NCT03930446

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2016

Typical duration for early_phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

April 25, 2022

Completed
Last Updated

April 25, 2022

Status Verified

February 1, 2022

Enrollment Period

3.4 years

First QC Date

April 25, 2019

Results QC Date

February 17, 2022

Last Update Submit

February 17, 2022

Conditions

Alcohol DrinkingBinge DrinkingDrinking BehaviorSubstance-Related DisordersEthanolPhysiological Effects of DrugsCentral Nervous System Depressants

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Ethanol

EXPERIMENTAL

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

Placebo (Juice)

PLACEBO COMPARATOR

Subjects will receive 4 color-coded beverages in green or blue cups, containing placebo (Juice).

Other: Placebo

Interventions

EthanolDRUG

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

Ethanol
PlaceboOTHER

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.

Placebo (Juice)

Eligibility Criteria

Age21 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 33201577DERIVED

MeSH Terms

Conditions

Alcohol DrinkingBinge DrinkingDrinking BehaviorSubstance-Related Disorders

Interventions

Ethanol

Condition Hierarchy (Ancestors)

BehaviorAlcohol-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Results Point of Contact

Title
Dr. Harriet de Wit
Organization
University of Chicago
dewitlab@yoda.bsd.uchicago.edu
7737023560

Study Officials

  • Jessica Weafer

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2019

First Posted

April 29, 2019

Study Start

January 1, 2016

Primary Completion

May 30, 2019

Study Completion

May 30, 2019

Last Updated

April 25, 2022

Results First Posted

April 25, 2022

Record last verified: 2022-02