Social Effects of Alcohol

Alcohol Drinking Clinical Trial

— SEA  

Official title:

Social Effects of Alcohol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05826951
• Other study ID #: IRB22-1696
• Secondary ID: 5R01DA002812-35
• Status: Completed
• Phase: Early Phase 1
• Start date: February 20, 2023
• Est. completion date: October 3, 2023

Study information

• Verified date: January 2024
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 3, 2023
• Est. primary completion date: October 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking

Intervention

Drug:
• Alcohol
Alcohol (0.8g/kg)
• Placebo
Placebo

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Chicago	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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