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Biphasic Effects of Acute Alcohol Intoxication on Bystander Intervention

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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05701865
Enrollment
153
Registered
2023-01-27
Start date
2023-03-09
Completion date
2024-08-15
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Intoxication

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.

Interventions

BEHAVIORALAlcohol 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

BEHAVIORALAlcohol 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

BEHAVIORALNo Alcohol Control

Participants will be assigned to a no alcohol control condition

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 30 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Articulated Thoughts of Barriers to Bystander Intervention1 hour post beverage consumptionNumber 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.
Number of Participants That Articulated Thoughts of Intentions to Intervene as a Bystander1 hour post beverage consumptionNumber of participants that articulated thoughts to intervene in simulated situations is a proxy for understanding intervention intentions.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRuschelle M Leone, PhD

University of Colorado, Denver

Baseline characteristics

Characteristic
Age, Continuous23.52 Years
STANDARD_DEVIATION 2.49
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
42 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants
Race (NIH/OMB)
Asian
8 Participants
Race (NIH/OMB)
Black or African American
60 Participants
Race (NIH/OMB)
More than one race
2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants
Race (NIH/OMB)
White
21 Participants
Sex: Female, Male
Female
34 Participants
Sex: Female, Male
Male
20 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 520 / 500 / 51
other
Total, other adverse events
0 / 520 / 500 / 51
serious
Total, serious adverse events
0 / 520 / 500 / 51

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026