Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients

Study Overview
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Brief Summary
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This randomized trial will evaluate whether varenicline directly observed therapy provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence.

Detailed Description
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There is a marked prevalence of tobacco use and tobacco-related disease among methadone maintenance patients. Varenicline's demonstrated efficacy may not be generalizable to methadone maintained smokers because of poor adherence, which is highly prevalent among drug users. Adherence to smoking cessation medication is strongly associated with cessation, and is one of the few factors shown to increase cessation among methadone maintained smokers, but strategies to promote smoking cessation medication adherence have not been evaluated in methadone patients. Based on the Information, Motivation, and Behavior model, the investigators plan a directly observed therapy (DOT)-based intervention targeting behavioral skills necessary for optimal adherence. Because methadone clinic-based DOT interventions have been shown to improve medication adherence and clinical outcomes in HIV and TB, the investigators plan to determine in a randomized trial whether DOT varenicline provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence. The investigators will also evaluate moderating effects of drug and alcohol use and psychiatric symptoms on DOT effects. The investigators hypothesize subjects in the mDOT arm will have greater 7 day point prevalence abstinence at 12 weeks, reduction in cigarettes/day, time to first daily cigarette, ≥ 24 hour quit attempts, and 7 day point prevalence abstinence at 24 weeks compared to subjects receiving self administered varenicline. The investigators also hypothesize that adherence in the mDOT arm will be higher than in the TAU arm. Lastly the investigators hypothesize that ongoing illicit drug use and psychiatric symptoms will moderate the effect of mDOT on adherence.

Official Title
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Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients

Conditions
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Tobacco Use Disorder, Medication Adherence

Intervention / Treatment
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* Drug: Varenicline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older English speaking Smoked at least 100 cigarettes/lifetime Smoke 5 or more cigarettes per day Interested in quitting smoking (preparation or contemplation stage of change) Enrolled in Einstein/Montefiore methadone program for 12 weeks or more Receiving methadone in clinic three, four, five or six times per week No more than 2 methadone clinic misses in prior 14 days Agree to use contraception for the duration of the trial (among women with reproductive potential) Willing to participate in all study components Able to provide informed consent Exclusion Criteria: Serious or unstable HIV/AIDS, liver, cardiovascular, or pulmonary disease Psychiatric instability Women who are pregnant, breastfeeding, or contemplating pregnancy Creatinine clearance <30 mL/min

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Varenicline treatment as usual (TAU)<br>Subjects in the TAU arm will self administer varenicline for 12 weeks. | Drug: Varenicline<br>* Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.<br>* Other names: Chantix;|
| Experimental: Varenicline directly observed therapy<br>Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends. | Drug: Varenicline<br>* Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.<br>* Other names: Chantix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Varenicline Adherence as Measured by Pill Count | Pill count adherence, measured as pills taken divided by pills dispensed, analyzed as a continuous measure | Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tobacco Abstinence Biochemically Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. at 12 Weeks | Number of participants achieving self reported, seven day point prevalence abstinence, biochemically verified with expired carbon monoxide (CO) < 8 p.p.m., missing = smoking | Week 12 of treatment | 
| Tobacco Abstinence Biochemically Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. at 24 Weeks | Number of participants achieving self reported, seven day point prevalence abstinence, biochemically verified with expired carbon monoxide (CO) < 8 p.p.m. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Substance-Related Disorders, medication adherence, Methadone