Version 2 (Scotland) 25th April 2016 PROTOCOL (SCOTLAND) Identification and characterization of the clinical toxicology of novel psychoactive substances (NPS) by laboratory analysis of biological samples from recreational drug users. Short title – Identification Of Novel psychoActive substances (IONA) Chief Investigator Prof SHL Thomas Professor of Clinical Pharmacology and Therapeutics, Newcastle University Consultant Physician, Newcastle Hospitals NHS Foundation Trust (Royal Victoria Infirmary) Director, National Poisons Information Service (Newcastle) Unit. Address Medical Toxicology Centre, Wolfson Building, Newcastle University, Newcastle NE2 4HH Email [email protected] Tel 0191 222 8095 Sponsor Organisation - Newcastle Hospitals NHS Foundation Trust (R&D Ref 7312) Funding Organisation - National Institute for Health Research (Ref HPRU-2012-10076) IRAS References - 172425 (Scotland), 168706 (England and Wales), REC References Scotland A REC – 15/SS/0047 North East - Newcastle& North Tyneside 2 - 15/NE/0023 (England & Wales), Project website http://www.ncl.ac.uk/hpru/research/neuro/nps/ 1 Version 2 (Scotland) 25th April 2016 Co-investigators Newcastle Health Protection Research Unit, Newcastle University Dr Simon Hill NIHR Health Protection Research Unit Dr Mick Dunn Medical Toxicology Centre Prof Peter Blain Wolfson Building Dr Christopher M Morris Newcastle University Newcastle NE2 4HH Dr Alasdair Blain School of Biology Prof Steven Rushton Newcastle University Newcastle NHS Toxicology Laboratories Dr Nigel Brown Wansbeck Hospital Toxicology Laboratory Northumbria Hospitals NHS Foundation Trust. Clinical Chemistry / Toxicology, Woodhorn Lane, Ashington, Northumberland NE63 9JJ Dr Jonathan Berg Toxicology Laboratory, Clinical Dr Loretta Ford Biochemistry, City Hospital, Sandwell and West Birmingham NHS Foundation Trust Dudley Road, Birmingham, B18 7QH Dr Alun Hutchings Cardiff Toxicology Laboratories The Academic Centre University Hospital Llandough Penarth, Vale of Glamorgan, CF64 2XX National Poisons Information Service Prof Michael Eddleston National Poisons Information Service, Dr Jonathan Wraight Edinburgh Unit, Royal Infirmary of Dr James Dear Edinburgh, QMRI, E3.20 47 Little France Cresc Edinburgh, EH16 4TJ Dr John Thompson National Poisons Information Service, Cardiff Unit, Academic Centre, University Hospital Llandough, Penlan Road, Penarth, Vale of Glamorgan CF64 2XW 2 Version 2 (Scotland) 25th April 2016 Prof Allister Vale National Poisons Information Service, Dr Sally Bradberry Birmingham Unit, City Hospital, Birmingham B187QH NHS Emergency Departments Names Departments Dr Simon Hill Newcastle Hospitals NHS Foundation Trust Dr John Wright Royal Victoria Infirmary, Queen Victoria Road, Newcastle NE1 4LP Prof Michael Eddleston NHS Lothian Dr Jonathan Wraight Royal Infirmary of Edinburgh Dr James Dear QMRI, E3.20, 47 Little France Crescent Edinburgh, EH16 4TJ Dr Paul Dargan Guy's and St Thomas' NHS Foundation Trust and King's Dr David M Wood Health Partners Clinical Toxicology, 3rd Floor, Block C, South Wing, St Thomas' Hospital, London SE1 7EH Dr John Thompson Cardiff and Vale University Health Board Dr James Coulson University Hospital Llandough, Penlan Road, Penarth, Vale of Glamorgan CF64 2XW Dr Johann Grundlingh Barts and the London NHS Foundation Trust Emergency Department, Acute and Family Division Royal London Hospital, Whitechapel London E1 1BB Dr Tim Nutbeam Plymouth Hospitals NHS Trust Emergency Department, Derriford Hospital Plymouth PL6 8DH Dr Mike Aisbit Southport and Omskirk Hospital NHS Trust, Southport and Formby District General Hospital Town Lane, Kew, Southport, Merseyside, PR8 6PN Dr Ashraf Kamour Pennine Acute Hospitals NHS Trust North Manchester General Hospital, Delaunays Road, Crumpsall Manchester M8 5RB Fairfield General Hospital, Rochdale Old Road, Bury, BL9 7TD; North Manchester General Hospital, Delaunays Road, 3 Version 2 (Scotland) 25th April 2016 Crumpsall, Manchester, M8 5RB Dr Paul Acheampong Royal Liverpool and Broadgreen University Hospitals NHS Trust Royal Liverpool University Hospital, Prescot Street Liverpool L7 8XP Mr Simon Tucker Blackpool Teaching Hospitals NHS Foundation Trust Blackpool Victoria Hospital, Whinney Heys Road Blackpool FY3 8NR Dr Heather Jarman St George’s University Hospitals NHS Foundation Trust Blackshaw Road, Tooting, London SW17 0QT Dr Nigel Brown Northumbria Hospitals NHS Foundation Trust, Wansbeck General Hospital, Woodhorn Lane , Ashington, Northumberland, NE63 9JJ Further departments and local PIs to be confirmed Start date 9th November 2015 End date 1st April 2019 Duration 41 months 4 Version 2 (Scotland) 25th April 2016 TABLE OF CONTENTS Co-investigators........................................................................................................................................... 2 TABLE OF CONTENTS ........................................................................................................................... 5 ABBREVIATIONS ..................................................................................................................................... 6 SUMMARY ................................................................................................................................................. 8 INTRODUCTION ..................................................................................................................................... 10 Novel Psychoactive Substances ............................................................................................................ 10 Drug control in the UK ......................................................................................................................... 12 Research in progress ............................................................................................................................. 13 Research gaps ........................................................................................................................................ 14 AIMS AND OBJECTIVES ...................................................................................................................... 16 METHODS ................................................................................................................................................ 17 Type of study .......................................................................................................................................... 17 Participants ............................................................................................................................................ 17 Research methods .................................................................................................................................. 18 Study 1. Analysis of NPIS enquiry data ........................................................................................... 18 Study 2. Collation of toxicology data provided by participating NHS laboratories .................... 20 Study 3. Further analysis of samples already collected as part of clinical care. .......................... 22 Study 4. Collection of samples for research purposes from people attending participating emergency departments .................................................................................................................... 25 Confidentiality and data protection ..................................................................................................... 35 Statistical aspects ................................................................................................................................... 37 Research approvals ............................................................................................................................... 38 Analytical methods ................................................................................................................................ 39 Mathematical and modelling methods................................................................................................. 40 Dissemination of research results ........................................................................................................ 41 REFERENCES .......................................................................................................................................... 42 APPENDIX 1: Classification of NPS and related traditional recreational drugs ............................... 47 APPENDIX 2: Clinical data collected (Study 4) .................................................................................... 48 APPENDIX 3: Substances included in Newcastle recreational drug and NPS screen and standards available (as of January 2015).................................................................................................................. 53 5 Version 2 (Scotland) 25th April 2016 ABBREVIATIONS 25I-NBOMe 2-(4-iodo-2,5-dimethoxyphenyl)-N-[(2-methoxyphenyl)methyl] ethanamine 2-AI, 2-aminoindan 2C-B 2,5-dimethoxy-4-bromophenethylamine 2C-E 2,5-dimethoxy-4-ethylphenethylamine 5-IAI 5-Iodo-2-aminoindane 5-IT 5-(2-Aminopropyl)indole ACMD Advisory Council on the Misuse of Drugs ALT Alanine transaminase AM-2201 (1-(5-fluoropentyl)-3-(1-naphthoyl)indole) AMT alphamethyltryptamine APB aminopropylbenzofuran APICA 1-Amino-5-phosphonoindan-1-carboxylic acid AST Aspartate transaminase BB-22 1-(cyclohexylmethyl)-1H-indole-3-carboxylic acid 8-quinolinyl ester BZP Benzylpiperazine CK Creatine kinase D2PM Diphenylprolinol DEWS Drugs