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

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Ethanol; Varenicline

Criteria

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