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

This study is currently recruiting participants.
Verified by The University of Texas Health Science Center at San Antonio, July 2008

Sponsors and Collaborators: The University of Texas Health Science Center at San Antonio
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00223444
  Purpose

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


Condition Phase
Alcoholism
Phase I
Phase II

MedlinePlus related topics:   Alcoholism   

ChemIDplus related topics:   Ethanol   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case Control, Prospective
Official Title:   Clinical-Genetic Variation in GABA/Alcohol Sensitivity

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

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.


Estimated Enrollment:   40
Study Start Date:   August 2002
Estimated Study Completion Date:   December 2008
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
1
Genotype group Pro/Pro
2
Genotype group Pro/Ser

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.

  Eligibility
Ages Eligible for Study:   21 Years to 25 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223444

Contacts
Contact: John D. Roache, Ph.D.     210-562-5401    
Contact: Deanne Hargita, MPA     210-562-5412     hargita@uthscsa.edu    

Locations
United States, Texas
UTHSCSA-START Center     Recruiting
      San Antonio, Texas, United States, 78229-3900
      Contact: Deanne Hargita, MPA     210-562-5412     hargita@uthscsa.edu    
      Contact: Sarah Lindauer, MBA     210-562-5402     lindauer@uthscsa.edu    
      Sub-Investigator: Joe Harrison, Ph.D.            
      Sub-Investigator: John H. Casada, M.D., Ph.D.            

Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
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    
  More Information


Responsible Party:   The University of Texas Health Science Center at San Antonio ( John D. Roache/Professor )
Study ID Numbers:   R21-AA13435-03-A1, AA13435-03A1
First Received:   September 13, 2005
Last Updated:   July 18, 2008
ClinicalTrials.gov Identifier:   NCT00223444
Health Authority:   United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
alcohol  
GABA  
genetic variation  

Study placed in the following topic categories:
Mental Disorders
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders
Ethanol

ClinicalTrials.gov processed this record on October 03, 2008




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