Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders

Study Overview
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Brief Summary
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The purpose of this study is the examine the effect of varenicline on cognition to a high dose (0.08 g/dL) of alcohol (vs. placebo alcohol) over the ascending and descending limb of the blood alcohol curve.

Official Title
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Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders

Conditions
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Alcohol Reactivity

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 and nonsmokers Meet criteria for alcohol use disorders Currently enrolled in NCT00580645 Exclusion Criteria: Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol Significant hepatocellular injury Positive test results 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 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 protocol 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>* 1mg/day or 2 mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645.<br>* Other names: Chantix;|
| Placebo Comparator: placebo<br>placebo | Drug: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Function as Measured by Omissions on the CPT | Cognitive function was measured using the Continuous Performance Task (CPT). The CPT assess attention and response inhibition and the main outcome was number of omissions (the number of times the target was present, but the subject did not respond) errors in response to go and stop targets. Participants are presented with stop and go targets that appear on a computer screen. They are told to press the space bar (respond) to go targets and to avoid pressing the space bar when stop targets appear. Presented in the data table are the average number of omissions (the number of times the target was present, but the subject did not respond). Higher omission rates indicate a greater level of inattention (range 0-324). | Following 3 weeks of medication. The CPT task was performed at 60 minutes following alcohol or placebo beverage consumption. | 

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