Alcohol Intoxication Clinical Trial
Official title:
Neurosteroids and Acute Alcohol Intoxication in Humans
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.
Status | Active, not recruiting |
Enrollment | 92 |
Est. completion date | March 2009 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years to 45 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No |
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