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Biphasic Effects of Acute Alcohol Intoxication on Bystander Intervention

Primary Purpose

Alcohol Intoxication

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alcohol Intoxication- Ascending Limb
Alcohol Intoxication- Descending Limb
No Alcohol Control
Sponsored by
Georgia State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcohol Intoxication

Eligibility Criteria

21 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Georgia State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alcohol Intoxication

No-Alcohol Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Articulated Thoughts of Barriers to Bystander Intervention
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].
Articulated Thoughts of Intentions to Intervene as a Bystander
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]

Secondary Outcome Measures

Full Information

First Posted
January 10, 2023
Last Updated
March 23, 2023
Sponsor
Georgia State University
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1. Study Identification

Unique Protocol Identification Number
NCT05701865
Brief Title
Biphasic Effects of Acute Alcohol Intoxication on Bystander Intervention
Official Title
Biphasic Effects of Acute Alcohol Intoxication on Bystander Intervention for Sexual Violence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgia State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alcohol Intoxication
Arm Type
Experimental
Arm Description
Participant will receive alcohol, the dose of which will be administered to result in a breath alcohol concentration of .08%.
Arm Title
No-Alcohol Control
Arm Type
Active Comparator
Arm Description
Participant will receive a no alcohol control beverage, therefore their breath alcohol concentration will be .00%.
Intervention Type
Behavioral
Intervention Name(s)
Alcohol Intoxication- Ascending Limb
Intervention Description
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
Intervention Name(s)
Alcohol Intoxication- Descending Limb
Intervention Description
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
Intervention Name(s)
No Alcohol Control
Intervention Description
Participants will be assigned to a no alcohol control condition
Primary Outcome Measure Information:
Title
Articulated Thoughts of Barriers to Bystander Intervention
Description
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].
Time Frame
35 minutes to 2.5 hours post-drinking
Title
Articulated Thoughts of Intentions to Intervene as a Bystander
Description
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]
Time Frame
35 minutes to 2.5 hours post-drinking

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Man or woman
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruschelle M Leone, PhD
Phone
4044131537
Email
rleone1@gsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruschelle M Leone, PhD
Organizational Affiliation
Georgia State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia State University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30302
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruschelle M Leone, PhD
Phone
404-413-1537
Email
rleone1@gsu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be available in the NIAAA Data Archive.

Learn more about this trial

Biphasic Effects of Acute Alcohol Intoxication on Bystander Intervention

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