Opioid Rapid Response System: Naloxone Training in Communities

NCT06238128 | Completed

• 1 other identifier: 2097714
• Study Type: interventional
• Target: 773
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

naloxone training; Community-engagement

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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

  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.

  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.

  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.

  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

  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

  Up to 6 months

• Number of participants to administer Narcan

  Single item: Whether participant administer Narcan to respond opioid overdose events in communities.

  Up to 6 months

Study Arms (2)

ORRS training group

EXPERIMENTAL

Online Naloxone training

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.

Behavioral: Non-active opioid overdose response training

Interventions

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.

ORRS training group

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.

Waitlist group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

Ewald & Wasserman Research Consultants, LLC

San Francisco, California, 94104, United States

Location

Related Publications (1)

• 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.

  PMID: 39909302 DERIVED

MeSH Terms

Conditions

Opiate Overdose

Condition Hierarchy (Ancestors)

Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders

Study Officials

• Hye Jeong Choi

  Univeristy of Missouri

  PRINCIPAL INVESTIGATOR

• Michael Hecht

  Real Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: February 2, 2024
• Study Start: May 24, 2024
• Primary Completion: December 29, 2025
• Study Completion: December 29, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: When project is completed.

Locations

US (1)