Smoking Cessation Clinical Trial
Official title:
An Innovative Approach to Maximizing the Impact of Efficacious Pharmacotherapies on Smoking Cessation Attempts.
Bupropion and varenicline are indicated for smoking cessation. The objectives of this study are two-fold: (1) to explore the logistic feasibility of distributing bupropion and varenicline free of charge to treatment-seeking smokers in the province of Ontario, Canada and (2) to evaluate the real-world effectiveness of bupropion and varenicline treatment in Ontario compared to a no-drug comparison group. In an open label study, Ontario smokers who smoke 10 or more cigarettes per day and intend to quit smoking in the next 30 days, will enroll via the study website, visit their physician to receive a prescription for bupropion or varenicline for 12 weeks or neither if they so choose, forming the no-drug comparison group. All participants will receive weekly motivational emails for 12 weeks. Abstinence measures will be taken at 4, 8 and 12 weeks and at 6 and 12 months. The proportion of eligible participants who were able to confirm an appointment with a physician to receive the prescription will be also measured.
Bupropion and varenicline are effective pharmacotherapies for smoking cessation, but their
population level impact is limited by a combination of factors. Both bupropion and
varenicline are only available through prescription, however smoking cessation clinics are
few in number and only about 25% of smokers receive information on smoking cessation aids
from their healthcare provider. Mass distribution approaches, bypassing clinics and
physicians, have been successful for nicotine replacement therapy in many jurisdictions,
including Ontario. However, bupropion and varenicline have the potential to make a greater
impact given their superior results from the clinical trials. Bupropion and varenicline
present a unique challenge as they are prescribed medications, therefore we have proposed a
variant of the mass distribution method to test whether it is practical to distribute them to
a large number of people over a expansive geographic area (i.e., Ontario).
We hypothesize that engaging smokers with the opportunity to receive free bupropion or
varenicline, to initiate an appointment with their physician to obtain a prescription that
would be filled and mailed to the smoker from a central pharmacy would be a logistically
feasible approach to reach high number of smokers from a wide geographic area. Our second
hypothesis is that consistent with the results from clinical studies, in the general
population varenicline would be associated with a higher abstinence rate than bupropion, and
both varenicline and bupropion groups would achieve higher abstinence rates than those making
quit attempts without any pharmacotherapy aid.
This is an open label, proof-of-concept study, wherein 2000 eligible participants will have
the opportunity to receive bupropion (Zyban®) or varenicline (Champix®) for 12 weeks in
conjunction with weekly motivational emails. Eligible participants will discuss with their
doctor which of the two medications is appropriate for them to use as smoking cessation aid.
It is also possible that the participant and his/her doctor may decide not to pursue smoking
cessation using either of these medications. These participants will form a third
intervention group, receiving only the weekly motivational emails. All participants will set
a quit date of their choosing, but those receiving medication will set a quit date 7 days
after starting the medication. The participants will enroll in the study via the study's
website, at which time they will read the consent form, answer the eligibility questions and
complete the baseline questionnaire. Data related to the outcome measures and adverse events
will be collected at 4, 8 and 12 weeks after the start of treatment and at 6 and 12 months
after the end of treatment.
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