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Social Effects of Alcohol (SEA)

Primary Purpose

Alcohol Drinking

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Alcohol

Placebo

About this trial

This is an interventional other trial for Alcohol Drinking

Eligibility Criteria

21 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Alcohol-alcohol

placebo-placebo

alcohol-placebo

placebo-alcohol

Arm Description

Both conversation partners receive alcohol

Both conversation partners receive placebo

participant receives alcohol and conversation partner receives placebo

participant receives placebo and conversation partner receives alcohol

Outcomes

Primary Outcome Measures

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

self-reported feelings of connection

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05826951

First Posted

March 30, 2023

Last Updated

April 11, 2023

Sponsor

University of Chicago

Collaborators

National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT05826951

Brief Title

Social Effects of Alcohol

Acronym

SEA

Official Title

Social Effects of Alcohol

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 20, 2023 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Chicago

Collaborators

National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Drinking

7. Study Design

Primary Purpose

Other

Study Phase

Early Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Alcohol-alcohol

Arm Type

Experimental

Arm Description

Both conversation partners receive alcohol

Arm Title

placebo-placebo

Arm Type

Placebo Comparator

Arm Description

Both conversation partners receive placebo

Arm Title

alcohol-placebo

Arm Type

Experimental

Arm Description

participant receives alcohol and conversation partner receives placebo

Arm Title

placebo-alcohol

Arm Type

Experimental

Arm Description

participant receives placebo and conversation partner receives alcohol

Intervention Type

Drug

Intervention Name(s)

Alcohol

Intervention Description

Alcohol (0.8g/kg)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

facial emotional responses

Description

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

Time Frame

during the length of the conversation (45 min)

Title

self-reported feelings of connection

Description

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

Time Frame

at the end of each session (3.5 hrs post-drug administration)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hanna Molla

Phone

773-702-3560

hmolla@uchicago.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Harriet de Wit

Organizational Affiliation

University of Chicago

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hanna Molla

hmolla@uchicago.edu

First Name & Middle Initial & Last Name & Degree

Harriet de Wit

12. IPD Sharing Statement

Learn more about this trial

Social Effects of Alcohol

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