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Opioid Rapid Response System: Naloxone Training in Communities

University of Missouri (MU) logo

University of Missouri (MU)

Status

Completed

Conditions

Opioid Overdose

Treatments

Behavioral: Non-active opioid overdose response training
Behavioral: Opioid Rapid Resonse System (ORRS) training

Study type

Interventional

Funder types

Other

Identifiers

NCT06238128
2097714

Details and patient eligibility

About

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.

Enrollment

773 patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

773 participants in 2 patient groups

ORRS training group
Experimental group
Description:
Online Naloxone training
Treatment:
Behavioral: Opioid Rapid Resonse System (ORRS) training
Waitlist group
Sham Comparator group
Description:
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.
Treatment:
Behavioral: Non-active opioid overdose response training

Trial contacts and locations

1

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Central trial contact

Michael Hecht; Hye Jeong Choi

Data sourced from clinicaltrials.gov

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