Summary
Take home naloxone intervention in multicentre emergency settings
Funder: NIHR
Background and study aims
People who take opioid drugs such as heroin can overdose. The number of people who die this way is increasing, with tragic consequences for families, friends and communities. Naloxone is a drug that can reverse the effects of opioid overdose. Emergency ambulance staff and doctors in the Emergency Department regularly give drug users naloxone, but some people die before they reach emergency medical services. There are schemes in the UK and internationally where naloxone is given to drug users to give to others in an emergency. This is called ‘Take Home Naloxone’ (THN). It is not known whether THN saves lives. There are some concerns that it could encourage risk-taking behaviour, with the drug user feeling that they have a ‘safety net’ and can take a higher dose. The aim of this study is to see whether it is possible for ambulance paramedics and Emergency Department staff to give out THN kits to drug users they see, and to see if it is possible to collect data to find out whether it reduces deaths from overdose.
Who can participate?
Adult (aged 18 or over) opioid users at risk of overdose who are attended by emergency ambulance paramedic or who attend ED, and their accompanying friends, relatives or carers.
What does the study involve?
This study is carried out in two areas where THN is given to patients who have overdosed or who are at risk of overdose, and two other areas where THN kits are not given out (treatment as usual). It is very difficult to follow up these patients because they don’t respond to phone calls or may have no fixed address, therefore this study follows what happens to patients using the routine information which health services already collect about everyone they see. Information is collected about deaths, overdoses, emergency ambulance calls and emergency department attendances and admissions up to 1 year after the patients are seen. These figures are compared between the areas which give out THN and the areas which do not. Interviews are also carried out to find out about the experiences and views of patients receiving THN and staff who give out the kits.
What are the possible benefits and risks of participating?
If this study shows it is possible to give out THN kits through emergency services, and that data can be collected about the effects, a larger study will be carried out to find out whether THN reduces deaths. THN is known to have the potential to save lives on an individual basis, but on an aggregate level the benefits and harms are unknown, which is the reason for this study. There are no participant incentives on offer due to the study design.
Where is the study run from?
1. Bristol Royal Infirmary (UK)
2. Hull Royal Infirmary (UK)
3. Northern General Hospital Sheffield (UK)
4. Wrexham Maelor Hospital (UK)
When is the study starting and how long is it expected to run for?
March 2018 to July 2022 (updated 19/07/2021, previously: November 2020)
Patient Privacy Notice
Please click here for the study’s patient privacy notice.
Contact Details
Trial Manager / Lead Contact: Matthew Jones
Email: m.b.jones@swansea.ac.uk
ISCRTN Number: 13232859; IRAS ID: 248818;