Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Pfizer
• Treatments: Varenicline

Criteria

Inclusion Criteria:

• Current male or female cigarette smokers who are motivated to stop smoking.

• Smoked an average of 10 cigarettes per day during past year and the month prior to first visit.

Exclusion Criteria:

• Patients who have used a nicotine replacement product, bupropion, clonidine or notriptyline within the past 6 months.

• Patients currently with depression or diagnosed with depression in past 12 months.

• Past or present history of psychosis, panic disorder, or bipolar disorder.