ASSIST: A Surveillance Study of Illicit Substance Toxicity

NCT05329142 | Unknown

• 1 other identifier: GN21AE239
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overdose, Drug; Drug Use; Drug Abuse; Drug Toxicity; Drug Effect; Illicit Drug Use; Illicit Drug Overdose; Illicit Drug Intoxication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Clinical phenotyping of patients attending due to acute illicit drug toxicity compared to reported / presumed drug taken

  1 year

• Proportion of patients who fit stage 2 criteria with biological sample mass spectrometry toxicology analysis

  1 year

• Production of frequency and trend data to deliver to Public Health Scotland

  1 year

• Proportion of illicit drug reported to have been taken and proportion of clinician presumed drug taken accurately matching toxicology analysis

  1 year

• 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

Study Arms (2)

Stage 1: Usual Care clinical data:

The patient will firstly be identified as having attended the ED due to acute illicit drug toxicity and must fit the inclusion and exclusion criteria. The research team will complete the electronic Case Report Form (eCRF), which will include defined data.

Stage 2: Surplus sampling Mass Spectrometry

The research team will select patients with acute moderate / severe toxicity, which will be defined as those requiring at least one of: * Patient admitted to hospital due to acute illicit drug toxicity * Pre-hospital cardio/pulmonary resuscitation * Any part of patient's ED care was in the Resuscitation area of the ED * Patient died in the ED or within 72 hours A surplus sample of the standard of care SST sample from this group will be analysed by way of Mass Spectrometry.

Diagnostic Test: Surplus sample toxicology analysis

Interventions

Surplus sample toxicology analysis DIAGNOSTIC_TEST

Anonymised surplus blood sample will be analysed for drugs and their metabolites by way of Mass Spectrometry and LGC Group, Cambridge.

Stage 2: Surplus sampling Mass Spectrometry

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stage 1: All adult patients attending Queen Elizabeth University Hospital ED due to acute illicit substance use. The target is 1000 patients. Stage 2: Patients from stage 1 with moderate / severe toxicity as described in section 7.1. The target number of participants in this study is 500.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• Public Health Scotland: collaborator

Study Sites (1)

Queen Elizabeth University Hospital, NHS GGC

Glasgow, G51 4FT, United Kingdom

RECRUITING

Related Publications (16)

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

  BACKGROUND

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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

• 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

  BACKGROUND

• Di Rico R, Nambiar D, Stoove 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.

  PMID: 30518362 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 27973993 BACKGROUND

• 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.

  PMID: 27213960 BACKGROUND

• 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.

  PMID: 29216524 BACKGROUND

• Dunlop LC, Craik V, Jarvie N, Hudson S, Walters M, Dear JW, Lowe DJ. Clinical characterisation of the novel benzodiazepine bromazolam-data from the ASSIST (A Surveillance Study of Illicit Substance Toxicity) study. Clin Toxicol (Phila). 2025 Nov;63(11):838-848. doi: 10.1080/15563650.2025.2524078. Epub 2025 Jul 28.

  PMID: 40719187 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

A surplus sample of blood taken as part of usual care biochemistry sample from selected patients will be analysed by way of Mass Spectrometry.

MeSH Terms

Conditions

Drug Overdose; Substance-Related Disorders; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Chemically-Induced Disorders; Mental Disorders

Study Officials

• David J Lowe, MBChB BMSc FRCEM

  NHS GGC R&I Non Commerical (Sponsor) Research Coordinator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa C Dunlop, MBChB, BSc FRCEM

CONTACT

0141 452 2930/1; lisa.dunlop2@nhs.scot

David J Lowe, MBChB BMSc FRCEM

CONTACT

01414522840; david.lowe@glasgow.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 14, 2022
• Study Start: August 19, 2022
• Primary Completion: August 19, 2023
• Study Completion: August 19, 2023
• Last Updated: September 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)