Status:
COMPLETED
Intravenous Alcohol Administration Using BrAc Method in Healthy Subjects With and Without a Family History of Alcoholism
Lead Sponsor:
Yale University
Collaborating Sponsors:
VA Connecticut Healthcare System
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcoholism
Eligibility:
All Genders
21-30 years
Phase:
NA
Brief Summary
The proposed study is the first to explore the contribution of brain glutamate systems, a major target of ethanol in the brain, to the vulnerability to develop alcoholism. This study may lead to an en...
Detailed Description
Males and females with a paternal family history of alcoholism have a high risk for developing alcoholism. These individuals have been shown to have decreased dysphoric responses to alcohol self-admin...
Eligibility Criteria
Inclusion
- Male and female between the ages of 21 and 30 years;
- medically and neurologically healthy on the basis of history, physical examination, EKG, Screening laboratories absence of current and/or past substance abuse on the basis of history and urine toxicology and breath alcohol levels at screening and on each test day.
- For Family History Positive (FHP) Subjects: 1) Biological father and another first or second-degree biological relative with history of alcoholism by Family History Assessment Module (FHAM) developed by COGA.
Exclusion
- DSM-IV psychiatric and substance abuse (excluding alcohol abuse) diagnosis by history on psychiatric evaluation that includes a structured diagnostic interview (Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-IV Axis I Disorders (SCID))
- Subjects who meet criteria for alcohol abuse and express an interest in stopping alcohol use and/or express an interest in treatment or are currently enrolled in treatment for alcoholism, or have sought treatment in the last 6 months.
- history of counseling or psychotherapy; except family therapy centered around another family member
- extended unwillingness to remain alcohol-free for 48 hours prior to test days;
- for women: positive pregnancy test at screening or intention to engage in unprotected sex during the study
- alcohol naïve
- Adoptee and no contact with family members.
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00612352
Start Date
March 1 2001
End Date
June 1 2015
Last Update
October 26 2021
Active Locations (1)
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1
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516