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Protocol for take-home naloxone In multicentre emergency (TIME) settings: Feasibility study

Jones, Matthew; Bell, Fiona; Benger, Jonathan; Black, Sarah; Buykx, Penny; Dixon, Simon; Driscoll, Tim; Evans, Bridie; Edwards, Adrian; Fuller, Gordon; Goodacre, Steve; Hoskins, Rebecca; Hughes, Jane; John, Ann; Jones, Jenna; Moore, Chris; Sampson, Fiona; Watkins, Alan; Snooks, Helen

Protocol for take-home naloxone In multicentre emergency (TIME) settings: Feasibility study Thumbnail


Matthew Jones

Fiona Bell

Jonathan Benger

Sarah Black

Penny Buykx

Simon Dixon

Tim Driscoll

Bridie Evans

Adrian Edwards

Gordon Fuller

Steve Goodacre

Rebecca Hoskins
Senior Lecturer in Advanced Practice

Jane Hughes

Ann John

Jenna Jones

Chris Moore

Fiona Sampson

Alan Watkins

Helen Snooks


Background: Opioids, such as heroin, kill more people worldwide by overdose than any other type of drug, and death rates associated with opioid poisoning in the UK are at record levels (World Drug Report 2018 [Internet]. [cited 2019 Nov 19]. Available from:; Deaths related to drug poisoning in England and Wales - Office for National Statistics [Internet]. [cited 2019 Nov 19]. Available from: Naloxone is an opioid antagonist which can be distributed in 'kits' for administration by witnesses in an overdose emergency. This intervention is known as take-home naloxone (THN). We know that THN can save lives on an individual level, but there is currently limited evidence about the effectiveness of THN distribution on an aggregate level, in specialist drug service settings or in emergency service settings. Notably, we do not know whether THN kits reduce deaths from opioid overdose in at-risk populations, if there are unforeseen harms associated with THN distribution or if THN is cost-effective. In order to address this research gap, we aim to determine the feasibility of a fully powered cluster randomised controlled trial (RCT) of THN distribution in emergency settings. Methods: We will carry out a feasibility study for a RCT of THN distributed in emergency settings at four sites, clustered by Emergency Department (ED) and catchment area within its associated ambulance service. THN is a peer-administered intervention. At two intervention sites, emergency ambulance paramedics and ED clinical staff will distribute THN to adult patients who are at risk of opioid overdose. At two control sites, practice will carry on as usual. We will develop a method of identifying a population to include in an evaluation, comprising people at risk of fatal opioid overdose, who may potentially receive naloxone included in a THN kit. We will gather anonymised outcomes up to 1 year following a 12-month 'live' trial period for patients at risk of death from opioid poisoning. We expect approximately 100 patients at risk of opioid overdose to be in contact with each service during the 1-year recruitment period. Our outcomes will include deaths, emergency admissions, intensive care admissions, and ED attendances. We will collect numbers of eligible patients attended by participating in emergency ambulance paramedics and attending ED, THN kits issued, and NHS resource usage. We will determine whether to progress to a fully powered trial based on pre-specified progression criteria: sign-up of sites (n = 4), staff trained (≥ 50%), eligible participants identified (≥ 50%), THN provided to eligible participants (≥ 50%), people at risk of death from opioid overdose identified for inclusion in follow-up (≥ 75% of overdose deaths), outcomes retrieved for high-risk individuals (≥ 75%), and adverse event rate (< 10% difference between study arms). Discussion: This feasibility study is the first randomised, methodologically robust investigation of THN distribution in emergency settings. The study addresses an evidence gap related to the effectiveness of THN distribution in emergency settings. As this study is being carried out in emergency settings, obtaining informed consent on behalf of participants is not feasible. We therefore employ novel methods for identifying participants and capturing follow-up data, with effectiveness dependent on the quality of the available routine data.

Journal Article Type Article
Acceptance Date Jul 9, 2020
Online Publication Date Jul 9, 2020
Publication Date Dec 9, 2020
Deposit Date Nov 2, 2021
Publicly Available Date Nov 2, 2021
Journal Pilot and Feasibility Studies
Electronic ISSN 2055-5784
Publisher BioMed Central
Peer Reviewed Peer Reviewed
Volume 6
Issue 1
Article Number 96
Keywords Medicine (miscellaneous)
Public URL
Additional Information Received: 2 January 2020; Accepted: 1 June 2020; First Online: 9 July 2020; : The TIME study has been approved by the HRA (Health Research Authority), CAG (Confidentiality Advisory Group), and REC (Research Ethics Committee) 18/WA/0337.; : Not applicable; : The authors declare that they have no competing interests.


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