Behavior Brain Responses

NCT03964350 | Completed Early Phase 1 Results DMC FDA Drug

• 1 other identifier: IRB19-0293
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (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 Across Sessions

  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.

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

Study Arms (2)

Ethanol

EXPERIMENTAL

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

Drug: Ethanol

Placebo (gelatin vehicle)

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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.

Ethanol

Placebo OTHER

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

Placebo (gelatin vehicle)

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Drinking Behavior

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Results Point of Contact

• Title: Dr. Harriet de Wit
• Organization: University of Chicago

dewitlab@yoda.bsd.uchicago.edu

7737023560

Study Officials

• Harriet de Wit

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 28, 2019
• Study Start: May 28, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 31, 2025
• Results First Posted: January 31, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)