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ASSIST: A Surveillance Study of Illicit Substance Toxicity (ASSIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05329142
Recruitment Status : Recruiting
First Posted : April 14, 2022
Last Update Posted : September 19, 2022
Sponsor:
Collaborator:
Public Health Scotland
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Overdose, Drug Drug Use Drug Abuse Drug Toxicity Drug Effect Illicit Drug Use Illicit Drug Overdose Illicit Drug Intoxication Diagnostic Test: Surplus sample toxicology analysis

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ASSIST: A Surveillance Study of Illicit Substance Toxicity - Clinical Characterisation and Toxicological Analysis of Emergency Department Presentations in Glasgow
Actual Study Start Date : August 19, 2022
Estimated Primary Completion Date : August 19, 2023
Estimated Study Completion Date : August 19, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
Anonymised surplus blood sample will be analysed for drugs and their metabolites by way of Mass Spectrometry and LGC Group, Cambridge.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of full data sets and toxicology analysis for all patient attending the ED due to acute illicit drug toxicity [ Time Frame: 1 year ]

    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



Secondary Outcome Measures :
  1. Clinical phenotyping of patients attending due to acute illicit drug toxicity compared to reported / presumed drug taken [ Time Frame: 1 year ]

    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


  2. Proportion of patients who fit stage 2 criteria with biological sample mass spectrometry toxicology analysis [ Time Frame: 1 year ]

    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


  3. Production of frequency and trend data to deliver to Public Health Scotland [ Time Frame: 1 year ]

    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


  4. Proportion of illicit drug reported to have been taken and proportion of clinician presumed drug taken accurately matching toxicology analysis [ Time Frame: 1 year ]

    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


  5. Production of automated pre-defined data capture, recording and auditing for the routine processing of drug related ED presentations that includes toxicological information [ Time Frame: 1 year ]

    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


  6. Share learning and data with Scottish Government, PHS and other NHS boards to inform national scale up [ Time Frame: 1 year ]

    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



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.

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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)
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05329142


Contacts
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Contact: Lisa C Dunlop, MBChB, BSc FRCEM 0141 452 2930/1 lisa.dunlop2@nhs.scot
Contact: David J Lowe, MBChB BMSc FRCEM 01414522840 david.lowe@glasgow.ac.uk

Locations
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United Kingdom
Queen Elizabeth University Hospital, NHS GGC Recruiting
Glasgow, United Kingdom, G51 4FT
Contact: Lisa C Dunlop, MBChB, BSc, FRCEM    0141 452 2930/1    lisa.dunlop2@nhs.scot   
Contact: David J Lowe, MBChB BMSc FRCEM    01414522840    david.lowe@glasgow.ac.uk   
Sub-Investigator: James Dear, PhD FRCP         
Sub-Investigator: Matthew Walters, MBE MD FRCP         
Sub-Investigator: Fraser Denny, MBChB FRCEM         
Sub-Investigator: Malcolm WG Gordon, MBChB FRCS FRCEM         
Sub-Investigator: Vicki Craik         
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Public Health Scotland
Investigators
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Principal Investigator: David J Lowe, MBChB BMSc FRCEM NHS GGC R&I Non Commerical (Sponsor) Research Coordinator
More Information
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Publications:
UK Public General Acts. Misuse of Drugs Act 1972 Schedule 2. Available from legislation.gov.uk. Accessed 25/02/2022
The Misuse if Drugs Regulations 2001, Dangerous Drugs. Available from legislation.giv.uk. Accessed 25/02/2022.
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
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.
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
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
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
European Monitoring Centre for Drugs and Drug Addiction (2021), European Drug Report 2021: Trends and Developments, Publications Office of the European Union, Luxembourg.
Office for National Statistics. Drug misuse in England and Wales: year ending March 2020 09/12/2020. Accessed 16/02/2022
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

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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT05329142    
Other Study ID Numbers: GN21AE239
First Posted: April 14, 2022    Key Record Dates
Last Update Posted: September 19, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Drug Overdose
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Mental Disorders