Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients

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.

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