NCT00247585

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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

December 6, 2006

Status Verified

December 1, 2006

First QC Date

November 1, 2005

Last Update Submit

December 4, 2006

Conditions

SleepNeurobehavioral Manifestations

Keywords

AlcoholAlcohol abuseAlcohol consumptionUnhealthy alcohol useResidual effectsSleep StagesRespiratory Physiology

Outcome Measures

Primary Outcomes (3)

  • Cognitive function in response to heavy drinking

  • Cognitive function in response to sleep quality

  • Self-reported residual effects of heavy drinking

Secondary Outcomes (1)

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

Interventions

Ethanol (Bourbon or Vodka)DRUG

Eligibility Criteria

Age21 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Neurobehavioral ManifestationsAlcoholismAlcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDrinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Jonathan Howland, PhD, MPH, MPA

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

November 1, 2005

First Posted

November 2, 2005

Study Start

September 1, 2003

Study Completion

June 1, 2006

Last Updated

December 6, 2006

Record last verified: 2006-12

Locations

US(1)