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

Phase 2

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo
varenicline	varenicline	varenicline 1mg/day or 2mg/day

Primary Outcome Measures

Name	Time	Method
Cognitive Function as Measured by Omissions on the CPT	Following 3 weeks of medication. The CPT task was performed at 60 minutes following alcohol or placebo beverage consumption.	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).

Secondary Outcome Measures