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Behavior Brain Responses (BBR)

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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