[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599034":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":48,"collaborators":50,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":19,"enrollmentInfo":69,"targetDuration":19,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":37,"whyStopped":19,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Region Skane","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"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",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"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.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Anders C Håkansson, MD, prof.","Malmö Addiction Center, Region Skåne, Sweden","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Julia Rehn, MD, PhD student","CONTACT","+46709464663","julia.rehn@med.lu.se",{"name":32,"role":28,"phone":19,"phoneExt":19,"email":33},"Josephine Hansson, Reg nurse, PM","josephine.hansson@skane.se",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":19,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":19},"Malmö Addiction Center","RECRUITING","Malmö","Skåne County","Sweden","SE",{"type":43,"coordinates":44},"Point",[45,46],13.00073,55.60587,{"lat":46,"lon":45},{"type":49,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[51,54,56],{"name":52,"class":53},"SOS Alarm Sverige AB","UNKNOWN",{"name":55,"class":6},"Lund University",{"name":57,"class":6},"Karolinska Institutet","100599034","a-model-to-save-lives-through-a-volunteer-first-responder-service-providing-antidote-treatment-in-opioid-overdose-100599034",false,"NCT07079241","A Model to Save Lives Through a Volunteer First Responder Service Providing Antidote Treatment in Opioid Overdose","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","RESPONDER","Inclusion Criteria for volunteer first responder:\n\n1. Give informed written consent to participate in the study\n2. 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.\n3. Download and register oneself as a user on the project-specific volunteer first responder app on a smartphone\n4. Purchase naloxone from a pharmacy and receive reimbursement for the full cost of the purchase upon submission of the pharmacy receipt\n\nExclusion Criteria for volunteer first responder:\n\n1\\. 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.\n\nInclusion Criteria for overdose alerts:\n\n1. Victim being ≥15 years old\n2. Any naloxone-responder being up to 10.000 meters from the situation, in Skåne\n\nExclusion Criteria for overdose alerts:\n\n1. Any trauma behind the condition\n2. Dispatcher impression of the scene to be unsafe for lay persons",true,"ALL","18 Years",{"count":70,"type":71},1000,"ESTIMATED","INTERVENTIONAL",[74],"NA","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.\n\nOur 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\u002Fparamedical 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.\n\nOur 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.",[77],"Opioid Overdose",[79,80,81,82,83,84,85,86,87,88,89],"Opioid overdose","Community first responder","Volunteer first responder","Medical emergency","Dispatcher","Naloxone","Overdose","Intoxication","Smartphone applications","First responder system","Emergency medical dispatcher","2025-12-16",{"date":92,"type":93},"2025-12-17","ACTUAL",{"date":95,"type":93},"2025-09-01",{"date":97,"type":71},"2027-08-31",{"name":5,"class":6},1]