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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03930446
Other study ID # IRB16-0015
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
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
Health authority
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

Study Design


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
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