Neurosteroids and Acute Alcohol Intoxication in Humans

NCT00608686 | Unknown Phase 1 DMC

• 2 other identifiers: NIAAA-WOLKOWITZ-AA013929NIH grant 5R01AA013929-04
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Intoxication

Keywords

NIAAA; Alcohol; Neurosteroids; Intoxication

Outcome Measures

Primary Outcomes (1)

• Behavioural Measures of Alcohol Intoxication, such as the Weingartner Verbal Memory Test, and the BVMT-R Visual Memory Test.

  Behavioural measures are assessed within 2 hours of alcohol administration.

Interventions

Pregnenolone DIETARY_SUPPLEMENT

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

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Alcoholic Intoxication

Interventions

Pregnenolone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 26, 2008
• First Posted: February 6, 2008
• Study Start: May 1, 2004
• Primary Completion: January 1, 2009
• Study Completion: March 1, 2009
• Last Updated: December 19, 2008

Record last verified: 2008-12

Locations

US (1)