Alcohol, Behavior, and Brain Imaging

Substance-Related Disorders Clinical Trial

— (DARC)  

Official title:

Alcohol, Behavior, and Brain Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03930446
• Other study ID #: IRB16-0015
• Status: Completed
• Phase: Early Phase 1
• Start date: January 1, 2016
• Est. completion date: May 30, 2019

Study information

• Verified date: February 2022
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within an hour post-stimulation condition