[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"naloxone\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:naloxone":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100535421","phase-2-naloxone-for-opioid-associated-out-of-hospital-cardiac-arrest-100535421",false,"NCT06251609","Naloxone for Opioid Associated Out of Hospital Cardiac Arrest","NOPACA","Inclusion Criteria:\n\nPatients will be eligible if all the following criteria are met:\n\n• Adults (age ≥ 18 years) in OHCA per EMS protocol. ACLS interventions have been initiated by EMS: chest compressions, ventilation; • 1st dose of epinephrine given via IV or IO.\n\n•. At risk of OA-OHCA (EMS presumed drug-related OHCA or NACARDI positive for occult OA-OHCA) as described above.\n\nExclusion Criteria:\n\n* EMS plans to administer naloxone, or administration of naloxone by EMS during the same encounter\n* Cardiac arrest apparently caused by trauma, choking, or drowning.\n* Known or apparent pregnancy\n* Patient experiences ROSC prior to study drug administration\n* Prior inclusion in the study\n* Patient has an opt out bracelet or family member states exclusion •. Children less than 18 years old","ALL","18 Years",{"count":19,"type":20},98,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The investigator's long-term goal is to conduct Naloxone for Opioid Associated out of Hospital Cardiac Arrest (NOPACA), a randomized, double blind, controlled trial to determine the efficacy of naloxone vs. placebo in Opioid Associated out of Hospital Cardiac Arrest. The investigative team plan to randomize patients in OHCA to early naloxone administration vs. placebo after initial resuscitation and measure ROSC and survival. Challenges to designing NOPACA include uncertainty regarding: 1) the available pool of participants and number of EMS agencies needed to meet enrollment targets; 2) acceptability among patients, EMS and Emergency Medicine provider stakeholders, and 3) estimates of the study outcomes needed for sample size estimates. Toward obtaining the necessary information to design NOPACA, the investigators propose a pilot RCT of participants at high risk for OA-OHCA to verify a reasonable recruitment rate; treatment fidelity and acceptability; and adequate retention and measurement of outcomes at follow up. The investigators propose incorporating hypothesis testing of the feasibility outcomes to determine progression to a definitive trial.",[26,27,28],"Heart Arrest, Out-Of-Hospital","Opioid Overdose","Naloxone","NOT_YET_RECRUITING","2025-03-07",{"date":32,"type":33},"2025-03-10","ACTUAL",{"date":35,"type":20},"2026-11",{"date":37,"type":20},"2028-12-31",{"name":39,"class":40},"University of California, San Francisco","OTHER"]