Neurosteroids and Acute Alcohol Intoxication in Humans

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified December 2008 by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
Recruitment status was: Active, not recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT00608686

First Posted: February 6, 2008

Last Update Posted: December 19, 2008

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Purpose

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	Intervention	Phase
Alcohol Intoxication	Dietary Supplement: Pregnenolone	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Basic Science
Official Title:	Neurosteroids and Acute Alcohol Intoxication in Humans

Resource links provided by NLM:

Drug Information available for: Pregnenolone

U.S. FDA Resources

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:

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. ]


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)

Intervention Details:

30mg of pregnenolone administered orally, once, at 2 of 5 study visits.

Show Detailed Description

Eligibility

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00608686

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


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 Submitted:	January 26, 2008
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

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