Residual Effects of Intoxication on Student Performance

NCT00183170 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: H-23064P60AA013759
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  next day

Secondary Outcomes (4)

• Cognitive Function in Response to Heavy Drinking

  next day

• Academic Function in Response to Heavy Drinking

  next day

• Reaction Time Affected by Residual Effects of Heavy Drinking

  next day

• Effectiveness of Psychomotor Vigilance Testing as a Fitness-for-duty Test

  next day

Study Arms (2)

Alcohol then Placebo

EXPERIMENTAL

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.

Drug: Alcohol; Other: Placebo

Placebo then Alcohol

EXPERIMENTAL

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.

Drug: Alcohol; Other: Placebo

Interventions

Alcohol 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.

Also known as: Beer

Alcohol then Placebo; Placebo then Alcohol

Placebo 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.

Also known as: Non-alcoholic drink

Alcohol then Placebo; Placebo then Alcohol

Eligibility Criteria

• Age: 21 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

General Clinical Research Center/Boston University School of Public Health

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• 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.

  PMID: 21859168 DERIVED

MeSH Terms

Conditions

Alcoholic Intoxication; Neurobehavioral Manifestations; Alcoholism

Interventions

Ethanol; Beer

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Alcoholic Beverages; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Beverages; Fermented Foods; Food and Beverages

Results Point of Contact

• Title: Dr. Jonathan Howland, Professor
• Organization: Boston University School of Public Health

jhowl@bu.edu

Study Officials

• Jonathan Howland, PhD MPH MPA

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: February 1, 2004
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: December 8, 2020
• Results First Posted: December 4, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)