Status:
COMPLETED
Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders
Lead Sponsor:
Yale University
Conditions:
Alcohol Reactivity
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01000987
Start Date
October 1 2009
End Date
November 1 2016
Last Update
February 19 2018
Active Locations (1)
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1
Yale Center for Clinical Investigation, Yale Human Behavioral Pharmacology Laboratory
New Haven, Connecticut, United States, 06519