Fish Oil vs. Placebo on Subjective Effects of Alcohol

Yale University

Status and phase: Completed; Phase 1

Conditions: Alcohol Dependence

Treatments: Drug: Placebo with ethanol and placebo ethanol infusions; Drug: Fish Oil with ethanol and placebo ethanol infusions

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03010917

1609018478

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 17 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

17 participants in 2 patient groups, including a placebo group

Fish Oil with ethanol and placebo ethanol infusions

Experimental group

Description:

Between days 30-40 subjects will participate in 2 test days at least 2 days apart and during the test day will receive an IV infusion of ethanol (placebo vs. targeted Breath Alcohol Concentration ((BrAC) of 100mg%) in a clamped fashion. Test days will be in a randomized order.

Treatment:

Drug: Fish Oil with ethanol and placebo ethanol infusions

Placebo with ethanol and placebo ethanol infusions

Placebo Comparator group

Description:

Between days 30-40 subjects will participate in 2 test days at least 2 days apart and during the test day will receive an IV infusion of ethanol (placebo vs. targeted Breath Alcohol Concentration ((BrAC) of 100mg%) in a clamped fashion. Test days will be in a randomized order.

Treatment:

Drug: Placebo with ethanol and placebo ethanol infusions