Prison-based Naloxone-on-release RCT to reduce drugs-related deaths

Lead Research Organisation: MRC Clinical Trials Unit
Department Name: UNLISTED

Abstract

Opiate overdose has become one of the main causes of death for young people and early adults. More than three-quarters of overdoses are accidental (associated with errors in the calculation of the dose, or lack of tolerance to the drug effect after a period of abstinence), and are not associated with suicidal intent. Most overdoses occur the user s own, or a friend?s home in the company of friends and peers, and involve heroin or other opiates. Consequently, many deaths could potentially be prevented by appropriate management of overdose by peers or family, who could administer a life saving emergency intramuscular injection of Naloxone whilst awaiting the arrival of emergency medical services. Naloxone is a total antidote to opiate overdose. Most opiate overdoses take place away from healthcare settings, especially in private dwellings or among the homeless. This makes fast and effective treatment somewhat problematic. The overdose must be identified, an ambulance must be called, the ambulance must find the location, and only then will the patient be treated with naloxone. Furthermore, the location of the overdose victim may be hard to find or difficult to access. Ambulance crews may also be reluctant to enter some of these areas without police support. These and other factors can contribute to further delay in the provision of vital treatment. Delay in emergency treatment contributes to the high mortality of opiate addicts due to accidental overdose. Antidote injection of Naloxone is now routinely carried in ambulances. The proposed trial involves the next step in the transfer of this technology: placement of emergency Naloxone in the hands of the potential drug user so that if they do overdose there is an opportunity for friends or family to prevent their death between when an ambulance is called and its arrival.

Technical Summary

Heroin-related deaths account for around 8% of all UK deaths in individuals aged 15 to 44. For UK prisoners, the risk of a drugs-related death is 7.5 times higher in the first fortnight after their release than at comparable other times at liberty.

More than three-quarters of overdoses are accidental (associated with errors in the calculation of the dose, or lack of tolerance to the drug effect, or binge use, after a period of abstinence), and are not associated with suicidal intent. Most overdoses occur in domestic situations (their own, or a friend?s, home), in the company of family, friends and peers, and involve injection of heroin or other opiates. Consequently, many deaths could potentially be prevented by prompt, competent management of overdose by peers or family, who could administer a life saving emergency intramuscular injection of the opiate antagonist Naloxone (the rapid-acting complete antidote to the effects of heroin and other opiates) whilst awaiting the arrival of emergency medical services. Users? and carers? willingness to intervene has been amply demonstrated.

Following the inadvertent injection of a heroin overdose, quick access to treatment is vital if death is to be avoided. However, this presents a problem. Most opiate overdoses take place away from healthcare settings, especially in private dwellings or among the homeless. The overdose must be identified, an ambulance called, the ambulance must find the location, and only then will the victim be treated and receive Naloxone. Furthermore, the location of the overdose victim may be hard to find or difficult to access. Delay in emergency treatment contributes to the high mortality of opiate addicts due to accidental overdose.

Antidote injection of Naloxone is now routinely carried in ambulances. This proposal involves the next step in the transfer of this familiar technology: placement of emergency Naloxone in the hands of the heroin user so that if they do overdose there is an opportunity for friends or family to prevent their death between when an ambulance is called and its arrival. We propose a randomised pilot trial. The N-ALIVE pilot will provide information on: (i) what happens to the Naloxone and the ex-prisoner once they leave prison; (ii) whether all the important practical arrangements for the trial will work, and (iii) whether the prisons and prisoners will come on board, and in the numbers needed.

People

ORCID iD

Publications

10 25 50
 
Title N-ALIVE 
Description Naloxone is an antidote to the effects of heroin and other opiates.The N-ALIVE trial is testing whether Naloxone can help to stop heroin injectors dying from a heroin overdose within 12 weeks of release from prison. 
Type Therapeutic Intervention - Drug
Current Stage Of Development Late clinical evaluation
Development Status Under active development/distribution
Clinical Trial? Yes
Impact The N-ALIVE pilot trial is a prison based randomised controlled trial. Few interventional trials have been carried out in the prison field and none have been carried out across as many prison sites as N-ALIVE. The N-ALIVE pilot trial is ongoing but our experience to date has shown that it is possible to set-up and recruit to such trials in the prison setting and that high quality data can be generated from them. 
URL http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=80
 
Description Article about N-ALIVE pilot trial in Inside Times - the national newspaper for prisoners (p35) 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact The article in the Inside Times newspaper resulted in a number of potential participants approaching N-ALIVE workers about the N-ALIVE trial

Not applicable
Year(s) Of Engagement Activity 2013
URL http://www.insidetime.org/index.asp?m=August_2013&pdf=August_2013.pdf
 
Description EMEA Clinical Trials Facilitation Group 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? Yes
Primary Audience Policymakers/politicians
Results and Impact presentations to and participation in working groups

the risk classification that was developed was used as the basis of the European Medicines Agency Reflection paper on risk based quality management in clinical trials published 4 August 2011
Year(s) Of Engagement Activity 2011
 
Description OECD Global Science Forum Working Group 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? Yes
Primary Audience Policymakers/politicians
Results and Impact presentations to and participation in working group

The risk classification was included in the report of the Working Group to Facilitate International Co-operation in Non-Commercial Clinical Trials to the OECD Global Science Forum (OECD GSF) in November 2011. The recommendations of the report were accepted by the OECD GSF and the mandate of the Working Group has been prolonged for 6 months with the objective of proposing draft text for an OECD council recommendation on the introduction of risk categories in national regulations.
Year(s) Of Engagement Activity 2011