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Opioid Rapid Response System: Naloxone Training in Communities

Developing and Testing the Opioid Rapid Response System

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06238128
Enrollment
773
Registered
2024-02-02
Start date
2024-05-24
Completion date
2025-12-29
Last updated
2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Overdose

Keywords

naloxone training, Community-engagement

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.

Interventions

BEHAVIORALOpioid 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.

BEHAVIORALNon-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.

Sponsors

University of Missouri-Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Knowledge of Overdose Signup to 2 weeksInvestigators 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 Managementup to 2 weeksInvestigators 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 Overdoseup to 2 weeksInvestigators 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 Overdoseup to 2 weeksInvestigators 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 Managementup to 2 weeksInvestigators 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 Communitiesup to 2 weeksInvestigators 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 NarcanUp to 6 monthsSingle item: how many days per week, on average, participants carry Narcn
Number of Participants to Response to Overdose Events From PulsePoint App.Up to 6 monthsSingle item: whether participant response to overdose events from PulsePoint notifications/alerts
Number of Participants to Administer NarcanUp to 6 monthsSingle item: Whether participant administer Narcan to respond opioid overdose events in communities.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORHye Jeong Choi

Univeristy of Missouri

PRINCIPAL_INVESTIGATORMichael Hecht

Real Prevention

Baseline characteristics

Characteristic
Age, Continuous37.25 years
STANDARD_DEVIATION 12.47
Concerns related to overdose management3.55 Score on a 1 to 5 scale
STANDARD_DEVIATION 1.04
Intent to intervene opioid overdose events in communities4.03 Score on a 1 to 5 scale
STANDARD_DEVIATION 0.93
Knowledge of overdose management0.57 Score on a 0 to 1 scale
STANDARD_DEVIATION 0.25
Knowledge of overdose sign0.77 Score on a 0 to 1 scale
STANDARD_DEVIATION 0.18
Race/Ethnicity, Customized
American Indian/Alaska Native
12 Participants
Race/Ethnicity, Customized
Asian or Pacific Islander
27 Participants
Race/Ethnicity, Customized
Bi-Racial or Multi-Racial
56 Participants
Race/Ethnicity, Customized
Black/African American
87 Participants
Race/Ethnicity, Customized
Others/Not reported
29 Participants
Race/Ethnicity, Customized
White/Caucasian American
238 Participants
Response efficacy about intervening opioid overdose70.30 Score on a 0 to 100 scale
STANDARD_DEVIATION 23.62
Self-Efficacy toward intervening opioid overdose50.95 Score on a 0 to 100 scale
STANDARD_DEVIATION 28.4
Sex/Gender, Customized
Man
175 Participants
Sex/Gender, Customized
Others
10 Participants
Sex/Gender, Customized
Woman
196 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 3830 / 390
other
Total, other adverse events
0 / 3830 / 390
serious
Total, serious adverse events
0 / 3830 / 390

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026