Title

TIME: Take home naloxone Intervention Multi centre Emergency setting feasibility trial

Principal / Lead investigator

Alan Watkins (Swansea Trials Unit/PRIME, Swansea University) – Interim CI while Helen Snooks (PRIME, Swansea University) is absent.

Co-investigators / research team
  • Steve Goodacre
  • Jonathan Benger
  • Gordon Fuller
  • Chris Moore
  • Sarah Black
  • Simon Dixon
  • Penny Buykx
  • Bridie Evans (PRIME, Swansea University)
  • Matthew Jones (PRIME, Swansea University)
  • Jenna Bulger (PRIME, Swansea University)
  • Ann John
  • Adrian Edwards (PRIME, Cardiff University)
  • Emma Parry
  • Rebecca Hoskins
  • Barbara Lawrence
  • Alan Watkins
  • Fiona Bell
Type of study

Feasibility study - Clustered Randomised Controlled Trial

Summary

People who take opioid drugs such as heroin can overdose. The number of people who die this way is increasing; which has 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 administer 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 administer to others in an emergency. This is called ‘Take Home Naloxone’ (THN). But we don’t know whether THN saves lives. There are some concerns that it could encourage risk-taking behaviour i.e. the drug user feeling that they have a “safety net” and can take a higher dose.

We will carry out an initial study to see:

  1. whether it is possible for ambulance paramedics and Emergency Department staff to give out THN kits to drug users they see, and;
  2. if we can collect data about this new way of distributing naloxone to find out whether it reduces deaths from overdose. We will include people who have overdosed and drug users who present with other drug-related problems such as an abscess. Because we know that drug users may share THN kits, we are aiming to reach as many drug users as possible in our follow up.

We will carry out this study in two areas where THN will be given to patients who have overdosed or who are at risk of overdose (Emergency Department and the ambulance paramedics who serve that hospital) and two other areas where THN kits are not given out.

We recently carried out a study with emergency ambulances in Cardiff so we know that paramedics will give out THN and that about half of suitable patients who had recovered from an overdose accepted a kit. We found that it is very difficult to follow up these patients because they don’t respond to phone calls or may have no fixed address. Therefore, in this study we will follow what happens to patients using the routine information which health services already collect about everyone they see.

We will collect information about deaths, overdoses, emergency ambulance calls and emergency department attendances and admissions up to 1 year after patients are seen. We will compare these figures between the area which gives out THN and the areas which do not. To find out about the experiences and views of patients receiving THN and staff who give out the kits, we will carry out interviews.

If this feasibility study shows it is possible to give out THN kits through emergency services, and that we can collect data about effects, we will plan a larger trial of THN in emergency settings to find out whether it reduces deaths. 

We have talked to family members affected by drug overdose and to services which help drug users and give out THN. We have also talked to a group of NHS patients who are involved in research about emergency care. They all believe this research is needed. Two people with personal experience of THN are part of our research team alongside researchers and specialists in emergency medicine, addiction, general practice, and public health. We have consulted national specialist groups and gained support from potential sites.

Lay involvement

We have involved two PPI (patient and public involvement) representatives as co-applicants and members of the study team from an early point in the development of the study. Barbara Lawrence is a long-standing member of SHARRP (SHeffield Addiction Recovery Research Panel) and been involved in a number of research studies involving substance abuse as a PPI representative, including a pilot study involving THN.

Emma Parry has experience in working with young people with opioid addictions and has appeared in a film produced by a local drug charity to promote naloxone, which her daughter had also taken part in before she sadly passed away due to opioid overdose. Barbara and Emma both have personal experience of death from heroin overdose within their families and will sit on the TMG throughout the trial, helping to make important decisions about how the research should be conducted.

PPI representatives will be involved in disseminating the outcomes of our research to help us ensure that our findings are easily accessible to service users and providers. In addition to our co-applicants Barbara and Emma, we have recruited two PPI representatives to sit on our Trial Steering Committee (TSC) to help oversee the study.

How could this research potentially benefit patients?

If administered correctly - to reverse opioid overdose prior to the arrival of ambulance personnel - THN has the potential to save lives and reduce morbidity associated with non-fatal overdose.

Who is the study sponsor?

Swansea University

Does the study involve commercial partnership activity?

Martindale Pharma ltd. currently provide THN kits (marketed as Prenoxad) which are licensed for use in out of hospital settings. Following consultation with Martindale, we the study team have agreed a cost-subsidised supply for Prenoxad kits along with accompanying training resources for use in the study.

UKCRN portfolio number (if relevant)

To follow

Funder

Welsh Ambulance Services NHS Trust

Total grant value

£750,890

Start date

01/03/2018

End date

01/11/2020

How could this research potentially benefit patients?

To follow

Further information (e.g. related web link)

Study summary on ISRCTN registry: http://www.isrctn.com/ISRCTN13232859

Outputs generated (Reports / Publications / Impact)  

We will publish our results in journals read by clinicians, policy makers, service managers and researchers. We will give presentations to conferences and meetings where these groups can also discuss our findings with us.