Early Phase 1 N=30 Randomized Double-blind Basic Science

Behavior Brain Responses

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

Bottom Line

View on ClinicalTrials.gov: NCT03964350 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: 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 — 3.65; 45.5; 62.3; 3.0 units on a scale — p=<.05

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Ethanol (Drug); Placebo (Other)
Age: Adult · 21+ yrs
Sex: Male
Sponsor: University of Chicago
Primary completion: Dec 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	3.65; 45.5; 62.3; 3.0; 33.7; 47.0	<.05 sig

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03964350). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.