Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00183170
Status:
COMPLETED
Last Update Posted:
2020-12-08
First Post:
2005-09-13
Brief Title:
Residual Effects of Intoxication on Student Performance
Sponsor:
Boston University
Organization:
Boston University
Study Overview
Official Title:
Residual Effects of Intoxication on Student Performance
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 primary hypothesis is that intoxication 010 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 010 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 010 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 010 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 nightdosing morning and receive either alcohol or placebo depending on what was administered the previous week and take different but comparable performance tests
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 010 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 nightdosing morning and receive either alcohol or placebo depending on what was administered the previous week and take different but comparable performance tests
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P60AA013759 | NIH | None | httpsreporternihgovquickSearchP60AA013759 |