NCT05826951

Brief Summary

In this study the investigator will assess the effect of a moderate dose of alcohol on emotional responses and feelings of connection during a dyadic semi-structured social interaction

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Feb 2023

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 30, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2023

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

8 months

First QC Date

March 30, 2023

Last Update Submit

January 23, 2024

Conditions

Alcohol Drinking

Outcome Measures

Primary Outcomes (2)

  • facial emotional responses

    alterations in the rate of positive facial expressions during the conversation, measured by muscle action units. These will be compared between the drug and placebo sessions

    during the length of the conversation (45 min)

  • self-reported feelings of connection

    self-other overlap measure ratings 1-7, greater ratings indicates greater feelings of connection

    at the end of each session (3.5 hrs post-drug administration). Changes across sessions will be assessed

Study Arms (4)

Alcohol-alcohol

EXPERIMENTAL

Both conversation partners receive alcohol

Drug: Alcohol

placebo-placebo

PLACEBO COMPARATOR

Both conversation partners receive placebo

Drug: Placebo

alcohol-placebo

EXPERIMENTAL

participant receives alcohol and conversation partner receives placebo

Drug: Alcohol

placebo-alcohol

EXPERIMENTAL

participant receives placebo and conversation partner receives alcohol

Drug: Placebo

Interventions

AlcoholDRUG

Alcohol (0.8g/kg)

Alcohol-alcoholalcohol-placebo
PlaceboDRUG

Placebo

placebo-alcoholplacebo-placebo

Eligibility Criteria

Age21 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • non-problem alcohol consumption of 2-20 drinks per week
  • high school diploma or equivalent
  • BMI between 19 and 26
  • verbal fluency in English

You may not qualify if:

  • High blood pressure
  • Any medical condition requiring regular medication
  • Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis
  • Women who are pregnant or trying to become pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Harriet de Wit

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 30, 2023

First Posted

April 24, 2023

Study Start

February 20, 2023

Primary Completion

October 3, 2023

Study Completion

October 3, 2023

Last Updated

January 24, 2024

Record last verified: 2024-01

Locations

US(1)