Background

Each year large numbers of people present to hospitals, especially emergency departments with unintended symptoms after non-medical substance use (sometimes termed 'drug misuse' or 'recreational drug use').  Some experience severe symptoms and fatal toxicity can occur.

Many hospital presentations and deaths are caused by substances that have been used over many years, such as heroin, cocaine, methadone, benzodiazepine (sedatives) and amphetamines, but over the last decade large numbers of newer substances have been encountered, sometimes termed novel or New Psychoactive Substances (NPS).  These NPS are often similar in chemical structure and have similar effects to traditional substances of misuse, but they can be attractive to users, for example they may not be illegal to possess and/or may not be detectable in standard drug screens.

An important challenge in monitoring toxicity and death caused by non-medical drug use is the accurate identification of the substances involved.  People affected may not know the precise constituents of preparations they have taken and the information they do provide can be inaccurate or incomplete, especially if NPS are involved.  The Identification Of Novel psychoActive substances (IONA) study was introduced in 2015 to analyse samples from people with toxicity after non-medical drug use so that the substances causing the toxicity can be accurately identified.

Study Overview

The Identification Of Novel psychoActive substances (IONA) study is an NIHR portfolio study currently funded by the Office for Health and Disparities (OHID), having previously been funded by Public Health England and the National Institute for Health Research.  It is an observational study that aims to:

• Obtain clinical information and biological samples from consenting adults (>16 years) presenting to hospitals with toxicity after non-medical substance use of any type
• Identify the responsible substances by analysing samples collected using state of the art laboratory methods
• Link the presence of analytically confirmed substance exposure with the toxic effects experienced
• Identify trends with time and regional differences in the substances involved

Inclusion Criteria

• Patient attending an emergency department with toxicity as a result of suspected drug misuse
• Patient consent (immediate or retrospective)

Exclusion Criteria

• Refusal of consent
• No clinical suspicion of drug misuse
• Children and young people <16 years old
• Known to be HIV positive
• Samples collected for investigation of suspected non-accidental injury

Inclusion criteria initially required severe toxicity (according to defined criteria, except in Scotland) and suspected NPS exposure, but exposure to non-medicinal opioids was added in 2017 to detect fentanyl and its analogues.  Since January 2020 those using any drug can be included and severe toxicity is no longer required.

Data Collected

After consent has been obtained the following are collected:

• Clinical data (age, sex, partial postcode, details of the reported substances, exposure, clinical features documented, results of investigations, treatments required, clinical outcome)
• Analytical data (results of comprehensive screening using high resolution accurate mass liquid chromatography-mass spectrometry)

Information is collected in linked anonymised format, with details of sample analysis fed back to local clinical teams and also to those providing the samples if they have requested that

The study has ethical approval and authorisation from the Health Research Authority.  The study in England and Wales is approved seperately to the study in Scotland because of legal differences between the administrations.