This pilot clinical trial studies varenicline or nicotine patch in promoting smoking cessation among current smokers. Varenicline or nicotine patch may help people stop smoking
PRIMARY OBJECTIVES: I. To determine if mail delivery of 12 weeks of varenicline results in improved smoking cessation outcomes relative to nicotine replacement therapy (NRT) in 300 smokers. II. To determine if delivery of varenicline is cost-effective as compared to nicotine patch. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo general smoking cessation counseling and receive varenicline orally (PO) twice daily (QD) on days 1-28. Courses repeat every 28 days for up to 12 weeks. ARM II: Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks. After completion of study treatment, patients are followed up at 4 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
300
Given PO
Roswell Park Cancer Institute
Buffalo, New York, United States
Quit Rate
The quit rate at 4 months will be compared between the 2 groups, using a logistic regression analysis with a 2-side 95% confidence interval.
Time frame: 4 months
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