GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA)
GPRA
2 other identifiers
interventional
141
1 country
1
Brief Summary
This study will assess whether the presence of a particular form of a gene, GABRA2, affects the functional responses of the human brain to alcohol administration and will evaluate that relationship in the context of factors known to increase the risk for future alcoholism.
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 May 2008
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
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 19, 2008
CompletedFirst Posted
Study publicly available on registry
May 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2012
CompletedApril 7, 2022
March 1, 2022
4 years
May 19, 2008
March 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Effect of GABRA2 SNP status on AUD risk
Results will assess the effect of GABRA2 SNPs on responses to alcohol and traits related to alcoholism risk
Both session responses and lifetime traits will be included in analysis
Secondary Outcomes (3)
Acute tolerance to alcohol
Within 3 hour session
Initial response to alcohol
Within 3 hour session
Responses to alcohol vs placebo
Within 3 hour session
Study Arms (1)
Responses to alcohol
EXPERIMENTALEach subject completed a total of 2 2.8 hr-long clamping sessions.Within each session, procedures differed only by the content of the infusate. In one session, 6% ethanol was infused. In the other session, only vehicle was infused, quantifying the placebo response for every subject. The order of alcohol or placebo sessions was counterbalanced; subjects were blind to which session was which; sessions were scheduled to occur about 2 weeks apart. Measures were collected before, and at beginning and end of infusion, and included subjective perceptions, EMG, EEG, stop-signal performance, eye movements, and auditory responses. Design allowed analysis of effect of alcohol vs placebo, initial effect of alcohol and acute tolerance to alcohol.
Interventions
Eligibility Criteria
You may qualify if:
- European American male and females between 21-27 years of age.
- Good health as determined by medical history, physical exam, and laboratory tests.
- Females must have a negative urine pregnancy (hCG) test at the start of each study session.
- People who consume 0.10 standard drinks per week (12 g-ethanol) per liter of total body water when averaged over the preceding month, or more, OR who have consumed more than 0.10 standard drinks per liter of total body water on any one occasion in the last month.
You may not qualify if:
- Inability to read or comprehend eighth grade English.
- Inability to hear or comprehend verbal instructions, or inability or unwillingness to cooperate with the procedures required for the study.
- Inability to resolve 2 dots, each 2 mm in diameter with centers placed 5 mm apart on a card placed 20 inches from the bridge of the nose, or the need to wear eyeglasses to do so.
- Current or prior history of any serious disease, including head trauma causing loss of consciousness, cancer, CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or alcohol or drug dependence, but not alcohol abuse or nicotine dependence.
- Positive hepatitis or HIV test at screening, provided subject consented to these tests.
- Current or prior history of alcohol-induced flushing reactions.
- Current diagnosis of Axis-I psychiatric illness.
- Positive result on urine drug screen obtained at the face-to-face interview.
- Pregnancy, as determined by urine HcG on each day of laboratory testing, or intention to become pregnant for women.
- Use of medications known to interact with alcohol within 2 weeks of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Indianapolis, Indiana, 46202, United States
Related Publications (2)
Kosobud AE, Wetherill L, Plawecki MH, Kareken DA, Liang T, Nurnberger JL, Windisch K, Xuei X, Edenberg HJ, Foroud TM, O'Connor SJ. Adaptation of Subjective Responses to Alcohol is Affected by an Interaction of GABRA2 Genotype and Recent Drinking. Alcohol Clin Exp Res. 2015 Jul;39(7):1148-57. doi: 10.1111/acer.12749. Epub 2015 Jun 19.
PMID: 26087834RESULTPlawecki MH, Windisch KA, Wetherill L, Kosobud AEK, Dzemidzic M, Kareken DA, O'Connor SJ. Alcohol affects the P3 component of an adaptive stop signal task ERP. Alcohol. 2018 Aug;70:1-10. doi: 10.1016/j.alcohol.2017.08.012. Epub 2017 Aug 31.
PMID: 29705707RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Martin H Plawecki, M.D.
Indiana University School of Medicine
- PRINCIPAL INVESTIGATOR
Sean J. O'Connor, M.D.
Indiana University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Department of Psychiatry and Biomedical Engineering
Study Record Dates
First Submitted
May 19, 2008
First Posted
May 21, 2008
Study Start
May 1, 2008
Primary Completion
April 14, 2012
Study Completion
April 14, 2012
Last Updated
April 7, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, ANALYTIC CODE
- Time Frame
- While lab analyses are ongoing, data is available on request
- Access Criteria
- Data access requests will be reviewed by the investigators. Requestors will be required to sign a data access agreement.
Requests for data sharing will be considered on a case by case basis. No sharing of HIPPA sensitive data will be allowed.