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Trial registered on ANZCTR


Registration number
ACTRN12621001205820
Ethics application status
Approved
Date submitted
30/06/2021
Date registered
9/09/2021
Date last updated
9/09/2021
Date data sharing statement initially provided
9/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Medicinal Cannabis Detection Trial
Scientific title
Detectability of THC in the oral fluid of patients prescribed medical cannabis
Secondary ID [1] 304668 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medical cannabis use 322627 0
Condition category
Condition code
Public Health 320247 320247 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This project will examine whether THC in medicinal cannabis products is detectable (present/absent) with commonly used single-use oral fluid drug detection devices among people who routinely use this medication, and for how long it might be present after consumption. We will assess this in a group of patients who are currently using medicinal cannabis products at different concentrations and in different preparations (e.g., oil and spray, THC dominant and THC/CBD-equivalent). We will also be assessing whether there are any changes to driving or cognitive ability due to using medicinal cannabis products that contain varying concentrations of THC and CBD. All research activities will take place at Swinburne University of Technology.

Participants will be required to attend a single 7-hour session involving providing 5x saliva and blood and 2x urine samples over the course of the session. Participants will also complete 3x driving simulation tests (~30 mins) and 3x CANTAB cognitive tests (~30 mins), including a baseline test and two further tests at 2.4h and 5h post medicine consumption. participants will also complete a series of questionnaires (5x) taking approximately 10 mins in total each time. Assessments will be conducted by a research assistant and a research nurse.

In the session, participants will supply and self-administer a single dose of their prescribed medical cannabis product. This will be witnessed by a member of the research team who will also cite that patients' script for accuracy in dosing.
Intervention code [1] 321031 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328108 0
Determine the overall sensitivity and specificity of the Securetec DrugWipe® TWIN in detecting the presence of THC in oral fluid following use of prescribed medicinal cannabis products over time.

Oral fluid THC concentrations will be verified using liquid chromatography–mass spectrometry. 80% sensitivity and specificity are the minimum recommended performance standards for oral fluid testing devices.
Timepoint [1] 328108 0
Oral fluid samples will be collected at 60 min, 120 min, 240 min, 360 min post medication consumption
Secondary outcome [1] 397660 0
Simulated driving performance as assessed by standard deviation of lateral position (SDLP).
Timepoint [1] 397660 0
150 and 300 min post medication consumption
Secondary outcome [2] 397662 0
Composite outcome - changes in eye closure and saccadic activity as measured with 1) saccade, 2) gaze entropy, 3) fixation, and 4) blink parameters (amplitude, velocity, duration) during simulated driving.
Timepoint [2] 397662 0
150 and 300 min post medication consumption
Secondary outcome [3] 397664 0
Cannabinoid concentrations in blood
Timepoint [3] 397664 0
120-150 and 240-300 min post medication consumption
Secondary outcome [4] 397665 0
Composite secondary outcome - changes in subjective drug effects and perceived driving ability as assessed using a 10 cm VAS
Timepoint [4] 397665 0
60 min, 120 min, 240 min, 360 min post medication consumption
Secondary outcome [5] 398934 0
Performance on the CANTAB Multitasking test
Timepoint [5] 398934 0
180 and 330 min post medication consumption
Secondary outcome [6] 399254 0
Performance on the CANTAB Spatial Working Memory test
Timepoint [6] 399254 0
180 and 330 min post medication consumption
Secondary outcome [7] 399255 0
Performance on the CANTAB Rapid Visual Information Processing test
Timepoint [7] 399255 0
180 and 330 min post medication consumption
Secondary outcome [8] 399260 0
Performance on the CANTAB Reaction Time test
Timepoint [8] 399260 0
180 and 330 min post medication consumption
Secondary outcome [9] 399261 0
Performance on the CANTAB Spatial Span test
Timepoint [9] 399261 0
180 and 330 min post medication consumption
Secondary outcome [10] 399262 0
Performance on the CANTAB Pattern Recognition Memory test
Timepoint [10] 399262 0
180 and 330 min post medication consumption
Secondary outcome [11] 399263 0
Performance on the DRUID cognitive test
Timepoint [11] 399263 0
180 and 330 min post medication consumption
Secondary outcome [12] 399264 0
Cannabinoid concentrations in oral fluid as determined by liquid chromatography–mass spectrometry
Timepoint [12] 399264 0
120-150 and 240-300 min post medication consumption
Secondary outcome [13] 399265 0
Cannabinoid concentrations in urine
Timepoint [13] 399265 0
120-150 and 240-300 min post medication consumption
Secondary outcome [14] 399270 0
Quality of life as assessed using the World Health Organisation Quality of Life (BREF) scale
Timepoint [14] 399270 0
60 min, 120 min, 240 min, 360 min post medication consumption
Secondary outcome [15] 399271 0
Simulator driving performance as assessed by standard deviation of speed (SDS, km/h)
Timepoint [15] 399271 0
150 and 300 min post medication consumption
Secondary outcome [16] 399272 0
Simulator driving performance as assessed by number of attentional lapses (change in mean lateral position of greater than 100 cm, lasting for at least 8s)
Timepoint [16] 399272 0
150 and 300 min post medication consumption

Eligibility
Key inclusion criteria
• Aged 21 years or older
• Have a full driver licence (current or expired/lapsed in past 12 months)
• Patients who have been prescribed medicinal cannabis under the Special Access Scheme B (SAS-B) containing predominately THC or that is THC/CBD equivalent for a refractory condition including, but not limited to:
o Chronic pain conditions
o Sleep disorders
o Inflammatory conditions
o Gastrointestinal disorders
o Movement disorders
o Respiratory conditions
• Able to attend a 7-hour session without using medical cannabis more than once
Minimum age
21 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patient is unable to provide written informed consent
• Patient is pregnant or lactating
• Patient has been previously enrolled in the study
• Patient is unable to abstain for illicit drug use for 7 days prior to testing

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Participants will be 40 men and women aged greater than or equal to 21 years. A-priori evaluation of study size revealed that a minimum sample size of 36 is required to detect a meaningful difference in driving performance scores (medium effect size, Cohens d =0.5) power at 95% using a two-tailed, repeated measured ANOVA (within and between design). Limited clinical studies have utilised similar, albeit typically smaller samples. Approximately 60 participants will be screened; approximately 50 participants will be enrolled with the aim of having 40 participants fully complete the study (evaluable population).

Demographic data will be presented with summary statistics (number of participants, gender ratio, mean, standard deviation, median and range of participants age). The number and percentage of subjects will be presented for categorical variables.

All statistical tests will be performed two tailed at the 5% significance level and performed using IBM SPSS statistical package. Z scores for the distribution will be calculated for each variable and displayed in histogram form. Out of range values will be recoded as missing values.

The primary outcome to be measured will be the scores on the drug screening device as a function of treatment type (THC dominant and THC/CBD equivalent) and will be presented as a binary outcome (detection yes/no). A binary logistic regression model will be used, with detection status (present/absent) as the outcome, and treatment type (THC dominant and THC/CBD equivalent) used as the categorical predictor variable. Baseline data and demographic information will be entered sequentially to assess whether these factors affect oral fluid THC concentrations/detectability.

Analysis of THC concentrations in biological matrices (blood, urine, and oral fluid) will be performed using mixed design analysis of variance (MANCOVA), with treatment type (THC dominant and THC/CBD equivalent) as the between-subject variable, timepoint as the within-subjects variable, and baseline score as the covariate.

Results for the driving simulator (SDLP, SPS and lapses) will also be compared using a mixed design analysis of variance (MANCOVA), with treatment type (THC dominant and THC/CBD equivalent) as the between-subject variable, time as the within-subjects variable, and baseline score as the covariate.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 309035 0
Government body
Name [1] 309035 0
Department of Transport
Address [1] 309035 0
1 Spring St, Melbourne VIC 3000
Country [1] 309035 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
Advanced Technologies Centre (ATC)
427-451 Burwood Rd,
Hawthorn, Victoria 3122 Australia
Country
Australia
Secondary sponsor category [1] 309973 0
None
Name [1] 309973 0
Address [1] 309973 0
Country [1] 309973 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308913 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 308913 0
ATC Building, 427-451 Burwood Rd, Hawthorn VIC 3122
Ethics committee country [1] 308913 0
Australia
Date submitted for ethics approval [1] 308913 0
Approval date [1] 308913 0
27/05/2021
Ethics approval number [1] 308913 0

Summary
Brief summary
The introduction of legal medical cannabis in Australia presents a unique challenge for the current roadside drug testing (RDT) approach which was designed to deter driving after illicit drug use and mitigate associated road safety risks. Having a legal prescription for a THC-containing medical cannabinoid product is not at present a valid legal defence against the charge of driving with a detectable concentration of a prescribed illicit drug, which means that medical cannabis patients are effectively prohibited from driving. Understanding the detectability of medical cannabis products using the Securetec DrugWipe® TWIN and investigating the driving-related effects of medical cannabis use, are important research priorities that can help to inform effective road safety policy and law enforcement strategy in this area.

This project will examine whether THC in medicinal cannabis products is detectable (present/absent) with commonly used single-use oral fluid drug detection devices among people who routinely use this medication, and for how long it might be present after consumption. We will assess this in a group of patients who are currently using medicinal cannabis products at different concentrations and in different preparations (e.g., oil and spray, THC dominant and THC/CBD-equivalent). We will also be assessing whether there are any changes to driving or cognitive ability due to using medicinal cannabis products that contain varying concentrations of THC and CBD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112322 0
Dr Amie Hayley
Address 112322 0
Swinburne University, L10, ATC, 427-451 Burwood Rd, Hawthorn VIC 3122
Country 112322 0
Australia
Phone 112322 0
+61 3 9214 5585
Fax 112322 0
Email 112322 0
ahayley@swin.edu.au
Contact person for public queries
Name 112323 0
Dr Amie Hayley
Address 112323 0
Swinburne University, L10, ATC, 427-451 Burwood Rd, Hawthorn VIC 3122
Country 112323 0
Australia
Phone 112323 0
+61 3 9214 5585
Fax 112323 0
Email 112323 0
ahayley@swin.edu.au
Contact person for scientific queries
Name 112324 0
Dr Amie Hayley
Address 112324 0
Swinburne University of Technology
L10, ATC, 427-451 Burwood Rd, Hawthorn VIC 3122
Country 112324 0
Australia
Phone 112324 0
+61 3 9214 5585
Fax 112324 0
Email 112324 0
ahayley@swin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified individual participant data of published results only
When will data be available (start and end dates)?
Immediately following publication, no end date determined
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
Contact the principal investigator - a.hayley@swin.edu.au
What supporting documents are/will be available?
No other documents available
Summary results
No Results