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Related Experiment Video

Updated: Jun 8, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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Take-home naloxone in multicentre emergency settings: the TIME feasibility cluster RCT.

Helen Snooks1, Jonathan Benger2, Fiona Bell3

  • 1Department of Medicine, Swansea University, Swansea, UK.

Health Technology Assessment (Winchester, England)
|November 2, 2024
PubMed
Summary

This study assessed the feasibility of a take-home naloxone (THN) trial in emergency settings. The trial did not meet feasibility criteria, indicating a need for improved methods for future evaluations of opioid overdose prevention strategies.

Keywords:
EMERGENCYFEASIBILITY STUDYNALOXONEOPIOIDSRANDOMISED CONTROLLED TRIAL

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Area of Science:

  • Public Health
  • Emergency Medicine
  • Pharmacology

Background:

  • Opioid overdose deaths are a significant public health crisis.
  • Naloxone is a critical opioid antagonist for reversing overdoses.
  • Take-home naloxone (THN) kits offer a strategy for peer administration.

Purpose of the Study:

  • To determine the feasibility of conducting a definitive randomized controlled trial (RCT) for take-home naloxone in emergency settings.
  • To assess the potential of developing a discriminant function for identifying high-risk individuals for fatal opioid overdose using routine data.

Main Methods:

  • A cluster RCT and qualitative study were conducted in emergency departments and ambulance catchment areas.
  • Feasibility was assessed against predefined criteria including site recruitment, staff training, patient identification, and intervention delivery.
  • Routine Welsh data (2015-2021) were analyzed to explore predictive models for fatal opioid overdose.

Main Results:

  • The study did not meet key progression criteria: less than 50% of eligible staff were trained, and less than 50% of eligible patients received THN kits.
  • Predictive models for fatal overdose using healthcare events showed a weak link, requiring monitoring of a large population.
  • Qualitative data revealed service user support for THN but concerns about withdrawal, and provider challenges with consent and training.

Conclusions:

  • The feasibility criteria for both the intervention and trial methods were not met.
  • The current study design and methods are insufficient for a definitive RCT of THN in emergency settings.
  • Further development and evaluation of THN interventions and trial methodologies are needed for emergency care settings.