Overdose, DrugASSISTNCT05329142
ASSIST: A Surveillance Study of Illicit Substance Toxicity
An observational study of Overdose, Drug and Drug Use, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Overdose, Drug, Drug Use, Drug Abuse
- What is being tested?
- Surplus sample toxicology analysis
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Aug 2022to 19 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Elizabeth University Hospital, NHS GGC
Glasgow, G51 4FT
Lisa C Dunlop, MBChB, BSc, FRCEM, 0141 452 2930/1, lisa.dunlop2@nhs.scot
David J Lowe, MBChB BMSc FRCEM, 01414522840, david.lowe@glasgow.ac.uk
About this study
Official title: ASSIST: A Surveillance Study of Illicit Substance Toxicity - Clinical Characterisation and Toxicological Analysis of Emergency Department Presentations in Glasgow
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.
Read the 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.
- Conditions
- Overdose, Drug, Drug Use, Drug Abuse, Drug Toxicity, Drug Effect, Illicit Drug Use
- Being tested
- Surplus sample toxicology analysis
- Medical subject headings
- Drug Overdose, Substance-Related Disorders, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surplus sample toxicology analysisDiagnostic test
Anonymised surplus blood sample will be analysed for drugs and their metabolites by way of Mass Spectrometry and LGC Group, Cambridge.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Surplus sample toxicology analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (6)
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
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
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
Measured: 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
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
Measured: 1 year
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start19 Aug 2022
- Primary completion19 Aug 2023 (estimated)
- Study completion19 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Overdose, DrugStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Scotland
- Responsible party
- Sponsor
- Investigators
- David J Lowe, MBChB BMSc FRCEM, Principal investigator, NHS GGC R&I Non Commerical (Sponsor) Research Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329142
- Sponsor's protocol ID
- GN21AE239
- Acronym
- ASSIST
- Status last verified
- Sep 2022
- First submitted
- 30 Mar 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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
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.
PubMed 30518362EMCDDA. 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
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.
PubMed 27973993Seywright 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.
PubMed 27213960Hikin 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.
PubMed 29216524
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSIST: A Surveillance Study of Illicit Substance Toxicity - Clinical Characterisation and Toxicological Analysis of Emergency Department Presentations in Glasgow
- ClinicalTrials.gov ID
- NCT05329142
- Acronym / sponsor ID
- ASSIST / GN21AE239
- Conditions
- Overdose, Drug, Drug Use, Drug Abuse, Drug Toxicity, Drug Effect, Illicit Drug Use
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- Public Health Scotland
- Study start
- 19 Aug 2022 (actual)
- Primary completion
- 19 Aug 2023 (estimated)
- Study completion
- 19 Aug 2023 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Diagnostic Test: Surplus sample toxicology analysisThe 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surplus sample toxicology analysisAnonymised surplus blood sample will be analysed for drugs and their metabolites by way of Mass Spectrometry and LGC Group, Cambridge. | Diagnostic test | Stage 2: Surplus sampling Mass Spectrometry |
Primary outcome
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
6 secondary outcomes
Clinical phenotyping of patients attending due to acute illicit drug toxicity compared to reported / presumed drug taken
Time frame: 1 year
Proportion of patients who fit stage 2 criteria with biological sample mass spectrometry toxicology analysis
Time frame: 1 year
Production of frequency and trend data to deliver to Public Health Scotland
Time frame: 1 year
Proportion of illicit drug reported to have been taken and proportion of clinician presumed drug taken accurately matching toxicology analysis
Time frame: 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
Time frame: 1 year
Share learning and data with Scottish Government, PHS and other NHS boards to inform national scale up
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- BackgroundUK Public General Acts. Misuse of Drugs Act 1972 Schedule 2. Available from legislation.gov.uk. Accessed 25/02/2022
- BackgroundThe Misuse if Drugs Regulations 2001, Dangerous Drugs. Available from legislation.giv.uk. Accessed 25/02/2022.
- BackgroundEMCDDA. European Drug Report, trends and Developments 2021. Available from https://www.emcdda.europa.eu/system/files/publications/13838/TDAT21001ENN.pdf accessed 14/02/2022
- BackgroundNational 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.
- BackgroundPublic Health Scotland, Drug-related Hospital Statistics, Scotland 2019 - 2020. Published 15/06/2021. Available from https://publichealthscotland.scot/. Accessed 14/02/2022
- BackgroundScottish 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: PubMed 30518362Di 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.
- BackgroundEMCDDA. 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
- BackgroundEuropean 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
- BackgroundEuropean Monitoring Centre for Drugs and Drug Addiction (2021), European Drug Report 2021: Trends and Developments, Publications Office of the European Union, Luxembourg.
- BackgroundOffice for National Statistics. Drug misuse in England and Wales: year ending March 2020 09/12/2020. Accessed 16/02/2022
- BackgroundDeaths 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
- Individual participant dataSharing planned: Yes
Related trials for Overdose, Drug
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
Not yet recruitingObservational study
Disease Intervention Specialist (DIS) for SUD
Substance Use Disorder (SUD), Opioid Use Disorder
Not yet recruiting
Prevention and Rapid Outreach for Treatment, Engagement, and Care Transition From the Emergency Department
Opioid Overdose Prevention, HIV Prevention and Care
Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Active, not recruiting
Introducing Electronic Alerts to Reduce Inappropriate Digoxin Prescribing in Older Adults
Drug-Related Side Effects and Adverse Reaction, Digoxin Overdose
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J Lowe, MBChB BMSc FRCEM principal investigator
NHS GGC R&I Non Commerical (Sponsor) Research Coordinator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overdose, Drug and Drug Use, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa C Dunlop, MBChB, BSc FRCEM (0141 452 2930/1, lisa.dunlop2@nhs.scot), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of full data sets and toxicology analysis for all patient attending the ED due to acute illicit drug toxicity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05329142, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.