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GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA) (GPRA)

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ClinicalTrials.gov Identifier: NCT00681655
Recruitment Status : Active, not recruiting
First Posted : May 21, 2008
Last Update Posted : December 7, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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 the context of factors known to increase the risk for future alcoholism.

Condition or disease Intervention/treatment
Alcoholism Drug: Alcohol Drug: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Two session, within subjects, single blind
Masking: None (Open Label)
Primary Purpose: Other
Official Title: GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA)
Study Start Date : May 2008
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Responses to alcohol
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, 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.
Drug: Alcohol
Alcohol (6% in saline vehicle) infused for 2.8 hour long clamping session (Breath alcohol level maintained at 60 mg/dL throughout).
Drug: Placebo
Placebo (saline vehicle) infused for 2.8 hour long session.


Outcome Measures

Primary Outcome Measures :
  1. Effect of GABRA2 SNP status on AUD risk [ Time Frame: Both session responses and lifetime traits will be included in analysis ]
    Results will assess the effect of GABRA2 SNPs on responses to alcohol and traits related to alcoholism risk


Secondary Outcome Measures :
  1. Acute tolerance to alcohol [ Time Frame: Within 3 hour session ]
    Comparison of measures taken during the initial hour of the clamp with the same measures taken during the 3rd hour of the alcohol clamp.

  2. Initial response to alcohol [ Time Frame: Within 3 hour session ]
    Comparison of measures taken during baseline with the same measures taken during the initial hour of the alcohol clamp.

  3. Responses to alcohol vs placebo [ Time Frame: Within 3 hour session ]
    Measures taken during the alcohol session will either be compared to those taken during placebo, or in some cases measures taken during the alcohol session will be corrected for placebo effects by subtracting placebo responses from alcohol responses


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 27 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681655


Locations
United States, Indiana
University Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Study Director: Martin H Plawecki, M.D. Indiana University School of Medicine
Principal Investigator: Sean J. O'Connor, M.D. Indiana University School of Medicine
More Information

Publications:
Responsible Party: Sean O'Connor, Professor, Department of Psychiatry and Biomedical Engineering, Indiana University
ClinicalTrials.gov Identifier: NCT00681655     History of Changes
Other Study ID Numbers: O'CONNOR_AA007611-18
P60AA007611 ( U.S. NIH Grant/Contract )
First Posted: May 21, 2008    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Requests for data sharing will be considered on a case by case basis. No sharing of HIPPA sensitive data will be allowed.

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs