Biphasic Effects of Acute Alcohol Intoxication on Bystander Intervention

NCT05701865 | Terminated Results DMC

• 1 other identifier: R21AA029225
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Articulated Thoughts of Barriers to Bystander Intervention

  Number of participants with articulated thoughts in simulated situations is a proxy for understanding barriers to intervention. Participants' articulated thoughts were coded into the presence or absence of 5 barriers (Step 1: Notice the Situation, Step 2: Interpret the Situation as Risky or Concerning, Step 3: Take Responsibility, Step 4: I Don't Know What To Do, Step 5: Intervention) as seen in the table below.

  1 hour post beverage consumption

• Number of Participants That Articulated Thoughts of Intentions to Intervene as a Bystander

  Number of participants that articulated thoughts to intervene in simulated situations is a proxy for understanding intervention intentions.

  1 hour post beverage consumption

Study Arms (2)

Alcohol Intoxication

EXPERIMENTAL

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; Behavioral: Alcohol Intoxication- Descending Limb

No-Alcohol Control

ACTIVE COMPARATOR

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

Behavioral: No Alcohol Control

Interventions

Alcohol Intoxication- Ascending Limb BEHAVIORAL

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

Alcohol Intoxication- Descending Limb BEHAVIORAL

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

Alcohol Intoxication

No Alcohol Control BEHAVIORAL

Participants will be assigned to a no alcohol control condition

No-Alcohol Control

Eligibility Criteria

• Age: 21 Years - 30 Years
• Gender Eligibility Details: Man or woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado, Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Alcoholic Intoxication

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Limitations and Caveats

Limitations include that the study was terminated prior to obtaining the full sample due to the Principal Investigator transferring institutions and NIH funds not being transferred to the new institution.

Results Point of Contact

• Title: Ruschelle Leone
• Organization: University of Colorado Anschutz Medical Campus

ruschelle.leone@cuanschutz.edu

303-724-7052

Study Officials

• Ruschelle M Leone, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 27, 2023
• Study Start: March 9, 2023
• Primary Completion: August 9, 2024
• Study Completion: August 15, 2024
• Last Updated: September 15, 2026
• Results First Posted: September 15, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)