Conditions: Smoking Cessation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 498
Healthy volunteers: no

Brief summary:
The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain abstinent at Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of treatment).

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Varenicline intervention 2: Placebo
Intervention descriptions: intervention 1: Varenicline 1mg twice daily intervention 2: Matched placebo twice daily

Protocol document: