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Hangover, Congeners, Sleep and Occupational Performance

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ClinicalTrials.gov Identifier: NCT00247585
Recruitment Status : Completed
First Posted : November 2, 2005
Last Update Posted : December 6, 2006
Sponsor:
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Tracking Information
First Submitted Date  ICMJE November 1, 2005
First Posted Date  ICMJE November 2, 2005
Last Update Posted Date December 6, 2006
Study Start Date  ICMJE September 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2005)
  • Cognitive function in response to heavy drinking
  • Cognitive function in response to sleep quality
  • Self-reported residual effects of heavy drinking
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2005)
Effectiveness of psychomotor vigilance testing as a fitness-for-duty test
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hangover, Congeners, Sleep and Occupational Performance
Official Title  ICMJE Hangover, Congeners, Sleep and Occupational Performance
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:

  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.
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:

  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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Sleep
  • Neurobehavioral Manifestations
Intervention  ICMJE Drug: Ethanol (Bourbon or Vodka)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: November 1, 2005)
140
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00247585
Other Study ID Numbers  ICMJE NIAAAHOW12087
NIH Grant R01 AA12087-04A1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jonathan Howland, PhD, MPH, MPA Boston University
PRS Account National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Verification Date December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP