Biphasic Effects of Acute Alcohol Intoxication on Bystander Intervention

Alcohol Intoxication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05701865
• Other study ID #: R21AA029225
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Georgia State University
• Contact: Ruschelle M Leone, PhD
• Phone: 4044131537
• Email: rleone1[@]gsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Intoxication
• Alcoholic Intoxication

Intervention

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
• 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
• No Alcohol Control
Participants will be assigned to a no alcohol control condition

Locations

Country	Name	City	State
United States	Georgia State University	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Georgia State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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].	35 minutes to 2.5 hours post-drinking
Primary	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]	35 minutes to 2.5 hours post-drinking