Background Opioids such as heroin kill more people worldwide than any other drug. Death rates associated with opioid poisoning in the UK are at record levels. Naloxone is an opioid agonist which can be distributed in take home ‘kits’. This intervention is known as Take Home Naloxone (THN).
Methods We propose to carry out a randomised controlled feasibility trial (RCT) of THN distributed in emergency settings clustered by Emergency Department (ED) catchment area, and local ambulance service; with anonymised linked data outcomes. This will include distribution of THN by paramedics and ED staff to patients at risk of opioid overdose. Existing linked data will be used to develop a discriminant function to retrospectively identify people at high risk of overdose death based on observable predictors of overdose to include in outcome follow up.
Results We will gather outcomes up to one year including; deaths (and drug related); emergency admissions; intensive care admissions; ED attendances (and overdose related); 999 attendances (and for overdose); THN kits issued; and NHS resource usage. We will agree progression criteria following consultation with research team members related to sign up of sites; successful identification and provision of THN to eligible participants; successful follow up of eligible participants and opioid decedents; adverse event rate; successful data matching and data linkage; and retrieval of outcomes within three months of projected timeline.
Conclusions THN programmes are currently run by some drug services in the UK. However, saturation is low. There has been a lack of experimental research in to THN, and so questions remain: Does THN reduce deaths? Are there unforeseen harms associated with THN? Is THN cost effective? This feasibility study will establish whether a fully powered cluster RCT can be used to answer these questions.
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