This trial is active, not recruiting.

Condition alcohol reactivity
Treatments varenicline, placebo
Phase phase 2
Sponsor Yale University
Start date October 2009
End date August 2016
Trial size 60 participants
Trial identifier NCT01000987, 0907005525


The purpose of this study is the examine the effect of varenicline on reactivity to a high dose (0.08 g/dL) of alcohol (vs. placebo alcohol) over the ascending and descending limb of the blood alcohol curve.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
varenicline 1mg/day or 2mg/day
varenicline Chantix
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.
(Placebo Comparator)
placebo placebo

Primary Outcomes

objective (cognitive function, psychomotor response, physiological reactivity, blood alcohol levels, adverse events) and subjective (craving, mood, intoxication, stimulation, sedation) reactivity to alcohol
time frame: during the fixed dose alcohol sessions

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders
Principal investigator Sherry A McKee, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Yale University.