Conditions: Smoking Cessation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 593
Healthy volunteers: no

Brief summary:
The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: varenicline tartrate (CP-526, 555-18) intervention 2: Placebo
Intervention descriptions: intervention 1: 1 mg twice a day for 12 weeks, starting with a 1-week titration period. intervention 2: matching placebo 1 tablet twice a day for 12 weeks

Protocol document: