Behavior Brain Responses

To compare responses to acute oral doses of ethanol in healthy young adults who experience mainly stimulant subjective effects from the drug or mainly sedative effects.

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Key information

Conditions

Alcohol Drinking Behavior Central Nervous System Depression Drinking Behavior Physiological Effects of Drugs

Age range

21 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

21-35 years old
4-30 alcoholic drinks per week (as reported on PHQ or TLFB)
No 'flushing' reaction to alcohol
BMI 19-26
High school education or greater, fluent in English
No night shift work
No current or past year Axis I psychiatric disorder including drug/alcohol dependence
No current psychopharmacological treatment
No lifetime ADHD or prescription for ADHD medication
No abnormal EKG, cardiovascular illness, high blood pressure
No medical condition or pharmacological treatment for which alcohol is contraindicated
Not pregnant, lactating, or planning to become pregnant
Smoke <6 cigarettes per day

Treatment and study plan

Ethanol

Drug

The 0.8 g/kg body weight dose of gelatin alcohol will be divided into an average of 10 servings of 0.08 g/kg each. The 0.8 g/kg dose is equivalent to 4 standard drinks, where a standard drink is defined as one 12 oz beer, one 5 oz glass of wine, or one 1.5 oz shot of 80 proof alcohol.

The 0.4 g/kg body weight dose of gelatin alcohol will be divided into an average of 5 servings of 0.08 g/kg each. The 0.4 g/kg dose is equivalent to 2 standard drinks, where a standard drink is defined as one 12 oz beer, one 5 oz glass of wine, or one 1.5 oz shot of 80 proof alcohol.

Placebo

Other

The placebo comparator will be individual servings of back cheery sugar-free jello.

Primary outcomes

Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Across Sessions

Time frame: At expected peak drug effect (30 min post drink administration)

Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective alcohol profile. The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states : "Feel Drug", "Feel High", "Like Drug", and "Want More". All sub-scales ("Feel Drug", "Feel High", "Like Drug", and "Want More") are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Behavior and Brain Responses to Drugs

Acronym: BBR

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: May 28, 2019
Registry last updated: Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed