Alcohol IntoxicationNCT05701865
Biphasic Effects of Acute Alcohol Intoxication on Bystander Intervention
A study testing Alcohol Intoxication- Ascending Limb and Alcohol Intoxication- Descending Limb in people with Alcohol Intoxication, run by University of Colorado, Denver at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 21 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Intoxication
- What is being tested?
- Alcohol Intoxication- Ascending Limb and Alcohol Intoxication- Descending Limb
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2023to 15 Aug 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado, Denver
Aurora, Colorado, 80045
About this study
Official title: Biphasic Effects of Acute Alcohol Intoxication on Bystander Intervention for Sexual Violence
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
- Being tested
- Alcohol Intoxication- Ascending Limb, Alcohol Intoxication- Descending Limb, No Alcohol Control
- Medical subject headings
- Alcoholic Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol Intoxication- Ascending LimbBehavioural
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 LimbBehavioural
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 ControlBehavioural
Participants will be assigned to a no alcohol control condition
| Study group | Role | What they receive |
|---|---|---|
| Alcohol Intoxication | Experimental | Participant will receive alcohol, the dose of which will be administered to result in a breath alcohol concentration of .08%. Receives: 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%. Receives: Behavioral: No Alcohol Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 hour post beverage consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start9 Mar 2023
- Primary completion9 Aug 2024
- Study completion15 Aug 2024
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol IntoxicationStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruschelle M Leone, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701865
- Sponsor's protocol ID
- R21AA029225
- Status last verified
- Aug 2026
- First submitted
- 10 Jan 2023
- Last updated
- 15 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available in the NIAAA Data Archive.