Neurosteroids and Acute Alcohol Intoxication in Humans

Study Description

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Brief Summary:

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:

• Baseline serum levels of pregnenolone, pregnenolone sulfate (PS), dehydroepiandrosterone (DHEA) and DHEA sulfate (DHEA-S) will be inversely correlated with the magnitude of acute behavioral responses to alcohol (sedation, anxiolysis, amnesia, psychomotor impairment and intoxication). That is, higher baseline levels of these neurosteroids will be associated with lessened behavioral responses to alcohol.
• Baseline serum levels of allopregnanolone, tetrahydrodeoxycorticosterone (THDOC), androstanediol, androsterone and GABA will be directly correlated with the magnitude of acute behavioral responses to alcohol. That is, higher baseline levels of these substances will be associated with heightened behavioral responses to alcohol.
• Acute alcohol ingestion, compared to placebo ingestion, will increase serum levels of allopregnanolone and THDOC and plasma levels of GABA and will decrease plasma levels of PS. (Effects on levels of other neurosteroids are not specifically predicted based on animal data but will be examined in an exploratory manner.)
• Acute alcohol-induced increases in serum levels of allopregnanolone and THDOC and in plasma levels of GABA will be directly correlated with the magnitude of acute behavioral responses to alcohol. Acute alcohol-induced decreases in serum levels of PS will be directly correlated with the magnitude of acute behavioral responses to alcohol. Correlations between alcohol-induced changes in other neurosteroids and changes in behavior are not specifically predicted but will be examined in an exploratory manner.
• Pregnenolone, compared to placebo, pre-treatment will antagonize the acute effects of alcohol on the behavioral measures.

Condition or disease	Intervention/treatment	Phase
Alcohol Intoxication	Dietary Supplement: Pregnenolone	Phase 1

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Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	92 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Basic Science
Official Title:	Neurosteroids and Acute Alcohol Intoxication in Humans
Study Start Date :	May 2004
Estimated Primary Completion Date :	January 2009
Estimated Study Completion Date :	March 2009

Arms and Interventions

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Intervention Details:

Dietary Supplement: Pregnenolone
30mg of pregnenolone administered orally, once, at 2 of 5 study visits.

Outcome Measures

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Primary Outcome Measures :

1. Behavioural Measures of Alcohol Intoxication, such as the Weingartner Verbal Memory Test, and the BVMT-R Visual Memory Test. [ Time Frame: Behavioural measures are assessed within 2 hours of alcohol administration. ]

Eligibility Criteria

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Ages Eligible for Study:	21 Years to 45 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• drinks alcohol more than 6 times a year.
• can understand english well enough to perform the required tasks.
• is in general good health.

Exclusion Criteria:

• having a member of immediate family who is alcoholic.
• using drugs that would interfere with study.
• not able to tolerate 3 alcoholic drinks within 30 minutes.

Contacts and Locations

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Locations

United States, California
University of California, San Francisco
San Francisco, California, United States, 94143

Sponsors and Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Owen Wolkowitz, MD, University of California, San Francisco, Dept. of Psychiatry
ClinicalTrials.gov Identifier:	NCT00608686 History of Changes
Other Study ID Numbers:	NIAAA-WOLKOWITZ-AA013929; NIH grant 5R01AA013929-04
First Posted:	February 6, 2008
Last Update Posted:	December 19, 2008
Last Verified:	December 2008

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

NIAAA; Alcohol; Neurosteroids; Intoxication

Additional relevant MeSH terms:

Alcoholic Intoxication; Alcoholism; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Ethanol	Neurotransmitter Agents; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action