Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit

Study Overview
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Brief Summary
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The investigators will randomize smokers to receive 1) Varenicline + smoking cessation/reduction counseling or 2) Placebo pill + smoking cessation/reduction counseling. Neither the participants nor the research therapists/evaluators will know to which condition (active or placebo pill) the participants have been assigned i.e., a double-blind study). The medication and weekly counseling will occur for 28 days. Participants will complete assessment measures just before the start of treatment (baseline), at the end-of-treatment, at 1-month, 3-month, and at 6-months to determine if there are differences in tobacco use between treatment groups.

Official Title
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Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Drug: Varenicline
* Drug: Placebo pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must smoke at least 10 cigarettes per day for past 6-months Must have a working cellular or land-line phone Exclusion Criteria: Must not be thinking of quitting in the next 30 days, but be interested in cutting down- Must not regularly (more than 1x/month) use tobacco products other than cigarettes Must not be currently receiving tobacco dependence treatment counseling Must not currently be taking varenicline, bupropion, nortriptyline, or any nicotine preparations (gum, lozenge, patch, spray, inhaler) Must not have positive screen on SCID-I/NP Psychotic Screen Must have no contraindications to using varenicline, including pregnancy, as measured by Medical History Form

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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 |
| --- | --- |
| Active Comparator: varenicline<br> | Drug: Varenicline<br>* Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.<br>|
| Placebo Comparator: placebo pill<br> | Drug: Placebo pill<br>* Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cigarette Reduction | 50% reduction in cigarettes per day as compared to baseline. Missing data are assumed to NOT have reduced. | At 6-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tobacco, nicotine, cigarette smoking