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Terminated

NCT Number: NCT05701865

Biphasic Effects of Acute Alcohol Intoxication on Bystander Intervention

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.

Why the study stopped: 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.
Terminated

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Key information

Conditions

Alcohol Intoxication Alcohol-Related Disorders Alcoholic Intoxication Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado, Denver

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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- 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

No Alcohol Control

Behavioral

Participants will be assigned to a no alcohol control condition

Primary outcomes

  1. Number of Participants With Articulated Thoughts of Barriers to Bystander Intervention

    Time frame: 1 hour post beverage consumption

    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.

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

    Time frame: 1 hour post beverage consumption

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

Interested in participating?

Terminated

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Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2023
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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