An Examination of the Efficacy, Safety, and Gender Differences in Using Varenicline as an Aid to Smoking Cessation in a Population of Methadone Maintained Opioid Dependent Patients (Pilot Trial)
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Vancouver Coastal Health
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence
Study Overview
Brief Summary
The main hypotheses guiding the study are:
- Stable methadone maintenance patients receiving varenicline will be more likely to maintain abstinence than patients receiving placebo
- There will be no differences in the type and number of symptoms reported between stable methadone maintenance patients receiving varenicline and placebo
- There will be no changes in methadone dosage between abstinent and non-abstinent smokers
- There will be no differences in efficacy, withdrawal symptoms, and safety of varenicline between male and female participants
Detailed Description
- 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 maintenance patients being treated for Opioid Dependence.
- HYPOTHESIS:
1.Stable methadone maintenance patients receiving varenicline will be more likely to maintain abstinence than patients receiving placebo 2.There will be no differences in the type and number of symptoms reported between stable methadone maintenance patients receiving varenicline and placebo 3.There will be no changes in methadone dosage between abstinent and non-abstinent smokers 4.There will be no differences in efficacy, withdrawal symptoms, and safety of varenicline between male and female participants
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JUSTIFICATION: Patients on methadone maintenance treatment have smoking prevalence rates of up 80-90% and consequently disproportionately high mortality compared to the general population. A majority of these patients express a desire to quit but are generally more heavily dependent on nicotine. Randomized controlled trials in non-drug using populations have shown varenicline to be more efficacious for smoking cessation than placebo and other smoking cessation medications. This placebo controlled research protocol will examine varenicline's effect on smoking cessation/reduction and potential sex and gender differences in a population of methadone maintained patients.
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OBJECTIVES:
Primary outcome:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 19 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
1
Intervention: Varenicline (Drug)
placebo
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence
Time Frame: 9-12 weeks; 9-26
Secondary Outcomes
- Sex differences in the efficacy, withdrawal symptoms, and safety of varenicline(week 26)