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Behavior Brain Responses (BBR)

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ClinicalTrials.gov Identifier: NCT03964350
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
University of Chicago

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : November 1, 2020

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.




Primary Outcome Measures :
  1. 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: 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.



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Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964350


Contacts
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Contact: Matthew Bona 773-702-3560 mbona@yoda.bsd.uchicago.edu

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Matthew Bona    773-702-3560    mbona@yoda.bsd.uchicago.edu   
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Harriet de Wit University of Chicago
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03964350    
Other Study ID Numbers: IRB19-0293
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs