An interventional study of 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 in Opioid Overdose, sponsored by Region Skane. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by Region Skane · Not applicable, Interventional, and Other
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.
The accuracy of opioid overdose recognition among medical dispatchers is as of today an underexplored field. The risk of naloxone-responders being alerted to other medical emergencies than opioid overdoses is as a consequence unknown. The first aid course aims to improve the knowledge and emergency management of responders who get alerted to false positive opioid overdoses, while the naloxone and overdose in-depth education aims to help responders to properly identify and manage true overdoses.
Naloxone reverses opioid effects temporally, which calls for prolonged medical assistance with observation and sometimes repeated doses of naloxone at the hospital. The integration of naloxone-responder alerts and emergency medical service dispatching when bystander call the national emergency number is therefore a model with both short- and long-term management of overdose conditions.
The RESPONDER trial is a two-year pilot project with a one-year follow-up of each registered participant, so called naloxone-responder. At least four different follow-up sub-studies will be performed during and 1-2 years after the pilot period:
3 and 4. Two qualitative studies exploring the experiences of: A. receiving naloxone from a naloxone-responder, from the overdose survivors' point of view, and B. accepting overdose alerts as a naloxone-responder, respectively.
70 studies on the registry are indexed under Opiate Overdose; 11 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 184 across 48 interventional studies indexed under Opiate Overdose.
Browse Opiate Overdose studies →Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for volunteer first responder:
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:
Exclusion Criteria for overdose alerts:
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
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.
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Mortality rates before versus after the trial
Current regional statistics post-trial and pre-trial.
Time frame: 1-2 years from trial start, compared to 1-3 years prior to trial start.
Plan to share: No
Started Sep 2025 (actual). Primary completion is estimated for Aug 2027, 23 months after the start.
Of 28 interventional studies with no phase under Opiate Overdose, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 41. This study's planned 23 months is below that.
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