Fish Oil vs. Placebo on Subjective Effects of Alcohol

NCT03010917 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 1609018478
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Dependence

Keywords

Alcohol Dependence; Fish Oil

Outcome Measures

Primary Outcomes (3)

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

  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).

  Baseline

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

  Week 4 (test session 1)

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

  Week 6 (test session 2)

Secondary Outcomes (12)

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

  Baseline

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

  Week 4 (test session 1)

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

  Week 6 (test session 2)

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

  Baseline

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

  Week 4 (test session 1)

Study Arms (2)

Fish Oil with ethanol and placebo ethanol infusions

EXPERIMENTAL

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

Placebo with ethanol and placebo ethanol infusions

PLACEBO COMPARATOR

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

Interventions

Fish Oil with ethanol and placebo ethanol infusions DRUG

Fish Oil with ethanol and placebo ethanol infusions

Fish Oil with ethanol and placebo ethanol infusions

Placebo with ethanol and placebo ethanol infusions DRUG

Placebo with ethanol and placebo ethanol infusions

Placebo with ethanol and placebo ethanol infusions

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• VA Connecticut Healthcare System: collaborator

Study Sites (1)

VA Connecticut Healtcare System

West Haven, Connecticut, 06516, United States

Location

Related Publications (3)

• Subramanian MG, Heil SH, Kruger ML, Collins KL, Buck PO, Zawacki T, Abbey A, Sokol RJ, Diamond MP. A three-stage alcohol clamp procedure in human subjects. Alcohol Clin Exp Res. 2002 Oct;26(10):1479-83. doi: 10.1097/01.ALC.0000034038.41972.36.

  PMID: 12394280 BACKGROUND

• Zimmermann US, O'Connor S, Ramchandani VA. Modeling alcohol self-administration in the human laboratory. Curr Top Behav Neurosci. 2013;13:315-53. doi: 10.1007/7854_2011_149.

  PMID: 21792747 BACKGROUND

• Ramchandani VA, O'Connor S, Blekher T, Kareken D, Morzorati S, Nurnberger J Jr, Li TK. A preliminary study of acute responses to clamped alcohol concentration and family history of alcoholism. Alcohol Clin Exp Res. 1999 Aug;23(8):1320-30.

  PMID: 10470974 BACKGROUND

MeSH Terms

Conditions

Alcoholism

Interventions

Fish Oils; Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oils; Lipids; Alcohols; Organic Chemicals

Study Officials

• Ismene Petrakis, M.D.

  Yale University/VA Connecticut Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: January 5, 2017
• Study Start: March 2, 2017
• Primary Completion: May 30, 2021
• Study Completion: September 8, 2021
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)