Skip to main content
OpenTrials
Completed

NCT Number: NCT03010917

Fish Oil vs. Placebo on Subjective Effects of Alcohol

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

VA Connecticut Healtcare System

West Haven, Connecticut, 06516, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and females, between the ages of 21 and 55;
  • No current drug use disorder of any drugs of abuse (except tobacco or marijuana);
  • No current medical problems and normal ECG;
  • For women, not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods.

Exclusion criteria

  • Current major psychiatric illnesses including mood, psychotic, or anxiety disorders;
  • 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;
  • Liver function tests (ALT or AST) greater than 3 times normal;
  • Allergy to seafood.

Treatment and study plan

Fish Oil with ethanol and placebo ethanol infusions

Drug

Fish Oil with ethanol and placebo ethanol infusions

Placebo with ethanol and placebo ethanol infusions

Drug

Placebo with ethanol and placebo ethanol infusions

Primary outcomes

  1. Assessment of stimulant and sedative effects of alcohol with the Biphasic Alcohol Effects Scale (BAES).

    Time frame: Baseline

    The BAES is a 14-item self-report scale. Seven items measure stimulant effects of alcohol during the test sessions and seven items measure sedative effects. Stimulant and sedative effect scores range from 0 (not at all) to 70 (extremely).

  2. Assessment of stimulant and sedative effects of alcohol with the Biphasic Alcohol Effects Scale (BAES).

    Time frame: Week 4 (test session 1)

  3. Assessment of stimulant and sedative effects of alcohol with the Biphasic Alcohol Effects Scale (BAES).

    Time frame: Week 6 (test session 2)

Secondary outcomes

  1. Cognitive performance measured with the Rapid Information Processing Task (RVIP)

    Time frame: Baseline

    (RVIP) is a widely used task to assess sustained attention, with a working memory component. In this task, a series of single digits is presented on a computer screen at a rate of 100 digits per minute for 4 min. Targets are defined as three consecutive odd digits (e.g., 7-9-3) or three consecutive even digits (e.g., 2-8-6). The percentage of targets correctly detected will be the main outcome measure.

  2. Cognitive performance measured with the Rapid Information Processing Task (RVIP)

    Time frame: Week 4 (test session 1)

    (RVIP) is a widely used task to assess sustained attention, with a working memory component. In this task, a series of single digits is presented on a computer screen at a rate of 100 digits per minute for 4 min. Targets are defined as three consecutive odd digits (e.g., 7-9-3) or three consecutive even digits (e.g., 2-8-6). The percentage of targets correctly detected will be the main outcome measure.

  3. Cognitive performance measured with the Rapid Information Processing Task (RVIP)

    Time frame: Week 6 (test session 2)

    (RVIP) is a widely used task to assess sustained attention, with a working memory component. In this task, a series of single digits is presented on a computer screen at a rate of 100 digits per minute for 4 min. Targets are defined as three consecutive odd digits (e.g., 7-9-3) or three consecutive even digits (e.g., 2-8-6). The percentage of targets correctly detected will be the main outcome measure.

  4. Cognitive performance measured by a "Go No-Go task" will assess the ability to withhold responses to an infrequently occurring target.

    Time frame: Baseline

    A series of blue and green rectangular shapes are presented every 1150 ms and participants are instructed to press a spacebar every time the green rectangular shape appeared, and to give equal importance to speed and accuracy. The primary outcome is the number of errors on the No-Go trials.

  5. Cognitive performance measured by a "Go No-Go task" will assess the ability to withhold responses to an infrequently occurring target.

    Time frame: Week 4 (test session 1)

    A series of blue and green rectangular shapes are presented every 1150 ms and participants are instructed to press a spacebar every time the green rectangular shape appeared, and to give equal importance to speed and accuracy. The primary outcome is the number of errors on the No-Go trials.

  6. Cognitive performance measured by a "Go No-Go task" will assess the ability to withhold responses to an infrequently occurring target.

    Time frame: Week 6 (test session 2)

    A series of blue and green rectangular shapes are presented every 1150 ms and participants are instructed to press a spacebar every time the green rectangular shape appeared, and to give equal importance to speed and accuracy. The primary outcome is the number of errors on the No-Go trials.

  7. Cognitive performance measured by the Hopkins Verbal Learning Test-Revised (HVLT-R).

    Time frame: Baseline

    The HVLT-R is a word list learning test of verbal memory. The outcome is the percent correct on immediate and delayed recall of words on a list.

  8. Cognitive performance measured by the Hopkins Verbal Learning Test-Revised (HVLT-R).

    Time frame: Week 4 (test session 1)

    The HVLT-R is a word list learning test of verbal memory. The outcome is the percent correct on immediate and delayed recall of words on a list.

  9. Cognitive performance measured by the Hopkins Verbal Learning Test-Revised (HVLT-R).

    Time frame: Week 6 (test session 2)

    The HVLT-R is a word list learning test of verbal memory. The outcome is the percent correct on immediate and delayed recall of words on a list.

  10. Motor Impairment: The Grooved Pegboard Test (Lafayette Instrument Company) is a manipulative dexterity test,

    Time frame: Baseline

    This is an eye-to hand timed coordination test. A quicker time indicates greater coordination.

  11. Motor Impairment: The Grooved Pegboard Test (Lafayette Instrument Company) is a manipulative dexterity test,

    Time frame: Week 4 (test session 1)

    This is an eye-to hand timed coordination test. A quicker time indicates greater coordination.

  12. Motor Impairment: The Grooved Pegboard Test (Lafayette Instrument Company) is a manipulative dexterity test,

    Time frame: Week 6 (test session 2)

    This is an eye-to hand timed coordination test. A quicker time indicates greater coordination.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • VA Connecticut Healthcare System

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2017
Registry last updated
Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.