Behavior Brain Responses

Early Phase 1

Completed

• Conditions: Alcohol Drinking; Central Nervous System Depression; Drinking Behavior; Physiological Effects of Drugs
• Interventions: Other: Placebo; Drug: Ethanol

• Registration Number: NCT03964350
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-24
• Study Start: 2019-05-28
• Study First Posted: 2019-05-28
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Results First Submitted: 2022-04-11
• Status Verified: 2024-01
• Results First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Results First Posted: 2025-01-31
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo (gelatin vehicle)	Placebo	Subjects will receive placebo of black cherry sugar-free jello.
Ethanol	Ethanol	Subjects will receive ethanol (0.4 or 0.8 g/kg) which will be administered in a gelatin vehicle.

Primary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States