Impact Of Smoking Cessation Treatment Reimbursement On The Quit Rates In Smokers Motivated To Quit

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Smoking Cessation, Insurance Coverage

Intervention / Treatment
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* Other: Full Smoking Cessation Treatment Coverage (100%)
* Other: No Smoking Cessation Treatment Coverage (0%)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Daily smokers (10 cigarettes per day or more); Smokers motivated to make a quit attempt within the next 14 days; Potential subjects must be outpatients; A subject must have a stable mental and physical medical condition (as per investigator's judgment). Exclusion Criteria: A subject currently eligible for smoking cessation treatment (SCT) reimbursement, whether from a public or a private drug insurance; A subject with an unknown drug insurance status; A subject living in a household where there is someone already recruited in the study; A subject with an unfilled SCT prescription issued within the past three months or with an unused SCT product; A subject with a life-threatening illness (ie, known or suspected cancer or other disease with a life expectancy of less than one year).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Full Smoking Cessation Treatment Coverage (100%)<br>A subject randomized to the intervention group will be eligible for smoking cessation treatment (SCT) reimbursement during the 26-week period following the randomization. | Other: Full Smoking Cessation Treatment Coverage (100%)<br>* 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.<br>|
| Other: No Smoking Cessation Treatment Coverage (0%)<br>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. | Other: No Smoking Cessation Treatment Coverage (0%)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence | 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? | Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco | 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]). | Week 26 | 
| Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52 | 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. | Week 26, Week 39, and Week 52 | 
| Percentage of Participants With 7-Day PP of Abstinence at Week 13 | 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? | Week 13 | 
| Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52 | 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 | Week 26 to Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking cessation, quit rates, reimbursement, drug coverage, effectiveness, cost-effectiveness, health policy, drug utilization, adherence, urine cotinine.