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

February 17, 2022 updated by: University of Chicago
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 29 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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).
Drug: Ethanol
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_COMPARATOR: Placebo (Juice)
Subjects will receive 4 color-coded beverages in green or blue cups, containing placebo (Juice).
Other: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within an hour post-stimulation condition

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Jessica Weafer, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

May 30, 2019

Study Completion (ACTUAL)

May 30, 2019

Study Registration Dates

First Submitted

April 25, 2019

First Submitted That Met QC Criteria

April 25, 2019

First Posted (ACTUAL)

April 29, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 25, 2022

Last Update Submitted That Met QC Criteria

February 17, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB16-0015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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