Conditions: Smoking
Keywords: smoking relapse withdrawal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 101
Healthy volunteers: yes

Brief summary:
This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation. Adult volunteers in generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of open-label varenicline therapy. At 12 weeks after their target quit date, they will be assigned in a random, double-blind manner to either 40 additional weeks of varenicline or placebo. It is hypothesized that biochemically-confirmed abstinence rates will be higher for the varenicline group at 52 weeks. Participants will be followed for an additional 26 weeks post-treatment.

Detailed description:

Arms:
arm 1: 52-week varenicline therapy + individual smoking cessation counseling arm 2: 13 weeks of varenicline therapy + individual smoking cessation counseling

Interventions: intervention 1: varenicline intervention 2: varenicline intervention 3: Individual smoking cessation counseling
Intervention descriptions: intervention 1: Extension of 1 mg twice daily treatment to 52 weeks intervention 2: Double-blind switch to placebo after 12 weeks of open-label therapy intervention 3: Brief (\<10 minutes) smoking cessation counseling delivered at clinic visits

Protocol document: