Clinical Trial: Residual Effects of Intoxication on Student Performance
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Residual Effects of Intoxication on Student Performance
Brief Summary: The primary goal of the study is to assess the residual effects of heavy drinking on academic performance. The investigators will also explore whether these effects differ by family history of alcohol abuse and hangover symptoms, as well as compare males and females with respect to these effects. The investigators' primary hypothesis is that intoxication (0.10g% blood alcohol concentration [BAC]) with an alcoholic beverage impairs next-day academic performance, as measured by scores on quizzes, standardized academic achievement tests, and standardized neurobehavioral assessments. Their secondary hypothesis is that family-history-positive individuals will show a greater performance decrement the day after heavy drinking than family-history-negative individuals.
Detailed Summary:
The primary goal of the study is to assess the effect of heavy drinking on next day academic performance. We are using a placebo-controlled 2-period crossover design to compare the effects of dosing status on academic performance, with participants serving as their own controls. Participants are dosed on two separate occasions, once with non- alcoholic beverage and the other time with alcoholic beverage sufficient to raise blood alcohol to 0.10 g%. The morning after dosing, participants' academic performance is measured using a standardized achievement test (Graduate Record Exam) and a quiz on material presented in the video lecture the prior afternoon before dosing. Participants' cognition is also tested using the Neurobehavioral Evaluation System (NES3) and the Psychomotor Vigilance Test (PVT). We are collecting data on participants' demographics, family history of drinking problems and alcohol use. We are also collecting information on hangover symptoms and sleep quality the morning after dosing, in addition to participants' self ratings of academic performance. The procedure is conducted twice with one week in between, switching the individuals' dosing status, presenting a different, but comparable lecture and reading, and administering a different quiz based on the new lecture and reading and a different, but comparable standardized achievement exam. This design is intended to test the hypothesis that intoxication (0.10 g% BAC) with alcoholic beverage impairs next-day academic performance.
Participation involves a total of five sessions over a two week period. Participants are undergraduates who volunteer and meet inclusion criteria. Prior to enrollment, volunteers are screened to ensure they meet initial eligibility criteria. Eligible volunteers receive written instructions regarding participation and are scheduled for the study sessions. Participants report to the
Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Current Primary Outcome:
- cognitive function in response to heavy drinking [ Time Frame: next day ]
- self-reported residual effects of heavy drinking [ Time Frame: next day ]
- academic function in response to heavy drinking [ Time Frame: next day ]
- reaction time affected by residual effects of heavy drinking [ Time Frame: next day ]
Original Primary Outcome:
- cognitive function in response to heavy drinking,
- self-reported residual effects of heavy drinking,
- academic function in response to heavy drinking,
- reaction time affected by residual effects of heavy drinking
Current Secondary Outcome: effectiveness of psychomotor vigilance testing as a fitness-for-duty test
Original Secondary Outcome: Same as current
Information By: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Dates:
Date Received: September 13, 2005
Date Started: February 2004
Date Completion: January 2009
Last Updated: June 14, 2007
Last Verified: June 2007
