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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03930446
Recruitment Status : Completed
First Posted : April 29, 2019
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alcohol Drinking Binge Drinking Drinking Behavior Substance-Related Disorders Ethanol Physiological Effects of Drugs Central Nervous System Depressants Drug: Ethanol Other: Placebo Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Alcohol, Behavior, and Brain Imaging
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : May 30, 2019
Actual Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ethanol

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in stop reaction time - Stop Signal Task [ Time Frame: Day 1, 3, 5, 7, 9, ]
    Stop Task measures behavioral inhibition of a prepotent response. Participants are required to respond as quickly as possible when a 'go' target appears and to inhibit that response when a 'stop' signal (an auditory tone) occasionally occurs. The duration of the delay to presentation of the stop signal following the go signal is adjusted until the participant is able to successfully inhibit the response on 50% of trials. The final mean delay of the stop signal, based on this 50% success rate criterion, is subtracted from the mean go reaction time, providing the stop reaction time (stop RT), which is the primary measure of impulsive action.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930446


Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Jessica Weafer University of Chicago
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03930446    
Other Study ID Numbers: IRB16-0015
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2019

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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
Additional relevant MeSH terms:
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Substance-Related Disorders
Binge Drinking
Alcohol Drinking
Drinking Behavior
Chemically-Induced Disorders
Mental Disorders
 Alcohol-Related Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs