Opioid OverdoseNCT06238128

Opioid Rapid Response System: Naloxone Training in Communities

A study testing Opioid Rapid Resonse System (ORRS) training and Non-active opioid overdose response training in people with Opioid Overdose, run by University of Missouri-Columbia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for: Opioid Overdose
What is being tested?: Opioid Rapid Resonse System (ORRS) training and Non-active opioid overdose response training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 773 participants
Where: 1 siteUnited States
Study dates: 24 May 2024to 29 Dec 2025
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 18 to 100 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Citizens who live in participating PulsePoint communities
Must to be 18 and older
Must be fluent in English
Must have access to the mobile data and able to download and use apps in a smartphone

Who cannot join

Citizens who do not live in participating PulsePoint communities
Under 18-year-old
Citizens who are not fluent in English
Citizens who do not have access to mobile data and unable to download and use apps in a smartphone.

Trial locations and contacts

1 site in 1 country.

United States1 site

Ewald & Wasserman Research Consultants, LLC
San Francisco, California, 94104

Other trials in United States

About this study

Official title: Developing and Testing the Opioid Rapid Response System

The pervasive impact of the opioid epidemic has touched all layers of society for the past two decades, resulting in over 115 deaths daily and imposing annual costs of $78.5 billion. Responding swiftly to overdoses, akin to various medical emergencies, poses a significant challenge, particularly in geographically dispersed rural areas and densely populated urban settings. Effectively delivering the life-saving drug naloxone, which counteracts the effects of overdoses, necessitates a well-coordinated and cost-efficient response system.

Simply opting for widespread distribution of naloxone, even with citizen involvement, proves to be a financially burdensome approach when compared to more targeted strategies. Moreover, obstacles such as limited access, inadequate or unavailable naloxone training, and delayed response times from emergency responders compound the problem. Addressing these issues, the proposed Opioid Rapid Response System (ORRS) project seeks to advance prevention science by adopting an innovative approach that incorporates technology and contemporary communication theory.

The primary objective of the ORRS project is to mitigate opioid overdose deaths by enlisting and training citizens to administer naloxone in response to such events. Leveraging the PulsePoint health app, which connects citizens to cardiac events, the ORRS project will extend its capabilities to respond to overdose incidents. This initiative involves comprehensive development of ORRS, followed by a randomized clinical trial on a national scale to assess its effectiveness. The study aims to contribute to both prevention and implementation science by identifying optimal recruitment strategies and testing a model of online training. In pursuit of these objectives, the study is guided by the following Specific Aims:

SA 1: Refine and complete the development of ORRS. SA 2: Conduct a randomized clinical trial to evaluate the effectiveness of the intervention. SA 3: Prepare ORRS for dissemination.

Conditions: Opioid Overdose
Being tested: Opioid Rapid Resonse System (ORRS) training, Non-active opioid overdose response training
Keywords: naloxone training, Community-engagement
Medical subject headings: Opiate Overdose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Opioid Rapid Resonse System (ORRS) trainingBehavioural
ORRS is on online system to train citizen responders to administer NARCAN to save the lives of opioid overdose victims. It capitalizes on the innovative PulsePoint technology to connect responders to overdose events. PulsePoint is an app that connects 911 requesting assistance for cardiac arrests to responders with Cardiopulmonary Resuscitation (CPR) training. ORRS allows us to partner with PulsePoint users to expand its reach to opioid overdoses, which share the need for a quick response that emergency responders are often unable to provide. ORRS has the advantage of expanding the population of responders with NARCAN, rescue breathing, and CPR training that can be connected to overdose events, increasing the likelihood of saving overdose victims' lives through a quick, efficient response. ORRS is delivered through an interactive, digital platform containing sequential, multi-media modules.
Non-active opioid overdose response trainingBehavioural
Investigators will provide online training about opioid prevalence in US, opioid mechanism, side effect, and addiction. However, Investigators do not provide any knowledge about opioid overdose management and naloxone in this training.
Once the project is completed, participants will receive online Naloxone training.

Study groups in NCT06238128
Study group	Role	What they receive
ORRS training group	Experimental	Online Naloxone training Receives: Behavioral: Opioid Rapid Resonse System (ORRS) training
Waitlist group	Sham comparator	Participants will receive non-active opioid overdose response training. Investigators will provide online training about opioid prevalence in US, opioid mechanism, side effect, and addiction. However, Investigators do not provide any knowledge about opioid overdose management and naloxone in this training. Once the project is completed, participants will receive online Naloxone training. Receives: Behavioral: Non-active opioid overdose response training

What is being measured

The primary outcome is the main question the study is designed to answer.

Knowledge of Overdose Sign
Investigators will use a subset of Opioid Overdose Knowledge Scale (OOKS) to measure through a forced choice scale with each choice coded as correct (=1) or incorrect (=0). Higher score indicated greater knowledge of overdose sign.
Measured: up to 2 weeks
Knowledge of Overdose Management
Investigators will use a subset of Opioid Overdose Knowledge Scale (OOKS) to measure through a forced choice scale with each choice coded as correct (=1) or incorrect (=0). Higher score indicated greater knowledge of overdose management.
Measured: up to 2 weeks
Self-Efficacy Toward Intervening Opioid Overdose
Investigators will modify self-efficacy scale developed and theorized by Bandura (2005). Response options are from 0 (no confident) to 100 (highly confident). Higher score indicates greater self-efficacy
Measured: up to 2 weeks
Response Efficacy About Intervening Opioid Overdose
Investigators will develop and measure how participants perceive the effectiveness of activities to intervene opioid overdose events in communities. Response options are from 0 (not effective) to 100 (highly effective). Higher score indicate greater response efficacy.
Measured: up to 2 weeks
Concerns Related to Overdose Management
Investigators will use a subset of Opioid Overdose Attitude Scale (OOAS) with 5 point scale (1: strongly disagree ~5: strongly agree). Higher score indicates the greater concerns.
Measured: up to 2 weeks
Intent to Intervene Opioid Overdose Events in Communities
Investigators will use behavioral intention scale developed by in the opioid training literature (Hecht et al., 2023) to measure intent to intervene opioid overdose events in communities (e.g., administering Narcan). Response options are from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicates grater intention to intervene opioid overdose events in communities.
Measured: up to 2 weeks
The Number of Days Per Week, on Average, to Carry Narcan
Single item: how many days per week, on average, participants carry Narcn
Measured: Up to 6 months
Number of Participants to Response to Overdose Events From PulsePoint App.
Single item: whether participant response to overdose events from PulsePoint notifications/alerts
Measured: Up to 6 months
Number of Participants to Administer Narcan
Single item: Whether participant administer Narcan to respond opioid overdose events in communities.
Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 May 202429 Dec 2025

First posted2 Feb 2024
Study start24 May 2024
Primary completion29 Dec 2025
Study completion29 Dec 2025

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Opioid OverdoseStudies of the same condition, open and under way.
More trials run by University of Missouri-ColumbiaThe 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 773 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06238128
Sponsor's protocol ID: 2097714
Status last verified: Jun 2026
First submitted: 21 Aug 2023
Last updated: 19 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Because this study is funded as a part of NIH HEAL initiative, investigators will follow the HEAL data sharing policy.

Publications

Carr DL, Hecht ML, Shiota MN, Zalake M, Krieger J, Choi HJ. Protocol for a national randomized controlled trial evaluating the Opioid Rapid Response System for overdose death prevention. Contemp Clin Trials. 2025 Mar;150:107835. doi: 10.1016/j.cct.2025.107835. Epub 2025 Feb 3.
PubMed 39909302

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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Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Active, not recruiting
Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone)
Overdose, Implementation as Usual
Not yet recruiting
Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Opioid Overdose (Trial 3 of 3)
Remote vs. In-Person, Remote Visits
Recruiting
Improving Jail Response to the Overdose Crisis: A Hybrid Trial of Jail ECHO to Improve MOUD Implementation and Public Health Outcomes
Opioid Abuse (Disorder)

All Opioid Overdose trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Developing and Testing the Opioid Rapid Response System
ClinicalTrials.gov ID: NCT06238128
Acronym / sponsor ID: 2097714
Conditions: Opioid Overdose
Keywords: naloxone training, Community-engagement
Study type: Interventional
Recruitment status: Completed
Enrolment: 773 participants (actual)
Lead sponsor: University of Missouri-ColumbiaUniversity, hospital or other
Study start: 24 May 2024 (actual)
Primary completion: 29 Dec 2025 (actual)
Study completion: 29 Dec 2025 (actual)
First posted: 2 Feb 2024 (actual)
Results: Posted 7 Jul 2026

Clinical summary

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

SA 1: Refine and complete the development of ORRS. SA 2: Conduct a randomized clinical trial to evaluate the effectiveness of the intervention. SA 3: Prepare ORRS for dissemination.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
ORRS training group	Experimental	Behavioral: Opioid Rapid Resonse System (ORRS) trainingOnline Naloxone training
Waitlist group	Sham comparator	Behavioral: Non-active opioid overdose response trainingParticipants will receive non-active opioid overdose response training. Investigators will provide online training about opioid prevalence in US, opioid mechanism, side effect, and addiction. However, Investigators do not provide any knowledge about opioid overdose management and naloxone in this training. Once the project is completed, participants will receive online Naloxone training.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Citizens who live in participating PulsePoint communities
Must to be 18 and older
Must be fluent in English
Must have access to the mobile data and able to download and use apps in a smartphone

Key exclusion criteria (4 listed)

Citizens who do not live in participating PulsePoint communities
Under 18-year-old
Citizens who are not fluent in English
Citizens who do not have access to mobile data and unable to download and use apps in a smartphone.

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
Opioid Rapid Resonse System (ORRS) trainingORRS is on online system to train citizen responders to administer NARCAN to save the lives of opioid overdose victims. It capitalizes on the innovative PulsePoint technology to connect responders to overdose events. PulsePoint is an app that connects 911 requesting assistance for cardiac arrests to responders with Cardiopulmonary Resuscitation (CPR) training. ORRS allows us to partner with PulsePoint users to expand its reach to opioid overdoses, which share the need for a quick response that emergency responders are often unable to provide. ORRS has the advantage of expanding the population of responders with NARCAN, rescue breathing, and CPR training that can be connected to overdose events, increasing the likelihood of saving overdose victims' lives through a quick, efficient response. ORRS is delivered through an interactive, digital platform containing sequential, multi-media modules.	Behavioural	ORRS training group
Non-active opioid overdose response trainingInvestigators will provide online training about opioid prevalence in US, opioid mechanism, side effect, and addiction. However, Investigators do not provide any knowledge about opioid overdose management and naloxone in this training. Once the project is completed, participants will receive online Naloxone training.	Behavioural	Waitlist group

Primary outcome

Knowledge of Overdose Sign
Time frame: up to 2 weeks
Investigators will use a subset of Opioid Overdose Knowledge Scale (OOKS) to measure through a forced choice scale with each choice coded as correct (=1) or incorrect (=0). Higher score indicated greater knowledge of overdose sign.
Knowledge of Overdose Management
Time frame: up to 2 weeks
Investigators will use a subset of Opioid Overdose Knowledge Scale (OOKS) to measure through a forced choice scale with each choice coded as correct (=1) or incorrect (=0). Higher score indicated greater knowledge of overdose management.
Self-Efficacy Toward Intervening Opioid Overdose
Time frame: up to 2 weeks
Investigators will modify self-efficacy scale developed and theorized by Bandura (2005). Response options are from 0 (no confident) to 100 (highly confident). Higher score indicates greater self-efficacy
Response Efficacy About Intervening Opioid Overdose
Time frame: up to 2 weeks
Investigators will develop and measure how participants perceive the effectiveness of activities to intervene opioid overdose events in communities. Response options are from 0 (not effective) to 100 (highly effective). Higher score indicate greater response efficacy.
Concerns Related to Overdose Management
Time frame: up to 2 weeks
Investigators will use a subset of Opioid Overdose Attitude Scale (OOAS) with 5 point scale (1: strongly disagree ~5: strongly agree). Higher score indicates the greater concerns.
Intent to Intervene Opioid Overdose Events in Communities
Time frame: up to 2 weeks
Investigators will use behavioral intention scale developed by in the opioid training literature (Hecht et al., 2023) to measure intent to intervene opioid overdose events in communities (e.g., administering Narcan). Response options are from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicates grater intention to intervene opioid overdose events in communities.
The Number of Days Per Week, on Average, to Carry Narcan
Time frame: Up to 6 months
Single item: how many days per week, on average, participants carry Narcn
Number of Participants to Response to Overdose Events From PulsePoint App.
Time frame: Up to 6 months
Single item: whether participant response to overdose events from PulsePoint notifications/alerts
Number of Participants to Administer Narcan
Time frame: Up to 6 months
Single item: Whether participant administer Narcan to respond opioid overdose events in communities.

Results and safety

Results posted to the registry on 7 Jul 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
Behavioral: Opioid Rapid Resonse System (ORRS) Training	383	107
Behavioral: Non-active Opioid Overdose Response Training	390	118

Primary outcome: Knowledge of Overdose Sign

Time frame: up to 2 weeks. Mean (Standard Deviation). Unit: scores

Measure	Behavioral: Opioid Rapid Resonse System (ORRS) Training n = 312	Behavioral: Non-active Opioid Overdose Response Training n = 338
Value	0.82 (0.17)	0.78 (0.16)

Behavioral: Opioid Rapid Resonse System (ORRS) Training vs Behavioral: Non-active Opioid Overdose Response Training: p <.001, Regression, Linear

Population analysed: The numbers differ from the numbers assigned in the Participant Flow because some randomized participants did not provide usable outcome data at this assessment.

Primary outcome: Knowledge of Overdose Management

Time frame: up to 2 weeks. Mean (Standard Deviation). Unit: scores

Measure	Behavioral: Opioid Rapid Resonse System (ORRS) Training n = 312	Behavioral: Non-active Opioid Overdose Response Training n = 338
Value	0.83 (0.15)	0.66 (0.21)

Behavioral: Opioid Rapid Resonse System (ORRS) Training vs Behavioral: Non-active Opioid Overdose Response Training: p <.001, Regression, Linear

Population analysed: The numbers differ from the numbers assigned in the Participant Flow because some randomized participants did not provide usable outcome data at this assessment.

Primary outcome: Self-Efficacy Toward Intervening Opioid Overdose

Time frame: up to 2 weeks. Mean (Standard Deviation). Unit: scores

Measure	Behavioral: Opioid Rapid Resonse System (ORRS) Training n = 312	Behavioral: Non-active Opioid Overdose Response Training n = 338
Value	80.12 (18.89)	62.22 (28.52)

Behavioral: Opioid Rapid Resonse System (ORRS) Training vs Behavioral: Non-active Opioid Overdose Response Training: p <.001, Regression, Linear

Population analysed: The numbers differ from the numbers assigned in the Participant Flow because some randomized participants did not provide usable outcome data at this assessment.

Primary outcome: Response Efficacy About Intervening Opioid Overdose

Time frame: up to 2 weeks. Mean (Standard Deviation). Unit: scores

Measure	Behavioral: Opioid Rapid Resonse System (ORRS) Training n = 312	Behavioral: Non-active Opioid Overdose Response Training n = 338
Value	85.66 (17.97)	76.25 (21.53)

Behavioral: Opioid Rapid Resonse System (ORRS) Training vs Behavioral: Non-active Opioid Overdose Response Training: p <.001, Regression, Linear

Population analysed: The numbers differ from the numbers assigned in the Participant Flow because some randomized participants did not provide usable outcome data at this assessment.

Adverse events

Time frame: From enrollment until end of follow-up, up to 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Behavioral: Opioid Rapid Resonse System (ORRS) Training	0 of 383 (0%)	0 of 383 (0%)	0 of 383
Behavioral: Non-active Opioid Overdose Response Training	0 of 390 (0%)	0 of 390 (0%)	0 of 390

Limitations and caveats (from the sponsor): Generalizability may be limited because participants were recruited online from selected regions, which may have introduced coverage and self-selection bias. Substantial loss to follow-up and missing outcome data, including differential attrition across study conditions, may have biased estimated intervention effects. In addition, intranasal naloxone became available over the counter in the United States while the trial was underway, which may have changed the composition of enrolled participant

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39909302Carr DL, Hecht ML, Shiota MN, Zalake M, Krieger J, Choi HJ. Protocol for a national randomized controlled trial evaluating the Opioid Rapid Response System for overdose death prevention. Contemp Clin Trials. 2025 Mar;150:107835. doi: 10.1016/j.cct.2025.107835. Epub 2025 Feb 3.
Individual participant dataSharing planned: Yes. Because this study is funded as a part of NIH HEAL initiative, investigators will follow the HEAL data sharing policy.

Related trials for Opioid Overdose

Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Active, not recruiting
Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone)
Overdose, Implementation as Usual
Not yet recruiting
Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Opioid Overdose (Trial 3 of 3)
Remote vs. In-Person, Remote Visits
Recruiting
Improving Jail Response to the Overdose Crisis: A Hybrid Trial of Jail ECHO to Improve MOUD Implementation and Public Health Outcomes
Opioid Abuse (Disorder)

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.

Hye Jeong Choi principal investigator

Univeristy of Missouri

Michael Hecht principal investigator

Real Prevention

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

Questions about this trial

What is this clinical trial studying?

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 4 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: finished, as of the sponsor's last update on 19 Aug 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. Some participants in this study may receive a placebo. 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 7 Jul 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?

Knowledge of Overdose Sign (time frame: up to 2 weeks). The study lists 9 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 NCT06238128, which also lists 1 linked publication.

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 19 Aug 2026.