Fish Oil vs. Placebo on Subjective Effects of Alcohol



Status:Active, not recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:21 - 55
Updated:1/20/2018
Start Date:March 2, 2017
End Date:January 2021

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Effect of Fish Oil vs. Placebo on Subjective Effects of Alcohol in Healthy Humans

This project represents a first step in examining the potential use of fish oil for the
treatment of alcohol use disorder (AUD). The investigators will be testing for attenuation of
alcohol-induced sedative and stimulant effects, as well as cognitive effects and cerebellar
effects in healthy social drinkers.

There have been no studies to date that have examined the relationship between fish oil and
alcohol response in humans. The current study was designed to examine the relationship
between fish oil and subjective alcohol effects in healthy social drinkers.

This project represents a first step in examining the potential use of fish oil for the
treatment of alcohol use disorder (AUD). The investigators will evaluate responses to alcohol
through administration of a steady state blood alcohol level (BAL) with an IV infusion using
a method that employs an infusion that is titrated to a breathalyzer reading and clamped at a
steady state. This approach allows direct comparisons of the acute effects of a specific dose
of ethanol between groups, without the confounding factors of variable alcohol absorption and
peak BAL's. This approach will allow the examiners to carefully examine if fish oil changes
the acute effects of alcohol on a number of outcome domains including subjective drug
effects, cognitive performance, and cerebellar effects.

As this study is a pilot study, it is not clear whether fish oil will attenuate alcohol
induced subjective stimulation or sedation. Since this is the first study to evaluate fish
oil's effects on alcohol-effects in the laboratory, the investigators will be testing for
attenuation of alcohol-induced sedative and stimulant effects, as well as cognitive effects
and cerebellar effects.

In this study, fish oil will be administered at 3 grams/day for 30-40 days (3 capsules twice
a day). The investigators will use 3 grams/day for two reasons: 1) it is within the range of
doses safely used in humans (1g to 6g) as a treatment for various psychiatric conditions
(depression, anxiety, borderline personality disorder), and 2) is a dose that has shown
efficacy in various clinical trials for psychiatric conditions.

Inclusion Criteria:

1. Male and females, between the ages of 21 and 55;

2. No current drug use disorder of any drugs of abuse (except tobacco or marijuana);

3. No current medical problems and normal ECG;

4. For women, not pregnant as determined by pregnancy screening nor breast feeding, and
using acceptable birth control methods.

Exclusion Criteria:

1. Current major psychiatric illnesses including mood, psychotic, or anxiety disorders;

2. History of major medical illnesses; including liver diseases, heart disease, chronic
pain or other medical conditions that the physician investigator deems contraindicated
for the subject to be in the study;

3. Liver function tests (ALT or AST) greater than 3 times normal;

4. Allergy to seafood.
We found this trial at
1
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West Haven, Connecticut 06516
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West Haven, CT
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