{"protocolSection":{"identificationModule":{"nctId":"NCT00689611","orgStudyIdInfo":{"id":"ZESCA 9197"},"secondaryIdInfos":[{"id":"ISRCTN75356261"}],"organization":{"fullName":"McGill University","class":"OTHER"},"briefTitle":"Zyban as an Effective Smoking Cessation Aid for Patients Following an Acute Coronary Syndrome: The ZESCA Trial","officialTitle":"Zyban as an Effective Smoking Cessation Aid for Patients Following an Acute Coronary Syndrome: The ZESCA Trial","acronym":"ZESCA"},"statusModule":{"statusVerifiedDate":"2015-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2005-12"},"primaryCompletionDateStruct":{"date":"2010-06","type":"ACTUAL"},"completionDateStruct":{"date":"2010-06","type":"ACTUAL"},"studyFirstSubmitDate":"2008-05-30","studyFirstSubmitQcDate":"2008-05-30","studyFirstPostDateStruct":{"date":"2008-06-03","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-12-11","resultsFirstSubmitQcDate":"2015-04-10","resultsFirstPostDateStruct":{"date":"2015-04-23","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-04-10","lastUpdatePostDateStruct":{"date":"2015-04-23","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR_INVESTIGATOR","investigatorFullName":"Mark Eisenberg","investigatorTitle":"MD, MPH, Professor of Medicine","investigatorAffiliation":"McGill University"},"leadSponsor":{"name":"Mark Eisenberg","class":"OTHER"},"collaborators":[{"name":"Canadian Institutes of Health Research (CIHR)","class":"OTHER_GOV"},{"name":"Heart and Stroke Foundation of Canada","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"Patients who continue to smoke after a heart attack have a 35% increased risk of a recurrent event or death compared with those who quit. Many patients attempt to stop smoking after a heart attack, but relapse rates approach 66%. A variety of smoking cessation aids have been shown to be effective for the general population. However, bupropion is the only non-nicotine replacement therapy shown to improve abstinence rates in healthy young smokers. Furthermore, nicotine replacement therapies (NRTs) are contraindicated in the immediate period following a heart attack because of the undesirable effects of nicotine. Although bupropion has been successfully used to reduce smoking rates in healthy young populations, its efficacy and safety in the setting of patients recovering from an ACS is unknown. These patients, if they continue to smoke, are at exceptionally high risk for recurrent cardiac events. If bupropion is effective in this population, it will have a major impact on secondary prevention of recurrent clinical events in patients who suffer a heart attack.","detailedDescription":"Patients who continue smoking after ACS have a 35% increased risk of reinfarction or death compared with those who quit. Many patients attempt to stop smoking after an acute coronary syndrome (ACS), but relapse rates approach 66%. A variety of smoking cessation aids have been shown to be effective for the general population. However, physicians are reluctant to use a nicotine-based therapy because of its hemodynamic effects. Bupropion is the only non-nicotine replacement therapy shown to improve abstinence rates in healthy young smokers by approximately 50%. Although bupropion has successfully been used to reduce smoking rates in healthy young populations, its efficacy and safety in the setting of patients recovering from an ACS is unknown.\n\nThe ZESCA Trial will directly compare the efficacy and safety of bupropion versus placebo as a means of reducing smoking rates in patients following an ACS. The ZESCA Trial will be a multi-center effort, coordinated from the Jewish General Hospital/McGill University (Montreal, Quebec). A total of 1500 patients will be randomized following an ACS but before hospital discharge via an Internet web site. Prior to the start of the treatment, patients in both treatment arms will receive a standard physician-administered counseling session regarding smoking cessation. Patients will begin treatment in-hospital and will be monitored in-hospital for ≥ 2 days prior to discharge. Half the patients will receive bupropion for 9 weeks and the other half will receive placebo pills for 9 weeks. Patients receiving bupropion will take 150 mg once per day for 3 days and then 150 mg twice per day for the remainder of 9 weeks. Prior to discharge, the patients will receive an information sheet listing the possible side effects of bupropion. They will be advised to consult the treating physician should they experience any listed side effects. While in-hospital, patients will have quit smoking and they will be instructed to not restart smoking when discharged. Phone calls to the patients will be made by the study nurses at weeks 1 and 2 of the 9-week treatment period. In addition, the patients will have clinic visits at weeks 4 and 9 as well as months 6 and 12. Smoking abstinence will be assessed at 4 weeks, 9 weeks, 6 months, and 12 months after randomization. Smoking abstinence will be defined as the complete abstinence in the week prior to the clinic visits and levels of exhaled carbon monoxide ≤ 10 ppm. Side effects of bupropion in patients following ACS as well as clinical events following initiation of treatment will be measured at weeks 1-8 (by telephone calls), and weeks 4 and 9 as well as months 6 and 12 (by clinic visits). Withdrawal symptoms will also be assessed by the nurses during their weekly calls.\n\nTrials previously conducted with bupropion involved young healthy smokers. The ZESCA trial will be the first to examine the utility of bupropion in a group of patients with an ACS. These patients, if they continue to smoke, are at exceptionally high risk for recurrent cardiac events. If bupropion is effective in this population, it will have a major impact on secondary prevention of recurrent clinical events in patients who suffer an ACS."},"conditionsModule":{"conditions":["Acute Coronary Syndrome","Myocardial Infarction","Smoking"],"keywords":["Acute coronary syndrome","Myocardial infarction","Smoking cessation","Zyban","Secondary intervention post-ACS"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":392,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"P","type":"PLACEBO_COMPARATOR","description":"Half of patients will receive placebo for 9 weeks.","interventionNames":["Drug: Placebo"]},{"label":"A","type":"ACTIVE_COMPARATOR","description":"Half of patients will receive bupropion for 9 weeks.","interventionNames":["Drug: Bupropion HCl ER"]}],"interventions":[{"type":"DRUG","name":"Bupropion HCl ER","description":"150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks","armGroupLabels":["A"],"otherNames":["Zyban"]},{"type":"DRUG","name":"Placebo","description":"Placebo","armGroupLabels":["P"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Smoking Abstinence","description":"The primary end point was 7-day point prevalence smoking abstinence at 12 months. Smoking cessation was defined as self-reported abstinence in the week before the 12-month clinic visit and a measurement of exhaled carbon monoxide less than 11 ppm.\n\nThe primary end point was analyzed on an intention-to-treat (ITT) basis. Our ITT analysis assumed that those who withdrew consent or were lost to follow-up had returned to smoking at their baseline rates. This assumption is common in smoking cessation trials.","timeFrame":"12 months"}],"secondaryOutcomes":[{"measure":"Composite Major Adverse Cardiovascular Events (MACE)","description":"All clinical end points were adjudicated by members of the Endpoints Evaluation Committee who were blinded to treatment assignment.\n\nComposite MACE (death, myocardial infarction, unstable angina)","timeFrame":"12 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* ≥ 18 years of age\n* Smoke at least 10 cigarettes/day for the past year\n* Suffered an enzyme-positive ACS\n* Planned hospitalization of ≥24 hours\n* Motivated to quit smoking\n* Likely to be available for follow-up\n* Able to understand and read English or French\n\nExclusion Criteria:\n\n* Medical condition with a prognosis of \\< 1 year\n* Pregnant or lactating\n* Current use of Wellbutrin or any other medications that contain bupropion\n* Current use of any medical therapy for smoking cessation (e.g. BuSpar, fluoxetine, doxepin, nicotine gum, or nicotine patch)\n* Current seizure disorder, history of seizures or predisposition to seizures (e.g. history of brain tumor, severe head trauma, or stroke)\n* History of bulimia or anorexia nervosa\n* Current diagnosis of major depression (requiring medication), bipolar disease, or dementia\n* History of suicidal events (previous suicide attempt, suicidal ideation) or family history of suicide\n* Diagnosed hepatic failure, cirrhosis, hepatitis or history of hepatic impairment (AST or ALT levels ≥ 2 times upper limit of normal prior to admission for ACS)\n* Renal impairment with creatinine levels ≥ 2 times the upper limit of normal\n* Excessive alcohol consumption defined as ≥ 14 alcoholic drinks per week\n* Use of any illegal drugs in the past year (e.g. cocaine, heroin, opiates)\n* Current use of medications that lower seizure threshold e.g. amantadine, anti-depressants, anti-malarials, anti-psychotics, levodopa, lithium, quinolone antibiotics, ritonavir, systemic steroids, theophyllin, type 1C antiarrhythmics (e.g. encainide, flecainide, propafenone)\n* Use of MAO inhibitors or thioridazine in the past 15 days\n* Current use of over-the-counter stimulants (e.g. ephedrine, phenylephrine) or anoretics","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Mark J Eisenberg, MD, MPH","affiliation":"Jewish General Hospital/ McGill University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Parkview Medcial Center","city":"Pueblo","state":"Colorado","zip":"81003","country":"United States","geoPoint":{"lat":38.25445,"lon":-104.60914}},{"facility":"Central Maine Medical Center","city":"Lewiston","state":"Maine","zip":"04240","country":"United States","geoPoint":{"lat":44.10035,"lon":-70.21478}},{"facility":"Bay Regional Medical Center","city":"Bay City","state":"Michigan","country":"United States","geoPoint":{"lat":43.59447,"lon":-83.88886}},{"facility":"Bassett Healthcare","city":"Cooperstown","state":"New York","zip":"13326","country":"United States","geoPoint":{"lat":42.70048,"lon":-74.92426}},{"facility":"United Health Services","city":"Johnson City","state":"New York","zip":"13790","country":"United States","geoPoint":{"lat":42.11563,"lon":-75.95881}},{"facility":"Stony Brook Hospital and Medical Center","city":"Stony Brook","state":"New York","zip":"11794-8167","country":"United States","geoPoint":{"lat":40.92565,"lon":-73.14094}},{"facility":"Schuster Cardiology","city":"Kettering","state":"Ohio","zip":"45429","country":"United States","geoPoint":{"lat":39.6895,"lon":-84.16883}},{"facility":"Southwest Cardiology","city":"Kettering","state":"Ohio","zip":"45429","country":"United States","geoPoint":{"lat":39.6895,"lon":-84.16883}},{"facility":"DVA Medical Center","city":"Oklahoma City","state":"Oklahoma","zip":"73104","country":"United States","geoPoint":{"lat":35.46756,"lon":-97.51643}},{"facility":"Advanced Cardiology Specialists","city":"Scranton","state":"Pennsylvania","zip":"18501","country":"United States","geoPoint":{"lat":41.40916,"lon":-75.6649}},{"facility":"Medical University of South Carolina","city":"Charleston","state":"South Carolina","zip":"29403","country":"United States","geoPoint":{"lat":32.77632,"lon":-79.93275}},{"facility":"Riverside Hospital","city":"Newport News","state":"Virginia","zip":"23601","country":"United States","geoPoint":{"lat":36.98038,"lon":-76.42975}},{"facility":"Charleston Area Medical Center","city":"South Charleston","state":"West Virginia","zip":"25309","country":"United States","geoPoint":{"lat":38.36843,"lon":-81.69957}},{"facility":"National Heart Foundation of Bangladesh","city":"Dhaka","country":"Bangladesh","geoPoint":{"lat":23.7104,"lon":90.40744}},{"facility":"Peter Lougheed Centre of the Calgary General Hospital","city":"Calgary","state":"Alberta","country":"Canada","geoPoint":{"lat":51.05011,"lon":-114.08529}},{"facility":"University of Alberta Hospital","city":"Edmonton","state":"Alberta","country":"Canada","geoPoint":{"lat":53.55014,"lon":-113.46871}},{"facility":"Vancouver Coastal Health","city":"Vancouver","state":"British Columbia","zip":"V5M 1L9","country":"Canada","geoPoint":{"lat":49.24966,"lon":-123.11934}},{"facility":"Victoria General Hospital","city":"Winnipeg","state":"Manitoba","zip":"R3T 2E8","country":"Canada","geoPoint":{"lat":49.8844,"lon":-97.14704}},{"facility":"St. Boniface General Hospital","city":"Winnipeg","state":"Manitoba","country":"Canada","geoPoint":{"lat":49.8844,"lon":-97.14704}},{"facility":"New Brunswick Heart Centre","city":"Saint Johns","state":"New Brunswick","country":"Canada"},{"facility":"Valley Regional Hospital","city":"Kentville","state":"Nova Scotia","country":"Canada","geoPoint":{"lat":45.0771,"lon":-64.49605}},{"facility":"The Ottawa Hospital, General Campus","city":"Ottawa","state":"Ontario","country":"Canada","geoPoint":{"lat":45.41117,"lon":-75.69812}},{"facility":"St. Michael's Hospital","city":"Toronto","state":"Ontario","country":"Canada","geoPoint":{"lat":43.70643,"lon":-79.39864}},{"facility":"Hopital de la Cite de la Sante","city":"Laval","state":"Quebec","zip":"H7M 3L9","country":"Canada","geoPoint":{"lat":45.56995,"lon":-73.692}},{"facility":"CHA Hotel-Dieu de Levis","city":"Lévis","state":"Quebec","country":"Canada","geoPoint":{"lat":46.80326,"lon":-71.17793}},{"facility":"SMBD- Jewish General Hospital","city":"Montreal","state":"Quebec","zip":"H3T 1E2","country":"Canada","geoPoint":{"lat":45.50884,"lon":-73.58781}},{"facility":"Hopital Sacre-Coeur de Montreal","city":"Montreal","state":"Quebec","country":"Canada","geoPoint":{"lat":45.50884,"lon":-73.58781}},{"facility":"Hotel-Dieu","city":"Montreal","state":"Quebec","country":"Canada","geoPoint":{"lat":45.50884,"lon":-73.58781}},{"facility":"Montreal General Hospital","city":"Montreal","state":"Quebec","country":"Canada","geoPoint":{"lat":45.50884,"lon":-73.58781}},{"facility":"Hopital Laval","city":"Québec","state":"Quebec","zip":"G1V 4G5","country":"Canada","geoPoint":{"lat":46.81228,"lon":-71.21454}},{"facility":"Hopital Fleurimont","city":"Sherbrooke","state":"Quebec","zip":"J1H 5N4","country":"Canada","geoPoint":{"lat":45.40008,"lon":-71.89908}},{"facility":"CSSS de Sorel-Tracy","city":"Sorel-Tracy","state":"Quebec","country":"Canada","geoPoint":{"lat":46.04178,"lon":-73.11358}},{"facility":"CSSS de la Region de Thetford","city":"Thetford-Mines","state":"Quebec","country":"Canada","geoPoint":{"lat":46.09371,"lon":-71.30539}},{"facility":"Saskatchewan Drug Research Institute","city":"Saskatoon","state":"Saskatchewan","zip":"S7N 0W8","country":"Canada","geoPoint":{"lat":52.13238,"lon":-106.66892}},{"facility":"Centre for Chronic Disease Control","city":"New Delhi","country":"India","geoPoint":{"lat":28.62137,"lon":77.2148}},{"facility":"Isfahan Cardiovascular Research Centre","city":"Isfahan","state":"Iran","country":"Iran","geoPoint":{"lat":32.65246,"lon":51.67462}},{"facility":"InterActive Research and Development","city":"Karachi","country":"Pakistan","geoPoint":{"lat":24.8608,"lon":67.0104}},{"facility":"University Hospital F. Bourguiba","city":"Sousse","state":"Sousse Governorate","country":"Tunisia","geoPoint":{"lat":35.82539,"lon":10.63699}}]},"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."},{"pmid":"34611902","type":"DERIVED","citation":"Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4."},{"pmid":"33687070","type":"DERIVED","citation":"Taylor GM, Lindson N, Farley A, Leinberger-Jabari A, Sawyer K, Te Water Naude R, Theodoulou A, King N, Burke C, Aveyard P. Smoking cessation for improving mental health. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD013522. doi: 10.1002/14651858.CD013522.pub2."},{"pmid":"25326910","type":"DERIVED","citation":"Zhang DD, Eisenberg MJ, Grandi SM, Joseph L, O'Loughlin J, Paradis G, Lozano P, Filion KB. Bupropion, smoking cessation, and health-related quality of life following an acute myocardial infarction. J Popul Ther Clin Pharmacol. 2014;21(3):e346-56. Epub 2014 Oct 8."},{"pmid":"24440324","type":"DERIVED","citation":"Shimony A, Grandi SM, Pilote L, Joseph L, O'Loughlin J, Paradis G, Rinfret S, Sarrafzadegan N, Adamjee N, Yadav R, Gamra H, Diodati JG, Eisenberg MJ; ZESCA Investigators. Utilization of evidence-based therapy for acute coronary syndrome in high-income and low/middle-income countries. Am J Cardiol. 2014 Mar 1;113(5):793-7. doi: 10.1016/j.amjcard.2013.11.024. Epub 2013 Dec 12."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Placebo","description":"Participants received placebo for 9 weeks."},{"id":"FG001","title":"Bupropion","description":"Participants received bupropion for 9 weeks.\n\nBupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"200"},{"groupId":"FG001","numSubjects":"192"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"159"},{"groupId":"FG001","numSubjects":"146"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"41"},{"groupId":"FG001","numSubjects":"46"}]}],"dropWithdraws":[{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"9"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"9"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"27"},{"groupId":"FG001","numSubjects":"28"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All enrolled participants were included in the baseline analyses.","groups":[{"id":"BG000","title":"Placebo","description":"participants received placebo for 9 weeks.\n\nPlacebo: Placebo"},{"id":"BG001","title":"Bupropion","description":"participants received bupropion for 9 weeks.\n\nBupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"200"},{"groupId":"BG001","value":"192"},{"groupId":"BG002","value":"392"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"53.4","spread":"10.3"},{"groupId":"BG001","value":"54.5","spread":"10.4"},{"groupId":"BG002","value":"53.9","spread":"10.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"34"},{"groupId":"BG001","value":"31"},{"groupId":"BG002","value":"65"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"166"},{"groupId":"BG001","value":"161"},{"groupId":"BG002","value":"327"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"35"},{"groupId":"BG001","value":"33"},{"groupId":"BG002","value":"68"}]}]},{"title":"Pakistan","categories":[{"measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"36"}]}]},{"title":"Canada","categories":[{"measurements":[{"groupId":"BG000","value":"101"},{"groupId":"BG001","value":"96"},{"groupId":"BG002","value":"197"}]}]},{"title":"Iran, Islamic Republic of","categories":[{"measurements":[{"groupId":"BG000","value":"31"},{"groupId":"BG001","value":"31"},{"groupId":"BG002","value":"62"}]}]},{"title":"Tunisia","categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"10"}]}]},{"title":"India","categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"19"}]}]}]},{"title":"No. of years smoked","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"32.6","spread":"11.9"},{"groupId":"BG001","value":"33.2","spread":"13.0"},{"groupId":"BG002","value":"32.9","spread":"12.4"}]}]}]},{"title":"No. of cigarettes/day (past year)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"cigarettes/day","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"23.2","spread":"10.4"},{"groupId":"BG001","value":"23.2","spread":"10.8"},{"groupId":"BG002","value":"23.2","spread":"10.6"}]}]}]},{"title":"Index admission was for ST-segment elevation myocardial infarction [STEMI]","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"133"},{"groupId":"BG001","value":"121"},{"groupId":"BG002","value":"254"}]}]}]},{"title":"Cardiac catheterization during index admission","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"136"},{"groupId":"BG001","value":"128"},{"groupId":"BG002","value":"264"}]}]}]},{"title":"Percutaneous coronary intervention during index admission","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"104"},{"groupId":"BG001","value":"93"},{"groupId":"BG002","value":"197"}]}]}]},{"title":"Coronary artery bypass graft during index admission","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"25"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Smoking Abstinence","description":"The primary end point was 7-day point prevalence smoking abstinence at 12 months. Smoking cessation was defined as self-reported abstinence in the week before the 12-month clinic visit and a measurement of exhaled carbon monoxide less than 11 ppm.\n\nThe primary end point was analyzed on an intention-to-treat (ITT) basis. Our ITT analysis assumed that those who withdrew consent or were lost to follow-up had returned to smoking at their baseline rates. This assumption is common in smoking cessation trials.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"12 months","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo for 9 weeks."},{"id":"OG001","title":"Bupropion","description":"Participants received bupropion for 9 weeks.\n\nBupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"194"},{"groupId":"OG001","value":"183"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"32.0"},{"groupId":"OG001","value":"37.2"}]}]}]},{"type":"SECONDARY","title":"Composite Major Adverse Cardiovascular Events (MACE)","description":"All clinical end points were adjudicated by members of the Endpoints Evaluation Committee who were blinded to treatment assignment.\n\nComposite MACE (death, myocardial infarction, unstable angina)","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"12 months","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo for 9 weeks."},{"id":"OG001","title":"Bupropion","description":"Participants received bupropion for 9 weeks.\n\nBupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"200"},{"groupId":"OG001","value":"192"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"11.0"},{"groupId":"OG001","value":"13.0"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"4","eventGroups":[{"id":"EG000","title":"Placebo","description":"Participants received placebo for 9 weeks.","seriousNumAffected":37,"seriousNumAtRisk":200,"otherNumAffected":48,"otherNumAtRisk":200},{"id":"EG001","title":"Bupropion","description":"Participants received bupropion for 9 weeks.\n\nBupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks","seriousNumAffected":34,"seriousNumAtRisk":192,"otherNumAffected":58,"otherNumAtRisk":192}],"seriousEvents":[{"term":"Death","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Deaths due to: coronary dissection, cardiac arrest (2), multisystem organ failure post-CABG, complications related to duodenal perforation and recurrent septic shock, ischemic event in the bowel or spinal cord.","stats":[{"groupId":"EG000","numEvents":6,"numAffected":6,"numAtRisk":200},{"groupId":"EG001","numEvents":9,"numAffected":9,"numAtRisk":192}]},{"term":"Myocardial Infarction","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":200},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":192}]},{"term":"Unstable Angina","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":11,"numAffected":11,"numAtRisk":200},{"groupId":"EG001","numEvents":12,"numAffected":12,"numAtRisk":192}]},{"term":"Stroke","organSystem":"Vascular disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":200},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":192}]},{"term":"Psychiatric event","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Includes delirium, hallucination, and suicidal ideation","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":200},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":192}]},{"term":"Other","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Specific adverse event terms by treatment group are unknown.","stats":[{"groupId":"EG000","numEvents":17,"numAffected":17,"numAtRisk":200},{"groupId":"EG001","numEvents":9,"numAffected":9,"numAtRisk":192}]}],"otherEvents":[{"term":"Insomnia","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":36,"numAffected":36,"numAtRisk":200},{"groupId":"EG001","numEvents":43,"numAffected":43,"numAtRisk":192}]},{"term":"Dry mouth","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":18,"numAffected":18,"numAtRisk":200},{"groupId":"EG001","numEvents":26,"numAffected":26,"numAtRisk":192}]},{"term":"Dizziness","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":17,"numAffected":17,"numAtRisk":200},{"groupId":"EG001","numEvents":15,"numAffected":15,"numAtRisk":192}]},{"term":"Dysgeusia","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":13,"numAffected":13,"numAtRisk":200},{"groupId":"EG001","numEvents":16,"numAffected":16,"numAtRisk":192}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":12,"numAffected":12,"numAtRisk":200},{"groupId":"EG001","numEvents":14,"numAffected":14,"numAtRisk":192}]},{"term":"Dream abnormality","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":17,"numAffected":17,"numAtRisk":200},{"groupId":"EG001","numEvents":7,"numAffected":7,"numAtRisk":192}]},{"term":"Pruritus","organSystem":"General 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