The N-ALIVE randomised prison-release naloxone trial: testing pre-provision of naloxone to prevent heroin overdose deaths

Transcription

1 The N-ALIVE randomised prison-release naloxone trial: testing pre-provision of naloxone to prevent heroin overdose deaths Professor John Strang National Addiction Centre, London, UK (on behalf of co-investigators Max Parmar, Sheila Bird and John Strang and the N-ALIVE trial team)

2 Declaration (personal & institutional) DH, NTA, Home Office, NACD, EMCDDA, WHO, UNODC, NIDA NHS provider (community & in- pabent); also Phoenix House, Lifeline, Clouds House, KCA (Kent Council on AddicBons) ReckiO- Benckiser, Schering- Plough, Napp, MarBndale, Auralis, Lundbeck, Alkermes, UCB, Mundipharma Europe, Lannacher, igen, Lightlake & others, including trying to work with possible pharma- manufacturers UKDPC (UK Drug Policy Commission), SSA (Society for the Study of AddicBon); and two Masters degrees (taught MSc and IPAS) and an AddicBons MOOC Work also with several charibes (and received support) including AcBon on AddicBon, and J Paul GeOy Charitable Trust (JPGT) and Pilgrim Trust Support from EMCDDA for this event

3 Acknowledgements All parbcipants and those who expressed interest in the trial N- ALIVE workers, Principal InvesBgators and all staff involved at each of our prisons N- ALIVE trial team: TMG and TS- DMC MHRN network co- ordinators

4 Structure of today s talk: Why do people die? When does it occur? Could we improve interim emergency care?

5 Drug use prevalence and Drug- related deaths: England &Wales 2011/12 (ONS) Drug Prevalence in gen population (last year, age 16-59) No. of deaths in 2011 Cannabis 6.9% 7 Cocaine 2.2% 112 Amphetamine 0.8% 62 Ecstasy 1.4% 13 Opiates (inc heroin & methadone) 0.3% 1,082

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7 Oxygen saturation: case study SpO2 (%) Male, age 49 Intravenous diamorphine (6 years) This dose = 120 mg Daily dose = 400mg Minutes post-injection

8 Structure of today s talk: Why do people die? When does it occur? Could we improve interim emergency care?

9 When in particular excess? During methadone early treatment Post-detox/rehab Prison release

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12 (1998)

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16 Structure of today s talk: Why do people die? When does it occur? Could we improve interim emergency care?

17 First serious consideration: Strang, J., Darke, S., Hall, W., Farrell, M. & Ali, R. (1996) Heroin overdose: the case for take-home naloxone? British Medical Journal, 312: 1435.

18 (1999)

19 Why is take- home naloxone so important? Most heroin overdoses are witnessed Most witnesses intervene acbvely (oyen wrongly) Many family members witness overdose

20 Twelve Scenarios (A1) pabent commencing OST; (A2) pabent concluding OST; (A3) client finishing rehab or hospital care; (B1) named client at syringe exchange scheme; (B2) named resident at hostel for homeless; (B3) unnamed contact of outreach worker; (C1) individual leaving prison; (C2) family member (e.g. parent) for their at- risk son/daughter/etc; (D1) stock supply for hostel staff or day centre; (D2) open availability at a syringe exchange scheme; (E1) to be carried by a taxi driver or non- clinical 'first responder'; (F1) over- the- counter from a community pharmacy.

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22 The MRC N-ALIVE Pilot Trial: NALoxone InVEstigation N- ALIVE Chief InvesBgators Prof. John Strang, Prof. Mahesh Parmar, Prof. Sheila Bird N- ALIVE CTU Trial Team Dr. Angela Meade and many crucial others Funding and support: MRC with research support from MHRN

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24 Background Heroin-related deaths account for 8% of all UK deaths in individuals aged yrs. About 30% of prisoners have previously used heroin. One in 200 prisoners with history of heroin use by injection dies from a drugs-related death (DRD) within 2 4 weeks of leaving prison. Current approaches have not prevented high rate of post-release overdose deaths.

25 N-ALIVE trial pilot & main phase N-ALIVE research trial to test/prove reduced deaths post-release Pilot current (n=approx 1,000; mar 2014) Main study n=30,000 (15k + 15k) Large randomised trial to test effectiveness of Naloxone-on-release to prevent deaths from overdose post-release

26 N-ALIVE Outcome Measures Primary: DRDs within 12 weeks of the prisoner s N-ALIVE release date Secondary: DRDs within 4 weeks of the prisoner s N-ALIVE release date NFOAs to A&E within the first 12 weeks after release

27 Why have an RCT? Main Reasons: Naloxone-on-release is not currently prescribed in English Prisons RCT is stronger trial design than uncontrolled observational study Prisoners realise that in order for prisons to improve their health services, effectiveness has to be beyond question Prison-based research deals with a captive population the highest ethical and scientific standards must apply Observational study would not answer whether prisons and prisoners would actually use naloxone-on-release as intended

28 N-ALIVE Pilot Trial Approvals/Collaborations Medical Research Council: peer-review to fund National Ethics Approval: Updated REC approval was obtained in September 2011 (protocol changed due to the introduction of the Scottish programme) Ministry of Justice Research Quality Assurance (Nov 2010) National Research Committee (approval to approach governors) (Aug 2011)* Formal adoption of the N-ALIVE trial into the Mental Health Research Network (MHRN)trial portfolio Global Research & Development (R&D) approval Office for National Statistics - for linkage with Register of Deaths NHS HSCIC: Hospital Episode Statistics for A&E data on NFOAs Local Prison Governor Approval/including engaging a local Principal Investigator Local R&D approval * Home Office/Ministry of Justice split required the N-ALIVE team to re-obtain relevant permissions

29 Eligibility Criteria Inclusion criteria History of heroin use by injection Aged 18 years or older Have been in prison for at least seven days Likely release date within three months Not previously randomised and then withdrawn their consent prior to release Written informed consent Exclusion criteria History of anaphylactic reaction to Naloxone Pregnant or planning to become pregnant within 6 months Resident outside of Scotland, England and Wales Most recent N-ALIVE release date is within 6 months Most recent N-ALIVE release date is m i s s i n g b u t p a r t i c i p a n t w a s randomised in N-ALIVE in the past year Participants receiving opiate substitution treatment are not excluded from participating in N-ALIVE

30 Trial Design Consent & Randomisation (prisoners incarcerated >7 days, & randomised <3 months prior to release date) Up to 3 months prerelease Naloxone Group 1:1 Control Group Prison release date Prisoner s N-ALIVE Release Date Prisoner given pack on release from custody Optional: Once-only Phone Contact in either weeks 1-2 or 3-4 post-release. Ratio: 2:1:1 Pre-paid Anonymised N-ALIVE Reply Card: re critical events 12 weeks postrelease 12 Weeks Post-Release National Death Record Review Retrospective prisoner consented A&E database linkage Up to 6 months after prisoner s N-ALIVE release date Returned Prisoner Self-Questionnaire - completed next time in prison

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34 N-ALIVE Milestones First site opened HMP Nobngham opened on 28 th May 2012 First parkcipant randomised HMP Nobngham randomised first 3 parbcipants on 29 th May 2012

35 N-ALIVE Milestones 15 sites open to recruitment HMP Oakwood opened on 11 th Feb 2014 Five sites opened in Jan/Feb 2014 First female prison HMP Holloway opened on 17 th Jan 2014 First female randomised on 27 th Feb 2014

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37 N-ALIVE trial YouTube clips Three trigger videos on Youtube (i) explanabon of the trial hops:// (ii) how to put your naloxone kit together and give the injecbon hops:// (iii) how to manage an overdose hops://

38 Thank you