{"protocolSection":{"identificationModule":{"nctId":"NCT00332644","nctIdAliases":["NCT00109447"],"orgStudyIdInfo":{"id":"P50DA19706-1"},"secondaryIdInfos":[{"id":"P50DA019706","type":"NIH","link":"https://reporter.nih.gov/quickSearch/P50DA019706"}],"organization":{"fullName":"University of Wisconsin, Madison","class":"OTHER"},"briefTitle":"Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms","officialTitle":"Pharmacotherapies: Efficacy, Mechanisms and Algorithms"},"statusModule":{"statusVerifiedDate":"2011-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2004-09"},"primaryCompletionDateStruct":{"date":"2010-08","type":"ACTUAL"},"completionDateStruct":{"date":"2010-08","type":"ACTUAL"},"studyFirstSubmitDate":"2006-06-01","studyFirstSubmitQcDate":"2006-06-01","studyFirstPostDateStruct":{"date":"2006-06-02","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-10-21","resultsFirstSubmitQcDate":"2011-10-21","resultsFirstPostDateStruct":{"date":"2011-11-30","type":"ESTIMATED"},"lastUpdateSubmitDate":"2011-10-21","lastUpdatePostDateStruct":{"date":"2011-11-30","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 proposed work will advance the understanding and effectiveness of tobacco dependence treatment and result in more smokers quitting successfully.","detailedDescription":"This research study will last for three years. The first year involves a comparison of smoking cessation medications (bupropion, nicotine patch, and nicotine lozenge), including medications used in combination. The results of this study may allow researchers and clinicians to decide which medications are best for helping people to quit smoking as well as what treatments work best for different people. In addition, the first year of this study may help to clarify how these medications work.The purpose of the second and third years of this research study will be to get long-term results on the physical health, mental health, lifestyle factors, and the overall quality of life of people attempting to quit smoking. The results of this study may help researchers and clinicians better understand the health improvements that come from quitting or not quitting smoking."},"conditionsModule":{"conditions":["Nicotine Dependence"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":1504,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"1","type":"EXPERIMENTAL","description":"nicotine patch alone treatment","interventionNames":["Drug: nicotine patch"]},{"label":"2","type":"EXPERIMENTAL","description":"nicotine lozenge alone treatment","interventionNames":["Drug: nicotine lozenge"]},{"label":"3","type":"EXPERIMENTAL","description":"nicotine patch + lozenge combination treatment","interventionNames":["Drug: nicotine patch + nicotine lozenge"]},{"label":"4","type":"EXPERIMENTAL","description":"bupropion alone treatment","interventionNames":["Drug: bupropion"]},{"label":"5","type":"EXPERIMENTAL","description":"bupropion + nicotine lozenge combination treatment","interventionNames":["Drug: bupropion + lozenge"]},{"label":"6","type":"PLACEBO_COMPARATOR","description":"placebo control (no active medication) treatment","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"nicotine patch","description":"used according to FDA package label","armGroupLabels":["1"]},{"type":"DRUG","name":"nicotine lozenge","description":"used according to FDA-approved package directions","armGroupLabels":["2"]},{"type":"DRUG","name":"nicotine patch + nicotine lozenge","description":"dosage of both according to FDA-approved dosing schedule","armGroupLabels":["3"]},{"type":"DRUG","name":"bupropion","description":"dosage according to FDA-approved instructions","armGroupLabels":["4"]},{"type":"DRUG","name":"bupropion + lozenge","description":"dosage according to FDA approved standard instructions","armGroupLabels":["5"]},{"type":"DRUG","name":"placebo","description":"dosage same as active drug conditions","armGroupLabels":["6"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed","description":"Smoking status was assessed both as 7-day point-prevalence abstinence (\"Have you smoked at all, even a puff, in the last 7 days?\") and continuous abstinence (smoking at all since the target quit day), using a smoking calendar and the timeline follow-back method. All participants' self-reports of smoking status during study visits were confirmed by an expired carbon monoxide level of less than 10 ppm measured using a Micro-3 Smokerlyzer (Bedfont Scientific, Williamsburg, Virginia).","timeFrame":"6 months post quit date"}]},"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\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":"Timothy B. Baker, PhD","affiliation":"University of Wisconsin, Madison","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"UW-CTRI Madison Research site","city":"Madison","state":"Wisconsin","zip":"53711","country":"United States","geoPoint":{"lat":43.07305,"lon":-89.40123}},{"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":"37335995","type":"DERIVED","citation":"Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2."},{"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."},{"pmid":"29251951","type":"DERIVED","citation":"Burgess-Hull AJ, Roberts LJ, Piper ME, Baker TB. The social networks of smokers attempting to quit: An empirically derived and validated classification. Psychol Addict Behav. 2018 Feb;32(1):64-75. doi: 10.1037/adb0000336. Epub 2017 Dec 18."},{"pmid":"25867447","type":"DERIVED","citation":"McCarthy DE, Ebssa L, Witkiewitz K, Shiffman S. Paths to tobacco abstinence: A repeated-measures latent class analysis. J Consult Clin Psychol. 2015 Aug;83(4):696-708. doi: 10.1037/ccp0000017. Epub 2015 Apr 13."},{"pmid":"24938369","type":"DERIVED","citation":"Smith SS, Fiore MC, Baker TB. Smoking cessation in smokers who smoke menthol and non-menthol cigarettes. Addiction. 2014 Dec;109(12):2107-17. doi: 10.1111/add.12661. Epub 2014 Jul 21."},{"pmid":"24893290","type":"DERIVED","citation":"Stein JH, Asthana A, Smith SS, Piper ME, Loh WY, Fiore MC, Baker TB. Smoking cessation and the risk of diabetes mellitus and impaired fasting glucose: three-year outcomes after a quit attempt. PLoS One. 2014 Jun 3;9(6):e98278. doi: 10.1371/journal.pone.0098278. eCollection 2014."},{"pmid":"22496918","type":"DERIVED","citation":"Johnson HM, Piper ME, Baker TB, Fiore MC, Stein JH. Effects of smoking and cessation on subclinical arterial disease: a substudy of a randomized controlled trial. PLoS One. 2012;7(4):e35332. doi: 10.1371/journal.pone.0035332. Epub 2012 Apr 9."},{"pmid":"22172440","type":"DERIVED","citation":"Asthana A, Piper ME, McBride PE, Ward A, Fiore MC, Baker TB, Stein JH. Long-term effects of smoking and smoking cessation on exercise stress testing: three-year outcomes from a randomized clinical trial. Am Heart J. 2012 Jan;163(1):81-87.e1. doi: 10.1016/j.ahj.2011.06.023. Epub 2011 Nov 14."},{"pmid":"21885891","type":"DERIVED","citation":"Julius BR, Ward BA, Stein JH, McBride PE, Fiore MC, Colbert LH. Ambulatory activity associations with cardiovascular and metabolic risk factors in smokers. J Phys Act Health. 2011 Sep;8(7):994-1003. doi: 10.1123/jpah.8.7.994."},{"pmid":"20236788","type":"DERIVED","citation":"Johnson HM, Gossett LK, Piper ME, Aeschlimann SE, Korcarz CE, Baker TB, Fiore MC, Stein JH. Effects of smoking and smoking cessation on endothelial function: 1-year outcomes from a randomized clinical trial. J Am Coll Cardiol. 2010 May 4;55(18):1988-95. doi: 10.1016/j.jacc.2010.03.002. Epub 2010 Mar 17."}],"seeAlsoLinks":[{"label":"home page of agency performing the research","url":"http://www.endcigs.com"}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Nicotine Patch","description":"nicotine patch alone treatment for nicotine dependence."},{"id":"FG001","title":"Nicotine Lozenge","description":"nicotine lozenge alone treatment"},{"id":"FG002","title":"Nicotine Patch + Lozenge","description":"nicotine patch + lozenge combination treatment"},{"id":"FG003","title":"Bupropion","description":"bupropion alone treatment"},{"id":"FG004","title":"Bupropion + Nicotine Lozenge","description":"bupropion + nicotine lozenge combination treatment"},{"id":"FG005","title":"Placebo Control","description":"placebo control (no active medication) treatment"}],"periods":[{"title":"Overall 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