Hangover, Congeners, Sleep and Occupational Performance

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

Overall Status

Completed

CT.gov ID

NCT00247585

Collaborator

(none)

140

Enrollment

Location

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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:

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;
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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Neurobehavioral Manifestations	Drug: Ethanol (Bourbon or Vodka)	Phase 2

Detailed Description

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:

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
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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double

Primary Purpose:

Prevention

Official Title:

Hangover, Congeners, Sleep and Occupational Performance

Study Start Date :

Sep 1, 2003

Study Completion Date :

Jun 1, 2006

Outcome Measures

Primary Outcome Measures

Cognitive function in response to heavy drinking []
Cognitive function in response to sleep quality []
Self-reported residual effects of heavy drinking []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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