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
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Tracking Information | ||||
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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 |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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:
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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:
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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Primary Purpose: Prevention |
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Condition ICMJE |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
140 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | June 2006 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |
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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 |