Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders
This trial is active, not recruiting.
|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.
|Endpoint classification||safety/efficacy study|
|Intervention model||factorial assignment|
|Masking||double blind (subject, investigator, outcomes assessor)|
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
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
|Official title||Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders|
|Principal investigator||Sherry A McKee, PhD|
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