Opioid OverdoseRESPONDERNCT07079241
A Model to Save Lives Through a Volunteer First Responder Service Providing Antidote Treatment in Opioid Overdose
A study testing 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 people with Opioid Overdose, run by Region Skane at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Overdose
- What is being tested?
- 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Victim being ≥15 years old
- Any naloxone-responder being up to 10.000 meters from the situation, in Skåne
Who cannot join
- 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.
- Any trauma behind the condition
- Dispatcher impression of the scene to be unsafe for lay persons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Josephine Hansson, Reg nurse, PM contact
Sweden1 site, 1 recruiting
- Recruiting
Malmö Addiction Center
Malmö, Skåne County
About this study
Official title: 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
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.
Read the detailed description
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:
- A quantitative study of feasibility, acceptability and safety of the intervention.
- A quantitative study on mortality post-pilot as primary outcome, and clinical outcome after intervention compared to no intervention as secondary outcome.
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.
- Conditions
- Opioid Overdose
- Being tested
- 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
- Keywords
- Opioid overdose, Community first responder, Volunteer first responder, Medical emergency, Dispatcher, Naloxone, Overdose, Intoxication, Smartphone applications, First responder system, Emergency medical dispatcher
- Medical subject headings
- Opiate Overdose, Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 overdosesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Current regional statistics post-trial and pre-trial.
Measured: 1-2 years from trial start, compared to 1-3 years prior to trial start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Sep 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid OverdoseStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- SOS Alarm Sverige AB, Lund University, Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Anders C Håkansson, MD, prof., Principal investigator, Malmö Addiction Center, Region Skåne, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079241
- Sponsor's protocol ID
- 2024-05887-01
- Acronym
- RESPONDER
- Status last verified
- Jun 2025
- First submitted
- 13 Jul 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rehn J, Andrell C, Hansson J, Troberg K, Isendahl P, Braback M, Svensson L, Byrsell F, Claesson A, Hakansson A. The RESPONDER trial: a feasibility study of an early intervention model deploying community first responders to administer intranasal naloxone in suspected opioid overdoses in Skane, Sweden. BMJ Open. 2026 Jun 28;16(6):e115692. doi: 10.1136/bmjopen-2025-115692.
PubMed 42365998
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07079241
- Acronym / sponsor ID
- RESPONDER / 2024-05887-01
- Conditions
- Opioid Overdose
- Keywords
- Opioid overdose, Community first responder, Volunteer first responder, Medical emergency, Dispatcher, Naloxone, Overdose, Intoxication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- SOS Alarm Sverige AB, Lund University, Karolinska Institutet
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- A quantitative study of feasibility, acceptability and safety of the intervention.
- A quantitative study on mortality post-pilot as primary outcome, and clinical outcome after intervention compared to no intervention as secondary outcome.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Naloxone-responders | Experimental | 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 overdosesNaloxone-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Victim being ≥15 years old
Key exclusion criteria (3 listed)
- 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.
- Any trauma behind the condition
- Dispatcher impression of the scene to be unsafe for lay persons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 overdosesThe 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. | Other | Naloxone-responders |
Primary outcome
Number of successful naloxone-responder alerts to true opioid overdoses
Time frame: 12 months of participation for every registered naloxone-responder
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
Positioning of and acceptability of alerts among naloxone-responders equipped with naloxone in relation to overdose locations
Time frame: Data during 12 months from registration for every naloxone-responder
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
Clinical outcome of overdose victims before versus after the trial
Time frame: Data compared 1.5-2 years post trial start.
Mental and clinical status, morbidity and survival rates from questionaires and medical records during the trial, compared to historic control period.
Safety and acceptability as experienced by naloxone-responders and overdose victims
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.
Experience of being at the scene from two different perspectives, with views collected through questionaires post-alerts and qualitative interviews post-trial.
1 secondary outcome
Mortality rates before versus after the trial
Time frame: 1-2 years from trial start, compared to 1-3 years prior to trial start.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Derived from this study: PubMed 42365998Rehn J, Andrell C, Hansson J, Troberg K, Isendahl P, Braback M, Svensson L, Byrsell F, Claesson A, Hakansson A. The RESPONDER trial: a feasibility study of an early intervention model deploying community first responders to administer intranasal naloxone in suspected opioid overdoses in Skane, Sweden. BMJ Open. 2026 Jun 28;16(6):e115692. doi: 10.1136/bmjopen-2025-115692.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Josephine Hansson, Reg nurse, PM contact
Anders C Håkansson, MD, prof. principal investigator
Malmö Addiction Center, Region Skåne, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Opioid Overdose, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia Rehn, MD, PhD student (+46709464663, julia.rehn@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of successful naloxone-responder alerts to true opioid overdoses (time frame: 12 months of participation for every registered naloxone-responder). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07079241, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.