{"protocolSection":{"identificationModule":{"nctId":"NCT00818207","orgStudyIdInfo":{"id":"A3051116"},"organization":{"fullName":"Pfizer","class":"INDUSTRY"},"briefTitle":"Impact Of Smoking Cessation Treatment Reimbursement On The Quit Rates In Smokers Motivated To Quit","officialTitle":"A Pragmatic, Randomized, Controlled Study Evaluating The Impact Of Access To Smoking Cessation Treatment Reimbursement On The Proportion Of Successful Quitters In A Canadian Population Of Smokers Motivated To Quit","acronym":"ACCESSATION"},"statusModule":{"statusVerifiedDate":"2012-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-03"},"primaryCompletionDateStruct":{"date":"2010-03","type":"ACTUAL"},"completionDateStruct":{"date":"2010-09","type":"ACTUAL"},"studyFirstSubmitDate":"2009-01-06","studyFirstSubmitQcDate":"2009-01-06","studyFirstPostDateStruct":{"date":"2009-01-07","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-02-29","resultsFirstSubmitQcDate":"2012-02-29","resultsFirstPostDateStruct":{"date":"2012-03-30","type":"ESTIMATED"},"lastUpdateSubmitDate":"2012-02-29","lastUpdatePostDateStruct":{"date":"2012-03-30","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Pfizer","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This study is based on the hypothesis that access to smoking cessation treatment (SCT) reimbursement may significantly increase the number of successful quitters in a population of smokers motivated to quit by: 1) increasing the use of SCTs in quit attempts, and 2) by improving subject adherence to treatment."},"conditionsModule":{"conditions":["Smoking Cessation","Insurance Coverage"],"keywords":["Smoking cessation","quit rates","reimbursement","drug coverage","effectiveness","cost-effectiveness","health policy","drug utilization","adherence","urine cotinine."]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"HEALTH_SERVICES_RESEARCH","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":1380,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Full Smoking Cessation Treatment Coverage (100%)","type":"OTHER","description":"A subject randomized to the intervention group will be eligible for smoking cessation treatment (SCT) reimbursement during the 26-week period following the randomization.","interventionNames":["Other: Full Smoking Cessation Treatment Coverage (100%)"]},{"label":"No Smoking Cessation Treatment Coverage (0%)","type":"OTHER","description":"Subjects in the control group choosing to quit using an SCT method will not be eligible for smoking cessation treatment (SCT) reimbursement and, thus, will have to purchase their treatment out of pocket.","interventionNames":["Other: No Smoking Cessation Treatment Coverage (0%)"]}],"interventions":[{"type":"OTHER","name":"Full Smoking Cessation Treatment Coverage (100%)","description":"This is a pragmatic study in which the intervention is a health policy (SCT reimbursement). Champix (varenicline), Zyban (bupropion) and NRTs (nicotine replacement therapies; patches, gums) are SCT eligible for reimbursement. Prescriptions will be issued as per the most recent version of the Product Monograph of the prescribed SCT or equivalent.","armGroupLabels":["Full Smoking Cessation Treatment Coverage (100%)"]},{"type":"OTHER","name":"No Smoking Cessation Treatment Coverage (0%)","description":"None of the subjects recruited in the study have access to SCT reimbursement in real-life. As such, subjects randomized to the control group represent lack of SCT coverage in real-life and are considered to receive standard of care for smoking cessation.","armGroupLabels":["No Smoking Cessation Treatment Coverage (0%)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence","description":"Percentage of participants who self-reported tobacco abstinence for the previous 7 days (7-day PP) with a negative response to the following questions: \"Have you smoked any cigarettes (even a puff) in the last 7 days?\" and \"Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a Nicotine Replacement Therapy (NRT) (smoking cessation treatment \\[SCT\\]) in the last 7 days?\"","timeFrame":"Week 26"}],"secondaryOutcomes":[{"measure":"Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco","description":"PP tobacco abstinence was adjudicated if the following conditions were met:(a) self-reported tobacco abstinence for the previous 7 days with a negative response to the questions \"Have you smoked any cigarettes (even a puff) in the last 7 days?\" and \"Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than an NRT (SCT) in the last 7 days?\" confirmed by negative urine cotinine test results (defined as cotinine levels less than \\[\\<\\]200 nanograms per milliliter \\[ng/mL\\]).","timeFrame":"Week 26"},{"measure":"Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52","description":"CA from smoking was adjudicated if the following conditions were met:(a) self-reported continuous tobacco abstinence during the defined time point with a negative response to the questions \"Have you smoked any cigarettes (even a puff) since the last contact/visit?\" at every visit from Week 26 through Week 52 (Weeks 26, 39, and 52) and \"Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than an NRT (SCT) since the last contact/visit?\" and (b) urine cotinine test results were neither positive (greater than or equal to \\[≥\\]200 ng/mL) nor missing.","timeFrame":"Week 26, Week 39, and Week 52"},{"measure":"Percentage of Participants With 7-Day PP of Abstinence at Week 13","description":"PP tobacco abstinence was adjudicated if the participant self-reported tobacco abstinence for the previous 7 days with a negative response to the following questions: \"Have you smoked any cigarettes (even a puff) in the last 7 days?\" and \"Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a NRT (SCT) in the last 7 days?\"","timeFrame":"Week 13"},{"measure":"Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52","description":"LTQR was adjudicated if the following conditions were met: the participant self-reported tobacco abstinence for the previous 7 days with a negative response to the following questions: \"Have you smoked any cigarettes (even a puff) in the last 7 days?\" and \"Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a NRT (SCT) in the last 7 days?\" and had no more than 6 cumulative days of using nicotine containing products from Weeks 26 to 52","timeFrame":"Week 26 to Week 52"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Daily smokers (10 cigarettes per day or more);\n* Smokers motivated to make a quit attempt within the next 14 days;\n* Potential subjects must be outpatients;\n* A subject must have a stable mental and physical medical condition (as per investigator's judgment).\n\nExclusion Criteria:\n\n* A subject currently eligible for smoking cessation treatment (SCT) reimbursement, whether from a public or a private drug insurance;\n* A subject with an unknown drug insurance status;\n* A subject living in a household where there is someone already recruited in the 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Brosky G, Oh P, Raymond V, Arteaga C, Ranger S. A pragmatic, randomized, controlled study evaluating the impact of access to smoking cessation pharmacotherapy coverage on the proportion of successful quitters in a Canadian population of smokers motivated to quit (ACCESSATION). BMC Public Health. 2014 May 7;14:433. doi: 10.1186/1471-2458-14-433."}],"seeAlsoLinks":[{"label":"To obtain contact information for a study center near you, click here.","url":"https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3051116&StudyName=Impact%20Of%20Smoking%20Cessation%20Treatment%20Reimbursement%20On%20The%20Quit%20Rates%20In%20Smokers%20Motivated%20To%20Quit"}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Reimbursement for Smoking Cessation Therapy (SCT)","description":"Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization."},{"id":"FG001","title":"No Reimbursement for SCT","description":"Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"696"},{"groupId":"FG001","numSubjects":"684"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"474"},{"groupId":"FG001","numSubjects":"417"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"222"},{"groupId":"FG001","numSubjects":"267"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"160"},{"groupId":"FG001","numSubjects":"146"}]},{"type":"Multiple reasons","reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"12"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"42"},{"groupId":"FG001","numSubjects":"104"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"5"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Reimbursement for Smoking Cessation Therapy (SCT)","description":"Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization."},{"id":"BG001","title":"No Reimbursement for SCT","description":"Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"696"},{"groupId":"BG001","value":"684"},{"groupId":"BG002","value":"1380"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"46.5","spread":"12.3"},{"groupId":"BG001","value":"46.7","spread":"12.3"},{"groupId":"BG002","value":"46.6","spread":"12.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"342"},{"groupId":"BG001","value":"347"},{"groupId":"BG002","value":"689"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"354"},{"groupId":"BG001","value":"337"},{"groupId":"BG002","value":"691"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence","description":"Percentage of participants who self-reported tobacco abstinence for the previous 7 days (7-day PP) with a negative response to the following questions: \"Have you smoked any cigarettes (even a puff) in the last 7 days?\" and \"Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a Nicotine Replacement Therapy (NRT) (smoking cessation treatment \\[SCT\\]) in the last 7 days?\"","populationDescription":"Intent to Treat (ITT) Population: all randomized participants","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Reimbursement for Smoking Cessation Therapy (SCT)","description":"Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization."},{"id":"OG001","title":"No Reimbursement for SCT","description":"Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"696"},{"groupId":"OG001","value":"684"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"20.8"},{"groupId":"OG001","value":"13.9"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0007","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.64","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.23","ciUpperLimit":"2.18"}]},{"type":"SECONDARY","title":"Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco","description":"PP tobacco abstinence was adjudicated if the following conditions were met:(a) self-reported tobacco abstinence for the previous 7 days with a negative response to the questions \"Have you smoked any cigarettes (even a puff) in the last 7 days?\" and \"Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than an NRT (SCT) in the last 7 days?\" confirmed by negative urine cotinine test results (defined as cotinine levels less than \\[\\<\\]200 nanograms per milliliter \\[ng/mL\\]).","populationDescription":"ITT","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Reimbursement for Smoking Cessation Therapy (SCT)","description":"Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization."},{"id":"OG001","title":"No Reimbursement for SCT","description":"Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"696"},{"groupId":"OG001","value":"684"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15.7"},{"groupId":"OG001","value":"10.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0018","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.68","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.21","ciUpperLimit":"2.33"}]},{"type":"SECONDARY","title":"Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52","description":"CA from smoking was adjudicated if the following conditions were met:(a) self-reported continuous tobacco abstinence during the defined time point with a negative response to the questions \"Have you smoked any cigarettes (even a puff) since the last contact/visit?\" at every visit from Week 26 through Week 52 (Weeks 26, 39, and 52) and \"Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than an NRT (SCT) since the last contact/visit?\" and (b) urine cotinine test results were neither positive (greater than or equal to \\[≥\\]200 ng/mL) nor missing.","populationDescription":"ITT","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Week 26, Week 39, and Week 52","groups":[{"id":"OG000","title":"Reimbursement for Smoking Cessation Therapy (SCT)","description":"Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization."},{"id":"OG001","title":"No Reimbursement for SCT","description":"Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"696"},{"groupId":"OG001","value":"684"}]}],"classes":[{"title":"Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"15.7"},{"groupId":"OG001","value":"10.1"}]}]},{"title":"Week 39","categories":[{"measurements":[{"groupId":"OG000","value":"7.8"},{"groupId":"OG001","value":"6.3"}]}]},{"title":"Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"6.6"},{"groupId":"OG001","value":"5.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Week 39 odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.2979","pValueComment":"p-value was not adjusted for multiple comparisons.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.25","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.82","ciUpperLimit":"1.90"},{"groupIds":["OG000","OG001"],"groupDescription":"Week 52 odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.4388","pValueComment":"p-value was not adjusted for multiple comparisons.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.19","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.76","ciUpperLimit":"1.87"}]},{"type":"SECONDARY","title":"Percentage of Participants With 7-Day PP of Abstinence at Week 13","description":"PP tobacco abstinence was adjudicated if the participant self-reported tobacco abstinence for the previous 7 days with a negative response to the following questions: \"Have you smoked any cigarettes (even a puff) in the last 7 days?\" and \"Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a NRT (SCT) in the last 7 days?\"","populationDescription":"ITT","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Week 13","groups":[{"id":"OG000","title":"Reimbursement for Smoking Cessation Therapy (SCT)","description":"Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization."},{"id":"OG001","title":"No Reimbursement for SCT","description":"Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"696"},{"groupId":"OG001","value":"684"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"34.1"},{"groupId":"OG001","value":"23.7"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"p-value was not adjusted for multiple comparisons.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.72","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.35","ciUpperLimit":"2.20"}]},{"type":"SECONDARY","title":"Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52","description":"LTQR was adjudicated if the following conditions were met: the participant self-reported tobacco abstinence for the previous 7 days with a negative response to the following questions: \"Have you smoked any cigarettes (even a puff) in the last 7 days?\" and \"Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a NRT (SCT) in the last 7 days?\" and had no more than 6 cumulative days of using nicotine containing products from Weeks 26 to 52","populationDescription":"ITT","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Week 26 to Week 52","groups":[{"id":"OG000","title":"Reimbursement for Smoking Cessation Therapy (SCT)","description":"Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. 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Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"696"},{"groupId":"OG001","value":"684"}]}],"classes":[{"title":"Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"20.8"},{"groupId":"OG001","value":"13.9"}]}]},{"title":"Week 30","categories":[{"measurements":[{"groupId":"OG000","value":"19.7"},{"groupId":"OG001","value":"12.6"}]}]},{"title":"Week 34","categories":[{"measurements":[{"groupId":"OG000","value":"17.4"},{"groupId":"OG001","value":"12.3"}]}]},{"title":"Week 39","categories":[{"measurements":[{"groupId":"OG000","value":"14.9"},{"groupId":"OG001","value":"11.3"}]}]},{"title":"Week 44","categories":[{"measurements":[{"groupId":"OG000","value":"13.7"},{"groupId":"OG001","value":"11.0"}]}]},{"title":"Week 48","categories":[{"measurements":[{"groupId":"OG000","value":"12.5"},{"groupId":"OG001","value":"10.8"}]}]},{"title":"Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"11.2"},{"groupId":"OG001","value":"9.9"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Week 52 odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.4551","pValueComment":"p-value was not adjusted for multiple comparisons.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.14","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.81","ciUpperLimit":"1.62"}]}]},"adverseEventsModule":{"frequencyThreshold":"0","description":"The same event may appear as both an adverse event (AE) and a serious AE (SAE). 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