Biphasic Effects of Acute Alcohol Intoxication on Bystander Intervention

March 23, 2023 updated by: Ruschelle Leone, Georgia State University

Biphasic Effects of Acute Alcohol Intoxication on Bystander Intervention for Sexual Violence

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

192

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ruschelle M Leone, PhD
  • Phone Number: 4044131537
  • Email: rleone1@gsu.edu

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30302
        • Recruiting
        • Georgia State University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alcohol Intoxication
Participant will receive alcohol, the dose of which will be administered to result in a breath alcohol concentration of .08%.
Behavioral: 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
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
Active Comparator: No-Alcohol Control
Participant will receive a no alcohol control beverage, therefore their breath alcohol concentration will be .00%.
Behavioral: No Alcohol Control
Participants will be assigned to a no alcohol control condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Articulated Thoughts of Barriers to Bystander Intervention
Time Frame: 35 minutes to 2.5 hours post-drinking
Participants will verbally respond to a heat-of-the-moment scenario where they are a bystander of a risky alcohol-related sexual violence situation using the articulate thoughts in simulated situations paradigm [Davidson et al., 1983].
35 minutes to 2.5 hours post-drinking
Articulated Thoughts of Intentions to Intervene as a Bystander
Time Frame: 35 minutes to 2.5 hours post-drinking
Participants will verbally respond to a heat-of-the-moment scenario where they are a bystander of a risky alcohol-related sexual violence situation using the articulate thoughts in simulated situations paradigm [Davidson et al., 1983]
35 minutes to 2.5 hours post-drinking

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgia State University

Investigators

  • Principal Investigator: Ruschelle M Leone, PhD, Georgia State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2023

Primary Completion (Anticipated)

July 31, 2024

Study Completion (Anticipated)

July 31, 2024

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

January 18, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21AA029225 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be available in the NIAAA Data Archive.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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