Clinical trial NCT03010917: Fish Oil vs. Placebo on Subjective Effects of Alcohol
Official title: Effect of Fish Oil vs. Placebo on Subjective Effects of Alcohol in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcohol Dependence
Keywords: Alcohol Dependence
Fish Oil
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: VA Connecticut Healthcare System
First posted: 2017-01-05
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Assessment of stimulant and sedative effects of alcohol with the Biphasic Alcohol Effects Scale (BAES).
timeFrame: Baseline
measure: Assessment of stimulant and sedative effects of alcohol with the Biphasic Alcohol Effects Scale (BAES).
timeFrame: Week 4 (test session 1)
measure: Assessment of stimulant and sedative effects of alcohol with the Biphasic Alcohol Effects Scale (BAES).
timeFrame: Week 6 (test session 2)
Secondary outcomes:
measure: Cognitive performance measured with the Rapid Information Processing Task (RVIP)
timeFrame: Baseline
measure: Cognitive performance measured with the Rapid Information Processing Task (RVIP)
timeFrame: Week 4 (test session 1)
measure: Cognitive performance measured with the Rapid Information Processing Task (RVIP)
timeFrame: Week 6 (test session 2)
measure: Cognitive performance measured by a "Go No-Go task" will assess the ability to withhold responses to an infrequently occurring target.
timeFrame: Baseline
measure: Cognitive performance measured by a "Go No-Go task" will assess the ability to withhold responses to an infrequently occurring target.
timeFrame: Week 4 (test session 1)
measure: Cognitive performance measured by a "Go No-Go task" will assess the ability to withhold responses to an infrequently occurring target.
timeFrame: Week 6 (test session 2)
measure: Cognitive performance measured by the Hopkins Verbal Learning Test-Revised (HVLT-R).
timeFrame: Baseline
measure: Cognitive performance measured by the Hopkins Verbal Learning Test-Revised (HVLT-R).
timeFrame: Week 4 (test session 1)
measure: Cognitive performance measured by the Hopkins Verbal Learning Test-Revised (HVLT-R).
timeFrame: Week 6 (test session 2)
measure: Motor Impairment: The Grooved Pegboard Test (Lafayette Instrument Company) is a manipulative dexterity test,
timeFrame: Baseline
measure: Motor Impairment: The Grooved Pegboard Test (Lafayette Instrument Company) is a manipulative dexterity test,
timeFrame: Week 4 (test session 1)
measure: Motor Impairment: The Grooved Pegboard Test (Lafayette Instrument Company) is a manipulative dexterity test,
timeFrame: Week 6 (test session 2)
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healtcare System
state: Connecticut
Study officials:
affiliation: Yale University/VA Connecticut Healthcare System
name: Ismene Petrakis, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.