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

Yale University

Status and phase

Completed

Phase 2

Conditions

Alcohol Reactivity

Treatments

Drug: varenicline

Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01000987

0907005525

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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