GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA)
This study is ongoing, but not recruiting participants.
Sponsor:
Indiana University
Collaborator:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00681655
First received: May 19, 2008
Last updated: April 3, 2013
Last verified: April 2013
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Purpose
This study will study the presence of a particular form of a gene, GABRA2, to characterize 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.
| Condition | Intervention |
|---|---|
|
Alcoholism |
Drug: Alcohol 6% Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA) |
Resource links provided by NLM:
Further study details as provided by Indiana University:
Primary Outcome Measures:
- Acute functional tolerance to alcohol (AFTA). [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Each subject will complete a total of 4 2.8 hr-long clamping sessions, conducted as two pairs of infusion sessions.Within each session, procedures differed only by the content of the infusate during the two clamping session. In one admission (AA), both sessions infused 6% ethanol; in the other (PA), the 1st session (always 1st) infused only the vehicle, quantifying the placebo response for every subject. The 2nd session of the PA was always another alcohol clamp.
|
Drug: Alcohol 6%
Alcohol 6% infused for 2.8 hour long clamping session
|
|
Placebo Comparator: 2
Each subject will complete a total of 4 2.8 hr-long clamping sessions, conducted as two pairs of infusion sessions.Within each session, procedures differed only by the content of the infusate during the two clamping session. In one admission (AA), both sessions infused 6% ethanol; in the other (PA), the 1st session (always 1st) infused only the vehicle, quantifying the placebo response for every subject. The 2nd session of the PA was always another alcohol clamp.
|
Drug: Placebo
1. Each subject will complete a total of 4 2.8 hr-long clamping sessions, conducted as two pairs of infusion sessions.Within each session, procedures differed only by the content of the infusate during the two clamping session. In one admission (AA), both sessions infused 6% ethanol; in the other (PA), the 1st session (always 1st) infused only the vehicle, quantifying the placebo response for every subject. The 2nd session of the PA was always another alcohol clamp.
|
Eligibility| Ages Eligible for Study: | 21 Years to 27 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681655
Locations
| United States, Indiana | |
| University Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
Sponsors and Collaborators
Indiana University
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT00681655 History of Changes |
| Other Study ID Numbers: | O'CONNOR_AA007611-18, P60AA007611 |
| Study First Received: | May 19, 2008 |
| Last Updated: | April 3, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Ethanol Anti-Infective Agents, Local |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013