Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking

OBJECTIVES:

Primary

- To determine whether varenicline, a nicotine receptor partial agonist, leads to a higher
rate of smoking cessation than combination nicotine replacement therapy with nicotine
patch prescription plus ad libitum nicotine gum delivery in methadone-maintained
smokers.

Secondary

- To test the effects of the treatments on smoking urges, withdrawal symptoms, and
reinforcing effects of smoking.

- To test the effects of the treatments on methadone treatment outcomes, including
retention in methadone maintenance, methadone dose changes, and continued use of illicit
drugs as measured by urine toxicologies.

OUTLINE: This is a multicenter study. Patients are stratified based on gender and level of
nicotine dependence. Patients are randomized to 1 of 3 intervention arms.

At baseline, all patients receive a minimal behavioral intervention using a 3-minute, simple
smoking cessation counseling strategy, a self-help manual, and a telephone quit-line number.

- Arm I (varenicline): Patients receive oral varenicline once daily on days 1-3 and twice
daily thereafter for a total of 6 months or when a comfortable level of smoking
abstinence is reached.

- Arm II (placebo): Patients receive oral varenicline placebo once daily on days 1-3 and
twice daily thereafter for a total of 6 months or when a comfortable level of smoking
abstinence is reached.

- Arm III (nicotine patch/gum): Patients receive a nicotine patch, with doses tapering
over time for a total of 26 weeks. Patients also receive nicotine gum to quell
breakthrough urges. Patients may stop treatment when a comfortable level of smoking
abstinence is reached.

Patients complete a brief interview over 10-15 minutes at 2 weeks and monthly during months
1-5. They complete a longer interview over 45 minutes at months 6 and 12 and provide breath
samples (for carbon monoxide monitoring) and urine samples (for cotinine testing).

NOTE: Smoking cessation may prevent certain smoking-related illnesses, including cancer.

PROJECTED ACCRUAL: A total of 602 patients (258 receiving varenicline, 258 receiving nicotine
replacement therapy, and 86 receiving placebo) will be accrued for this study.

INCLUSION CRITERIA

- Current and regular cigarette smokers (over 10 cigarettes/day for the past 3 months)

- Interested in quitting smoking

- Willing to set a quit date 7 days after baseline assessment

- Participating in 1 of 5 methadone maintenance treatment programs across Rhode Island
at any of the following institutions:

- Codac, Inc. (with two independent sites)

- Addiction Recovery Institute

- Center for Treatment and Recovery

- Discovery House

- Has received methadone for at least the past month

EXCLUSION CRITERIA

- Pregnant or nursing (Must have negative pregnancy test)

- Non-English speaking

- No personal telephone or does not live close to a relative or neighbor with a
telephone

- Unwilling to make their methadone dose and methadone maintenance treatment program
urine toxicologies available for review

- Unvailable for this study for the next 12 months

- Suffering from any unstable medical condition which would preclude the use of the
nicotine patch (e.g., unstable angina or uncontrolled hypertension)

- Active skin condition (e.g., psoriasis)

- History of skin allergy

- History of a suicide attempt

- Working as pilots, drivers, or operators of heavy machinery

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No concurrent insulin or blood thinners

- No concurrent smokeless tobacco, nicotine replacement therapy, or other smoking
cessation treatment