ASSIST: A Surveillance Study of Illicit Substance Toxicity

NHS Trust

Status: Enrolling

Conditions: Illicit Drug Intoxication; Overdose, Drug; Illicit Drug Overdose; Drug Abuse; Drug Effect; Drug Use; Illicit Drug Use; Drug Toxicity

Treatments: Diagnostic Test: Surplus sample toxicology analysis

Study type: Observational

Funder types: Other

Identifiers

NCT05329142

GN21AE239

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

1,000 participants in 2 patient groups

Stage 1: Usual Care clinical data:

Description:

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

Description:

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.

Treatment:

Diagnostic Test: Surplus sample toxicology analysis