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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
1,380
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.
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.
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?"
Time frame: Week 26
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 \[ng/mL\]).
Time frame: 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.
Time frame: 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?"
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Pfizer Investigational Site
Burnaby, British Columbia, Canada
Pfizer Investigational Site
Chilliwack, British Columbia, Canada
Pfizer Investigational Site
Coquitlam, British Columbia, Canada
Pfizer Investigational Site
Kamloops, British Columbia, Canada
Pfizer Investigational Site
Kelowna, British Columbia, Canada
Pfizer Investigational Site
Langley, British Columbia, Canada
Pfizer Investigational Site
North Vancouver, British Columbia, Canada
Pfizer Investigational Site
Penticton, British Columbia, Canada
Pfizer Investigational Site
Vancouver, British Columbia, Canada
Pfizer Investigational Site
Vancouver, British Columbia, Canada
...and 46 more locations
Time frame: 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
Time frame: Week 26 to Week 52