The RESPONDER trial: a feasibility study of an early intervention model deploying community first responders to administer intranasal naloxone in suspected opioid overdoses in Skåne, Sweden
Julia Rehn, Cecilia Andréll, Josephine Hansson, Katja Troberg, Pernilla Isendahl, Martin Bråbäck, Leif Svensson, Fredrik Byrsell, Andreas Claesson, Anders HåkanssonIntroduction
Opioid use continues to cause harm and fatalities worldwide, despite ongoing preventive efforts. Early administration of the antidote naloxone can reverse potentially fatal opioid overdoses. Naloxone distribution programmes have increased survival across regions; however, additional efforts are needed to reduce opioid overdose mortality. One approach is to expand naloxone availability within communities.
Methods and analysis
The feasibility trial RESPONDER (REgion Skåne Preventing Overdose deaths through Naloxone Distribution with Emergency Runners) introduces a unique smartphone alerting system with community first responders (CFRs) dispatched to suspected opioid overdoses, in addition to the dispatch of regular emergency medical services (EMS). The aim is to investigate if trained CFRs can successfully recognise and reverse overdoses caused by opioids, prior to EMS arrival. The CFRs will be equipped with nasal naloxone and introduced to a novel naloxone algorithm during a study-specific course prior to participation. The course will offer practical training in basic life support and first aid, and it will also assess competence in the low-arousal approach, as well as the legal and ethical aspects of being a CFR.
Main outcomes of the trial are feasibility, acceptability and safety. The trial will be performed in the region of Skåne, Sweden, between 1 September 2025 and 31 August 2027, with every CFR followed for up to 12 months.
Ethics and dissemination
The trial has been approved by the Swedish Ethical Review Authority (file number 2024–05887-01). Written informed consent is required from participating CFRs. This is also required of overdose survivors to allow the collection of clinical data from hospital records.
Information regarding the project and recruitment will be disseminated via social media, news media, through the healthcare region’s communication channels and within public transportation hubs. Outcomes and analyses will be submitted to peer-reviewed journals.
ClinicalTrials.gov-ID