Long-term Varenicline Treatment for Smoking Cessation

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation. Adult volunteers in generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of open-label varenicline therapy. At 12 weeks after their target quit date, they will be assigned in a random, double-blind manner to either 40 additional weeks of varenicline or placebo. It is hypothesized that biochemically-confirmed abstinence rates will be higher for the varenicline group at 52 weeks. Participants will be followed for an additional 26 weeks post-treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborator: Pfizer
• Treatments: Varenicline

Criteria

Inclusion Criteria:

• daily smoker

• 5+ cigarettes per day for at least one year

• expired carbon monoxide level of 5+ ppm

Exclusion Criteria:

• current use of smoking cessation pharmacotherapies

• current or history of psychotic disorder

• current major depressive disorder

• history of suicidal ideation in the previous 3 months

• unstable medical condition

• pregnant, nursing, or planning to become pregnant

• planning to move from study area within 18 months