BBR: Behavior Brain Responses

Sponsor

University of Chicago (Other)

Overall Status

Completed

CT.gov ID

NCT03964350

Collaborator

(none)

Enrollment

Location

Arms

19.2

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Drinking Drinking Behavior Physiological Effects of Drugs Central Nervous System Depression	Drug: Ethanol Other: Placebo	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

Behavior and Brain Responses to Drugs

Actual Study Start Date :

May 28, 2019

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ethanol Subjects will receive ethanol (0.4 or 0.8 g/kg) which will be administered in a gelatin vehicle.	Drug: Ethanol 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 Comparator: Placebo (gelatin vehicle) Subjects will receive placebo of black cherry sugar-free jello.	Other: Placebo The placebo comparator will be individual servings of back cheery sugar-free jello.

Arm

Intervention/Treatment

Experimental: Ethanol

Subjects will receive ethanol (0.4 or 0.8 g/kg) which will be administered in a gelatin vehicle.

Drug: Ethanol

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 Comparator: Placebo (gelatin vehicle)

Subjects will receive placebo of black cherry sugar-free jello.

Other: Placebo

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

Outcome Measures

Primary Outcome Measures

Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire [Time Frame: Day 1 (baseline), 3, 5, 7]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 35 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago	Chicago	Illinois	United States	60637

Sponsors and Collaborators

University of Chicago

Investigators

Principal Investigator: Harriet de Wit, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Chicago

ClinicalTrials.gov Identifier:

NCT03964350

Other Study ID Numbers:

IRB19-0293

First Posted:

May 28, 2019

Last Update Posted:

Jan 22, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Alcohol Drinking

Drinking Behavior

Ethanol

Study Results

No Results Posted as of Jan 22, 2021