SEA: Social Effects of Alcohol

• Sponsor: University of Chicago (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05826951
• Collaborator: National Institutes of Health (NIH) (NIH), National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 36
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 9.3
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Alcohol Drinking	Drug: Alcohol; Drug: Placebo	Early Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Social Effects of Alcohol
• Actual Study Start Date: Feb 20, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. facial emotional responses [during the length of the conversation (45 min)]

   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

2. self-reported feelings of connection [at the end of each session (3.5 hrs post-drug administration)]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago
• National Institutes of Health (NIH)
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Harriet de Wit, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT05826951
• Other Study ID Numbers: IRB22-1696; 5R01DA002812-35
• First Posted: Apr 24, 2023
• Last Update Posted: Apr 24, 2023
• Last Verified: Apr 1, 2023

• 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
• Additional relevant MeSH terms: Alcohol Drinking

Study Results

No Results Posted as of Apr 24, 2023