Back to resultsBehavior Brain Responses (BBR)
Primary Purpose
Alcohol Drinking, Drinking Behavior, Physiological Effects of Drugs
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ethanol
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Alcohol Drinking
Eligibility Criteria
- 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
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ethanol
Placebo (gelatin vehicle)
Arm Description
Subjects will receive ethanol (0.4 or 0.8 g/kg) which will be administered in a gelatin vehicle.
Subjects will receive placebo of black cherry sugar-free jello.
Outcomes
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03964350
Brief Title
Behavior Brain Responses
Acronym
BBR
Official Title
Behavior and Brain Responses to Drugs
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 28, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Drinking Behavior, Physiological Effects of Drugs, Central Nervous System Depression
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ethanol
Arm Type
Experimental
Arm Description
Subjects will receive ethanol (0.4 or 0.8 g/kg) which will be administered in a gelatin vehicle.
Arm Title
Placebo (gelatin vehicle)
Arm Type
Placebo Comparator
Arm Description
Subjects will receive placebo of black cherry sugar-free jello.
Intervention Type
Drug
Intervention Name(s)
Ethanol
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The placebo comparator will be individual servings of back cheery sugar-free jello.
Primary Outcome Measure Information:
Title
Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire
Description
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.
Time Frame
Time Frame: Day 1 (baseline), 3, 5, 7
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harriet de Wit
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Behavior Brain Responses
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