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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alcohol Reactivity

In brief

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.

Key facts

Study ID

NCT01000987

Run by

Yale University

People needed

44

Starts

2009-10-01

Expected to finish

2016-11-01

Last updated by the study team

2018-02-19

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Yale Center for Clinical Investigation, Yale Human Behavioral Pharmacology Laboratory — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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