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ASSIST: A Surveillance Study of Illicit Substance Toxicity

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05329142
Acronym
ASSIST
Enrollment
1000
Registered
2022-04-14
Start date
2022-08-19
Completion date
2023-08-19
Last updated
2022-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIAGNOSTIC_TESTSurplus sample toxicology analysis

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

Sponsors

Public Health Scotland
CollaboratorUNKNOWN
NHS Greater Glasgow and Clyde
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Proportion of full data sets and toxicology analysis for all patient attending the ED due to acute illicit drug toxicity1 yearObjective: 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

Secondary

MeasureTime frameDescription
Proportion of patients who fit stage 2 criteria with biological sample mass spectrometry toxicology analysis1 yearObjective: 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
Production of frequency and trend data to deliver to Public Health Scotland1 yearObjective: 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
Clinical phenotyping of patients attending due to acute illicit drug toxicity compared to reported / presumed drug taken1 yearObjective: 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
Production of automated pre-defined data capture, recording and auditing for the routine processing of drug related ED presentations that includes toxicological information1 yearObjective: 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
Share learning and data with Scottish Government, PHS and other NHS boards to inform national scale up1 yearObjective: 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
Proportion of illicit drug reported to have been taken and proportion of clinician presumed drug taken accurately matching toxicology analysis1 yearObjective: 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

Countries

United Kingdom

Contacts

Primary ContactLisa C Dunlop, MBChB, BSc FRCEM
lisa.dunlop2@nhs.scot0141 452 2930/1
Backup ContactDavid J Lowe, MBChB BMSc FRCEM
david.lowe@glasgow.ac.uk01414522840

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026