Social Effects of Alcohol

NCT ID: NCT05826951

Last Updated: 2024-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-20

Study Completion Date

2023-10-03

Brief Summary

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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

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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.

Conditions

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Alcohol Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Alcohol-alcohol

Both conversation partners receive alcohol

Group Type EXPERIMENTAL

Alcohol

Intervention Type DRUG

Alcohol (0.8g/kg)

placebo-placebo

Both conversation partners receive placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

alcohol-placebo

participant receives alcohol and conversation partner receives placebo

Group Type EXPERIMENTAL

Alcohol

Intervention Type DRUG

Alcohol (0.8g/kg)

placebo-alcohol

participant receives placebo and conversation partner receives alcohol

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo

Interventions

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Alcohol

Alcohol (0.8g/kg)

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harriet de Wit

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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5R01DA002812-35

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB22-1696

Identifier Type: -

Identifier Source: org_study_id

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