Pilot Study of Varenicline vs. Nicotine Patch Delivered by a Telephone Quitline to Promote Smoking Cessation
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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.
Roswell Park Cancer Institute
United States: Institutional Review Board
|Roswell Park Cancer Institute||Buffalo, New York 14263|