Do Treatments for Smoking Cessation Affect Alcohol Drinking?

Study Overview
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Brief Summary
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The purpose of this study is to examine the effect of smoking cessation medications on alcohol drinking. Effect of 2mg/day, 1mg/day, placebo varenicline was evaluated. Following 7 days of medication pre-treatment to achieve steady state levels, participants complete a laboratory session assessing alcohol self-administration behavior. Study enrolls heavy drinking smokers (not tested under nicotine deprivation), non-daily smokers, and nonsmokers. Volunteers are administered either varenicline (Chantix) or placebo.

Official Title
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Do Treatments for Smoking Cessation Affect Alcohol Drinking?

Conditions
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Alcohol Drinking

Intervention / Treatment
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* Drug: varenicline
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21 years old or older Able to read and write in English Smokers, non-daily smokers, and non-smokers Heavy Drinkers and/or meet criteria for alcohol use disorders Exclusion Criteria: Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol Significant hepatocellular injury Positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines Women who are pregnant or nursing Suicidal, homicidal, or evidence of severe mental illness Prescription of any psychotropic drug in the 30 days prior to study enrollment Blood donation within the past 8 weeks Individuals who are seeking treatment for drinking or smoking or who have attempted to quit drinking or smoking within the past 3 months Specific exclusions for administration of bupropion not specified above including: having taken monoamine inhibitors in the past six weeks; history of anorexia or bulimia; previous hypersensitivity to bupropion; history of alcohol or drug dependence in the past year; history of seizure disorder of any etiology Known allergy to varenicline or taking H2blockers Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current study Subjects likely to exhibit clinically significant alcohol withdrawal during the study

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: varenicline<br>varenicline 1mg/day or 2mg/day | Drug: varenicline<br>* 2mg/day or 1mg/day with 1-week medication lead-in period.<br>* Other names: Chantix;|
| Placebo Comparator: Placebo<br>Placebo Controlled | Drug: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Drinks Consumed | number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session | 2 hour ad-lib drinking period, during the laboratory session (Day 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol Craving | alcohol craving during the alcohol priming dose period using a visual analog scale of alcohol craving (1-100; higher scores = higher craving) | during laboratory session (Day 8) at baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol, smoking cessation, varenicline, bupropion, smoking cessation medications