Clinical trial NCT05329142: ASSIST: A Surveillance Study of Illicit Substance Toxicity
Official title: ASSIST: A Surveillance Study of Illicit Substance Toxicity - Clinical Characterisation and Toxicological Analysis of Emergency Department Presentations in Glasgow
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overdose, Drug
Drug Use
Drug Abuse
Drug Toxicity
Drug Effect
Illicit Drug Use
Illicit Drug Overdose
Illicit Drug Intoxication
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: Public Health Scotland
First posted: 2022-04-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of full data sets and toxicology analysis for all patient attending the ED due to acute illicit drug toxicity
timeFrame: 1 year
Secondary outcomes:
measure: Clinical phenotyping of patients attending due to acute illicit drug toxicity compared to reported / presumed drug taken
timeFrame: 1 year
measure: Proportion of patients who fit stage 2 criteria with biological sample mass spectrometry toxicology analysis
timeFrame: 1 year
measure: Production of frequency and trend data to deliver to Public Health Scotland
timeFrame: 1 year
measure: Proportion of illicit drug reported to have been taken and proportion of clinician presumed drug taken accurately matching toxicology analysis
timeFrame: 1 year
measure: Production of automated pre-defined data capture, recording and auditing for the routine processing of drug related ED presentations that includes toxicological information
timeFrame: 1 year
measure: Share learning and data with Scottish Government, PHS and other NHS boards to inform national scale up
timeFrame: 1 year
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital, NHS GGC
Study officials:
affiliation: NHS GGC R&I Non Commerical (Sponsor) Research Coordinator
name: David J Lowe, MBChB BMSc FRCEM
role: PRINCIPAL_INVESTIGATOR
References:
citation: UK Public General Acts. Misuse of Drugs Act 1972 Schedule 2. Available from legislation.gov.uk. Accessed 25/02/2022
citation: The Misuse if Drugs Regulations 2001, Dangerous Drugs. Available from legislation.giv.uk. Accessed 25/02/2022.
citation: 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
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.
citation: Public Health Scotland, Drug-related Hospital Statistics, Scotland 2019 - 2020. Published 15/06/2021. Available from https://publichealthscotland.scot/. Accessed 14/02/2022
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