Overview

This trial is active, not recruiting.

Condition alcoholism
Treatments alcohol 6%, placebo
Sponsor Indiana University
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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking open label
Arm
(Experimental)
Each subject will complete a total of 4 2.8 hr-long clamping sessions, conducted as two pairs of infusion sessions.Within each session, procedures differed only by the content of the infusate during the two clamping session. In one admission (AA), both sessions infused 6% ethanol; in the other (PA), the 1st session (always 1st) infused only the vehicle, quantifying the placebo response for every subject. The 2nd session of the PA was always another alcohol clamp.
alcohol 6%
Alcohol 6% infused for 2.8 hour long clamping session
(Placebo Comparator)
Each subject will complete a total of 4 2.8 hr-long clamping sessions, conducted as two pairs of infusion sessions.Within each session, procedures differed only by the content of the infusate during the two clamping session. In one admission (AA), both sessions infused 6% ethanol; in the other (PA), the 1st session (always 1st) infused only the vehicle, quantifying the placebo response for every subject. The 2nd session of the PA was always another alcohol clamp.
placebo
1. Each subject will complete a total of 4 2.8 hr-long clamping sessions, conducted as two pairs of infusion sessions.Within each session, procedures differed only by the content of the infusate during the two clamping session. In one admission (AA), both sessions infused 6% ethanol; in the other (PA), the 1st session (always 1st) infused only the vehicle, quantifying the placebo response for every subject. The 2nd session of the PA was always another alcohol clamp.

Primary Outcomes

Measure
Acute functional tolerance to alcohol (AFTA).
time frame: 48 hours

Eligibility Criteria

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.

Additional Information

Official title GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA)
Principal investigator Sean J. O'Connor, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Indiana University.