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| Sponsor: | Indiana University |
|---|---|
| Collaborator: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| Information provided by: | Indiana University |
| 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 |
|---|---|
|
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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Indiana | |
| University Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| 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
| Responsible Party: | Sean O'Connor, MD, Indiana University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00681655 History of Changes |
| Other Study ID Numbers: | O'CONNOR_AA007611-18, P60AA007611 |
| Study First Received: | May 19, 2008 |
| Last Updated: | June 21, 2011 |
| Health Authority: | United States: Federal Government |
|
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 |