Alcohol, Behavior, and Brain Imaging | Clinical Trial

Key information

Conditions

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

Age range

21 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ethanol

Drug

The 0.8 g/kg body weight dose of oral alcohol (190-proof ethanol) will be divided into 4 servings of 0.2 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. Women will receive a reduced dose (0.68 g/kg) to account for sex differences in total body water

Placebo

Other

The placebo beverage will consist of the cranberry or orange juice plus 1% alcohol added as a taste mask. All beverages will be sprayed with an alcoholic mist to provide a strong alcoholic scent.

Primary outcomes

Stop Signal Task (SST)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Acronym: (DARC)

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Apr 29, 2019
Registry last updated: Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed