Feasibility Study for Take Home Naloxone Kits: TIME

• Research type

  Research Study

• Full title

  Take home naloxone Intervention Multicentre Emergency setting feasibility trial (TIME)

• IRAS ID

  248818

• Contact name

  Alan Watkins

• Contact email

  a.watkins@swansea.ac.uk

• Sponsor organisation

  Swansea University

• ISRCTN Number

  ISRCTN13232859

• Duration of Study in the UK

  2 years, 8 months, 1 days

• Research summary

  Opioid drugs such as heroin are involved in fatal overdose more often than any other drug, and deaths from overdose are increasing, with tragic consequences for families, friends and communities.

  Naloxone is a medicine that reverses opioid drug overdoses and is routinely used by paramedics and doctors in emergency settings. There are schemes in the UK and in other countries where naloxone is included in 'kits' which are given to drug users, along with brief training in how to use them. These ‘Take Home Naloxone’ (THN) kits contain a dose of naloxone, a means of administering this dose, and written/graphic instructions. Despite the increasing popularity of THN, we know very little about the relative harms and benefits of this intervention, especially on a population level.

  We will carry out a study to see:
  1) whether it is possible for paramedics and emergency department doctors and nurses to give out THN kits to drug users
  2) if we can collect data in a future trial to determine whether this method of distributing THN reduces deaths from overdose

  We will carry out this study in four areas of the UK. In two areas, THN kits will be given to patients who are at risk of overdose via the emergency department and the ambulance service. We will collect information about deaths, overdoses, and related emergency ambulance calls and emergency department attendances and admissions. We will compare these figures with those from two areas where THN is not distributed in this way.

  We will also carry out interviews and focus groups to find out about the experiences and views of patients and staff regarding THN.

  If we find that we can give out THN kits through emergency services, and that we can collect relevant outcome data, we will plan a larger trial to find out whether this intervention reduces deaths.

• REC name

  Wales REC 4

• REC reference

  18/WA/0337

• Date of REC Opinion

  16 Oct 2018

• REC opinion

  Favourable Opinion