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John strang-0313min

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  • Purpose of Outcome Studies 04/03/13 Dwayne Simpson
  • Just leaves me to thank the RIOTT team and collaborators for all their hard work on the project & to thank the 127 patients who took part in this trial.
  • Purpose of Outcome Studies 04/03/13 Dwayne Simpson
  • Purpose of Outcome Studies 04/03/13 Dwayne Simpson
  • Purpose of Outcome Studies 04/03/13 Dwayne Simpson
  • Purpose of Outcome Studies 04/03/13 Dwayne Simpson
  • Purpose of Outcome Studies 04/03/13 Dwayne Simpson
  • Purpose of Outcome Studies 04/03/13 Dwayne Simpson We know that Overdose is the biggest cause of death in opiate users Relative to the no. of users opiates (such as heroin & methodone) have by far the greatest mortality rate of all illicit drugs 1 in 10 use cannabis only 78 deaths in 5 years deaths from all others substances are relatively low in relation to the no. of users However for opiates only 0.2% use but yet there have been >6000 deaths in last 5 yrs Conservative prevalence rates, as a result of the broad age bracket and would be inflated if it looking at say 16-30 where drug use is more common
  • Purpose of Outcome Studies 04/03/13 Dwayne Simpson We know that Overdose is the biggest cause of death in opiate users Relative to the no. of users opiates (such as heroin & methodone) have by far the greatest mortality rate of all illicit drugs 1 in 10 use cannabis only 78 deaths in 5 years deaths from all others substances are relatively low in relation to the no. of users However for opiates only 0.2% use but yet there have been >6000 deaths in last 5 yrs Conservative prevalence rates, as a result of the broad age bracket and would be inflated if it looking at say 16-30 where drug use is more common
  • Transcript

    • 1. MHRN & Addictions 1-2-3 (MHRN Annual Conference, March 2013) Professor John Strang National Addiction Centre, London, UK(comprising Addictions Department, IoP, Kings College London, and Soutn London & Maudsley NHS Foundation Trust) within Kings Health Partners Academic Health Sciences Centre
    • 2. Declaration - general• DH, NTA, Home Office, NACD, EMCDDA, WHO, UNODC, NIDA• NHS provider (community & in-patient); also Phoenix House, Lifeline, Clouds House, KCA (Kent Council on Addictions)• Reckitt-Benckiser, Schering-Plough, Genus-Britannia, Napp, Titan, Martindale, Catalent, Auralis, Lundbeck, Astra-Zeneca, Alkermes, UCB, Fidelity, Rusan, Mundipharma Europe, Lannacher, Lightlake & others• UKDPC (UK Drug Policy Commission), SSA (Society for the Study of Addiction); and two Masters degrees (taught MSc and IPAS)• Work also with several charities (and have received support) including Action on Addiction, and also with J Paul Getty Charitable Trust (JPGT) and Pilgrim Trust
    • 3. Addictions area 1;Addictions area 2;Addictions area 3
    • 4. Addictions area 1: RIOTT: randomised trial of supervised heroinprescribing for chronic refractory heroin addictsAddictions area 2: ConMan: Contingency management techniquesto improve benefit in Addictions treatmentsAddictions area 3: N-ALIVE: randomised trial of take-homenaloxone to prevent post-prison overdose deaths
    • 5. Addictions area 1:RIOTT: randomised trial of supervised heroinprescribing for chronic refractory heroin addicts
    • 6. RIOTT funding support & declarations• Research Funding – Community Fund (Big Lottery) & Action on Addiction & Hedley Foundation• Clinical Services Funding – National Treatment Agency, Department of Health, and Home Office – Local DATs & PCTs• Medications: – Diamo, Switzerland; Cardinal, UK; Auralis, UK; also Genus, UK• Other support – The Band Trust – DVD – EMCDDA – European analysis and ‘Insights’ report• Clinical colleagues: – Marina House, Maudsley; Darlington; Brighton• Service users/patients/study subjects:
    • 7. RIOTT Team & Collaborators Investigators/trial coordination • RIOTT clinical team leaders – Prof John Strang – Rob van der Waal, London – Dr Nicholas Lintzeris – Anne McNutt, Darlington – Dr Nicola Metrebian – Ian Wilson, Brighton• Local Investigators • Trial co-ordination – Dr Deborah Zador / Dr James Bell – National Addiction Centre, Institute of – Dr Tom Carnwath/Dr Soraya Mayet Psychiatry, KCL – Dr Hugh Williams • Statistician• Research staff – Laura Potts, Clinical Trials Unit, – Vikki Charles Institute of Psychiatry, KCL – Luciana Forzisi – Teodora Groshkova • Health Economics – Chris Hallam – Dr Sarah Byford Institute of – Anthea Martin Psychiatry, KCL – Barbara Barrett, Institute of Psychiatry• Clinical Trial Pharmacist – Glynis Ivin, Maudsley Hospital – Godwin Achunine, London clinic Randomisation – Clinical Trials Unit, IoP Diamorphine suppliers  DiaMo Narcotics GmbH, Switzerland • Pathology  Auralis, UK – Dr Andy Marsh & Richard Evers, Kings College Hospital
    • 8. Operating costs• ‘An ineffective service is inefficient and cannot be cost-effective, no matter how cheaply it is provided’ • Cochrane, 1972
    • 9. Target populationEntrenched heroin addicts who haverepeatedly been found to fail tobenefit from existing treatments(despite treatment, continuing to injectheroin on all/most days per month)
    • 10. Second-line use of injectable maintenanceRx-seeking Treat with oraldependent good-qualityheroin user maintenance repeated treatment ‘failure’ Poor benefit with oral maintenance ‘Optimisation box’ still treatment minimal ‘failure’ benefit Still poor benefit with oral Brief test trial of Immersion in full ‘RIOTT’ treatment ‘RIOTT’ treatment Good benefit
    • 11. Computer generated randomisation Injecting heroin User in opioid Maintenance Treatment for 6 months Methadone EnhancedDiamorphine iv/im Ampoules iv/im Oral+/- oral methadone +/- oral methadone Methadone
    • 12. Treatments to be investigated Supervised Injectable Heroin (SIH) Supervised Injectable Methadone (SIM) Optimised Oral Methadone (OOM)
    • 13. Sample to be analysed Intention-To-Treat (ITT) sample Per-Protocol (PP) sample
    • 14. Primary outcomeRetention in treatment ΧReducing/quitting ‘street heroin’Other drug use; well-being;Criminal behaviour ?
    • 15. ‘responder’ or ‘abstinent’? Major reduction in frequency of use of ‘street heroin’ Completely abstinent from ‘street heroin’
    • 16. Which measure of primary outcome? Urine test results Observations and measurements Self-report
    • 17. To begin at the endFour important conclusions, as I see them• SIH (heroin) group strongest achievement• SIM (inj methadone) better than control group• OOM (optimised oral) – notable benefit• Rapid onset of benefit and gain
    • 18. RIOTT - data on ‘responders’ and ‘non-responders’ – broken down as % - at baseline (OOM, SIM, SIH) 100% non-responder 90% 80% responder 70% 60% 50% 100 100 100 40% 30% 20% 10% 0 0 0 0% OOM SIM SIH RI OTT t r eat m ent group
    • 19. RIOTT - data on ‘responders’ and ‘non-responders’ – broken down as % - at Months 4- 6 (OOM, SIM, SIH) 100% 90% non-resp - some clean 27 80% responder 70% 72 67 60% 50% 40% 73 30% 20% 28 33 10% 0% OOM SIM SIH RI OTT t r eat m ent group
    • 20. RIOTT - data on ‘responders’ and ‘non-responders’ – broken down as % - at Months 4- 6 (OOM, SIM, SIH) non-responder 100% responder - only one dirty 90% responder - all clean 27 80% 70% 72 67 60% 50% 54 40% 30% 20% 31 10% 19 7 2 0% OOM SIM SIH RI OTT t reat m ent gr oup
    • 21. RIOTT - data on ‘responders’ and ‘non-responders’ – broken down as % - at Months 4- 6 (OOM, SIM, SIH) non-responder 100% responder - > one dirty 90% responder - only one dirty 27 responder - all clean 80% 70% 72 67 60% 35 50% 40% 30% 19 20% 19 24 10% 7 19 7 2 0% OOM SIM SIH RI OTT t r eat m ent group
    • 22. RIOTT - data on ‘responders’ and ‘non-responders’ – broken down as % - at Months 4- 6 (OOM, SIM, SIH) non-responder 100% responder - >2 dirty 90% responder - only 2 dirty 27 responder - only one dirty 80% responder - all clean 70% 72 67 16 60% 50% 19 40% 30% 19 20% 17 24 2 0 10% 7 19 7 2 0% OOM SIM SIH RI OTT t r eat m ent group
    • 23. “… rolling out the prescription of injectableheroin and methadone to clients who donot respond to other forms of treatment,subject to the findings, due in 2009, ofpilots exploring the use of this type oftreatment”. (H.M.Government Drug Strategy, 2008)
    • 24. Addictions area 2:ConMan: Contingency management techniquesto improve benefit in Addictions treatments
    • 25. The ConMan Research Programme: Developing a UK evidence base for contingency management in drug treatment Funding: NIHR (National Institute for Health Research) Programme Chief Investigators Prof John Strang (Kings, NAC / SLaM) Dr Tim Weaver (Imperial / CNWL) Prof Steve Pilling (UCL / Camden & Islington) Programme Co-ordinator: Dr Nicola MetrebianCM Psychologists: Dr Luke Mitcheson (SLaM) & Dr Frank Ryan (CNWL & C&I) Researchers: Vikki Charles, Dilkushi Poovendran & Nicholas Little Statistical and Health Economic Analysis: Jenny Hellier Prof Sarah Byford & Hiong Tie Prof Alan Brennan & Rachid Rafia University of Sheffield
    • 26. The Research Programme Module 1: Cross Cutting Themes Organisational analysis & Theme A: Theme B: intervention Management, The service user modelling Workforce & perspective Training Module 2: CM & completion of Hep B Vaccination Module 3: CM & Retention in treatment and Abstinence from Street DrugsTime (5 year programme)
    • 27. The Research Programme Module 1: Cross Cutting Themes Organisational analysis & Theme A: Theme B: intervention Management, The service user modelling Workforce & perspective Training Module 2: CM & completion of Hep B Vaccination Module 3: CM & Retention in treatment and Abstinence from Street DrugsTime (5 year programme)
    • 28. Module 2:Contingency Management & completion of Hep B Vaccination
    • 29. Aims & Study HypothesesAim:Measure the effectiveness of two CM schedules in improving completion of Hep B vaccination (when compared with clients offered no incentive).Hypotheses:• The proportions of clients who complete Hep B vaccination will be highest amongst groups offered incentives when compared to a control group to whom no incentives are offered.• Reward schedules with the same aggregate value but with different incentive schedules (i.e. fixed or escalating) will achieve different completion rates.
    • 30. Clinical Assessment, BBV Vaccination & Research Assessments Staff member assesses new client – Provides client with information about trial & obtains informed consent Research Interview – Baseline assessment & disclosure of research allocationOutcome DataRecording: Hep B vacc - Day 0 1st vaccination (+/- incentive)Record client’scompliancewith the Hep B vacc – Day 7vaccination 2nd vaccination (+/- incentive)schedule.Audio-recording Hep B vacc– Day 21consultations 3rd vaccination (+/- incentive)
    • 31. Clinical Assessment, BBV Vaccination & Research Assessments Staff member assesses new client – Provides client with information about trial & obtains informed consent Research Interview – Baseline assessment & disclosure of research allocationOutcome DataRecording: Hep B vacc - Day 0 1st vaccination (+/- incentive)Record client’scompliancewith the Hep B vacc – Day 7vaccination 2nd vaccination (+/- incentive)schedule.Audio-recording Hep B vacc– Day 21consultations 3rd vaccination (+/- incentive)
    • 32. Module 2: Cluster Randomised Trial Design 12 sitesArm 1: (4 sites) Arm 2: (4 sites) Arm 3: (4 sites)Hep B Vaccination Hep B Vaccination + Hep B Vaccination +(Treatment as usual) fixed CM schedule escalating CM schedule(No incentive) (£10, £10, £10) (£5, £10, £15)Recruitment: 16 – 20 clients per site (64 per arm, 192 in total)Trial ResearchResearcher - Baseline interview with each client.BBV Nurse - Record compliance with vaccination schedule & audio-recordingof consultations
    • 33. ConMan HepB trialCluster Randomised trial of CM-fixed or CM-esc vs control (TAU)
    • 34. Results• Still being prepared for submission etc• In strict confidence and not for reporting without authors’ explicit permission
    • 35. ConMan HepB trial Cluster Randomised trial of CM-fixed or CM-esc vs control (TAU) Payment by Results? Results by Payment?
    • 36. Addictions area 3:N-ALIVE: randomised trial of take-home naloxoneto prevent post-prison overdose deaths
    • 37. The MRC N-ALIVE Pilot Trial: NALoxone InVEstigation • N-ALIVE Chief Investigators – Prof. John Strang – Prof. Mahesh Parmar – Prof. Sheila Bird • N-ALIVE CTU Trial Team – Dr. Angela Meade – Scientific Lead – Laura Nichols – Trial Manager – Lizzie Armstrong – Clinical Project Manager – Tracey Pepple – Data Manager • Funding and support: MRC with research support from MHRN.
    • 38. n
    • 39. n
    • 40. Background• Heroin-related deaths account for 8% of all UK deaths in individuals aged 15-44 yrs.• One in 200 prisoners with a history of heroin use by injection dies from a drugs- related death (DRD) within 2 – 4 weeks of leaving prison.• Current prevention approaches have not resolved this high rate of overdose death soon after release.
    • 41. Drug-related deaths in England and Wales 1997 – 2002 (ONS) Drug Prevalence in general No. of deaths in the population (use in last last 5 years year, age 16-59) Cannabis 10.8% 78 Cocaine 2.4% 508 Amphetamine 1.5% 436 Ecstasy 2% 200 Opiates (inc Heroin, 0.2% 6,194 morphine & methadone)
    • 42. Drug-related deaths in England and Wales 1997 – 2002 (ONS) Drug Prevalence in general No. of deaths in the population (use in last last 5 years year, age 16-59) Cannabis 10.8% 78 Cocaine 2.4% 508 Amphetamine 1.5% 436 Ecstasy 2% 200 Opiates (inc Heroin, 0.2% 6,194 morphine & methadone)
    • 43. Excess mortality ratio for different time periods post-release by cause of death (Singleton, Farrell, Marsden et al 2003) 45 40 35 Drug-related deaths Not drug-related 30Excess mortality ratio 25 20 15 10 5 0 to 1 to 2 to 4 to 8 3 6 2 = 52 otal p to 1 p to 2 p to 5 > T U 1 up 2 up 4 up 8 up 13 u 26 u Time since release (w eeks)
    • 44. Background• The N-ALIVE pilot, a prison-based Naloxone-on-release randomised controlled prevention trial.•• Naloxone - opiate antagonist reverses heroin overdose.• pilot N-ALIVE – feasibility; 10% sample (n=5,600).
    • 45. Eligibility Criteria Inclusion criteria Exclusion criteria• History of heroin use by • History of anaphylactic reaction to injection Naloxone• Aged 18-44 years • Pregnant or planning to become • Have been in prison for at least pregnant within 6 months seven days • Resident outside of Scotland,• Likely release date within three England and Wales months • Most recent N-ALIVE release date is• Not previously randomised and within 6 months then withdrawn their consent • Most recent N-ALIVE release date prior to release missing but participant was• Written informed consent randomised in the past year     N.B. Participants receiving OST not excluded from participating in N-ALIVE
    • 46. N-ALIVE Process Chart
    • 47. MHRN Networks & N-ALIVE Sites
    • 48. MHRN Networks & N-ALIVE Sites
    • 49. N-ALIVE Site Progress Total No. Sites Open MHRN Hub N-ALIVE Workers Open Date Randomised Sites in Set-up Elizabeth AndrewHMP Nottingham East Midlands 28th May 2012 59 Amy Shuttlewood HMP Doncaster South LondonHMP Winchester Joanne McCarthy 12th October 2012 17 and South East HMP Dorchester Anne Chafer HMP Lincoln East Midlands 08th October 2012 6 Diane Brennan HMP Liverpool HMP Becca BishopExeter/Channings West 29th October 2012 33 HMP Styal Wood/Dartmoor Dave BrightHMP Gloucester Genevieve Riley HMP Highpoint North and West 2nd November 2012 11 South (now closed) Emma Page, Simon Ball Kim Thompson HMP Dovegate East Midlands 26th November 2012 1 HMP Blunsden Tim Lewington Sheila Shatford HMP Bristol West 27th November 2012 26 HMP Eastwood Park Karen Alloway Total Recruitment (175 up to 15th March) 153
    • 50. N-ALIVE recruitmentN = 175 and rising daily We still need extra prison release sites: Contact Laura Nichols at MRC CTU at lln@ctu.mrc.ac.uk  or  nalivepilot@ctu.mrc.ac.uk
    • 51. Acknowledgments• The N-ALIVE Trial Management Group wishes to acknowledge the support and contribution of MHRN staff to date. MHRN staff from 5 MHRN hubs are helping to get the trial initiated and in some cases taking on the key role of N-ALIVE worker; building strong relationships with prison staff, introducing the trial to potential participants, obtaining informed consent and managing the trial locally.
    • 52. Addictions area 4:Naltrexone Enhanced Addiction Treatment (NEAT)for opioid dependence: RCT of implantedextended-release naltrexone vs oral naltrexone
    • 53. Addictions area 1: RIOTT: randomised trial of supervised heroinprescribing for chronic refractory heroin addictsAddictions area 2: ConMan: Contingency management techniquesto improve benefit in Addictions treatmentsAddictions area 3: N-ALIVE: randomised trial of take-homenaloxone to prevent post-prison overdose deaths
    • 54. Thank you