At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Innovative Approach to Maximizing the Impact of Efficacious Pharmacotherapies on Smoking Cessation Attempts.
In Brief
A Phase 4 clinical trial evaluating bupropion, varenicline, and 1 other intervention for Tobacco Use Disorder and 2 related conditions. Completed, enrolled 893 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks
varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks
brief motivational emails, sent weekly for 12 weeks