Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000012370
Ethics application status
Approved
Date submitted
28/11/2016
Date registered
4/01/2017
Date last updated
25/06/2021
Date data sharing statement initially provided
31/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Western Australian Illicit Substance Evaluation
Scientific title
Western Australian Illicit Substance Evaluation - assessing blood levels and types of illicit substances in patients suspected to be intoxicated with stimulant or hallucinogenic drugs in the emergency department.
Secondary ID [1] 288629 0
Nil known
Universal Trial Number (UTN)
U1111-1180-5861
Trial acronym
WISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
illicit drug use 297788 0
novel psychoactive substance abuse 300719 0
methamphetamine abuse 301157 0
Condition category
Condition code
Public Health 297972 297972 0 0
Other public health
Mental Health 300958 300958 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients intoxicated with a stimulant, hallucinogenic or cannabinoid substance. Observed for duration of hospital stay. Blood sample at time of enrolment tested for classic and novel psychoactive substances, and their concentration, using specialised liquid chromatography-mass spectrometry analytical techniques. This is related to the clinical findings and observations, and also with what the patient believed they had taken. Patients' vital signs, symptoms, hospital interventions and length of stay parameters will be observed.
Intervention code [1] 294036 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299978 0
Type of Illicit drug detected in blood sample
Timepoint [1] 299978 0
Sample collected at time of enrolment
Primary outcome [2] 300606 0
Concentration of illicit drug detected in blood sample
Timepoint [2] 300606 0
Sample collected at time of enrolment
Secondary outcome [1] 328736 0
Related examination findings. Enrolling clinician may confirm the presence or absence of 39 pre-determined clinical findings:

thought disordered
agitated
paranoid
delusions
pressured speech
hypervigilant or startles easily
delirium
visual hallucinations
auditory hallucinations
muttering/unintelligible speech
drowsy
unconscious
choreoathetoid (writhing) movements
restlessness
picking at things
facial automatisms
single seizure
multiple seizures
myoclonic jerks
nystagmus
ocular clonus
increased tone
rigidity
trismus
bruxism
clonus 3 or more beats
temperature > 38 at any point during first 24 hours
hyperreflexia
tremor
bladder scan > 500ml
urinary retention (tries and unable to void)
vomiting
diarrhoea
chest pain
dry mucuous membranes
salivation
sweating
flushed face
palpitations
Timepoint [1] 328736 0
At time of enrolment.
Secondary outcome [2] 329823 0
Length of stay in the emergency department
Timepoint [2] 329823 0
Completed by research staff from electronic medical record post discharge
Secondary outcome [3] 329824 0
Requirement for intravenous sedation
Timepoint [3] 329824 0
During stay in the emergency department. Completed by research staff from review of medical records
Secondary outcome [4] 329825 0
Requirement for hospital security officers
Timepoint [4] 329825 0
During stay in the emergency department. Completed by research staff from review of medical records
Secondary outcome [5] 329826 0
The drug the patient believed they had taken
Timepoint [5] 329826 0
At time of enrolment. Completed by research staff from review of medical records

Eligibility
Key inclusion criteria
Patients presenting to the hospital emergency department can be enrolled if the clinician strongly suspects they are currently intoxicated with a stimulant, hallucinogenic or cannabinoid substance; and they are already having blood sampled or an intravenous cannula inserted for clinical purposes.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presumed primarily opiate or alcohol intoxication. Presumed that behavioural disturbance, rather than illicit drug intoxication, is the primary reason for presentation.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The study will run for an initial period of 2 years. It is assumed that 600 patients will be enrolled during this time. Descriptive statistics will be used to evaluate the study population and their characteristics. Symptoms, signs and outcomes will be described for individual drugs detected.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
Actual
4/08/2016
Date of last participant enrolment
Anticipated
1/08/2018
Actual
4/09/2018
Date of last data collection
Anticipated
14/08/2018
Actual
18/09/2018
Sample size
Target
600
Accrual to date
638
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 7000 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 14730 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 294794 0
Hospital
Name [1] 294794 0
Royal Perth Hospital
Country [1] 294794 0
Australia
Funding source category [2] 294796 0
Government body
Name [2] 294796 0
ChemCentre WA
Country [2] 294796 0
Australia
Funding source category [3] 298526 0
Charities/Societies/Foundations
Name [3] 298526 0
Royal Perth Hospital Medical Research Foundation
Country [3] 298526 0
Australia
Funding source category [4] 301815 0
Charities/Societies/Foundations
Name [4] 301815 0
Australasian College for Emergency Medicine Foundation
Country [4] 301815 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Wellington Street, Perth WA 6000
Country
Australia
Secondary sponsor category [1] 293637 0
Government body
Name [1] 293637 0
ChemCentre WA
Address [1] 293637 0
Curtin University, Manning Road, Bentley WA 6102
Country [1] 293637 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296196 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 296196 0
Level 2, Southern Research Facility (Perkins building)
Fiona Stanley Hospital, 11 Robin Warren Drive, MURDOCH WA 6150
Ethics committee country [1] 296196 0
Australia
Date submitted for ethics approval [1] 296196 0
08/02/2016
Approval date [1] 296196 0
17/05/2016
Ethics approval number [1] 296196 0
16-026

Summary
Brief summary
Recreational drug use is becoming an increasing public health issue in our society. Methamphetamine usage in Australia has been described as an ‘epidemic’ that is ‘tearing our country apart’, and has recently been the subject of a Prime Ministerial National Ice Task Force. The average purity of methamphetamine seized by police in Western Australia has increased from 10% to 75% in just six years. In addition to this, there are a huge new range of synthetic drugs entering circulation, which are collectively termed novel psychoactive substances. These include many novel stimulants and hallucinogens, such as cathinones, NBOMe type drugs, and synthetic cannabinoid receptor antagonists. There were seven unrelated deaths in Australia over the 2015-2016 summer festival season related to synthetic drug use, as publicised in the ABC Four Corners investigation “Dying to Dance” (February 2016).

This project is a novel study, based in the emergency department (ED), where patients suspected of being under the influence of recreational drugs have a single blood sample taken to identify the causative agent. The analysis will be undertaken by ChemCentre WA, with whom we have an established collaboration, using liquid chromatography-mass spectrometry analytical techniques. Prior to analysis, the sample is permanently de-identified. We aim to identify the agent (or agents), determine its concentration, and relate it to the clinical picture and complications. We will also compare the analytic result with what the patient believed they had taken.

Where novel drugs are identified, repeat analytical work can be undertaken to aim to develop new assays and reference standards for future analysis. Samples will be stored frozen for five years to enable this work. We will be able to identify trends in recreational drug use in patients presenting to the ED, which is vitally important from a public health perspective. Should information of early interest to clinicians or the general public be identified, this would be released in the interest of public safety.
Trial website
Trial related presentations / publications
Public notes
A note regarding the age of study participants - the ethics approval for the study includes enrolment of children under 18 although they are not the primary target of the study. There is not a specified minimum age. The age of 12 is nominated for ANZCTR to cover for high-school aged children enrolled, but is not an absolute cut-off. At the primary recruiting site, children over about 14 years old are sometimes seen in the adult emergency department intoxicated with drugs. The second recruiting site is a mixed adult and paediatric emergency department.

Contacts
Principal investigator
Name 63922 0
Dr David McCutcheon
Address 63922 0
Emergency Department
Royal Perth Hospital
GPO Box X2213
Perth WA 6847
Country 63922 0
Australia
Phone 63922 0
+61892242662
Fax 63922 0
Email 63922 0
[email protected]
Contact person for public queries
Name 63923 0
Dr David McCutcheon
Address 63923 0
Emergency Department
Royal Perth Hospital
GPO Box X2213
Perth WA 6847
Country 63923 0
Australia
Phone 63923 0
+61892242662
Fax 63923 0
Email 63923 0
[email protected]
Contact person for scientific queries
Name 63924 0
Dr David McCutcheon
Address 63924 0
Emergency Department
Royal Perth Hospital
GPO Box X2213
Perth WA 6847
Country 63924 0
Australia
Phone 63924 0
+61892242662
Fax 63924 0
Email 63924 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Strict permanent de-identification process in place for the study as a condition of ethics approval.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1142Study protocolMcCutcheon D, Raghavan M, Soderstrom J, Oosthuizen F, Douglas B, MacDonald E, Fatovich D. An early warning system for emerging drugs of concern in the emergency department: Protocol for the Western Australian Illicit Substance Evaluation (WISE) study. Emerg Med Australas 31(3):411-416, 2019.https://onlinelibrary.wiley.com/doi/full/10.1111/1742-6723.13185  Methods paper published in Emergency Medicine Aust... [More Details]
6444OtherMcCutcheon D, Raghavan M, Soderstrom J, Oosthuizen F, Douglas B, MacDonald E, Fatovich D. An early warning system for emerging drugs of concern in the emergency department: Protocol for the Western Australian Illicit Substance Evaluation (WISE) study. Emerg Med Australas. 31(3):411-416, 2019 https://onlinelibrary.wiley.com/doi/full/10.1111/1742-6723.13185  Laboratory analysis plan Case Report Form



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.