Clinical-Genetic Variation in GABA/Alcohol Sensitivity (GABA-Alcohol)

April 30, 2009 updated by: The University of Texas Health Science Center at San Antonio
The purpose of the study is to better understand how genetic factors influence individual sensitivity to alcohol.

Study Overview

Status

Completed

Conditions

Detailed Description

We want to find out if there are specific characteristics of a person's genes which will cause them to respond differently to alcohol. Genes are parts of the chromosomes found in the cells of our bodies which control our physical characteristics such the color of our hair, eyes, and other features. Genes are made up of molecules called "DNA" which carry the genetic information we receive from our parents. Just as genes control our physical characteristics, differences in genetic information may also explain why some people are more sensitive to alcohol or have problems drinking too much.

Study Type

Observational

Enrollment (Actual)

23

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who are English-speaking, children of Hispanic ancestry, 21-25 years of age, who drink alcohol but are not alcohol dependent will be recruited.

Description

Inclusion Criteria:

  • The subject is male or female with at least one Hispanic birth parent of Mexican ancestry, 21-25 years of age, and able to read the English-language consent form.
  • The subject self-reports current use of 3-30 standard drinks
  • The subject is in good physical health as determined by history, physical and laboratory studies of hematology and chemistry
  • The subject has a Body Mass Index (BMI) between 20-28
  • The subject is not concurrently using psychoactive medication or illicit drugs
  • If subject is female, she is not pregnant (determined by weekly urine pregnancy screens), is practicing barrier or chemical methods of birth control, and not nursing babies

Exclusion Criteria:

  • The subject meets DSM-IV criteria for any lifetime history of alcohol dependence, or dependence or abuse on any other drug in the past two years excepting tobacco dependence
  • The subject currently meets DSM-IV for any other psychiatric (Axis I) disorder, excepting tobacco dependence
  • The subject cannot consistently provide alcohol-free breath samples and drug-free urine samples
  • The subject uses > 20 cigarettes per day or > 500 mg caffeine per day
  • The subject's physical exam, lab tests, and medical histories indicate medical illness requiring treatment or interacting with the alcohol or benzodiazepine treatments
  • The subject has a sleep apnea or narrow angle-glaucoma (contraindications for benzodiazepines)
  • The subject reports extreme hypersensitivity or allergic reactions to benzodiazepines or unusual hypersensitivity to multiple medications
  • The subject is unwilling or unable to consent to all experimental procedures including confidential family history interviews and genetic testing specified by the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Genotype group Pro/Pro
2
Genotype group Pro/Ser

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: John D. Roache, Ph.D., The University of Texas Health Science Center at San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

May 1, 2009

Last Update Submitted That Met QC Criteria

April 30, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21AA013435-03A1 (U.S. NIH Grant/Contract)
  • AA13435-03A1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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