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Residual Effects of Intoxication on Student Performance

Primary Purpose

Alcoholic Intoxication, Neurobehavioral Manifestations

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Alcohol
Placebo
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcoholic Intoxication focused on measuring 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

Eligibility Criteria

21 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • General Clinical Research Center/Boston University School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Alcohol then Placebo

Placebo then Alcohol

Arm Description

Participants report for their first dosing night where they receive several alcohol drinks. After a wash out period of 1 week they then return and receive several placebo drinks. Participants sleep at the study site, are monitored overnight, and the next morning are awakened and escorted to the performance trials.

Participants report for their first night where they receive several placebo drinks. After a wash out period of 1 week they then return and receive several alcohol drinks. Participants sleep at the study site, are monitored overnight, and the next morning are awakened and escorted to the performance trials.

Outcomes

Primary Outcome Measures

Self-reported Residual Effects of Heavy Drinking
This outcome will be measured by the afternoon total mood disturbance score. This is part of the Profile of Mood States Questionnaire (POMS). POMS is a 35 item instrument with Likert responses from 0 to 4 where 0=not at all and 4=extremely. Range of scores can be 0 to 140, lower scores are more favorable.

Secondary Outcome Measures

Cognitive Function in Response to Heavy Drinking
This outcome measure will be assessed using the Visual Span Test- Backwards (VST-B). This is the mean maximum span of words repeated backwards correctly. Higher scores are more favorable
Academic Function in Response to Heavy Drinking
This outcome will be measured by the mean Graduate Record Exam (GRE) quantitative score. The quantitative score can range from 200-800. Higher scores are more favorable.
Reaction Time Affected by Residual Effects of Heavy Drinking
This outcome will be measured with the Continuous Performance Test (CPT) for reaction time in mean milliseconds (ms). Lower reaction times are more favorable.
Effectiveness of Psychomotor Vigilance Testing as a Fitness-for-duty Test
This outcome will be assessed with the Psychomotor Vigilance Test (PVT) in median milliseconds. The 10-min PVT measures sustained or vigilant attention by recording response times to visual (or auditory) stimuli that occur at random inter-stimulus intervals. Lower number of milliseconds are associated with greater vigilant attention.

Full Information

First Posted
September 13, 2005
Last Updated
December 4, 2020
Sponsor
Boston University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00183170
Brief Title
Residual Effects of Intoxication on Student Performance
Official Title
Residual Effects of Intoxication on Student Performance
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 2004 (Actual)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
239 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alcohol then Placebo
Arm Type
Experimental
Arm Description
Participants report for their first dosing night where they receive several alcohol drinks. After a wash out period of 1 week they then return and receive several placebo drinks. Participants sleep at the study site, are monitored overnight, and the next morning are awakened and escorted to the performance trials.
Arm Title
Placebo then Alcohol
Arm Type
Experimental
Arm Description
Participants report for their first night where they receive several placebo drinks. After a wash out period of 1 week they then return and receive several alcohol drinks. Participants sleep at the study site, are monitored overnight, and the next morning are awakened and escorted to the performance trials.
Intervention Type
Drug
Intervention Name(s)
Alcohol
Other Intervention Name(s)
Beer
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Non-alcoholic drink
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-reported Residual Effects of Heavy Drinking
Description
This outcome will be measured by the afternoon total mood disturbance score. This is part of the Profile of Mood States Questionnaire (POMS). POMS is a 35 item instrument with Likert responses from 0 to 4 where 0=not at all and 4=extremely. Range of scores can be 0 to 140, lower scores are more favorable.
Time Frame
next day
Secondary Outcome Measure Information:
Title
Cognitive Function in Response to Heavy Drinking
Description
This outcome measure will be assessed using the Visual Span Test- Backwards (VST-B). This is the mean maximum span of words repeated backwards correctly. Higher scores are more favorable
Time Frame
next day
Title
Academic Function in Response to Heavy Drinking
Description
This outcome will be measured by the mean Graduate Record Exam (GRE) quantitative score. The quantitative score can range from 200-800. Higher scores are more favorable.
Time Frame
next day
Title
Reaction Time Affected by Residual Effects of Heavy Drinking
Description
This outcome will be measured with the Continuous Performance Test (CPT) for reaction time in mean milliseconds (ms). Lower reaction times are more favorable.
Time Frame
next day
Title
Effectiveness of Psychomotor Vigilance Testing as a Fitness-for-duty Test
Description
This outcome will be assessed with the Psychomotor Vigilance Test (PVT) in median milliseconds. The 10-min PVT measures sustained or vigilant attention by recording response times to visual (or auditory) stimuli that occur at random inter-stimulus intervals. Lower number of milliseconds are associated with greater vigilant attention.
Time Frame
next day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Howland, PhD MPH MPA
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Clinical Research Center/Boston University School of Public Health
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21859168
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.
Results Reference
derived

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Residual Effects of Intoxication on Student Performance

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