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Hangover, Congeners, Sleep and Occupational Performance

Primary Purpose

Sleep, Neurobehavioral Manifestations

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ethanol (Bourbon or Vodka)
Sponsored by
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sleep focused on measuring Alcohol, Alcohol abuse, Alcohol consumption, Unhealthy alcohol use, Residual effects, Sleep Stages, Respiratory Physiology

Eligibility Criteria

21 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • General Clinical Research Center, Boston University School of Public Health/Boston Medical Center

Outcomes

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

Full Information

First Posted
November 1, 2005
Last Updated
December 4, 2006
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00247585
Brief Title
Hangover, Congeners, Sleep and Occupational Performance
Official Title
Hangover, Congeners, Sleep and Occupational Performance
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Neurobehavioral Manifestations
Keywords
Alcohol, Alcohol abuse, Alcohol consumption, Unhealthy alcohol use, Residual effects, Sleep Stages, Respiratory Physiology

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
140 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ethanol (Bourbon or Vodka)
Primary Outcome Measure Information:
Title
Cognitive function in response to heavy drinking
Title
Cognitive function in response to sleep quality
Title
Self-reported residual effects of heavy drinking
Secondary Outcome Measure Information:
Title
Effectiveness of psychomotor vigilance testing as a fitness-for-duty test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Howland, PhD, MPH, MPA
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Clinical Research Center, Boston University School of Public Health/Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

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Hangover, Congeners, Sleep and Occupational Performance

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