication.","recruitmentDetails":"Participants were 1346 smokers recruited in 12 Aurora Health Care primary care clinics in eastern Wisconsin from October 2005 through May 2007.","groups":[{"id":"FG000","title":"Patch"},{"id":"FG001","title":"Nicotine Lozenge"},{"id":"FG002","title":"Bupropion"},{"id":"FG003","title":"Patch + Lozenge"},{"id":"FG004","title":"Buproion + Lozenge"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"282"},{"groupId":"FG001","numSubjects":"261"},{"groupId":"FG002","numSubjects":"256"},{"groupId":"FG003","numSubjects":"279"},{"groupId":"FG004","numSubjects":"268"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"250"},{"groupId":"FG001","numSubjects":"233"},{"groupId":"FG002","numSubjects":"222"},{"groupId":"FG003","numSubjects":"262"},{"groupId":"FG004","numSubjects":"248"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"28"},{"groupId":"FG002","numSubjects":"34"},{"groupId":"FG003","numSubjects":"17"},{"groupId":"FG004","numSubjects":"20"}]}],"dropWithdraws":[{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"27"},{"groupId":"FG002","numSubjects":"32"},{"groupId":"FG003","numSubjects":"16"},{"groupId":"FG004","numSubjects":"19"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Patch"},{"id":"BG001","title":"Nicotine Lozenge"},{"id":"BG002","title":"Bupropion"},{"id":"BG003","title":"Patch + Lozenge"},{"id":"BG004","title":"Buproion + Lozenge"},{"id":"BG005","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"282"},{"groupId":"BG001","value":"261"},{"groupId":"BG002","value":"256"},{"groupId":"BG003","value":"279"},{"groupId":"BG004","value":"268"},{"groupId":"BG005","value":"1346"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"44.5","spread":"12.4"},{"groupId":"BG001","value":"42.9","spread":"11.7"},{"groupId":"BG002","value":"44","spread":"11.6"},{"groupId":"BG003","value":"44.8","spread":"12.4"},{"groupId":"BG004","value":"45.4","spread":"12.2"},{"groupId":"BG005","value":"44.3","spread":"12.1"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"158"},{"groupId":"BG001","value":"142"},{"groupId":"BG002","value":"143"},{"groupId":"BG003","value":"158"},{"groupId":"BG004","value":"152"},{"groupId":"BG005","value":"753"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"124"},{"groupId":"BG001","value":"119"},{"groupId":"BG002","value":"113"},{"groupId":"BG003","value":"121"},{"groupId":"BG004","value":"116"},{"groupId":"BG005","value":"593"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"282"},{"groupId":"BG001","value":"261"},{"groupId":"BG002","value":"256"},{"groupId":"BG003","value":"279"},{"groupId":"BG004","value":"268"},{"groupId":"BG005","value":"1346"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"6 Month Self-reported Abstinence From Smoking","description":"Primary postquit outcomes was 7-day point prevalence abstinence (0, abstinent; 1, smoking) at 6 months (based on the week 24 interview)","populationDescription":"intent to treat","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"6 months","groups":[{"id":"OG000","title":"Patch"},{"id":"OG001","title":"Lozenge"},{"id":"OG002","title":"Bupropion"},{"id":"OG003","title":"Patch + Lozenge"},{"id":"OG004","title":"Buproion + Lozenge"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"279"},{"groupId":"OG001","value":"261"},{"groupId":"OG002","value":"256"},{"groupId":"OG003","value":"279"},{"groupId":"OG004","value":"268"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"52"},{"groupId":"OG002","value":"45"},{"groupId":"OG003","value":"75"},{"groupId":"OG004","value":"80"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"6 months collection at scheduled follow up time points","eventGroups":[{"id":"EG000","title":"Patch","seriousNumAffected":4,"seriousNumAtRisk":282,"otherNumAffected":18,"otherNumAtRisk":282},{"id":"EG001","title":"Nicotine Lozenge","seriousNumAffected":1,"seriousNumAtRisk":261,"otherNumAffected":15,"otherNumAtRisk":261},{"id":"EG002","title":"Bupropion","seriousNumAffected":2,"seriousNumAtRisk":256,"otherNumAffected":12,"otherNumAtRisk":256},{"id":"EG003","title":"Patch + Lozenge","seriousNumAffected":1,"seriousNumAtRisk":279,"otherNumAffected":13,"otherNumAtRisk":279},{"id":"EG004","title":"Buproion + Lozenge","seriousNumAffected":1,"seriousNumAtRisk":268,"otherNumAffected":6,"otherNumAtRisk":268}],"seriousEvents":[{"term":"death","organSystem":"Cardiac disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":282},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":261},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":256},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":279},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":268}]}],"otherEvents":[{"term":"skin irritation","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":15,"numAffected":15,"numAtRisk":282},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":261},{"groupId":"EG002","numEvents":6,"numAffected":6,"numAtRisk":256},{"groupId":"EG003","numEvents":5,"numAffected":5,"numAtRisk":279},{"groupId":"EG004","numEvents":3,"numAffected":3,"numAtRisk":268}]},{"term":"nausea","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":282},{"groupId":"EG001","numEvents":12,"numAffected":12,"numAtRisk":261},{"groupId":"EG002","numEvents":6,"numAffected":6,"numAtRisk":256},{"groupId":"EG003","numEvents":8,"numAffected":8,"numAtRisk":279},{"groupId":"EG004","numEvents":3,"numAffected":3,"numAtRisk":268}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"The present study is limited to some extent by the fact that self-reported abstinence was not biochemically confirmed. However, there is evidence that self-reported abstinence rates are generally accurate in low-contact effectiveness studies."},"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Stevens Smith, PhD","organization":"UW-Center for Tobacco Research and Intervention","email":"sss@ctri.medicine.wisc.edu","phone":"608-262-7563"}}},"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":"D061485","term":"Tobacco Use Cessation Devices"},{"id":"D016642","term":"Bupropion"},{"id":"D057968","term":"Transdermal Patch"}],"ancestors":[{"id":"D013812","term":"Therapeutics"},{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D004864","term":"Equipment and Supplies"}]}},"hasResults":true}