Clinical trial NCT00183170: Residual Effects of Intoxication on Student Performance
Official title: Residual Effects of Intoxication on Student Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcoholic Intoxication
Neurobehavioral Manifestations
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
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2005-09-16
Enrollment: 239
Sex: ALL
Minimum age (years): 21
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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 (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.

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

Primary outcomes:
measure: Self-reported Residual Effects of Heavy Drinking
timeFrame: next day
Secondary outcomes:
measure: Cognitive Function in Response to Heavy Drinking
timeFrame: next day
measure: Academic Function in Response to Heavy Drinking
timeFrame: next day
measure: Reaction Time Affected by Residual Effects of Heavy Drinking
timeFrame: next day
measure: Effectiveness of Psychomotor Vigilance Testing as a Fitness-for-duty Test
timeFrame: next day
Other outcomes:
Locations:
city: Boston
country: United States
facility: General Clinical Research Center/Boston University School of Public Health
state: Massachusetts
Study officials:
affiliation: Boston University
name: Jonathan Howland, PhD MPH MPA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rohsenow DJ, Howland J, Winter M, Bliss CA, Littlefield CA, Heeren TC, Calise TV. Hangover sensitivity after controlled alcohol administration as predictor of post-college drinking. J Abnorm Psychol. 2012 Feb;121(1):270-5. doi: 10.1037/a0024706. Epub 2011 Aug 22.