Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 11/23/2017 |
| Start Date: | October 2009 |
| End Date: | November 2016 |
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.
dose (0.08 g/dL) of alcohol (vs. placebo alcohol) over the ascending and descending limb of
the blood alcohol curve.
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
We found this trial at
1
site
New Haven, Connecticut 06519
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