Recruiting

Observational Study

Sponsor:

Georgia State University

Code:

NCT05701865

Conditions

Alcohol Intoxication

Eligibility Criteria

Sex: All

Age: 21 - 30

Healthy Volunteers: Accepted

Interventions

Alcohol Intoxication- Ascending Limb

Alcohol Intoxication- Descending Limb

No Alcohol Control

Study Details

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.

Conditions

Alcohol Intoxication

Study ID

NCT05701865

Start date

Mar 9, 2023

Status verified date

Jun, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 30

Healthy Volunteers: Accepted

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 Design

Enrollment

192 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Alcohol Intoxication

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

active comparator: No-Alcohol Control

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

Interventions

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

Primary outcome measure

  • Articulated Thoughts of Barriers to Bystander Intervention [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Ruschelle M Leone, PhD

4044131537rleone1@gsu.edu

Locations

Georgia State University

Recruiting

Atlanta, Georgia, United States, 30302

Contacts

Ruschelle M Leone, PhD

404-413-1537rleone1@gsu.edu

More Information

Sponsor

Georgia State University

Last update posted

Jun 12, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgia State University on 2024-06-12.