Status:

COMPLETED

GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA)

Lead Sponsor:

Indiana University

Collaborating Sponsors:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Conditions:

Alcoholism

Eligibility:

All Genders

21-27 years

Phase:

NA

Brief Summary

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...

Detailed 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 ses...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 14 2012

Estimated Enrollment :

141 Patients enrolled

Trial Details

Trial ID

NCT00681655

Start Date

May 1 2008

End Date

April 14 2012

Last Update

April 7 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University Hospital

Indianapolis, Indiana, United States, 46202