Residual Effects of Intoxication on Student Performance
Condition: Alcoholic Intoxication; Neurobehavioral Manifestations
MeSH terms: Neurobehavioral Manifestations; Alcoholic Intoxication
Study type: Interventional
Phase: Phase 2

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 primary hypothesis is that intoxication (0.10 g% 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. The 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 description: 
      The primary goal of the study is to assess the effect of heavy drinking on next day academic
      performance. A placebo-controlled 2-period crossover design will be used 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). Participants' cognition is tested using the the
      Psychomotor Vigilance Test (PVT). 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 study site on the first session for an additional screening by the
      study physician and go through the informed consent process. Eligible participants report
      back the next week for their first dosing night where they receive several drinks (alcohol or
      placebo) sufficient to raise their Breath Alcohol Level (BrAC) to 0.10 g%; the amount of
      beverage administered is based on their body weight. Those receiving placebo receive the same
      total quantity of beverage as those receiving alcohol. Both alcohol-dosed and placebo-dosed
      participants are breath-tested after they have completed their required dose. Participants
      sleep at the study site and are monitored overnight. The next morning they are awakened and
      are escorted to the exam room for the performance trials. They return the next week for the
      second dosing night/dosing morning, and receive either alcohol or placebo, depending on what
      was administered the previous week, and take different but comparable performance tests.
    

Intervention name(s): Alcohol; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants report for their first dosing night where they receive several alcohol/beer drinks sufficient to raise their BrAC to 0.10 g%. Participants are breath-tested after completing their required dose. Participants return in a week for the 2nd session and receive placebo drinks. Participants are breath-tested after completing their placebo drinks.; Participants report for their first night where they receive several placebo drinks. Participants are breath-tested after completing their placebo drinks. Participants return in a week for the 2nd session and receive alcohol drinks sufficient to raise their BrAC to 0.10 g%. Participants are breath-tested after completing their required dose.
Other intervention name(s): Beer; Non-alcoholic drink
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Alcohol abuse; Alcoholic beverages (beer); Residual effects; Psychomotor performance; Psychomotor vigilance test; Neurobehavioral Evaluation System; Family history of alcohol use; Alcoholic Consumption; Unhealthy alcohol use; Alcohol