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Sponsored by: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
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Information provided by: | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
ClinicalTrials.gov Identifier: | NCT00608686 |
1. The major aims are to assess: (1) the relationship of basal and alcohol-induced neurosteroid and GABA levels to the degree of acute alcohol intoxication in healthy male and female volunteers; and (2) the effect of acute pregnenolone administration on the degree of acute alcohol intoxication in these same volunteers. Specific hypotheses are:
Condition | Intervention | Phase |
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Alcohol Intoxication |
Dietary Supplement: Pregnenolone |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | Neurosteroids and Acute Alcohol Intoxication in Humans |
Estimated Enrollment: | 92 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 21 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | University of California, San Francisco, Dept. of Psychiatry ( Owen Wolkowitz, MD ) |
Study ID Numbers: | NIAAA-WOLKOWITZ-AA013929, NIH grant 5R01AA013929-04 |
Study First Received: | January 26, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00608686 History of Changes |
Health Authority: | United States: Federal Government |
NIAAA Alcohol Neurosteroids Intoxication |
Mental Disorders Alcoholism Alcoholic Intoxication Substance-Related Disorders |
Poisoning Disorders of Environmental Origin Alcohol-Related Disorders Ethanol |
Mental Disorders Alcoholism Alcoholic Intoxication Substance-Related Disorders |
Poisoning Disorders of Environmental Origin Alcohol-Related Disorders |