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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ORRS training group | Experimental | Online Naloxone 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid Rapid Resonse System (ORRS) training | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hye Jeong Choi | Univeristy of Missouri | Principal Investigator |
| Michael Hecht | Real Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ewald & Wasserman Research Consultants, LLC | San Francisco | California | 94104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39909302 | Derived | 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. |
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Because this study is funded as a part of NIH HEAL initiative, investigators will follow the HEAL data sharing policy.
When project is completed.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 26, 2026 | Jun 26, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000083682 | Opiate Overdose |
| ID | Term |
|---|---|
| D062787 | Drug Overdose |
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D019966 | Substance-Related Disorders |
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|
| Non-active opioid overdose response training | 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. |
|
| D064419 |
| Chemically-Induced Disorders |
| D009293 | Opioid-Related Disorders |
| D000079524 | Narcotic-Related Disorders |
| D001523 | Mental Disorders |