Relapse Prevention With Varenicline

Study Overview
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Brief Summary
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This study aims to determine if varenicline (Chantix®), currently used as a smoking cessation aid, will decrease the likelihood of relapse to smoking following a programmed lapse in the laboratory. The hypothesis is that varenicline will reduce the reinforcing effects of smoking and will delay or prevent relapse compared to placebo.

Detailed Description
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In this study, the investigators plan to use an experimental model of a lapse, in which volunteers smoke two cigarettes after a brief period of (12-24 hours). The goals of this study are to assess the impact of varenicline on the subjective and reinforcing effects of cigarettes, as well as the latency to resume smoking (relapse) following the lapse exposure.

Official Title
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Relapse Prevention With Varenicline

Conditions
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Recurrence, Smoking Cessation, Substance-Related Disorders

Intervention / Treatment
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* Drug: Varenicline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75 years old Reports smoking at least 10 cigarettes per day AND provides a urine sample that tests positive for nicotine metabolites at intake Contemplating a smoking cessation attempt in the near future Willing to engage in a practice quit attempt during which they will be asked to smoke on one occasion Able to give informed consent Exclusion Criteria: Currently meets Diagnostic and Statistical Manual (DSM-IV) criteria for depression, bi-polar disorder, or schizophrenia History of attempted suicide or expresses any current suicidal ideation Pregnant, breast feeding, or planning to become pregnant within the next 3 months Reports desire for immediate treatment of tobacco/nicotine dependence Severe impairment of renal function indicated by Glomerular Filtration Rate (GFR) less than 30 ml/min calculated using the Cockcroft and Gault prediction method (plasma creatinine adjusted by weight, gender, and age)

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Group given placebo. | Drug: Placebo<br>* Placebo given twice a day or five weeks.<br>|
| Experimental: Varenicline<br>Experimental group given varenicline dosing. | Drug: Varenicline<br>* Varenicline given twice a day or five weeks.<br>* Other names: Varenicline (Chantix®);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days to Relapse | Number of days following the programmed lapse exposure until relapse to smoking occurred | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapse, Smoking Cessation, Substance Abuse