GABA Mechanisms Underlying the Vulnerability to Alcohol Dependence (NCT00611767) | Clinical Trial Compass
CompletedNot Applicable
GABA Mechanisms Underlying the Vulnerability to Alcohol Dependence
United States73 participantsStarted 2005-11
Plain-language summary
This Project will explore the hypothesis that individuals with a family history positive for alcohol dependence (without any current Axis I disorder, except nicotine dependence), experience an alteration in the reward "valence" (balance of positive and negative effects) of the GABAA receptor agonist barbiturate (thiopental) compared to family history negative age-matched subjects. Further, variation in genes involved in brain GABA function may influence the risk for alcoholism by altering a component of the discriminative stimulus effects of ethanol.
Who can participate
Age range
21 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female between the ages of 21 and 30 years
. medically and neurologically healthy on the basis of history, physical examination, Electrocardiogram (EKG), screening laboratories
. absence of any evidence of substance abuse (with the exception of nicotine dependence) on the basis of history and drug and ethanol-free at the time of testing based on urine toxicology and breath alcohol levels at screening and on each test day.
Exclusion criteria
. Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) Axis I psychiatric and substance abuse or dependence diagnosis by history on psychiatric evaluation that includes a structured diagnostic interview (SCID)
. unwillingness to remain alcohol-free for three days prior to each test day;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual Analog Scales of Similarity to Alcohol - Baseline
Timeframe: Baseline
2
Visual Analog Scales of Similarity to Alcohol - 15 Minutes
Timeframe: 15 minutes
3
Visual Analog Scales of Similarity to Alcohol - 45 Minutes
Timeframe: 45 minutes
4
Visual Analog Scales of Similarity to Alcohol - 80 Minutes
Timeframe: 80 minutes
5
Visual Analog Scales of Similarity to Alcohol - 110 Minutes
Timeframe: 110 minutes
6
Visual Analog Scales of Similarity to Alcohol - 170 Minutes
Timeframe: 170 minutes
7
Visual Analog Scales of Similarity to Alcohol - 230 Minutes
. for women, positive pregnancy test at screening or intention to engage in unprotected sex during the study and
. alcohol naive. For Family History Positive Subjects: 1) Biological father and another first or second-degree biological relative with history of alcoholism by Family History Assessment Module (FHAM) developed by The Collaborative Study on the Genetics of Alcoholism (COGA).