Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use

A Randomized, Multicenter, Double Blind, Placebo Controlled Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use

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

Inclusion Criteria:

• Male or female daily smokeless tobacco users aged 18 years and older, who are motivated to stop use of all tobacco products.
• Subjects must be daily users of nicotine containing smokeless tobacco and using smokeless tobacco on at least 8 occasions per day averaged over a week.
• Have used smokeless tobacco for at least 1 year prior to screening with no period of abstinence >3 months in the past year.

Exclusion Criteria:

• Subjects using nicotine containing products (including smoking tobacco) other than smokeless tobacco for 3 months prior to screening.
• Subjects with exhaled Carbon Monoxide (CO) >10 ppm at baseline.
• Subjects who have used varenicline, bupropion, or NRT within 3 months of screening.
• Subjects currently or within the past 12 months requiring treatment for depression or have a current or prior history of panic disorder, psychosis, bipolar disorder or any other serious mental illness.