Biphasic Effects of Acute Alcohol Intoxication on Bystander Intervention

NCT ID: NCT05701865

Last Updated: 2024-06-12

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

RECRUITING

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-09

Study Completion Date

2024-12-31

Brief Summary

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The goal of this experimental study is to examine the effect of alcohol, gender, and bystander attitudes on bystander barriers and sexual violence intervention among young adult men and women (age 21-20). The main questions it aims to answer are:

* Does alcohol intoxication and gender influence bystander barriers and sexual violence intervention?
* Does alcohol intoxication have a greater impact on bystander barriers and sexual violence intervention among men, compared to women?
* Does alcohol intoxication have a greater impact on bystander barriers and sexual violence intervention among those with higher, compared to lower, prosocial bystander attitudes?

Participants will be randomly assigned to one of two beverage conditions (alcohol or control beverage) and those assigned to alcohol will complete the study on either the ascending or descending alcohol limb. Participants will project themselves into a heat-of-the moment, risky sexual violence scenario that will assess bystander barriers and behavioral intentions. Researchers will compare those assigned to the alcohol and control beverage condition and men/women to see if this impacts bystander barriers and sexual violence intervention.

Detailed Description

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Conditions

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Alcohol Intoxication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Alcohol Intoxication

Participant will receive alcohol, the dose of which will be administered to result in a breath alcohol concentration of .08%.

Group Type EXPERIMENTAL

Alcohol Intoxication- Ascending Limb

Intervention Type BEHAVIORAL

Participants will be assigned to moderate alcohol dose condition (target breath alcohol concentration .08%) with NIAAA approved alcohol administration procedures and complete the study task on the ascending limb

Alcohol Intoxication- Descending Limb

Intervention Type BEHAVIORAL

Participants will be assigned to moderate alcohol dose condition (target breath alcohol concentration .08%) with NIAAA approved alcohol administration procedures and complete the study task on the descending limb

No-Alcohol Control

Participant will receive a no alcohol control beverage, therefore their breath alcohol concentration will be .00%.

Group Type ACTIVE_COMPARATOR

No Alcohol Control

Intervention Type BEHAVIORAL

Participants will be assigned to a no alcohol control condition

Interventions

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Alcohol Intoxication- Ascending Limb

Participants will be assigned to moderate alcohol dose condition (target breath alcohol concentration .08%) with NIAAA approved alcohol administration procedures and complete the study task on the ascending limb

Intervention Type BEHAVIORAL

Alcohol Intoxication- Descending Limb

Participants will be assigned to moderate alcohol dose condition (target breath alcohol concentration .08%) with NIAAA approved alcohol administration procedures and complete the study task on the descending limb

Intervention Type BEHAVIORAL

No Alcohol Control

Participants will be assigned to a no alcohol control condition

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Between the ages of 21 and 30
* Report that on at least 3 days in the past year they have consumed an alcohol quantity on a single occasion that was equal or greater to the dose administered in the lab

Exclusion Criteria

* Currently seeking treatment or in recovery for an alcohol or substance use disorder
* A medical condition or medication use in which alcohol consumption is medically contraindicated
* Pregnant, nursing, or has engaged in sexual intercourse without effective contraception in the past two weeks
* If the participant is less than six feet tall and weighs over 250 pounds or is over six feet tall and weighs over 300 pounds
Minimum Eligible Age

21 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Georgia State University

OTHER

Sponsor Role lead

Responsible Party

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Ruschelle Leone

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ruschelle M Leone, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgia State University

Locations

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Georgia State University

Atlanta, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ruschelle M Leone, PhD

Role: CONTACT

4044131537

Facility Contacts

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Ruschelle M Leone, PhD

Role: primary

404-413-1537

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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R21AA029225

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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