- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00906386
Methadone Maintenance Treatment and Smoking Cessation (MMTASC)
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)
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
Study Overview
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
3. 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.
4. OBJECTIVES:
Primary outcome:
- Continuous abstinence from smoking during the last 4 weeks of treatment (weeks 9-12).
Secondary outcomes:
- 7-day point prevalence of abstinence
- Continuous abstinence Weeks 9-26
- Sex and gender differences
- Psychological assessment (Beck Depression Inventory)
Adverse effects (Nausea, Dry mouth, Flatulence, Constipation, Insomnia, -Abnormal dreams, Irritability, Sleep disorder, Headaches, Dizziness e.t.c.)
5. RESEARCH METHOD: This pilot randomized, double-blind, placebo-controlled trial will be conducted at Vancouver Coastal Health Tobacco Dependence Clinic Vancouver, BC with a 12-week treatment period and follow-up of smoking status to week 26. The intervention will include the use of Varenicline titrated to 1 mg twice daily or placebo for 12 weeks, plus weekly brief smoking cessation counseling.
6. All significance tests will be 2-tailed with an overall level of significance of a = 0.05. The primary outcome will be the analysis of continuous abstinence using a logistic regression model. The secondary outcomes will be:
- the analysis of 7-day abstinence and 9-26 week continuous abstinence using logistic regression analysis.
- Minnesota Nicotine Withdrawal Scale, Beck's Depression Inventory, and changes in methadone dose outcome using repeated measures analysis, and
- Chi-square tests and t-tests (or Mann-Whitney U) to determine sex and gender differences (male vs female) as well as differences in adverse effects of treatment (varenicline vs placebo)
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6Z 1W2
- Three Bridges Community Health Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
oral, 1 mg twice daily, 12 weeks
Other Names:
|
Placebo Comparator: placebo
|
oral, 1 mg twice daily, 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence
Time Frame: 9-12 weeks; 9-26
|
9-12 weeks; 9-26
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sex differences in the efficacy, withdrawal symptoms, and safety of varenicline
Time Frame: week 26
|
week 26
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 60409
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smoking
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
University of VirginiaRecruitingSmoking | Smoking Cessation | Smoking Reduction | Smoking, Tobacco | Smoking, Cigarette | Quitting SmokingUnited States
-
University GhentRecruitingSmoking | Smoking Tobacco | Smoking Prevention | Smoking CigaretteBelgium
-
Medical University of South CarolinaCompletedSmoking | Smoking Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
Columbia UniversityNational Cancer Institute (NCI)RecruitingSmoking | Smoking Cessation | Smoking Reduction | Smoking BehaviorsUnited States
-
National Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Cigarette Smoking | Tobacco, SmokingUnited States
-
Maastricht University Medical CenterThe Investigative Desk; SEO Amsterdam Economics; IVO Research InstituteEnrolling by invitationSmoking Cessation | Smoking Reduction | Smoking, Tobacco | Smoking BehaviorsNetherlands
-
Jennifer Marler, MDCompletedSmoking Cessation | Smoking Reduction | Smoking, Tobacco | Smoking BehaviorsUnited States
-
Medical University of South CarolinaRecruitingSmoking | Smoking Cessation | Tobacco Smoking | Cigarette SmokingUnited States
-
Abramson Cancer Center at Penn MedicineNational Cancer Institute (NCI); New York University; Stanford UniversityRecruitingSmoking | Smoking, Tobacco | Smoking, CigaretteUnited States
Clinical Trials on Varenicline
-
Arizona State UniversityNational Institute on Drug Abuse (NIDA); Pfizer; University of Nevada, Reno; Los...CompletedSmoking Cessation | Withdrawal Symptoms | Tobacco DependenceUnited States
-
PfizerWithdrawn
-
University of California, Los AngelesNational Institute on Drug Abuse (NIDA)CompletedMethamphetamine Addiction | Crystal Meth Addiction | Amphetamine AddictionUnited States
-
Korea University Anam HospitalCompletedHealthyKorea, Republic of
-
Butler HospitalBrown UniversityCompletedDepressive Disorder | SmokingUnited States
-
Medical University of South CarolinaCompletedSmoking | Smoking Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)Enrolling by invitation
-
PfizerCompletedSmoking CessationUnited States, Korea, Republic of, Taiwan, Canada, Georgia, Russian Federation
-
Oyster Point Pharma, Inc.CompletedHealthy SubjectsUnited States