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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Lobeline; Varenicline

Criteria

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.