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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07079241

Feasibility Study of a Smartphone-Based Volunteer First Responder System Providing Naloxone Treatment for Suspected Opioid Overdoses

Led by Region Skane · Updated on 2025-12-17

1000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

R

Region Skane

Lead Sponsor

S

SOS Alarm Sverige AB

Collaborating Sponsor

AI-Summary

What this Trial Is About

Opioid overdose causes significant global health problems, and while prevention and treatment programs exist, more efforts are needed to reduce deaths and complications. This research evaluates a novel smartphone-based volunteer first responder system integrated with national emergency call services to assist suspected opioid overdoses. The system aims to alert trained volunteers equipped with naloxone, an opioid antidote, to provide early treatment before emergency medical services arrive, potentially saving lives by reducing the time to naloxone administration. Volunteer responders, called naloxone-responders, will complete training in opioid overdose recognition, naloxone use, and first aid based on European and Swedish guidelines. They will also learn low-arousal communication techniques for interacting with overdose victims. Each responder receives a kit with two doses of nasal naloxone and will be registered on a dedicated responder smartphone app. The study includes a two-year pilot phase with one-year follow-up per participant, along with multiple sub-studies examining feasibility, safety, acceptability, mortality, and experiences of responders and overdose survivors. Participants will be monitored through questionnaires, app data, and medical records from dispatchers, paramedics, and hospitals. The primary outcomes include the number of successful naloxone responder alerts, responder acceptability, clinical outcomes of overdose victims, and safety experiences during alerts. Mortality rates before and after the trial will also be analyzed. The study runs from September 2025 to August 2027, assessing both short- and long-term effects of integrating volunteer responders with emergency medical dispatch.

CONDITIONS

Brief Title

A Model to Save Lives Through a Volunteer First Responder Service Providing Antidote Treatment in Opioid Overdose

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Give informed written consent to participate in the study
  • Successfully complete an opioid overdose and naloxone course plus a first aid course following current guidelines
  • Download and register as a user on the volunteer first responder smartphone app
  • Purchase naloxone from a pharmacy and submit the receipt for reimbursement
  • Overdose victim must be 15 years or older for alerts
  • Naloxone-responders must be within 10,000 meters of the overdose situation in Skåne
Not Eligible

You will not qualify if you...

  • Display inappropriate behavior during the education or training sessions
  • Presence of trauma behind the overdose condition
  • Dispatcher assesses the scene as unsafe for lay persons

Research Team

J

Julia Rehn, MD, PhD student

J

Josephine Hansson, Reg nurse, PM

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