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Residual Effects of Intoxication on Student Performance

Residual Effects of Intoxication on Student Performance

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00183170
Enrollment
239
Registered
2005-09-16
Start date
2004-02-29
Completion date
2009-01-31
Last updated
2020-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DRUGAlcohol

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.

OTHERPlacebo

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.

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
Boston University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Self-reported Residual Effects of Heavy Drinkingnext dayThis 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

MeasureTime frameDescription
Cognitive Function in Response to Heavy Drinkingnext dayThis 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 Drinkingnext dayThis 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 Drinkingnext dayThis 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 Testnext dayThis 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.

Countries

United States

Participant flow

Pre-assignment details

239 participants were enrolled but 27 dropped out prior to randomization into the study arms so a total of 212 were randomized.

Participants by arm

ArmCount
Alcohol, Then Placebo94
Placebo, Then Alcohol99
Total193

Withdrawals & dropouts

PeriodReasonFG000FG001
First InterventionDid not complete study10
First InterventionDid not meet targeted BrAC10
Second InterventionDid not complete study10
Second InterventionDid not meet targeted BrAC02
Washout 1 WeekDid not complete study68

Baseline characteristics

CharacteristicTotalAlcohol, Then PlaceboPlacebo, Then Alcohol
Age, Continuous21.47 years
STANDARD_DEVIATION 0.64
21.46 years
STANDARD_DEVIATION 0.62
21.48 years
STANDARD_DEVIATION 0.66
Amount of alcohol received
Females
1122 ml
STANDARD_DEVIATION 178
1137 ml
STANDARD_DEVIATION 172
1106 ml
STANDARD_DEVIATION 187
Amount of alcohol received
Males
1609 ml
STANDARD_DEVIATION 288
1607 ml
STANDARD_DEVIATION 310
1611 ml
STANDARD_DEVIATION 272
Family history of alcohol problems
Adopted
3 Participants2 Participants1 Participants
Family history of alcohol problems
No
119 Participants64 Participants55 Participants
Family history of alcohol problems
Yes
71 Participants28 Participants43 Participants
Maximum breath alcohol concentration (BrAC)0.12 g%
STANDARD_DEVIATION 0.01
0.12 g%
STANDARD_DEVIATION 0.01
0.12 g%
STANDARD_DEVIATION 0.01
Race/Ethnicity, Customized
Asian
13 Participants7 Participants6 Participants
Race/Ethnicity, Customized
Black
8 Participants3 Participants5 Participants
Race/Ethnicity, Customized
Other
17 Participants9 Participants8 Participants
Race/Ethnicity, Customized
White
155 Participants75 Participants80 Participants
Region of Enrollment
United States
193 participants94 participants99 participants
Sex: Female, Male
Female
86 Participants45 Participants41 Participants
Sex: Female, Male
Male
107 Participants49 Participants58 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
5 / 1930 / 193
serious
Total, serious adverse events
0 / 1930 / 193

Outcome results

Primary

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.

Time frame: next day

Population: 153 POMS questionnaires were analyzed since 40 of the 193 participants did not return the POMS questionnaire by the next day.

ArmMeasureValue (MEAN)Dispersion
AlcoholSelf-reported Residual Effects of Heavy Drinking4.3 scores on a scaleStandard Deviation 10.19
PlaceboSelf-reported Residual Effects of Heavy Drinking1.93 scores on a scaleStandard Deviation 8.39
Secondary

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.

Time frame: next day

ArmMeasureValue (MEAN)Dispersion
AlcoholAcademic Function in Response to Heavy Drinking615.75 score on a scaleStandard Deviation 98.92
PlaceboAcademic Function in Response to Heavy Drinking612.38 score on a scaleStandard Deviation 94.64
Secondary

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

Time frame: next day

Population: Data were analyzed for 186 of the 193 participants since 7 did not complete the VST-B.

ArmMeasureValue (MEAN)Dispersion
AlcoholCognitive Function in Response to Heavy Drinking5.41 backwards wordsStandard Deviation 0.89
PlaceboCognitive Function in Response to Heavy Drinking5.67 backwards wordsStandard Deviation 1.16
Secondary

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.

Time frame: next day

Population: Data were analyzed for 190 of the 193 participants since 3 did not complete the PVT.

ArmMeasureValue (MEDIAN)Dispersion
AlcoholEffectiveness of Psychomotor Vigilance Testing as a Fitness-for-duty Test223.40 milliseconds of response timeStandard Deviation 22.81
PlaceboEffectiveness of Psychomotor Vigilance Testing as a Fitness-for-duty Test218.57 milliseconds of response timeStandard Deviation 20.25
Secondary

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.

Time frame: next day

Population: Data were analyzed for 187 of the 193 participants since 6 did not complete the CPT.

ArmMeasureValue (MEAN)Dispersion
AlcoholReaction Time Affected by Residual Effects of Heavy Drinking378.77 millisecondsStandard Deviation 35.48
PlaceboReaction Time Affected by Residual Effects of Heavy Drinking375.98 millisecondsStandard Deviation 35.82

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026