Opioid Rapid Response System: Naloxone Training in Communities

NCT ID: NCT06238128

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

773 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-24

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Opioid Overdose

Keywords

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naloxone training Community-engagement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ORRS training group

Online Naloxone training

Group Type EXPERIMENTAL

Opioid Rapid Resonse System (ORRS) training

Intervention Type BEHAVIORAL

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.

Waitlist group

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.

Group Type SHAM_COMPARATOR

Non-active opioid overdose response training

Intervention Type BEHAVIORAL

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.

Interventions

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Opioid Rapid Resonse System (ORRS) training

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Hye Jeong Choi

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hye Jeong Choi

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Missouri

Michael Hecht

Role: PRINCIPAL_INVESTIGATOR

Real Prevention

Locations

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Ewald & Wasserman Research Consultants, LLC

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39909302 (View on PubMed)

Other Identifiers

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2097714

Identifier Type: -

Identifier Source: org_study_id