Long-term Varenicline Treatment for Smoking Cessation

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.

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Key information

Conditions

Smoking Behavior Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Center for Tobacco Research and Intervention, Madison, Wisconsin, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Varenicline

Drug

Extension of 1 mg twice daily treatment to 52 weeks

Individual smoking cessation counseling

Behavioral

Brief (<10 minutes) smoking cessation counseling delivered at clinic visits

Primary outcomes

Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52

Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

Pfizer

Registry information

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2011
First posted: Jan 23, 2009
Registry last updated: Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed