ASSIST: A Surveillance Study of Illicit Substance Toxicity
NCT ID: NCT05329142
Last Updated: 2022-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
1000 participants
OBSERVATIONAL
2022-08-19
2023-08-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments
NCT01207791
Routine Clinical Screening for Substance Use Disorders in the Emergency Room Setting
NCT01661465
Brief Intervention and Referral to Treatment With Substance Use Disorders in the Emergency Room Setting
NCT01661517
Brief Intervention for Drug Misuse in the Emergency Department
NCT01124591
Alcohol Brief Intervention Integrated With Mobile Chat-based Support for Risky Drinkers in Emergency Departments
NCT05018624
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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)
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Public Health Scotland
UNKNOWN
NHS Greater Glasgow and Clyde
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David J Lowe, MBChB BMSc FRCEM
Role: PRINCIPAL_INVESTIGATOR
NHS GGC R&I Non Commerical (Sponsor) Research Coordinator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Queen Elizabeth University Hospital, NHS GGC
Glasgow, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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
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.
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.
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.
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 Jul 28:1-11. doi: 10.1080/15563650.2025.2524078. Online ahead of print.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GN21AE239
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.