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Recruiting NCT07079241

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

Trial Parameters

Condition Opioid Overdose
Sponsor Region Skane
Study Type INTERVENTIONAL
Phase N/A
Enrollment 1,000
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-09-01
Completion 2027-08-31
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

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.

Eligibility Criteria

Inclusion Criteria for volunteer first responder: 1. Give informed written consent to participate in the study 2. 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. 3. Download and register oneself as a user on the project-specific volunteer first responder app on a smartphone 4. Purchase naloxone from a pharmacy and receive reimbursement for the full cost of the purchase upon submission of the pharmacy receipt Exclusion Criteria for volunteer first responder: 1\. 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. Inclusion Criteria for overdose alerts: 1. Victim being ≥15 years old 2. Any naloxone-res

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