Take home naloxone intervention in multicentre emergency settings

INTERVENTION: This is a feasibility study for an RCT of Take Home Naloxone (THN) in emergency settings clustered by emergency department (ED) catchment area and local ambulance service. Anonymised linked data outcomes will be captured for trial participants and their peers, and aggregate outcomes at general population level. The trialists will also collect qualitative data to examine implementation, patient safety and experience. The four sites to be randomly allocated to study arms are: Bristol: Bristol Royal Infirmary & associated ambulance service catchment area Hull: Hull Royal Infirmary & associated ambulance service catchment area Sheffield: Northern General Hospital Sheffield & associated ambulance service catchment area Wrexham: Wrexham Maelor Hospital & associated ambulance service catchment area It was agreed that the randomisation would be stratified to ensure that the two sites served by the Yorkshire Ambulance Service would be in different study arms; this reduced the randomisation options to four, as listed below: Option A: Intervention: Wrexham, Sheffield Control: Bristol, Hull Option B: Intervention: Bristol, Hull Control: Wrexham, Sheffield Option C: Intervention: Bristol, Sheffield Control: Wrexham, Hull Option D: Intervention: Wrexham, Hull Control: Bristol, Sheffield Four identical opaque envelopes, each containing one option, were prepared, presented to a person not involved in their preparation, and one selected at random. The chosen envelope contained Option B, so that the proposed allocation is: Intervention: Bristol, Hull Control: Wrexham, Sheffield The THN intervention will consist of training for participating paramedics and ED staff; a protocol for the supply of THN kits to those eligible for the intervention; a single use THN kit (ampoule of Naloxone Hydrochloride 400 micrograms/ml solution for intramuscular injection and syringe; and instructions on how to correctly administer the naloxone dose and provide basic life support in event of over CONDITION: Opioid overdose ; Injury, Occupational Diseases, Poisoning ; Other opioids PRIMARY OUTCOME: Mortality (total and opioid overdose related), collected using anonymised data linkage at a single time point 12 months post intervention SECONDARY OUTCOME: Collected using anonymised data linkage at a single time point 12 months post intervention:; 1. Emergency admissions; 2. ITU admissions; 3. ED attendances (total and opioid overdose related); 4. 999 attendances (total and opioid overdose related); 5. THN kits issued; 6. NHS resource usage INCLUSION CRITERIA: Eligible for intervention: Adult (18 years of age or over, male or female) opioid users at risk of overdose who are attended by emergency ambulance paramedic or who attend ED Accompanying friends, relatives or carers (18 years of age or over, male or female) of opioid users at risk of overdose who are attended by emergency ambulance paramedic or who attend ED Eligible for inclusion in outcome follow up and analyses: High risk peers (18 years of age or over, male or female) ‐ opioid users at high risk of fatal opioid overdose who make up a wider peer group who may or may not make contact with emergency services at study site during the study period