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Area of Science:

  • Public Health
  • Emergency Medicine
  • Pharmacology

Background:

  • Opioid overdose deaths, particularly from heroin, are a global crisis with record levels in the UK.
  • Take-home naloxone (THN) kits are distributed to witnesses for overdose emergencies, saving lives individually.
  • Limited evidence exists on THN's aggregate effectiveness in specialist drug or emergency services.

Purpose of the Study:

  • To determine the feasibility of a large-scale cluster randomised controlled trial (RCT) for THN distribution in emergency settings.
  • To investigate whether THN kits reduce opioid overdose deaths in at-risk populations.
  • To assess potential unforeseen harms and cost-effectiveness of THN distribution.

Main Methods:

  • A feasibility study for an RCT of THN distribution in emergency settings across four sites (Emergency Department and ambulance service clusters).
  • Intervention sites: paramedics and ED staff distribute THN to at-risk patients; control sites maintain usual practice.
  • Data collection includes deaths, admissions, kit issuance, NHS resource use, and participant identification for up to 1 year post-recruitment.

Main Results:

  • The study aims to establish feasibility based on pre-defined progression criteria for site recruitment, staff training, participant identification, THN provision, and outcome retrieval.
  • Specific criteria include: 4 sites signed up, ≥50% staff trained, ≥50% eligible participants identified and receiving THN, ≥75% high-risk individuals identified for follow-up, ≥75% outcomes retrieved, and <10% adverse event rate difference.

Conclusions:

  • This is the first randomised, robust investigation of THN distribution in emergency settings.
  • The study addresses a critical evidence gap regarding THN's effectiveness in emergency care.
  • Novel methods for participant identification and data capture are employed due to the infeasibility of informed consent in emergency settings.