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Alcohol, Behavior, and Brain Imaging ((DARC))

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The University of Chicago

Status and phase

Completed
Early Phase 1

Conditions

Central Nervous System Depressants
Physiological Effects of Drugs
Substance-Related Disorders
Ethanol
Drinking Behavior
Binge Drinking
Alcohol Drinking

Treatments

Other: Placebo
Drug: Ethanol

Study type

Interventional

Funder types

Other

Identifiers

NCT03930446
IRB16-0015

Details and patient eligibility

About

To evaluate the relationship of extraversion to both the acute subjective and behavioral effects of alcohol, and the neural reactivity to the anticipation of reward.

Enrollment

80 patients

Sex

All

Ages

21 to 29 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • 21-29 years old
  • 7-30 alcoholic drinks per week (as reported on PHQ or TLFB)
  • At least one binge episode (4 for females/5 for males) per month
  • No 'flushing' reaction to alcohol
  • Females must be on birth control or in the beginning of follicular phase (1-14 days after start of menstruation)
  • 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
  • No previous participation in studies that have used the Stop Task (except IDAC) o Previous Stop Task studies: GOI, CAP, STEM, JAM, MACI, PAC, CAM

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

80 participants in 2 patient groups, including a placebo group

Ethanol
Experimental group
Description:
Subjects will receive 4 color-coded beverages in green or blue cups, containing ethanol (0.2 g/kg per dose, total dose 0.8 g/kg).
Treatment:
Drug: Ethanol
Placebo (Juice)
Placebo Comparator group
Description:
Subjects will receive 4 color-coded beverages in green or blue cups, containing placebo (Juice).
Treatment:
Other: Placebo

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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