ASSIST: A Surveillance Study of Illicit Substance Toxicity

Drug Abuse Clinical Trial

— ASSIST  

Official title:

ASSIST: A Surveillance Study of Illicit Substance Toxicity - Clinical Characterisation and Toxicological Analysis of Emergency Department Presentations in Glasgow

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05329142
• Other study ID #: GN21AE239
• Status: Recruiting
• Start date: August 19, 2022
• Est. completion date: August 19, 2023

Study information

• Verified date: September 2022
• Source: NHS Greater Glasgow and Clyde
• Contact: Lisa C Dunlop, MBChB, BSc FRCEM
• Phone: 0141 452 2930/1
• Email: lisa.dunlop2[@]nhs.scot
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

There is a drug-related death crisis in Scotland. This study aims to collaborate with Public Health Scotland in order to assess the feasibility of introducing a surveillance system to the Emergency Department to highlight illicit drug-related attendances. This will utilise both clinical data and toxiclogical analysis of anonymised samples. The data will inform of prevalence, trend data and utcome of ED patients attending with acute illict drug toxicity.

Description:

The purpose of this research is to establish the introduction of a robust toxicology surveillance system in the Emergency Department (ED) in order to inform public health interests. The study will explore the feasibility of reporting characteristics and causative agents of patients attending hospital as an emergency due illicit substance use. The term illicit substance used during this study encompasses any substance which is not prescribed to the individual and is a controlled drug as per the Misuse of Drugs act 1971 and Misuse of Drugs Regulations 2001. The study will look at standard care clinical data from all individuals attending the Emergency Department due to acute illicit drug toxicity. Surplus blood samples will be anonymised and analysed for toxicological profiling. The study will allow identification of emerging drug trends and will be shared contemporaneously with Public Health Scotland and inform the Scottish Government of current incidences to inform public health measures to tackle the drugs death crisis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 19, 2023
• Est. primary completion date: August 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Age >16
• Patient attending QEUH ED directly relating to acute illicit drug use
• Patients with reported acute illicit drug use toxicity who are unwell before they are seen in the Emergency Department but appear well in the ED should also be included

Exclusion Criteria:

• Condition more likely due to cause other than acute illicit drug use
• Condition due to withdrawal of drugs / alcohol
• Condition primarily related to alcohol use and no evidence of acute illicit drug use
• Attendance is due to complication of previous drug use - i.e., BBV / infected injection site (without acute drug toxicity)

Related Conditions & MeSH terms

• Drug Abuse
• Drug Effect
• Drug Overdose
• Drug Toxicity
• Drug Use
• Drug-Related Side Effects and Adverse Reactions
• Illicit Drug Use
• Overdose, Drug
• Substance-Related Disorders

Intervention

Diagnostic Test:
• Surplus sample toxicology analysis
Anonymised surplus blood sample will be analysed for drugs and their metabolites by way of Mass Spectrometry and LGC Group, Cambridge.

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth University Hospital, NHS GGC	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	Public Health Scotland

Country where clinical trial is conducted

United Kingdom, 

References & Publications (15)

Adams AJ, Banister SD, Irizarry L, Trecki J, Schwartz M, Gerona R. "Zombie" Outbreak Caused by the Synthetic Cannabinoid AMB-FUBINACA in New York. N Engl J Med. 2017 Jan 19;376(3):235-242. doi: 10.1056/NEJMoa1610300. Epub 2016 Dec 14. — View Citation

Deaths mentioning a new psychoactive substance by broad age-group, England and Wales, 2011 to 2015 registrations. 18 January 2017. Available from: https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/adhocs/06556deathsmentioninganewpsychoactivesubstancebybroadagegroupenglandandwales2011to2015registrations. Accessed 19/12/2018

Di Rico R, Nambiar D, Stoové M, Dietze P. Drug overdose in the ED: a record linkage study examining emergency department ICD-10 coding practices in a cohort of people who inject drugs. BMC Health Serv Res. 2018 Dec 5;18(1):945. doi: 10.1186/s12913-018-3756-8. — View Citation

EMCDDA. Drug-related deaths and mortality in Europe. Update from EMCDDA expert network July 2019. Available from https://www.emcdda.europa.eu. Accessed 09/02/2020

EMCDDA. European Drug Report, trends and Developments 2021. Available from https://www.emcdda.europa.eu/system/files/publications/13838/TDAT21001ENN.pdf accessed 14/02/2022

European Monitoring Centre for Drugs and Drug Addiction (2021), European Drug Report 2021: Trends and Developments, Publications Office of the European Union, Luxembourg.

European Monitoring Centre for Drugs and Drug Addiction. (2016) Health responses to new psychoactive substances. Available from http://www.emcdda.europa.eu/system/files/publications/2812/TD0216555ENN.pdf. Accessed 15/02/2022

Hikin L, Smith PR, Ringland E, Hudson S, Morley SR. Multiple fatalities in the North of England associated with synthetic fentanyl analogue exposure: Detection and quantitation a case series from early 2017. Forensic Sci Int. 2018 Jan;282:179-183. doi: 10.1016/j.forsciint.2017.11.036. Epub 2017 Nov 29. — View Citation

National Records of Scotland. Drug-related deaths in Scotland in 2020, published 30/07/21. Available from https://www.nrscotland.gov.uk. Accessed 14/02/2022.

Office for National Statistics. Drug misuse in England and Wales: year ending March 2020 09/12/2020. Accessed 16/02/2022

Public Health Scotland, Drug-related Hospital Statistics, Scotland 2019 - 2020. Published 15/06/2021. Available from https://publichealthscotland.scot/. Accessed 14/02/2022

Scottish Government. Evidence-Based Strategies for Preventing Drug-Related Deaths in Scotland, Our Emergency Response. January 2020. Available from https://www.gov.scot/. Accessed 10/02/2021

Seywright A, Torrance HJ, Wylie FM, McKeown DA, Lowe DJ, Stevenson R. Analysis and clinical findings of cases positive for the novel synthetic cannabinoid receptor agonist MDMB-CHMICA. Clin Toxicol (Phila). 2016 Sep;54(8):632-7. doi: 10.1080/15563650.2016.1186805. Epub 2016 May 23. — View Citation

The Misuse if Drugs Regulations 2001, Dangerous Drugs. Available from legislation.giv.uk. Accessed 25/02/2022.

UK Public General Acts. Misuse of Drugs Act 1972 Schedule 2. Available from legislation.gov.uk. Accessed 25/02/2022

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of full data sets and toxicology analysis for all patient attending the ED due to acute illicit drug toxicity	Objective: Assess the feasibility of prospective surveillance of Emergency Department presentations relating to acute illicit drug toxicity; Outcome measure: Proportion of full data sets and toxicology analysis for all patient attending the ED due to acute illicit drug toxicity	1 year
Secondary	Clinical phenotyping of patients attending due to acute illicit drug toxicity compared to reported / presumed drug taken	Objective: Describe the clinical characteristics and reported / presumed toxicological profile of drug related presentations to the Emergency Department; Outcome measure: Clinical phenotyping of patients attending due to acute illicit drug toxicity compared to reported / presumed drug taken	1 year
Secondary	Proportion of patients who fit stage 2 criteria with biological sample mass spectrometry toxicology analysis	Objective: Establish the feasibility of ED presentation toxicological surveillance by anonymised surplus sample mass spect analysis; Outcome Measure: Proportion of patients who fit stage 2 criteria with biological sample mass spectrometry toxicology analysis	1 year
Secondary	Production of frequency and trend data to deliver to Public Health Scotland	Objective: Describe the frequency and trends of drug related presentations to the ED, both clinically and by biological sample analysis; Outcome measure: Production of frequency and trend data to deliver to Public Health Scotland	1 year
Secondary	Proportion of illicit drug reported to have been taken and proportion of clinician presumed drug taken accurately matching toxicology analysis	Objective: Assess the accuracy of reported / clinician presumptive toxidrome diagnosis compared to biological sample analysis; Outcome Measure: Proportion of illicit drug reported to have been taken and proportion of clinician presumed drug taken accurately matching toxicology analysis	1 year
Secondary	Production of automated pre-defined data capture, recording and auditing for the routine processing of drug related ED presentations that includes toxicological information	Objective: Develop a framework to standardise data capture, recording and auditing for the routine processing of drug related ED presentations that includes toxicological information; Outcome measure: Production of automated pre-defined data capture, recording and auditing for the routine processing of drug related ED presentations that includes toxicological information	1 year
Secondary	Share learning and data with Scottish Government, PHS and other NHS boards to inform national scale up	Objective: Identify and compare options for national scale up - including the use of existing hospital toxicology facilities and additional services; Outcome measure: Share learning and data with Scottish Government, PHS and other NHS boards to inform national scale up	1 year