Back to resultsAlcohol, Behavior, and Brain Imaging ((DARC))
Primary Purpose
Alcohol Drinking, Binge Drinking, Drinking Behavior
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Ethanol
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Alcohol Drinking
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ethanol
Placebo (Juice)
Arm 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).
Subjects will receive 4 color-coded beverages in green or blue cups, containing placebo (Juice).
Outcomes
Primary Outcome Measures
Stop Signal Task (SST)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03930446
First Posted
April 25, 2019
Last Updated
February 17, 2022
Sponsor
University of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT03930446
Brief Title
Alcohol, Behavior, and Brain Imaging
Acronym
(DARC)
Official Title
Alcohol, Behavior, and Brain Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
May 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Binge Drinking, Drinking Behavior, Substance-Related Disorders, Ethanol, Physiological Effects of Drugs, Central Nervous System Depressants
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ethanol
Arm Type
Experimental
Arm 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).
Arm Title
Placebo (Juice)
Arm Type
Placebo Comparator
Arm Description
Subjects will receive 4 color-coded beverages in green or blue cups, containing placebo (Juice).
Intervention Type
Drug
Intervention Name(s)
Ethanol
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
Stop Signal Task (SST)
Description
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.
Time Frame
Within an hour post-stimulation condition
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Weafer
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
33201577
Citation
Li J, Murray CH, Weafer J, de Wit H. Subjective Effects of Alcohol Predict Alcohol Choice in Social Drinkers. Alcohol Clin Exp Res. 2020 Dec;44(12):2579-2587. doi: 10.1111/acer.14476. Epub 2020 Nov 17.
Results Reference
derived
Learn more about this trial
Alcohol, Behavior, and Brain Imaging
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