The RESPONDER trial: A feasibility study of an early intervention model deploying community first responders to administer intranasal naloxone in suspected opioid overdoses

IntroductionOpioid 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 programs 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 analysisThe feasibility trial RESPONDER (REgion Sk[a]ne Preventing Overdose 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 dispatch of regular emergency medical services (EMS). The aim is to investigate if trained CFRs can successfully recognize 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 Sk[a]ne, Sweden, between September 1st, 2025, and August 31st, 2027, with every CFR followed for up to 12 months. Ethics and disseminationThe 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 regions communication channels, and within public transportation hubs. Outcomes and analyses will be submitted to peer-reviewed journals. ConclusionSafe, early and effective management of opioid overdoses by trained CFRs prior to EMS arrival may reduce morbidity and mortality among people who use opioids. Findings from the current trial may contribute to further knowledge on how to implement and improve CFR systems for opioid overdoses globally. ClinicalTrials.gov-ID: NCT07079241. Article SummaryO_ST_ABSStrengths and limitations of this studyC_ST_ABS- The RESPONDER trial introduces a novel community first responder system for time-critical opioid overdose reversal in addition to out-of-hospital cardiac arrest. - The trial aims to enhance access to naloxone and raise community awareness, improving the likelihood of early and potentially life-saving overdose reversal. - A study-specific course introduces a novel naloxone algorithm which has been developed by expertise in the fields of resuscitation, First Aid and opioid use disorder. - The study group consists of researchers and clinicians with a broad range of expertise concerning opioid overdose management, substance use disorders, First Aid education, emergency medical services, emergency medical dispatch centre operations and community first responder systems, adding several in-depth perspectives to this community first responder model. - A limitation may be that overdose events unreported to emergency dispatch centres will not reach the trials community first responders.