Actively Recruiting
REgion Skåne Preventing Overdose Through Naloxone Distribution With Emergency Runners: a Feasibility Study for 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
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
Eligibility Criteria
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for course completion and registration
Duration - 12 months of active participation
Participants complete training courses on opioid overdose recognition, naloxone usage, and first aid, then become active volunteer responders equipped with naloxone and a smartphone app to respond to suspected opioid overdoses.
Ongoing use of the responder app and naloxone kit during the 12 months
Duration - 12 months post-participation follow-up
Participants and overdose victims are surveyed to assess safety, acceptability, and clinical outcomes during and up to 12 months after participation.
1 to 2 surveys after participation
Trial Site Locations
Total: 1 location
1
Malmö Addiction Center
Malmö, Skåne County, Sweden
Actively Recruiting
Research Team
J
Julia Rehn, MD, PhD student
J
Josephine Hansson, Reg nurse, PM
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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