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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Other trials in United States

About this study

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

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 groups in NCT05701865
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.

9 Mar 202315 Aug 2024

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)

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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Biphasic Effects of Acute Alcohol Intoxication on Bystander Intervention for Sexual Violence
ClinicalTrials.gov ID: NCT05701865
Acronym / sponsor ID: R21AA029225
Conditions: Alcohol Intoxication
Study type: Interventional
Recruitment status: TerminatedReason 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.
Enrolment: 153 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Study start: 9 Mar 2023 (actual)
Primary completion: 9 Aug 2024 (actual)
Study completion: 15 Aug 2024 (actual)
First posted: 27 Jan 2023 (actual)
Results: Posted 15 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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?

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Alcohol Intoxication	Experimental	Behavioral: Alcohol Intoxication- Ascending Limb, Behavioral: Alcohol Intoxication- Descending LimbParticipant will receive alcohol, the dose of which will be administered to result in a breath alcohol concentration of .08%.
No-Alcohol Control	Active comparator	Behavioral: No Alcohol ControlParticipant will receive a no alcohol control beverage, therefore their breath alcohol concentration will be .00%.

Who may qualify

Ages: 21 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Alcohol Intoxication- Ascending LimbParticipants 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	Behavioural	Alcohol Intoxication
Alcohol Intoxication- Descending LimbParticipants 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	Behavioural	Alcohol Intoxication
No Alcohol ControlParticipants will be assigned to a no alcohol control condition	Behavioural	No-Alcohol Control

Primary outcome

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.
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.

Results and safety

Results posted to the registry on 15 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Alcohol Intoxication, Ascending Limb	52	52
No-Alcohol Control	50	50
Alcohol Intoxication, Descending Limb	51	51

Primary outcome: Number of Participants With Articulated Thoughts of Barriers to Bystander Intervention

Time frame: 1 hour post beverage consumption. Count of participants. Unit: Participants

Measure	Alcohol Intoxication, Ascending Limb n = 45	No-Alcohol Control n = 46	Alcohol Intoxication, Descending Limb n = 44
Step 1- Absence or presence of noticing the situation: Failure to Notice the Situation	6	6	5
Step 1- Absence or presence of noticing the situation: Noticed the Situation	39	40	39
Step 1- Absence or presence of noticing the situation: Failure to Interpret the Situation as Risky or Concerning	0	0	0
Step 1- Absence or presence of noticing the situation: Interpreted the Situation as Risky or Concerning	0	0	0
Step 1- Absence or presence of noticing the situation: Failure to Take Responsibility	0	0	0
Step 1- Absence or presence of noticing the situation: Took Responsibility	0	0	0
Step 1- Absence or presence of noticing the situation: Failure to Know What to Do	0	0	0
Step 1- Absence or presence of noticing the situation: Knew What to Do	0	0	0

Population analysed: The number of participants assigned to the arms in the Participant Flow represent the number of participants consented and randomized to a condition. The numbers reported here for analysis include the usable transcripts from those participants, as not all transcripts were usable upon review. For the Outcome Measure Data Table below, certain categories were only observed for certain steps.

Primary outcome: Number of Participants That Articulated Thoughts of Intentions to Intervene as a Bystander

Time frame: 1 hour post beverage consumption. Count of participants. Unit: Participants

Measure	Alcohol Intoxication, Ascending Limb n = 45	No-Alcohol Control n = 46	Alcohol Intoxication, Descending Limb n = 44
Value	45	46	43

Adverse events

Time frame: Up to 8 hours. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alcohol Intoxication, Ascending Limb	0 of 52 (0%)	0 of 52 (0%)	0 of 52
No-Alcohol Control	0 of 50 (0%)	0 of 50 (0%)	0 of 50
Alcohol Intoxication, Descending Limb	0 of 51 (0%)	0 of 51 (0%)	0 of 51

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. IPD will be available in the NIAAA Data Archive.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ruschelle M Leone, PhD principal investigator

University of Colorado, Denver

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Articulated Thoughts of Barriers to Bystander Intervention (time frame: 1 hour post beverage consumption). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05701865.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.