Long-term Varenicline Treatment for Smoking Cessation

Completed · Phase 4 · Has a placebo group

Conditions studied: Smoking

In brief

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.

Key facts

Study ID

NCT00828113

Run by

University of Wisconsin, Madison

People needed

101

Starts

2009-01-01

Expected to finish

2011-02-01

Last updated by the study team

2015-11-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• daily smoker
• 5+ cigarettes per day for at least one year
• expired carbon monoxide level of 5+ ppm

You may not qualify if…

• 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

Where it is running

• Center for Tobacco Research and Intervention — Madison, Wisconsin, United States
• Center for Tobacco Research and Intervention — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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