Biphasic Effects of Acute Alcohol Intoxication on Bystander Intervention

Sponsor
Georgia State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05701865
Collaborator
(none)
192
1
2
18
10.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Alcohol Intoxication- Ascending Limb
  • Behavioral: Alcohol Intoxication- Descending Limb
  • Behavioral: No Alcohol Control
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
192 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Biphasic Effects of Acute Alcohol Intoxication on Bystander Intervention for Sexual Violence
Anticipated Study Start Date :
Jan 31, 2023
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Articulated Thoughts of Barriers to Bystander Intervention [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].

  2. Articulated Thoughts of Intentions to Intervene as a Bystander [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Georgia State University Atlanta Georgia United States 30302

Sponsors and Collaborators

  • Georgia State University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ruschelle Leone, Assistant Professor, Georgia State University
ClinicalTrials.gov Identifier:
NCT05701865
Other Study ID Numbers:
  • R21AA029225
First Posted:
Jan 27, 2023
Last Update Posted:
Jan 27, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2023