Social Effects of Alcohol (SEA)

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

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking
• Intervention / Treatment: Drug: Placebo; Drug: Alcohol

Detailed Description

The study will use a within-subject crossover design with four sessions, in which participants receive alcohol or placebo across sessions. During the four sessions, the participants will engage in a conversation with a stranger, and emotional responses and feelings of connection will be assessed.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alcohol-alcohol; Both conversation partners receive alcohol	Drug: Alcohol; Alcohol (0.8g/kg)
Placebo Comparator: placebo-placebo; Both conversation partners receive placebo	Drug: Placebo; Placebo
Experimental: alcohol-placebo; participant receives alcohol and conversation partner receives placebo	Drug: Alcohol; Alcohol (0.8g/kg)
Experimental: placebo-alcohol; participant receives placebo and conversation partner receives alcohol	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Harriet de Wit, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Actual): October 3, 2023
• Study Completion (Actual): October 3, 2023

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: IRB22-1696; 5R01DA002812-35 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes