Lung Cancer Clinical Trial
Official title:
Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers
RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is
not yet known whether varenicline is more effective than the nicotine patch given together
with nicotine gum in helping smokers quit smoking.
PURPOSE: This randomized clinical trial is studying varenicline to see how well it works
compared with the nicotine patch given together with 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.
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