Conditions: Tobacco Use Cessation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 432
Healthy volunteers: no

Brief summary:
The primary goal of this study is to compare efficacy of varenicline to placebo for cessation of use of smokeless tobacco.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Varenicline Tartrate intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period. intervention 2: Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.

Protocol document: