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临床试验/NCT00247585
NCT00247585已完成2 期

Hangover, Congeners, Sleep and Occupational Performance

National Institute on Alcohol Abuse and Alcoholism (NIAAA)2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2003年9月1日最近更新:
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试验速览

阶段
2 期
状态
已完成
发起方
入组人数
140
试验地点
2
主要终点
Cognitive function in response to sleep quality

研究概览

简要总结

The objective is to investigate residual effects of heavy drinking, with or without hangover symptoms. The primary aim is to test several hypotheses about residual effects of heavy drinking. Hypotheses about how heavy drinking affects next-day performance include direct physiological effects of alcohol, alcohol withdrawal effects, and non-ethanol effects, such as congeners, or family history of alcohol problems. The investigators will test the following hypotheses:

  1. relative to placebo, heavy drinking will degrade next-day performance, and this relationship will be mediated in full or in part by quality of sleep;
  2. a high congener alcoholic beverage will affect performance to a greater degree than a low congener beverage and this relationship will be mediated by severity of hangover symptoms.

详细描述

The primary aim of the proposed study is to test several hypotheses about residual effects of heavy drinking. Hypotheses about how heavy drinking affects next-day performance include direct physiological effects of alcohol (e.g., electrolyte imbalance, low blood sugar, sleep disturbance), alcohol withdrawal effects, acetaldehyde toxicity, and non-ethanol effects, such as congeners or family history of alcohol (Swift and Davidson, 1998). Using a placebo-controlled randomized trial, we will dose participants with placebo or with a high or low congener alcoholic beverage (to a level of 0.10 g% BAC) the night before they perform exercises on a neurobehavioral evaluation system. We will monitor participants' sleep to assess sleep disturbance. We will collect information on hangover symptoms the morning after dosing. We will also collect data on participants' family history of drinking problems. We will test the following hypotheses:

  1. relative to placebo, heavy drinking will degrade next-day cognitive performance, and this relationship will be mediated in full or in part by quality of sleep; and
  2. a high congener alcoholic beverage will affect performance to a greater degree than a low congener beverage and this relationship will be mediated by severity of hangover symptoms.

We will explore whether the residual effects of heavy drinking on next-day cognitive performance are attenuated among participants positive for a family history of alcohol problems, relative to family-history-negative participants.

A secondary aim is to test the effectiveness of the Psychomotor Vigilance Test (PVT), a validated measure of fatigue, as a fitness-for-duty test. We will test whether the PVT can distinguish dosing status (alcohol or placebo) of participants at the time performance is measured the next day and the extent to which PVT measures correlate with performance scores.

Participants will be young adults ages 21-30 who are currently enrolled in an undergraduate college or university or have graduated from a college or university. Alcoholic beverages will be bourbon (high-congener) in soda or vodka (low-congener) in soda. Placebo will be tonic alone. We will use a mixed within- and between-subjects design, balancing the order of placebo and alcohol administration. Performance will be measured using a computer-based neurobehavioral evaluation system.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double

入排标准

年龄范围
21 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 21-30
  • Currently enrolled or have completed college/university
  • Have had 5 or more drinks (4 if female) in the last 30 days
  • Score less than a 5 on the Short Michigan Alcohol Screening Test (SMAST)
  • No self-reported history of counseling or treatment for substance abuse
  • Not taking any medication contraindicated for alcohol use or that disrupts sleep
  • Doesn't have a health condition contraindicated for alcohol use
  • Has not been diagnosed with a primary sleep disorder
  • Has not been diagnosed with a mental health disorder
  • Not currently working night shifts at a job
  • Not routinely taking medications that affect sleep
  • No evidence of extreme morningness or eveningness as assessed by questionnaire
  • Not a regular smoker

排除标准

  • Less than age 21 and greater than age 30
  • Not currently enrolled or has not completed college/university
  • Hasn't had 5 or more drinks (4 if female) in the last 30 days (not a regular drinker)
  • Score greater than or equal to 5 on the Short Michigan Alcohol Screening Test (SMAST)
  • Self-reported history of counseling or treatment for substance abuse
  • Taking any medication contraindicated for alcohol use or that disrupts sleep
  • Has a health condition contraindicated for alcohol use
  • Has been diagnosed with a primary sleep disorder
  • Has been diagnosed with a mental health disorder
  • Currently working night shifts at a job
  • Routinely taking medications that affect sleep
  • Evidence of extreme morningness or eveningness as assessed by questionnaire
  • Is a regular smoker
  • Not a regular drinker
  • Is pregnant or nursing

结局指标

主要结局

Cognitive function in response to sleep quality

Self-reported residual effects of heavy drinking

Cognitive function in response to heavy drinking

次要结局

  • Effectiveness of psychomotor vigilance testing as a fitness-for-duty test

研究者

发起方
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
申办方类型
Nih

研究点 (2)

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