GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA)

Indiana University

Status: Completed

Conditions: Alcoholism

Treatments: Other: Alcohol; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00681655

O'CONNOR_AA007611-18

P60AA007611 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will assess whether the presence of a particular form of a gene, GABRA2, affects the 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.

Full description

Each subject completed a total of 2 2.8 hr-long clamping sessions.Within each session, procedures differed only by the content of the infusate. In one session, 6% ethanol was infused. In the other session, only vehicle was infused, quantifying the placebo response for every subject. The order of alcohol or placebo sessions was counterbalanced; subjects were blind to which session was which; sessions were scheduled to occur approximately 2 weeks apart. Measures were collected before, and at beginning and end of infusion, and included subjective perceptions, EMG, EEG, stop-signal performance, eye movements, and auditory responses. Design allowed analysis of effect of alcohol vs placebo, initial effect of alcohol and acute tolerance to alcohol.

Enrollment: 141 patients

Sex: All

Ages: 21 to 27 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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141 participants in 1 patient group

Responses to alcohol

Experimental group

Description:

Each subject completed a total of 2 2.8 hr-long clamping sessions.Within each session, procedures differed only by the content of the infusate. In one session, 6% ethanol was infused. In the other session, only vehicle was infused, quantifying the placebo response for every subject. The order of alcohol or placebo sessions was counterbalanced; subjects were blind to which session was which; sessions were scheduled to occur about 2 weeks apart. Measures were collected before, and at beginning and end of infusion, and included subjective perceptions, EMG, EEG, stop-signal performance, eye movements, and auditory responses. Design allowed analysis of effect of alcohol vs placebo, initial effect of alcohol and acute tolerance to alcohol.

Treatment:

Other: Placebo

Other: Alcohol