Alcohol, Behavior, and Brain Imaging

Early Phase 1

Completed

• Conditions: Alcohol Drinking; Binge Drinking; Drinking Behavior; Substance-Related Disorders; Ethanol; Physiological Effects of Drugs; Central Nervous System Depressants
• Interventions: Other: Placebo; Drug: Ethanol

• Registration Number: NCT03930446
• Lead Sponsor: University of Chicago

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-29
• Primary Completion: 2019-05-30
• Study Completion: 2019-05-30
• Status Verified: 2022-02
• Results First Submitted: 2022-02-17
• Results First Submitted QC: 2022-02-17
• Last Update Submitted: 2022-02-17
• Results First Posted: 2022-04-25
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo (Juice)	Placebo	Subjects will receive 4 color-coded beverages in green or blue cups, containing placebo (Juice).
Ethanol	Ethanol	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).

Primary Outcome Measures

Name	Time	Method
Stop Signal Task (SST)	Within an hour post-stimulation condition	The Stop-Signal Task (SST) is a task requiring inhibition of a prepotent motor response. The SST requires participants to respond to a target stimulus as quickly and accurately as possible by pressing a button, but also to withhold their response when they hear an auditory signal. Thus, this task involves a competition between activating and inhibiting processes. The primary outcome variable is change in the stop signal reaction time (SSRT) for the task administered seconds to minutes before and seconds to minutes after stimulation. The theoretical minimum is zero seconds and there is no theoretical maximum. Higher SSRT scores reflect greater impulsivity.