Phase 4
N=887
Distribution of Bupropion and Varenicline to Increase Smoking Cessation Attempts
Tobacco Use Disorder · Smoking · Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT01023659 ↗Enrolled (actual)
887
Serious AEs
—
Results posted
Mar 2013
Primary outcome: Primary: 7-day Point Prevalence of Abstinence — 45; 22; 50 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- bupropion (Drug); varenicline (Drug); motivational emails (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Centre for Addiction and Mental Health
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 7-day Point Prevalence of Abstinence |
45; 22; 50 | — |
| PRIMARY Proportion of Eligible Participants Who Were Able to Attend an Appointment With a Physician |
588 | — |
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.
Eligibility Criteria
Inclusion Criteria
- male or female, at least 18 years of age, resident of Ontario, smoke at least 10 cigarettes per day, had smoked daily for at least the past 3 months, had smoked at least 100 cigarettes in their lifetime and intended to quit smoking in the next 30 days.
Exclusion Criteria
- history of brain injury or seizure(s); pregnancy, lactation or risk of becoming pregnant; allergy or sensitivity to bupropion or varenicline; current use of monoamine oxidase inhibitors (MAOIs), thioridazine, varenicline or buproprion; severe liver impairment; or history of anorexia and /or bulimina.
Data sourced from ClinicalTrials.gov (NCT01023659). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.