{"protocolSection":{"identificationModule":{"nctId":"NCT00962988","orgStudyIdInfo":{"id":"HIPRC-6749"},"organization":{"fullName":"Ottawa Heart Institute Research Corporation","class":"OTHER"},"briefTitle":"Efficacy and Cost-Effectiveness of Cost-free Pharmacotherapy for Smoking Cessation for High-risk Smokers With Cerebrovascular Disease","officialTitle":"Efficacy and Cost-effectiveness of Cost-free Pharmacotherapy for Smoking Cessation for High-risk Smokers With Cerebrovascular Disease"},"statusModule":{"statusVerifiedDate":"2022-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-12"},"primaryCompletionDateStruct":{"date":"2015-04","type":"ACTUAL"},"completionDateStruct":{"date":"2015-04","type":"ACTUAL"},"studyFirstSubmitDate":"2009-08-18","studyFirstSubmitQcDate":"2009-08-19","studyFirstPostDateStruct":{"date":"2009-08-20","type":"ESTIMATED"},"resultsFirstSubmitDate":"2026-05-27","resultsFirstSubmitQcDate":"2026-06-23","resultsFirstPostDateStruct":{"date":"2026-08-10","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-06-23","lastUpdatePostDateStruct":{"date":"2026-08-10","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Ottawa Heart Institute Research Corporation","class":"OTHER"},"collaborators":[{"name":"Heart and Stroke Foundation of Ontario","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"Research Aims\n\nThe aims of this research study are to determine whether cost-free smoking cessation pharmacotherapy:\n\n1. Helps smokers with Transient Ischemic Attack (TIA) or stroke to quit smoking over the long-term, compared to simply providing a prescription for these medications;\n2. Is a more cost-effective alternative to providing a prescription only for these medications in this high risk population.\n\nHypotheses to be Tested\n\nThe hypotheses to be tested include the following:\n\n1. The CO-validated continuous abstinence rate at weeks 26 and 52 following a target quit date will be at least 10% higher for the cost-free smoking cessation pharmacotherapy intervention group compared to the prescription only usual care group;\n2. Cost-free smoking cessation pharmacotherapy will have a greater cost-effectiveness (i.e., cost/quit) than providing a prescription only.","detailedDescription":"Smokers with Transient Ischemic Attack (TIA) or stroke attending a Stroke Prevention Clinic and willing to quit smoking will be randomly assigned (1:1) to either a prescription only (PO) usual care group or a cost-free (CF) pharmacotherapy experimental group. Participants assigned to the prescription only usual care group will be asked to have their prescription for smoking cessation pharmacotherapy filled at their own cost at their local community pharmacy. Participants assigned to the cost-free pharmacotherapy group will be provided with a 12-week supply of NRT, or a 12-week supply of bupropion or varenicline. The pharmacotherapy will be provided by the research nurse to the patient immediately. All participants will receive identical advice regarding smoking from the attending neurologist, nurse counseling for smoking cessation, and follow-up tracking and telephone-based support for up to 26 weeks after the target quit date. Non-treatment follow-up will continue to week 52 after the target quit date."},"conditionsModule":{"conditions":["Cerebrovascular Disorders","Smoking Cessation"],"keywords":["Cerebrovascular disease","stroke","Transient Ischemic Attack","smoking cessation","Pharmacotherapy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"PREVENTION","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":194,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Cost-Free Group","type":"EXPERIMENTAL","interventionNames":["Drug: Cost-Free Pharmacotherapy Group"]},{"label":"Prescription Only Group","type":"OTHER","interventionNames":["Other: Prescription Only Group"]}],"interventions":[{"type":"DRUG","name":"Cost-Free Pharmacotherapy Group","description":"Participants assigned to the cost-free pharmacotherapy group will be provided with a 12-week supply of NRT, or a 12-week supply of bupropion or varenicline.\n\nPatients smoking 10 cigarettes or less will be prescribed 7mg/24hours for 12 weeks. Those who smoke 11- 20 cigarettes per day will be prescribed 14 mg/24 hours for 8 weeks and then nicotine patch 7mg for 4 weeks. Those smoking ≥ 20 cigarettes per day will be prescribed 21 mg/daily for 6 weeks and then nicotine patch 14mg/daily for 4 weeks and then nicotine patch 7 mg/daily for 2 weeks.\n\nFor patients who are prescribed varenicline, they will start the medication 8 days before the quit date using the following regime: Days 1-3: 0.5mg once/day; Days 4-7: 0.5 mg BID; Day 8-12 weeks 1.0 mg twice daily.\n\nFor patients who are prescribed bupropion, they will start the medication 8 days before the quit date using the following regime: Days 1-3: 150 mg daily (in the morning); Day 4-30: 150 mg BID for 3 months.","armGroupLabels":["Cost-Free Group"],"otherNames":["Nicotine Patch","Champix","Chantix","Wellbutrin"]},{"type":"OTHER","name":"Prescription Only Group","description":"Participants assigned to the prescription only usual care group will be asked to have their prescription for smoking cessation pharmacotherapy filled at their own cost at their local community pharmacy","armGroupLabels":["Prescription Only Group"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Biochemically Confirmed (Exhaled CO < 10 Ppm) of Self-reported Continuous Abstinence From Weeks 12 to 52 Following the Target Quit Date.","timeFrame":"52 weeks"}],"secondaryOutcomes":[{"measure":"Biochemically Confirmed (Exhaled CO < 10 Ppm) of Self-reported Continuous Abstinence From Weeks 12 to 26 Following the Target Quit Date.","timeFrame":"26 weeks"},{"measure":"Self-reported 7-day Point Prevalence Abstinence at 12 Week Followup","timeFrame":"12 weeks"},{"measure":"Verified 7-day Point Prevalence Abstinence at 26 Week Follow-up","timeFrame":"26 weeks"},{"measure":"Verified 7-day Point Prevalence Abstinence at 52 Week Follow-up","timeFrame":"52 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. Patient is a current daily smoker (one cigarette per day in the month preceding the visit to the Stroke Prevention Clinic)\n2. Patient has been diagnosed with TIA or stroke at any point in time\n3. Patient is able, in the opinion of the neurologist, to comprehend and participate in the smoking cessation interventions\n4. Patient is 18 years of age or older\n5. Patient is willing to set a quit date\n6. Patient willing to travel to study centre for follow-up visits\n7. Patient is willing to provide informed consent\n\nExclusion Criteria:\n\n1. Patient is unable to understand English or French\n2. Patient is not willing to use pharmacotherapy to quit\n3. Patient has been using smoking cessation medication for more than 6 weeks directly prior to clinic visit or hospital admission.\n4. Patient is pregnant, lactating or planning to become pregnant during the study period\n5. Patient has contraindication(s) to all of the following smoking cessation medications:\n\n   * Nicotine replacement therapy (allergy to adhesive, serious cardiac arrhythmias (e.g., tachycardia), vasospastic disease (e.g., Buerger's disease, Prinzmetal's variant angina)\n   * Bupropion (history of seizure disorder or head trauma; presently taking Wellbutrin; previous reaction to bupropion/Zyban/Wellbutrin; pre-existing or current eating disorder; taking anti-depressants, antipsychotics, corticosteroids, MAO inhibitors, theophylline, cocaine or diet pills; taking a quinalone antibiotic (e.g., ciprofloxacin, levoflozacin); currently using oral hypoglycemic product or insulin; severe hepatic impairment; CNS tumour; and\n   * Varenicline (renal failure; use of cimetidine; previous reaction to varenicline)","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Grant Stotts, MD","affiliation":"The Ottawa Hospital","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Andrew Pipe, MD","affiliation":"Ottawa Heart Institute Research Corporation","role":"STUDY_CHAIR"},{"name":"Sophia Papadakis, MHA","affiliation":"Ottawa Heart Institute Research Corporation","role":"STUDY_CHAIR"},{"name":"Debbie Aitken, RN BScN","affiliation":"Ottawa Heart Institute Research Corporation","role":"STUDY_CHAIR"},{"name":"Kerri-Anne Mullen, MSc","affiliation":"Ottawa Heart Institute Research Corporation","role":"STUDY_CHAIR"},{"name":"Sophia Gocan, RN BScN","affiliation":"The Ottawa Hospital","role":"STUDY_CHAIR"},{"name":"Mary Ann Laplante, RN BScN","affiliation":"The Ottawa Hospital","role":"STUDY_CHAIR"},{"name":"Robert Reid, MBA PhD","affiliation":"Ottawa Heart Institute Research Corporation","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Hamilton Health Sciences -Stroke Prevention Clinic","city":"Hamilton","state":"Ontario","zip":"L8L 2X2","country":"Canada","geoPoint":{"lat":43.25011,"lon":-79.84963}},{"facility":"The Ottawa Hospital - Stroke Prevention Clinic","city":"Ottawa","state":"Ontario","zip":"K1Y 4E9","country":"Canada","geoPoint":{"lat":45.41117,"lon":-75.69812}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Cost-Free Group","description":"Participants were provided a 12-week supply of cessation medication."},{"id":"FG001","title":"Prescription Only Group","description":"Participants were provided with a prescription for cessation medication to be gilled at a pharmacy at their own cost."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"99"},{"groupId":"FG001","numSubjects":"95"}]},{"type":"Analyzed","achievements":[{"groupId":"FG000","numSubjects":"97"},{"groupId":"FG001","numSubjects":"93"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"68"},{"groupId":"FG001","numSubjects":"52"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"31"},{"groupId":"FG001","numSubjects":"43"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Cost-Free Group","description":"Participants were provided a 12-week supply of cessation medication."},{"id":"BG001","title":"Prescription Only Group","description":"Participants were provided with a prescription for cessation medication to be gilled at a pharmacy at their own cost."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"99"},{"groupId":"BG001","value":"95"},{"groupId":"BG002","value":"194"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"99"},{"groupId":"BG001","value":"95"},{"groupId":"BG002","value":"194"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"55.5","spread":"9.7"},{"groupId":"BG001","value":"56.7","spread":"10.7"},{"groupId":"BG002","value":"56.1","spread":"10.2"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"99"},{"groupId":"BG001","value":"95"},{"groupId":"BG002","value":"194"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"49"},{"groupId":"BG001","value":"39"},{"groupId":"BG002","value":"88"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"56"},{"groupId":"BG002","value":"106"}]}]}]},{"title":"Race and Ethnicity Not Collected","populationDescription":"Race and Ethnicity were not collected from any participant.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}],"categories":[{"measurements":[{"groupId":"BG002","value":"0"}]}]}]},{"title":"Years of formal education","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"99"},{"groupId":"BG001","value":"95"},{"groupId":"BG002","value":"194"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"12.1","spread":"2.6"},{"groupId":"BG001","value":"12.1","spread":"2.4"},{"groupId":"BG002","value":"12.1","spread":"2.5"}]}]}]},{"title":"Body Mass Index","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg/m^2","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"99"},{"groupId":"BG001","value":"95"},{"groupId":"BG002","value":"194"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"27.4","spread":"5.7"},{"groupId":"BG001","value":"28.1","spread":"6.3"},{"groupId":"BG002","value":"27.7","spread":"6.0"}]}]}]},{"title":"Reason for stroke prevention clinic referral","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Trans-ischemic attack","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"99"},{"groupId":"BG001","value":"95"},{"groupId":"BG002","value":"194"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"45"},{"groupId":"BG001","value":"46"},{"groupId":"BG002","value":"91"}]}]},{"title":"Stroke","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"99"},{"groupId":"BG001","value":"95"},{"groupId":"BG002","value":"194"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"54"},{"groupId":"BG001","value":"49"},{"groupId":"BG002","value":"103"}]}]}]},{"title":"History of depression","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"99"},{"groupId":"BG001","value":"95"},{"groupId":"BG002","value":"194"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"31"},{"groupId":"BG002","value":"59"}]}]}]},{"title":"History of Diabetes","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"99"},{"groupId":"BG001","value":"95"},{"groupId":"BG002","value":"194"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"34"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"56"}]}]}]},{"title":"Years smoked","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"99"},{"groupId":"BG001","value":"95"},{"groupId":"BG002","value":"194"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"35.5","spread":"10.9"},{"groupId":"BG001","value":"37.1","spread":"12.8"},{"groupId":"BG002","value":"36.3","spread":"11.9"}]}]}]},{"title":"Cigarettes per day","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"cigarettes per day","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"99"},{"groupId":"BG001","value":"95"},{"groupId":"BG002","value":"194"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"17.9","spread":"10.7"},{"groupId":"BG001","value":"16.5","spread":"7.5"},{"groupId":"BG002","value":"17.2","spread":"9.3"}]}]}]},{"title":"Fagerstrom nicotine dependence score","description":"Score range 0-10 with higher scores indication greater dependence.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"score","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"99"},{"groupId":"BG001","value":"95"},{"groupId":"BG002","value":"194"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"4.6","spread":"2.2"},{"groupId":"BG001","value":"4.5","spread":"2.2"},{"groupId":"BG002","value":"4.55","spread":"2.2"}]}]}]},{"title":"Quit attempts in past year","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Number of quit attempts","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"99"},{"groupId":"BG001","value":"95"},{"groupId":"BG002","value":"194"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"1.3","spread":"2.0"},{"groupId":"BG001","value":"1.4","spread":"1.9"},{"groupId":"BG002","value":"1.35","spread":"1.95"}]}]}]},{"title":"Importance of quitting smoking scale","description":"Scored from 1-5 with higher scores indicating greater importance","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"score","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"99"},{"groupId":"BG001","value":"95"},{"groupId":"BG002","value":"194"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"4.4","spread":"1.0"},{"groupId":"BG001","value":"4.6","spread":"0.9"},{"groupId":"BG002","value":"4.5","spread":"0.95"}]}]}]},{"title":"Confidence in ability to quit smoking scale","description":"Scores from 1-5 with higher scores indicating higher confidence","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Score","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"99"},{"groupId":"BG001","value":"95"},{"groupId":"BG002","value":"194"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"3.4","spread":"1.2"},{"groupId":"BG001","value":"3.3","spread":"1.4"},{"groupId":"BG002","value":"3.35","spread":"1.3"}]}]}]},{"title":"Has insurance coverage for cessation medication","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"99"},{"groupId":"BG001","value":"95"},{"groupId":"BG002","value":"194"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"40"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Biochemically Confirmed (Exhaled CO < 10 Ppm) of Self-reported Continuous Abstinence From Weeks 12 to 52 Following the Target Quit Date.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"52 weeks","groups":[{"id":"OG000","title":"Cost-Free Group","description":"Participants were provided a 12-week supply of cessation medication."},{"id":"OG001","title":"Prescription Only Group","description":"Participants were provided with a prescription for cessation medication to be gilled at a pharmacy at their own cost."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"93"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"13"}]}]}]},{"type":"SECONDARY","title":"Biochemically Confirmed (Exhaled CO < 10 Ppm) of Self-reported Continuous Abstinence From Weeks 12 to 26 Following the Target Quit Date.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"26 weeks","groups":[{"id":"OG000","title":"Cost-Free Group","description":"Participants were provided a 12-week supply of cessation medication."},{"id":"OG001","title":"Prescription Only Group","description":"Participants were provided with a prescription for cessation medication to be gilled at a pharmacy at their own cost."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"93"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"15"}]}]}]},{"type":"SECONDARY","title":"Self-reported 7-day Point Prevalence Abstinence at 12 Week Followup","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"12 weeks","groups":[{"id":"OG000","title":"Cost-Free Group","description":"Participants were provided a 12-week supply of cessation medication."},{"id":"OG001","title":"Prescription Only Group","description":"Participants were provided with a prescription for cessation medication to be gilled at a pharmacy at their own cost."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"93"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"25"}]}]}]},{"type":"SECONDARY","title":"Verified 7-day Point Prevalence Abstinence at 26 Week Follow-up","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"26 weeks","groups":[{"id":"OG000","title":"Cost-Free Group","description":"Participants were provided a 12-week supply of cessation medication."},{"id":"OG001","title":"Prescription Only Group","description":"Participants were provided with a prescription for cessation medication to be gilled at a pharmacy at their own cost."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"93"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"17"}]}]}]},{"type":"SECONDARY","title":"Verified 7-day Point Prevalence Abstinence at 52 Week Follow-up","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"52 weeks","groups":[{"id":"OG000","title":"Cost-Free Group","description":"Participants were provided a 12-week supply of cessation medication."},{"id":"OG001","title":"Prescription Only Group","description":"Participants were provided with a prescription for cessation medication to be gilled at a pharmacy at their own cost."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"93"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"16"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Baseline to 52 weeks","eventGroups":[{"id":"EG000","title":"Cost-Free Group","description":"Participants were provided a 12-week supply of cessation medication.","deathsNumAffected":1,"deathsNumAtRisk":99,"seriousNumAffected":10,"seriousNumAtRisk":99,"otherNumAffected":0,"otherNumAtRisk":99},{"id":"EG001","title":"Prescription Only Group","description":"Participants were provided with a prescription for cessation medication to be gilled at a pharmacy at their own cost.","deathsNumAffected":1,"deathsNumAtRisk":95,"seriousNumAffected":12,"seriousNumAtRisk":95,"otherNumAffected":0,"otherNumAtRisk":95}],"seriousEvents":[{"term":"Death","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":99},{"groupId":"EG001","numAffected":1,"numAtRisk":95}]},{"term":"Stroke, worsening stroke, or trans ischemic attack","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":99},{"groupId":"EG001","numAffected":2,"numAtRisk":95}]},{"term":"Carotid endarterectomy","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":99},{"groupId":"EG001","numAffected":1,"numAtRisk":95}]},{"term":"Myocardial infarction","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":99},{"groupId":"EG001","numAffected":0,"numAtRisk":95}]},{"term":"Angina (Stable or Unstable)","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":99},{"groupId":"EG001","numAffected":1,"numAtRisk":95}]},{"term":"Cardiac revascularization","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":99},{"groupId":"EG001","numAffected":2,"numAtRisk":95}]},{"term":"Implantable cardioverter-defibrillator insertion","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":99},{"groupId":"EG001","numAffected":0,"numAtRisk":95}]},{"term":"Deep vein thrombosis","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":99},{"groupId":"EG001","numAffected":1,"numAtRisk":95}]},{"term":"Other, requiring hospitalization","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":99},{"groupId":"EG001","numAffected":8,"numAtRisk":95}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"Results were inconclusive. The intended sample size was not reached due to many smokers not being ready to quit smoking within 30 days of their stroke prevention clinic visit."},"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Dr. Robert Reid","organization":"University of Ottawa Heart Institute","email":"EQuirouette@ottawaheart.ca","phone":"6136967000"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D002561","term":"Cerebrovascular Disorders"},{"id":"D016540","term":"Smoking Cessation"},{"id":"D020521","term":"Stroke"},{"id":"D002546","term":"Ischemic Attack, Transient"}],"ancestors":[{"id":"D001927","term":"Brain Diseases"},{"id":"D002493","term":"Central Nervous System Diseases"},{"id":"D009422","term":"Nervous System Diseases"},{"id":"D014652","term":"Vascular Diseases"},{"id":"D002318","term":"Cardiovascular Diseases"},{"id":"D015438","term":"Health Behavior"},{"id":"D001519","term":"Behavior"},{"id":"D002545","term":"Brain Ischemia"}]},"interventionBrowseModule":{"meshes":[{"id":"D061485","term":"Tobacco Use Cessation Devices"},{"id":"D000068580","term":"Varenicline"},{"id":"D016642","term":"Bupropion"}],"ancestors":[{"id":"D013812","term":"Therapeutics"},{"id":"D001552","term":"Benzazepines"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D011810","term":"Quinoxalines"},{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}