Long-term Varenicline Treatment for Smoking Cessation

Phase 4

Completed

• Conditions: Smoking
• Interventions: Drug: varenicline; Behavioral: Individual smoking cessation counseling

• Registration Number: NCT00828113
• Lead Sponsor: University of Wisconsin, Madison

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-21
• Study First Submitted QC: 2009-01-21
• Study First Posted: 2009-01-23
• Primary Completion: 2010-09
• Study Completion: 2011-02
• Results First Submitted: 2012-06-13
• Results First Submitted QC: 2012-06-13
• Results First Posted: 2012-07-18
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-22
• Last Update Posted: 2015-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extended treatment	varenicline	52-week varenicline therapy + individual smoking cessation counseling
Extended treatment	Individual smoking cessation counseling	52-week varenicline therapy + individual smoking cessation counseling
Standard treatment	Individual smoking cessation counseling	13 weeks of varenicline therapy + individual smoking cessation counseling
Standard treatment	varenicline	13 weeks of varenicline therapy + individual smoking cessation counseling

Primary Outcome Measures

Name	Time	Method
Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52	7-day point prevalence	Self-report of no smoking (not even a puff) in the previous seven days confirmed by an expired carbon monoxide reading of \< 10 parts per million as assessed at Week 52

Trial Locations

Locations (1)

Center for Tobacco Research and Intervention; 🇺🇸 Milwaukee, Wisconsin, United States