Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients

Not Applicable

Completed

Conditions: Tobacco Use Disorder
Medication Adherence

Interventions: Drug: Varenicline

Registration Number: NCT01378858

Lead Sponsor: Albert Einstein College of Medicine

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Varenicline treatment as usual (TAU)	Varenicline	Subjects in the TAU arm will self administer varenicline for 12 weeks.
Varenicline directly observed therapy	Varenicline	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1): Albert Einstein College of Medicine
🇺🇸
Bronx, New York, United States
Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States