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Fish Oil vs. Placebo on Subjective Effects of Alcohol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03010917
Recruitment Status : Active, not recruiting
First Posted : January 5, 2017
Last Update Posted : September 2, 2020
Sponsor:
Collaborator:
VA Connecticut Healthcare System
Information provided by (Responsible Party):
Yale University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: Fish Oil with ethanol and placebo ethanol infusions Drug: Placebo with ethanol and placebo ethanol infusions Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Fish Oil vs. Placebo on Subjective Effects of Alcohol in Healthy Humans
Actual Study Start Date : March 2, 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

Arm Intervention/treatment
Experimental: Fish Oil with ethanol and placebo ethanol infusions
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.
Drug: Fish Oil with ethanol and placebo ethanol infusions
Fish Oil with ethanol and placebo ethanol infusions

Placebo Comparator: Placebo with ethanol and placebo ethanol infusions
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.
Drug: Placebo with ethanol and placebo ethanol infusions
Placebo with ethanol and placebo ethanol infusions




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03010917


Locations
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United States, Connecticut
VA Connecticut Healtcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
VA Connecticut Healthcare System
Investigators
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Principal Investigator: Ismene Petrakis, M.D. Yale University/VA Connecticut Healthcare System
Publications:
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03010917    
Other Study ID Numbers: 1609018478
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
Alcohol Dependence
Fish Oil
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs