Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT07079241

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

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

1000

Participants Needed

1

Research Sites

104 weeks

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

Opioids are responsible for the greatest drug-related global health burden. Prevention and treatment programs for people with opioid use disorder are widely implemented, but further actions are required to reduce the mortality and morbidity caused by opioid use and dependence. We suggest a novel and unique approach with a volunteer first responder system for suspected opioid overdoses, integrated with national emergency call services. The idea derives from the success of volunteer first responder systems for out-of-hospital cardiac arrests. Several reports exist globally with results of increased survival rates, less complications and a beneficial time-gain to start of cardiopulmonary resuscitation before emergency services (like ambulance and fire fighters) arrival. Our model aims to investigate feasibility, acceptability and safety of a smartphone-based volunteer first responder system for suspected opioid overdoses. The volunteer responders will be equipped with an emergency kit including two doses of the opioid antidote naloxone, which can reverse life-threatening respiratory arrest caused by intoxication of opioids. The responders will, prior to registration, accomplish an in-depth overdose and naloxone education, as well as a first aid course aligned with current European and Swedish resuscitation guidelines. The results will be collected through questionnaires to the responder participants, technical data from the responder application, and dispatcher, pre-medical/paramedical and hospital records among others. Both quantitative and qualitative methods will be used. The major question is if the model is feasible in alerting lay persons with naloxone to suspected overdose situations and successfully administer naloxone prior to emergency service arrival. Furthermore, experiences of safety during alerts among volunteer first responders and overdose victims will also be studied. Our model is unique in its integration with emergency medical dispatch service along with overdose and first aid education prior to participant registration. The respiratory arrest of opioids is an acute life-threatening condition, which - in similarity to cardiac arrests - need emergent actions for survival. A reduced time to naloxone administration through volunteer first responders prior to ambulance arrival could save lives.

CONDITIONS

Official 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...

  • Provide informed written consent to participate in the study
  • Successfully complete an opioid overdose and naloxone course plus a first aid course following current Swedish and European guidelines
  • Download and register on the project-specific volunteer first responder smartphone app
  • Purchase naloxone from a pharmacy and submit the receipt for full reimbursement
  • Overdose victim must be at least 15 years old
  • Volunteer naloxone-responders located within 10,000 meters of the overdose in Skåne region
Not Eligible

You will not qualify if you...

  • Display inappropriate behavior during the education or training sessions, such as not following low-arousal, non-confrontational emergency guidelines
  • Overdose events caused by trauma
  • Emergency scene judged unsafe for lay responders by medical dispatchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Malmö Addiction Center

Malmö, Skåne County, Sweden

Actively Recruiting

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Research Team

J

Julia Rehn, MD, PhD student

CONTACT

J

Josephine Hansson, Reg nurse, PM

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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