Fish Oil vs. Placebo on Subjective Effects of Alcohol

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Drug: Fish Oil with ethanol and placebo ethanol infusions
* Drug: Placebo with ethanol and placebo ethanol infusions


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fish Oil with ethanol and placebo ethanol infusions<br>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<br>* Fish Oil with ethanol and placebo ethanol infusions<br>|
| Placebo Comparator: Placebo with ethanol and placebo ethanol infusions<br>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<br>* Placebo with ethanol and placebo ethanol infusions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive performance measured with the Rapid Information Processing Task (RVIP) | (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. | Baseline | 
| Cognitive performance measured with the Rapid Information Processing Task (RVIP) | (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. | Week 4 (test session 1) | 
| Cognitive performance measured with the Rapid Information Processing Task (RVIP) | (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. | 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. | 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. | Baseline | 
| Cognitive performance measured by a Go No-Go task will assess the ability to withhold responses to an infrequently occurring target. | 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. | Week 4 (test session 1) | 
| Cognitive performance measured by a Go No-Go task will assess the ability to withhold responses to an infrequently occurring target. | 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. | Week 6 (test session 2) | 
| Cognitive performance measured by the Hopkins Verbal Learning Test-Revised (HVLT-R). | 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. | Baseline | 
| Cognitive performance measured by the Hopkins Verbal Learning Test-Revised (HVLT-R). | 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. | Week 4 (test session 1) | 
| Cognitive performance measured by the Hopkins Verbal Learning Test-Revised (HVLT-R). | 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. | Week 6 (test session 2) | 
| Motor Impairment: The Grooved Pegboard Test (Lafayette Instrument Company) is a manipulative dexterity test, | This is an eye-to hand timed coordination test. A quicker time indicates greater coordination. | Baseline | 
| Motor Impairment: The Grooved Pegboard Test (Lafayette Instrument Company) is a manipulative dexterity test, | This is an eye-to hand timed coordination test. A quicker time indicates greater coordination. | Week 4 (test session 1) | 
| Motor Impairment: The Grooved Pegboard Test (Lafayette Instrument Company) is a manipulative dexterity test, | This is an eye-to hand timed coordination test. A quicker time indicates greater coordination. | Week 6 (test session 2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol Dependence, Fish Oil