NCT03964350

Behavior Brain Responses

Behavior and Brain Responses to Drugs

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: Male
• Age: 21 Years – 35 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.
OTHER	Placebo	The placebo comparator will be individual servings of back cheery sugar-free jello.

Timeline

• Start date: 2019-05-28
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2019-05-28
• Last updated: 2025-01-31
• Results posted: 2025-01-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study