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

NCT07079241 | Recruiting

• 1 other identifier: 2024-05887-01
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Opioid Overdose

Keywords

Opioid overdose; Community first responder; Volunteer first responder; Medical emergency; Dispatcher; Naloxone; Overdose; Intoxication; Smartphone applications; First responder system; Emergency medical dispatcher

Outcome Measures

Primary Outcomes (4)

• Number of successful naloxone-responder alerts to true opioid overdoses

  Emergency calls with dispatchers' activation of alerts to naloxone-responders who manage to administer naloxone in situations of true opioid overdoses prior to EMS arrival

  12 months of participation for every registered naloxone-responder

• Positioning of and acceptability of alerts among naloxone-responders equipped with naloxone in relation to overdose locations

  Distance between naloxone-responders and emergency scenes when receiving alerts and the frequency of accepting or rejecting the notification among responders with versus without their naloxone-kit on hand

  Data during 12 months from registration for every naloxone-responder

• Clinical outcome of overdose victims before versus after the trial

  Mental and clinical status, morbidity and survival rates from questionaires and medical records during the trial, compared to historic control period.

  Data compared 1.5-2 years post trial start.

• Safety and acceptability as experienced by naloxone-responders and overdose victims

  Experience of being at the scene from two different perspectives, with views collected through questionaires post-alerts and qualitative interviews post-trial.

  Ongoing during the trial period of one year for every naloxone-responder and overdose victim during the time. A second survey 12-months post-registration for every naloxone-responder.

Secondary Outcomes (1)

• Mortality rates before versus after the trial

  1-2 years from trial start, compared to 1-3 years prior to trial start.

Study Arms (1)

Naloxone-responders

EXPERIMENTAL

Naloxone-responder is the name of a volunteer first responder who participate in the study. These participants will fulfill a pre-registration course on overdose and opioid recognition, naloxone usage and first aid education following European and national guidelines. The participants will also be educated in low-arousal approaches to beneficially meet and communicate with potential overdose victims. Naloxone-responders will be equipped with a kit containing two doses of nasal naloxone and registered as active users on the unique RESPONDER application. Minimum age is 18 years old to become a responder.

Other: Naloxone-responder: A volunteer first responder system connected to emergency dispatch service and alerting overdose and first aid educated volunteers with naloxone to suspected opioid overdoses

Interventions

Naloxone-responder: A volunteer first responder system connected to emergency dispatch service and alerting overdose and first aid educated volunteers with naloxone to suspected opioid overdoses OTHER

The model is a smartphone-based alert system with an app which is connected to dispatcher centers. Volunteer first responders will be alerted in addition to standard emergency medical service (like ambulance) to suspected opioid overdoses and also cardiac arrests. The aim is to see if volunteers equipped with naloxone and with up-do-date knowledge of overdose treatment and first aid can arrive and reverse the condition safely prior to emergency service arrival.

Naloxone-responders

Eligibility Criteria

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

You may qualify if:

• Give informed written consent to participate in the study
• Successfully complete an opioid overdose and naloxone course in addition to a first aid course, following current first aid guidelines from the Swedish Resuscitation Council and the European Resuscitation Council.
• Download and register oneself as a user on the project-specific volunteer first responder app on a smartphone
• Purchase naloxone from a pharmacy and receive reimbursement for the full cost of the purchase upon submission of the pharmacy receipt

You may not qualify if:

• \. Displaying inappropriate behavior during the education day (or otherwise in time, as witnessed or experienced by course instructors or the project team). Such conduct could for example be to not follow the guidelines of low-arousal (non-confrontational) approach in emergencies.
• Victim being ≥15 years old
• Any naloxone-responder being up to 10.000 meters from the situation, in Skåne
• Any trauma behind the condition
• Dispatcher impression of the scene to be unsafe for lay persons

Sponsors & Collaborators

• Region Skane: lead
• SOS Alarm Sverige AB: collaborator
• Lund University: collaborator
• Karolinska Institutet: collaborator

Study Sites (1)

Malmö Addiction Center

Malmo, Skåne County, Sweden

RECRUITING

MeSH Terms

Conditions

Opiate Overdose; Drug Overdose

Condition Hierarchy (Ancestors)

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

Study Officials

• Anders C Håkansson, MD, prof.

  Malmö Addiction Center, Region Skåne, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Rehn, MD, PhD student

CONTACT

+46709464663; julia.rehn@med.lu.se

Josephine Hansson, Reg nurse, PM

CONTACT

josephine.hansson@skane.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: July 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)