Residual Effects of Intoxication on Student Performance

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:
NCT00183170
First received: September 13, 2005
Last updated: June 14, 2007
Last verified: June 2007
  Purpose

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 investigators' primary hypothesis is that intoxication (0.10g% 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. Their secondary hypothesis is that family-history-positive individuals will show a greater performance decrement the day after heavy drinking than family-history-negative individuals.


Condition Intervention Phase
Alcoholic Intoxication
Neurobehavioral Manifestations
Drug: Beer (alcohol)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Residual Effects of Intoxication on Student Performance

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:
  • cognitive function in response to heavy drinking [ Time Frame: next day ]
  • self-reported residual effects of heavy drinking [ Time Frame: next day ]
  • academic function in response to heavy drinking [ Time Frame: next day ]
  • reaction time affected by residual effects of heavy drinking [ Time Frame: next day ]

Secondary Outcome Measures:
  • effectiveness of psychomotor vigilance testing as a fitness-for-duty test

Estimated Enrollment: 200
Study Start Date: February 2004
Estimated Study Completion Date: January 2009
Detailed Description:

The primary goal of the study is to assess the effect of heavy drinking on next day academic performance. We are using a placebo-controlled 2-period crossover design 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) and a quiz on material presented in the video lecture the prior afternoon before dosing. Participants' cognition is also tested using the Neurobehavioral Evaluation System (NES3) and the Psychomotor Vigilance Test (PVT). We are collecting 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 BAC to 0.10g%; 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 trial, which includes a quiz on the lecture and reading material, a GRE examination, the NES3 battery and the PVT. 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

Ages Eligible for Study:   21 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183170

Contacts
Contact: Barbara Cole 617-638-4600 barbcole@bu.edu
Contact: Jacey A Greece, MPH 617-414-1894 jabloom@bu.edu

Locations
United States, Massachusetts
General Clinical Research Center/Boston University School of Public Health Recruiting
Boston, Massachusetts, United States, 02118
Contact: Jacey A Greece, MPH    617-414-1894    jabloom@bu.edu   
Contact: Jonathan Howland, PhD, MPH, MPA    617-638-5158    jhowl@bu.edu   
Principal Investigator: David Rosenbloom, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: David Rosenbloom, PhD General Clinical Research Center, Boston University School of Public Health/Boston Medical Center
  More Information

No publications provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00183170     History of Changes
Other Study ID Numbers: NIAAAHOW013759, NIH P60 AA013759
Study First Received: September 13, 2005
Last Updated: June 14, 2007
Health Authority: United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
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

Additional relevant MeSH terms:
Alcoholic Intoxication
Neurobehavioral Manifestations
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Substance-Related Disorders

ClinicalTrials.gov processed this record on October 30, 2014