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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00223444
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 1, 2009
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
The University of Texas Health Science Center at San Antonio

Brief Summary:
The purpose of the study is to better understand how genetic factors influence individual sensitivity to alcohol.

Condition or disease
Alcoholism

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.

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Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Clinical-Genetic Variation in GABA/Alcohol Sensitivity
Study Start Date : August 2002
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


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



Biospecimen Retention:   Samples With DNA
Specifically, we will determine whether the subject's gene for a brain protein called GABA-alpha-6 is of the "Pro" type or "Ser" type.


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

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): NCT00223444


Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: John D. Roache, Ph.D. The University of Texas Health Science Center at San Antonio
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Responsible Party: John D. Roache/Professor, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00223444    
Other Study ID Numbers: R21AA013435-03A1 ( U.S. NIH Grant/Contract )
AA13435-03A1
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 1, 2009
Last Verified: April 2009
Keywords provided by The University of Texas Health Science Center at San Antonio:
alcohol
GABA
genetic variation
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders