Behavior Brain Responses

NCT ID: NCT03964350

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-28
• Study Completion Date: 2020-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Ethanol

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

Group Type: EXPERIMENTAL

Ethanol

Intervention Type: 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.

Placebo (gelatin vehicle)

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harriet de Wit

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB19-0293

Identifier Type: -

Identifier Source: org_study_id