Conditions: Tobacco Use Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 300
Healthy volunteers: no

Brief summary:
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

Detailed description:
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.

Arms:
arm 1: Patients undergo general smoking cessation counseling and receive varenicline PO QD on days 1-28. Courses repeat every 28 days for up to 12 weeks. arm 2: Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks.

Interventions: intervention 1: varenicline intervention 2: nicotine patch
Intervention descriptions: intervention 1: Given PO intervention 2: None

Protocol document: