Behavior Brain Responses (BBR)

The University of Chicago

Status and phase: Completed; Early Phase 1

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

Treatments: Other: Placebo; Drug: Ethanol

Study type: Interventional

Funder types: Other

Identifiers

NCT03964350

IRB19-0293

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Male

Ages: 21 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Ethanol

Experimental group

Description:

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

Treatment:

Drug: Ethanol

Placebo (gelatin vehicle)

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo