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| Sponsor: | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
|---|---|
| Information provided by: | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| ClinicalTrials.gov Identifier: | NCT00681655 |
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 |
|---|---|
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Alcoholism |
Drug: Alcohol 6% Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study |
| Official Title: | GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA) |
| 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 |
|---|---|
|
1: Experimental
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.
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Drug: Alcohol 6%
Alcohol 6% infused for 2.8 hour long clamping session
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2: Placebo Comparator
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.
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Carmen Malone | 317-278-6550 | camalon1@iupui.edu |
| United States, Indiana | |
| University Hospital | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Carmen Malone 317-278-6550 camalon1@iupui.edu | |
| Principal Investigator: Sean O'Connor, MD | |
More Information
| Responsible Party: | Indiana University School of Medicine ( Sean O'Connor, MD ) |
| Study ID Numbers: | O'CONNOR_AA007611-18, P60AA007611-18 |
| Study First Received: | May 19, 2008 |
| Last Updated: | November 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00681655 History of Changes |
| Health Authority: | United States: Federal Government |
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Mental Disorders Alcoholism Substance-Related Disorders Disorders of Environmental Origin Alcohol-Related Disorders |