Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT00183170 |
Other study ID # |
H-23064 |
Secondary ID |
P60AA013759 |
Status |
Completed |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
February 2004 |
Est. completion date |
January 2009 |
Study information
Verified date |
December 2020 |
Source |
Boston University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.