Sleep Clinical Trial
Official title:
Hangover, Congeners, Sleep and Occupational Performance
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.
Status | Completed |
Enrollment | 140 |
Est. completion date | June 2006 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years to 30 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | General Clinical Research Center, Boston University School of Public Health/Boston Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cognitive function in response to heavy drinking | |||
Primary | Cognitive function in response to sleep quality | |||
Primary | Self-reported residual effects of heavy drinking | |||
Secondary | Effectiveness of psychomotor vigilance testing as a fitness-for-duty test |
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