GABA Mechanisms Underlying the Vulnerability to Alcohol Dependence
Gamma-Aminobutyric Acid (GABA) Mechanisms Underlying the Vulnerability to Alcohol Dependence
2 other identifiers
interventional
73
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 27, 2007
CompletedFirst Posted
Study publicly available on registry
February 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
March 17, 2017
CompletedMarch 17, 2017
November 1, 2016
6.4 years
December 27, 2007
November 17, 2016
January 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Visual Analog Scales of Similarity to Alcohol - Baseline
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
Baseline
Visual Analog Scales of Similarity to Alcohol - 15 Minutes
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
15 minutes
Visual Analog Scales of Similarity to Alcohol - 45 Minutes
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
45 minutes
Visual Analog Scales of Similarity to Alcohol - 80 Minutes
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
80 minutes
Visual Analog Scales of Similarity to Alcohol - 110 Minutes
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
110 minutes
Visual Analog Scales of Similarity to Alcohol - 170 Minutes
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
170 minutes
Visual Analog Scales of Similarity to Alcohol - 230 Minutes
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
230 minutes
Secondary Outcomes (71)
Number of Drinks Felt Consumed at Baseline
Baseline
Number of Drinks Felt Consumed - 15 Minutes
15 minutes
Number of Drinks Felt Consumed - 45 Minutes
45 minutes
Number of Drinks Felt Consumed - 80 Minutes
80 minutes
Number of Drinks Felt Consumed - 110 Minutes
110 minutes
- +66 more secondary outcomes
Study Arms (2)
Family History Negative for Alcoholism
ACTIVE COMPARATORFamily History Negative for Alcoholism subjects will receive 2 interventions
Family History Positive for Alcoholism
PLACEBO COMPARATORFamily History Positive for Alcoholism subjects will receive 2 interventions
Interventions
A 2-day test design involving 2 conditions: saline (Placebo) or Thiopental 1.5mg/kg (loading) with a subsequent infusion rate of 40 mcg/kg/minute (60 minute infusion).
A 2-day test design involving 2 conditions: saline (Placebo) or Thiopental 1.5mg/kg (loading) with a subsequent infusion rate of 40 mcg/kg/minute (60 minute infusion).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- 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).
- For Family History Negative Subjects: NO family history of alcoholism in any first or second-degree relatives. Subjects must reliably report on three first-degree relatives.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- VA Connecticut Healthcare Systemcollaborator
Study Sites (1)
VA Connecticut Healthcare System
West Haven, Connecticut, 06516, United States
Related Publications (1)
Petrakis IL, Kerfoot K, Pittman B, Perrino A, Koretski J, Newcomb J, Limoncelli D, Acampora G, Ralevski E. Subjective Effects of Thiopental in Young Adults with and without a Family History of Alcoholism. J Addict Res Ther. 2012 May 14;Suppl 7(2):6336. doi: 10.4172/2155-6105.S7-002.
PMID: 24273687RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Ismene L. Petrakis, Professor of Psychiatry
- Organization
- Yale University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Ismene L Petrakis, MD
Yale University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2007
First Posted
February 11, 2008
Study Start
November 1, 2005
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
March 17, 2017
Results First Posted
March 17, 2017
Record last verified: 2016-11