Status:
UNKNOWN
Methadone Maintenance Treatment and Smoking Cessation
Lead Sponsor:
Vancouver Coastal Health
Collaborating Sponsors:
British Columbia Centre of Excellence for Women's Health
Conditions:
Smoking
Eligibility:
All Genders
19-75 years
Phase:
PHASE2
Brief Summary
The main hypotheses guiding the study are: 1. Stable methadone maintenance patients receiving varenicline will be more likely to maintain abstinence than patients receiving placebo 2. There will be n...
Detailed Description
1. PURPOSE: The purpose of this placebo controlled study is to determine the efficacy, safety, and gender differences in using varenicline for smoking cessation in a population of stable methadone mai...
Eligibility Criteria
Inclusion
- Stable on methadone maintenance (an individual is considered 'stable' if they have had a 4 week constant/fixed dose of methadone by self report and verified by B.C. Pharmanet review)
- Subjects must have smoked at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year
- Ages 19 to 75 years (inclusive) and motivated to quit smoking
- Should read and understand English
- For female subjects:
- instructed and agrees to avoid pregnancy through 30 days after the last dose of study medication
- has a negative urine pregnancy test at screening
- agrees to use birth control method(s) for duration of the study
- Should be available by telephone
Exclusion
- Subjects who have used varenicline previously or are currently on other Nicotine Replacement Therapy or pharmacotherapy for smoking cessation (e.g., nicotine patch, zyban or wellbutrin)
- Subjects who have a prior or current history of depression, bipolar affective disorder or a prior or current history of psychotic episodes or suicidal ideation (on the basis of self-report augmented by medical chart review where appropriate and/or corroborating history with previous or current health care provider)
- Subjects who have not reached a stable dose of methadone in their methadone maintenance therapy (4 weeks at a constant/fixed dose of methadone by self-report and verified by B.C. Pharmanet review)
- Pregnancy or currently nursing
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2011
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00906386
Start Date
May 1 2009
End Date
February 1 2011
Last Update
March 2 2010
Active Locations (1)
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1
Three Bridges Community Health Centre
Vancouver, British Columbia, Canada, V6Z 1W2