CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 239 enrolled
Drug / intervention
Alcohol +1 moredrug
Likely dose
Alcohol sufficient to raise breath alcohol concentration (BrAC) to 0.10 g%AI-extracted
Key inclusion· 10
  • Age 21-30 years old
  • Currently enrolled in college or university
  • Consumed 5 or more drinks (4 if female) within the last 30 days
  • Score less than 5 on Short Michigan Alcohol Screening Test (SMAST)
Key exclusion· 12
  • Age outside 21-30 range
  • Not currently enrolled in college or university
  • Fewer than 5 drinks (4 if female) in the last 30 days
  • Score of 5 or greater on SMAST

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00183170
NCT00183170Phase 2Completed

Residual Effects of Intoxication on Student Performance

Boston University·interventional·Posted Sep 16, 2005·Updated Dec 8, 2020

In Brief

A Phase 2 clinical trial evaluating Alcohol and Placebo for Alcoholic Intoxication and Neurobehavioral Manifestations. Completed, enrolled 239 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartFeb 1, 2004
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 20.8 years ago

Interventions

Alcoholdrug

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.

Placeboother

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.