Tobacco Use Disorder Clinical Trial
Official title:
Pilot Study of Varenicline vs. Nicotine Patch Delivered by a Telephone Quitline to Promote Smoking Cessation
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.
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