Phase 2
N=212
Residual Effects of Intoxication on Student Performance
Alcoholic Intoxication · Neurobehavioral Manifestations
Bottom Line
View on ClinicalTrials.gov: NCT00183170 ↗Enrolled (actual)
212
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Self-reported Residual Effects of Heavy Drinking — 4.3; 1.93 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Alcohol (Drug); Placebo (Other)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Boston University
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-reported Residual Effects of Heavy Drinking |
4.3; 1.93 | — |
| SECONDARY Cognitive Function in Response to Heavy Drinking |
5.41; 5.67 | — |
| SECONDARY Academic Function in Response to Heavy Drinking |
615.75; 612.38 | — |
| SECONDARY Reaction Time Affected by Residual Effects of Heavy Drinking |
378.77; 375.98 | — |
| SECONDARY Effectiveness of Psychomotor Vigilance Testing as a Fitness-for-duty Test |
223.40; 218.57 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Ages 21-30
- Currently enrolled in college/university
- Have had 5 or more drinks (4 if female) in the last 30 days
- Score less than a 5 on the Short Michigan Alcohol Screening Test (SMAST)
- No self-reported history of counseling or treatment for substance abuse
- Not taking any medication contraindicated for alcohol use or that disrupts sleep
- Doesn't have a health condition contraindicated for alcohol use
- Has not been diagnosed with a primary sleep disorder
- Has not been diagnosed with a mental health disorder
- Not currently working night shifts at a job
- Not routinely taking medications that affect sleep
- If female, is using reliable birth control when necessary
- Not a regular smoker
- Likes the taste of beer
Exclusion Criteria
- Less than age 21 and greater than age 30
- Not currently enrolled in college/university
- Hasn't had 5 or more drinks (4 if female) in the last 30 days (not a regular drinker)
- Score greater than or equal to 5 on the Short Michigan Alcohol Screening Test (SMAST)
- Self-reported history of counseling or treatment for substance abuse
- Taking any medication contraindicated for alcohol use or that disrupts sleep
- Has a health condition contraindicated for alcohol use
- Has been diagnosed with a primary sleep disorder
- Has been diagnosed with a mental health disorder
- Currently working night shifts at a job
- Routinely taking medications that affect sleep
- Is a regular smoker
- Is currently pregnant or nursing
- If female, is not using reliable birth control when necessary
- Not a regular drinker
- Dislikes the taste of beer
Data sourced from ClinicalTrials.gov (NCT00183170). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.