Effect of Fish Oil vs. Placebo on Subjective Effects of Alcohol in Healthy Humans
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Assessment of stimulant and sedative effects of alcohol with the Biphasic Alcohol Effects Scale (BAES).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Fish Oil with ethanol and placebo ethanol infusions (Drug)
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.
干预措施: Placebo with ethanol and placebo ethanol infusions (Drug)
结局指标
主要结局
Assessment of stimulant and sedative effects of alcohol with the Biphasic Alcohol Effects Scale (BAES).
时间窗: Week 6 (test session 2)
次要结局
- Cognitive performance measured by the Hopkins Verbal Learning Test-Revised (HVLT-R).(Week 6 (test session 2))
- Cognitive performance measured with the Rapid Information Processing Task (RVIP)(Week 6 (test session 2))
- Motor Impairment: The Grooved Pegboard Test (Lafayette Instrument Company) is a manipulative dexterity test,(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.(Week 6 (test session 2))