Long-term Varenicline Treatment for Smoking Cessation

Study Overview
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Brief Summary
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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.

Official Title
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Long-term Varenicline Treatment for Smoking Cessation

Conditions
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Smoking

Intervention / Treatment
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* Drug: varenicline
* Drug: varenicline
* Behavioral: Individual smoking cessation counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extended treatment<br>52-week varenicline therapy + individual smoking cessation counseling | Drug: varenicline<br>* Extension of 1 mg twice daily treatment to 52 weeks<br>Drug: varenicline<br>* Double-blind switch to placebo after 12 weeks of open-label therapy<br>Behavioral: Individual smoking cessation counseling<br>* Brief (<10 minutes) smoking cessation counseling delivered at clinic visits<br>|
| Active Comparator: Standard treatment<br>13 weeks of varenicline therapy + individual smoking cessation counseling | Drug: varenicline<br>* Extension of 1 mg twice daily treatment to 52 weeks<br>Drug: varenicline<br>* Double-blind switch to placebo after 12 weeks of open-label therapy<br>Behavioral: Individual smoking cessation counseling<br>* Brief (<10 minutes) smoking cessation counseling delivered at clinic visits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 | 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 | 7-day point prevalence | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, relapse, withdrawal