Residual Effects of Intoxication on Student Performance

NCT ID: NCT00183170

Last Updated: 2020-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 239 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2009-01-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Alcohol then Placebo

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.

Group Type: EXPERIMENTAL

Alcohol

Intervention Type: DRUG

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.

Placebo

Intervention Type: OTHER

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.

Placebo then Alcohol

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.

Group Type: EXPERIMENTAL

Alcohol

Intervention Type: DRUG

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.

Placebo

Intervention Type: OTHER

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.

Interventions

Alcohol

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: DRUG

Placebo

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.

Intervention Type: OTHER

Other Intervention Names

Beer; Non-alcoholic drink

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Howland, PhD MPH MPA

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

General Clinical Research Center/Boston University School of Public Health

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 21859168 (View on PubMed)

Other Identifiers

P60AA013759

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-23064

Identifier Type: -

Identifier Source: org_study_id