Completed

NCT Number: NCT01000987

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcohol Reactivity

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale Center for Clinical Investigation, Yale Human Behavioral Pharmacology Laboratory

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Varenicline

Drug

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.

Other names: Chantix

Placebo

Drug

placebo

Primary outcomes

Cognitive Function as Measured by Omissions on the CPT

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2016
Study completion: 2016
First posted: Oct 23, 2009
Registry last updated: Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.