GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA)
This trial is active, not recruiting.
|Treatments||alcohol 6%, placebo|
|Collaborator||National Institute on Alcohol Abuse and Alcoholism (NIAAA)|
|Start date||May 2008|
|End date||May 2018|
|Trial size||141 participants|
|Trial identifier||NCT00681655, O'CONNOR_AA007611-18, P60AA007611|
This study will study the presence of a particular form of a gene, GABRA2, to characterize functional responses of the human brain to alcohol administration and will evaluate that relationship in the context of factors known to increase the risk for future alcoholism.
|Endpoint classification||pharmacokinetics study|
|Intervention model||parallel assignment|
Acute functional tolerance to alcohol (AFTA).
time frame: 48 hours
Male or female participants from 21 years up to 27 years old.
Inclusion Criteria: - European American male and females between 21-27 years of age. - Good health as determined by medical history, physical exam, and laboratory tests. - Females must have a negative urine pregnancy (hCG) test at the start of each study session. - People who consume 0.10 standard drinks per week (12 g-ethanol) per liter of total body water when averaged over the preceding month, or more, OR who have consumed more than 0.10 standard drinks per liter of total body water on any one occasion in the last month. Exclusion Criteria: - Inability to read or comprehend eighth grade English. - Inability to hear or comprehend verbal instructions, or inability or unwillingness to cooperate with the procedures required for the study. - Inability to resolve 2 dots, each 2 mm in diameter with centers placed 5 mm apart on a card placed 20 inches from the bridge of the nose, or the need to wear eyeglasses to do so. - Current or prior history of any serious disease, including head trauma causing loss of consciousness, cancer, CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or alcohol or drug dependence, but not alcohol abuse or nicotine dependence. - Positive hepatitis or HIV test at screening, provided subject consented to these tests. - Current or prior history of alcohol-induced flushing reactions. - Current diagnosis of Axis-I psychiatric illness. - Positive result on urine drug screen obtained at the face-to-face interview. - Pregnancy, as determined by urine HcG on each day of laboratory testing, or intention to become pregnant for women. - Use of medications known to interact with alcohol within 2 weeks of the study.
|Official title||GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA)|
|Principal investigator||Sean J. O'Connor, M.D.|
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