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Trial registered on ANZCTR
Registration number
ACTRN12624001118594p
Ethics application status
Submitted, not yet approved
Date submitted
28/08/2024
Date registered
17/09/2024
Date last updated
17/09/2024
Date data sharing statement initially provided
17/09/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
An On-track Trial to Assess Driving from Medical Cannabis
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Scientific title
A Closed-Circuit Track Trial to Assess Risk, Impairment and Performance from Medical Cannabis Among Patients
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Secondary ID [1]
312778
0
Nil known
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Universal Trial Number (UTN)
U1111-1312-6170
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Trial acronym
CAN-TRACK
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neurological
334832
0
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Condition category
Condition code
Eye
331390
331390
0
0
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Normal eye development and function
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Mental Health
331391
331391
0
0
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Anxiety
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Mental Health
331392
331392
0
0
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The CAN-TRACK trial is a closed-circuit track study designed to assess the effects of medical cannabis on driving performance, focusing on cognitive and behavioural outcomes among patients currently prescribed medical cannabis for managing chronic pain, anxiety, or sleep disorders. Participants must be on a stable dose of at least 2 mg THC per dose for a minimum of 3 months. Medical cannabis will be administered as prescribed (oral or inhaled), under the supervision of the research team during the study sessions. The intervention will be delivered face-to-face, individually, at two testing sites: the Australian Automotive Research Centre (AARC) and Metropolitan Traffic Education Centre (METEC).
This semi-naturalistic baseline-controlled study will assess real-world driving performance in 72 patients who are prescribed THC-containing medical cannabis. Patients will be stratified based on their health condition (chronic pain, anxiety, or sleep disorder) and the primary route of administration (oral or inhaled products). Patients will undergo repeated driving assessments on three separate days, with additional biological and impairment assessments conducted before and after consuming their prescribed cannabis product. The study schedule is detailed below-
(0) Screening session:
Eligibility criteria assessed by a registered research nurse at Swinburne University of Technology. This screening session will last approximately 1-hour.
(1) Baseline session at AARC:
A practice drive will be completed 15 minutes prior to baseline. Baseline driving performance will be assessed at least 12-hours following last medical cannabis self-administration and approximately 20-hours prior to administering the next dose. This session will last approximately 2 hours and will occur on Day 1 (i.e., Monday).
(2) Morning after/post-administration session at AARC:
For patients with inhaled medical cannabis prescriptions, driving performance will be assessed at T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose). For patients with orally consumed medical cannabis prescriptions, driving performance will be assessed continuously at T1 (pre-dose), T2 (1.5-hours post-dose), and (3.5-hours post-dose). This session will last approximately 7 hours and will occur on Day 2 (i.e., Tuesday).
(3) Next day/post-administration session at METEC:
For patients with inhaled medical cannabis prescriptions, driving performance will be assessed continuously at T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose). For patients with orally consumed medical cannabis prescriptions, driving performance will be assessed continuously at T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose). This session will last approximately 7 hours and will occur on Day 5 (i.e., Friday).
The entire study duration for each participant is approximately two weeks (inclusive of screening a week prior).
Adherence to the intervention will be closely monitored, with researchers supervising the administration of medical cannabis during the study sessions.
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Intervention code [1]
329306
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Treatment: Drugs
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Intervention code [2]
329307
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Behaviour
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Comparator / control treatment
Participant performance during the experimental sessions will be compared against their baseline (pre-dosing) performance.
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Control group
Active
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Outcomes
Primary outcome [1]
339156
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AARC: Standard deviation of lateral position (SDLP)
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Assessment method [1]
339156
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Standard deviation of lateral position (SDLP) measures the amount of lateral deviation or "weaving" of the vehicle within the driving lane. SDLP is measured using GPS-enabled external cameras that track the vehicle's position within the lane, providing precise data on how much the vehicle moves laterally while driving.
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Timepoint [1]
339156
0
• AARC/Inhaled Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (0.5-hours, post-dose), and T3 (2.5-hours post-dose).
• AARC/Oral Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
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Primary outcome [2]
339166
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Primary for METEC Only: Frequency of lane excursions during driving.
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Assessment method [2]
339166
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Lane excursions are instances where the vehicle crosses the centre lane marking or drifts out of its lane without a clear or intentional reason (such as making a turn). These events are recorded both visually by the driving instructor and confirmed through video analysis of the driving footage captured during the sessions.
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Timepoint [2]
339166
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• METEC/Inhaled Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• METEC/Oral Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
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Secondary outcome [1]
438782
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Steering variability (SV)
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Assessment method [1]
438782
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Steering variability (SV) measures the fluctuation in the steering angle during the driving task. SV is recorded using the vehicle's telemetry system, which continuously monitors and logs steering inputs throughout the driving session.
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Timepoint [1]
438782
0
• AARC/Inhaled Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• AARC/Oral Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1.5-hours post-dose) to capture peak impairment, and T3 (3.5-hours post-dose) to capture residual effects.
• METEC/Inhaled Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (0.5-hours post-dose) to capture peak impairment, and T3 (2.5-hours post-dose) to capture residual effects.
• METEC/Oral Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (1.5-hours post-dose) to capture peak impairment, and T3 (3.5-hours post-dose) to capture residual effects.
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Secondary outcome [2]
438783
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Standard deviation of speed (SDS)
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Assessment method [2]
438783
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Standard deviation of speed (SDS) measures the variability in the participant's speed during the driving task. SDS is recorded using the vehicle's telemetry system, which continuously monitors and logs speed data throughout the driving session.
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Timepoint [2]
438783
0
• AARC/Inhaled Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• AARC/Oral Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1.5-hours post-dose), and (3.5-hours post-dose).
• METEC/Inhaled Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• METEC/Oral Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
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Secondary outcome [3]
438784
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Secondary for AARC Only: Frequency of lane excursions during driving.
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Assessment method [3]
438784
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Lane excursions are instances where the vehicle crosses the centre lane marking or drifts out of its lane without a clear or intentional reason (such as making a turn). These events are recorded both visually by the driving instructor and confirmed through video analysis of the driving footage captured during the sessions.
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Timepoint [3]
438784
0
• AARC/Inhaled Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• AARC/Oral Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
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Secondary outcome [4]
438785
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Drive terminations during driving.
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Assessment method [4]
438785
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Drive terminations occur when the driving task is stopped prematurely due to safety concerns, either at the discretion of the driving instructor or upon request by the participant. These terminations are recorded and analysed to assess the frequency and circumstances under which they occur. Drive terminations will be recorded as they occur throughout each driving session.
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Timepoint [4]
438785
0
• AARC/Inhaled Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• AARC/Oral Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
• METEC/Inhaled Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• METEC/Oral Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
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Secondary outcome [5]
438786
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Adherence to instructed speeds during driving.
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Assessment method [5]
438786
0
Speed adherence is measured by comparing the participant's actual driving speed to the instructed or posted speed limits for each segment of the driving course. Speed adherence is recorded using the vehicle's telemetry system, which continuously monitors and logs speed data throughout the driving session.
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Timepoint [5]
438786
0
• AARC/Inhaled Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• AARC/Oral Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
• AMETEC/Inhaled Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• METEC/Oral Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
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Secondary outcome [6]
438787
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Assessor-rated driving performance.
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Assessment method [6]
438787
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Driving performance is evaluated by a trained driving instructor using a standardised assessment form, designed specifically for this study, to rate various aspects of driving behaviour, including lane discipline, speed control, reaction to traffic situations, and overall driving competence.
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Timepoint [6]
438787
0
• AARC/Inhaled Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• AARC/Oral Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
• METEC/Inhaled Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• METEC/Oral Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
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Secondary outcome [7]
438788
0
Vehicle Telemetry Acceleration.
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Assessment method [7]
438788
0
Vehicle telemetry acceleration measures the frequency and magnitude of longitudinal acceleration events, indicating how often and how intensely the participant accelerates the vehicle. This system continuously monitors and logs data related to vehicle movement, providing a detailed record of the participant's driving behaviour throughout the session.
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Timepoint [7]
438788
0
• AARC/Inhaled Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• AARC/Oral Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
• METEC/Inhaled Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• METEC/Oral Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
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Secondary outcome [8]
438789
0
Vehicle Telemetry Braking.
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Assessment method [8]
438789
0
Vehicle telemetry braking records the frequency and intensity of braking events, including both gradual and abrupt stops. Inconsistent or harsh braking may indicate impaired motor control or delayed reaction times. This system continuously monitors and logs data related to vehicle movement, providing a detailed record of the participant's driving behaviour throughout the session.
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Timepoint [8]
438789
0
• AARC/Inhaled Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• AARC/Oral Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
• METEC/Inhaled Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• METEC/Oral Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
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Secondary outcome [9]
438790
0
Vehicle Telemetry Speeding.
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Assessment method [9]
438790
0
Vehicle telemetry speeding measures the time spent driving over the posted or instructed speed limits. Persistent speeding or fluctuating speeds can suggest difficulties in maintaining control, possibly due to impairment. This system continuously monitors and logs data related to vehicle movement, providing a detailed record of the participant's driving behaviour throughout the session.
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Timepoint [9]
438790
0
• AARC/Inhaled Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• AARC/Oral Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
• METEC/Inhaled Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• METEC/Oral Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
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Secondary outcome [10]
438791
0
Gaze transition entropy (GTE)
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Assessment method [10]
438791
0
Gaze Transition Entropy (GTE) measures the randomness or unpredictability of gaze shifts from one location to another. GTE is assessed using advanced eye-tracking technology installed in the test vehicles. This system continuously monitors and records the participant's eye movements, providing detailed data on where and how long the participant looks at different areas of the driving environment.
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Timepoint [10]
438791
0
• AARC/Inhaled Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• AARC/Oral Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
• METEC/Inhaled Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• METEC/Oral Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
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Secondary outcome [11]
438792
0
Stationary Gaze Entropy (SGE)
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Assessment method [11]
438792
0
Stationary Gaze Entropy (SGE) measures the complexity or randomness of gaze patterns when the participant's gaze is stationary or focused on a specific location. SGE is assessed using advanced eye-tracking technology installed in the test vehicles. This system continuously monitors and records the participant's eye movements, providing detailed data on where and how long the participant looks at different areas of the driving environment.
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Timepoint [11]
438792
0
• AARC/Inhaled Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• AARC/Oral Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
• METEC/Inhaled Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• METEC/Oral Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
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Secondary outcome [12]
438793
0
Long Glance Away (LGA) events
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Assessment method [12]
438793
0
Long Glance Away (LGA) events are defined as instances where the participant's gaze is directed away from the road or primary driving task for a prolonged period, typically exceeding 2 seconds. LGA events are assessed using eye-tracking technology installed in the test vehicles. This system continuously monitors and records the participant's eye movements, providing detailed data on where and for how long the participant's gaze is focused during the driving task.
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Timepoint [12]
438793
0
• AARC/Inhaled Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• AARC/Oral Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
• METEC/Inhaled Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• METEC/Oral Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
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Secondary outcome [13]
438794
0
Visual Attention Time Sharing (VATS) Events
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Assessment method [13]
438794
0
Visual Attention Time Sharing (VATS) events refer to instances where the participant's visual attention is divided between the primary task of driving and secondary tasks or stimuli (e.g., checking mirrors, dashboard displays, or handling in-vehicle distractions). Both LGA and VATS events are assessed using eye-tracking technology installed in the test vehicles. This system continuously monitors and records the participant's eye movements, providing detailed data on where and for how long the participant's gaze is focused during the driving task.
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Timepoint [13]
438794
0
• AARC/Inhaled Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• AARC/Oral Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
• METEC/Inhaled Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• METEC/Oral Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
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Secondary outcome [14]
438795
0
Blink Rate
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Assessment method [14]
438795
0
Blink rate refers to the number of blinks per minute and is assessed using eye-tracking technology that continuously monitors the participant's eye movements during the driving task.
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Timepoint [14]
438795
0
• AARC/Inhaled Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• AARC/Oral Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
• METEC/Inhaled Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• METEC/Oral Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
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Secondary outcome [15]
438796
0
Blink Duration
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Assessment method [15]
438796
0
Blink duration measures the length of time (in milliseconds) each blink lasts. These metrics are assessed using eye-tracking technology that continuously monitors the participant's eye movements during the driving task.
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Timepoint [15]
438796
0
• AARC/Inhaled Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• AARC/Oral Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
• METEC/Inhaled Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• METEC/Oral Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
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Secondary outcome [16]
438797
0
Fixation Rate
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Assessment method [16]
438797
0
Fixation Rate is the number of times per minute that a participant's gaze is held steadily on a specific point or object in the driving environment. Fixation rate is assessed using eye-tracking technology installed in the test vehicles. This system continuously monitors and records the participant's eye movements, providing precise data on where, how often, and for how long the participant focuses their gaze within the driving environment.
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Timepoint [16]
438797
0
• AARC/Inhaled Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• AARC/Oral Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
• METEC/Inhaled Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• METEC/Oral Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
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Secondary outcome [17]
438798
0
Fixation Duration
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Assessment method [17]
438798
0
Fixation Duration is the length of time (in milliseconds) that the participant's gaze remains fixed on a particular point or object. Fixation duration is assessed using eye-tracking technology installed in the test vehicles. This system continuously monitors and records the participant's eye movements, providing precise data on where, how often, and for how long the participant focuses their gaze within the driving environment.
Query!
Timepoint [17]
438798
0
• AARC/Inhaled Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• AARC/Oral Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
• METEC/Inhaled Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• METEC/Oral Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
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Secondary outcome [18]
438799
0
Eye Closure (Percent of Time Spent with Eyes Closed)
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Assessment method [18]
438799
0
Percent Eye Closure (PERCLOS) measures the percentage of time that a participant's eyes are closed over a given period while driving. PERCLOS is assessed using eye-tracking technology installed in the test vehicles. This system continuously monitors the participant's eye movements, including the duration and frequency of eye closures, providing real-time data on the participant's alertness level.
Query!
Timepoint [18]
438799
0
• AARC/Inhaled Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• AARC/Oral Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
• METEC/Inhaled Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• METEC/Oral Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
Query!
Secondary outcome [19]
438800
0
Microsleeps
Query!
Assessment method [19]
438800
0
Microsleeps are brief episodes of sleep that last for a few seconds (at least 500 milliseconds), during which the participant might close their eyes or have a significant drop in alertness. Microsleeps are assessed using eye-tracking technology installed in the test vehicles. This system continuously monitors the participant's eye movements, including the duration and frequency of eye closures, providing real-time data on the participant's alertness level.
Query!
Timepoint [19]
438800
0
• AARC/Inhaled Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• AARC/Oral Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
• METEC/Inhaled Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• METEC/Oral Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
Query!
Secondary outcome [20]
438801
0
Detection Response Task (DRT)
Query!
Assessment method [20]
438801
0
Detection Response Task (DRT) assesses participants' reaction times to visual or tactile stimuli presented during the driving task. Participants are required to respond to these stimuli by pressing a button or performing a specific action as quickly as possible. The DRT is administered using a handheld device or a button integrated into the vehicle, which records the time taken for participants to respond to the stimuli. This technology is synchronised with the vehicle's telemetry system to ensure precise timing and correlation with driving performance data.
Query!
Timepoint [20]
438801
0
• AARC/Inhaled Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• AARC/Oral Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
• METEC/Inhaled Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• METEC/Oral Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
Query!
Secondary outcome [21]
438803
0
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Query!
Assessment method [21]
438803
0
This outcome assesses various aspects of cognitive function, including memory, attention, executive function, and visuomotor coordination, using tasks from the Cambridge Neuropsychological Test Automated Battery (CANTAB). The CANTAB is a widely used, computer-based cognitive assessment tool that provides precise measurements of cognitive abilities. The CANTAB tasks are administered on a tablet or computer, and participants complete a series of standardised cognitive tests. The results are automatically recorded.
Query!
Timepoint [21]
438803
0
• AARC/Inhaled Cannabis: Assessed following each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1-hour post-dose), and T3 (3-hours post-dose).
• AARC/Oral Cannabis: Assessed following each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (2-hours post-dose), and T3 (4-hours post-dose).
• METEC/Inhaled Cannabis: Assessed following each driving session at T1 (pre-dose), T2 (1-hour post-dose), and T3 (3-hours post-dose).
• METEC/Oral Cannabis: Assessed following each driving session at T1 (pre-dose), T2 (2-hours post-dose), and T3 (4-hours post-dose).
Query!
Secondary outcome [22]
438804
0
NASA Task Load Index (NASA-TLX)
Query!
Assessment method [22]
438804
0
NASA Task Load Index (NASA-TLX) is a widely used subjective workload assessment tool that evaluates the perceived mental, physical, and temporal demands of a task, as well as the effort, performance, and frustration experienced by the participant. It is composed of six subscales: Mental Demand, Physical Demand, Temporal Demand, Performance, Effort, and Frustration. Participants rate each of these subscales on a scale, and these ratings are then combined to produce an overall workload score. The NASA-TLX is administered through a digital survey or paper questionnaire immediately after each driving session.
Query!
Timepoint [22]
438804
0
• AARC/Inhaled Cannabis: Assessed following each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1-hour post-dose), and T3 (3-hours post-dose).
• AARC/Oral Cannabis: Assessed following each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (2-hours post-dose), and T3 (4-hours post-dose).
• METEC/Inhaled Cannabis: Assessed following each driving session at T1 (pre-dose), T2 (1-hour post-dose), and T3 (3-hours post-dose).
• METEC/Oral Cannabis: Assessed following each driving session at T1 (pre-dose), T2 (2-hours post-dose), and T3 (4-hours post-dose).
Query!
Secondary outcome [23]
438805
0
Subjective Driving Ability
Query!
Assessment method [23]
438805
0
Subjective Driving Ability assesses the participant's self-reported evaluation of their driving competence during the study. Participants rate their ability to drive effectively, including their confidence in handling the vehicle, maintaining lane position, adhering to speed limits, and responding to road conditions. This self-assessment typically involves using a visual analogue scale, where participants indicate their perceived driving ability on a continuum (e.g., from "very poor" to "excellent").
Query!
Timepoint [23]
438805
0
• AARC/Inhaled Cannabis: Assessed following each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1-hour post-dose), and T3 (3-hours post-dose).
• AARC/Oral Cannabis: Assessed following each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (2-hours post-dose), and T3 (4-hours post-dose).
• METEC/Inhaled Cannabis: Assessed following each driving session at T1 (pre-dose), T2 (1-hour post-dose), and T3 (3-hours post-dose).
• METEC/Oral Cannabis: Assessed following each driving session at T1 (pre-dose), T2 (2-hours post-dose), and T3 (4-hours post-dose).
Query!
Secondary outcome [24]
438806
0
Blood THC Levels
Query!
Assessment method [24]
438806
0
Blood THC Levels: This outcome measures the concentration of delta-9-tetrahydrocannabinol (THC) in the participant's blood. Blood samples are drawn from participants at specific timepoints during the study. These samples are processed and analysed in a laboratory using techniques such as liquid chromatography-tandem mass spectrometry (LC-MS/MS) to accurately measure THC concentrations.
Query!
Timepoint [24]
438806
0
• Inhaled Cannabis: Assessed at T1 (pre-dose), T2 (15-minutes post-dose), and T3 (2-hours 15-minutes post-dose).
• Oral Cannabis: Assessed at T1 (pre-dose), T2 (1-hour 15-minutes post-dose), and T3 (3-hours 15-minutes post-dose).
Query!
Secondary outcome [25]
438808
0
Percent Road Centre (PRC)
Query!
Assessment method [25]
438808
0
Percent Road Centre (PRC) measures the percentage of time that a participant's gaze is focused on the central area of the road, typically defined as a specific angular range from the road's centre. PRC is measured using eye-tracking technology that continuously monitors the participant's gaze direction during the driving task.
Query!
Timepoint [25]
438808
0
• AARC/Inhaled Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• AARC/Oral Cannabis: Assessed continuously during each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
• METEC/Inhaled Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose).
• METEC/Oral Cannabis: Assessed continuously during each driving session at T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose).
Query!
Secondary outcome [26]
438809
0
Karolinska Sleepiness Scale (KSS)
Query!
Assessment method [26]
438809
0
The Karolinska Sleepiness Scale (KSS) is a subjective measure used to assess the participant's level of sleepiness at various points during the study. Participants rate their sleepiness on a scale from 1 (extremely alert) to 9 (very sleepy). The KSS is administered through a questionnaire or digital survey.
Query!
Timepoint [26]
438809
0
• AARC/Inhaled Cannabis: Assessed following each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1-hour post-dose), and T3 (3-hours post-dose).
• AARC/Oral Cannabis: Assessed following each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (2-hours post-dose), and T3 (4-hours post-dose).
• METEC/Inhaled Cannabis: Assessed following each driving session at T1 (pre-dose), T2 (1-hour post-dose), and T3 (3-hours post-dose).
• METEC/Oral Cannabis: Assessed following each driving session at T1 (pre-dose), T2 (2-hours post-dose), and T3 (4-hours post-dose).
Query!
Secondary outcome [27]
438811
0
Brief Pain Inventory (BPI)
Query!
Assessment method [27]
438811
0
The Brief Pain Inventory (BPI) is used to assess the intensity of pain and its impact on daily function. The BPI evaluates pain severity and interference with activities. The BPI is administered through questionnaires on an iPad or computer.
Query!
Timepoint [27]
438811
0
Assessed at the time of in-person medical screening (post-enrolment).
Query!
Secondary outcome [28]
438812
0
36-Item Short Form Health Survey (SF-36)
Query!
Assessment method [28]
438812
0
The SF-36 is a widely used measure of overall health-related quality of life. It includes 36 items that cover eight domains, including physical functioning, role limitations due to physical and emotional problems, bodily pain, general health perceptions, vitality, social functioning, and mental health. The SF-36 is administered through a standardised questionnaire.
Query!
Timepoint [28]
438812
0
Assessed at the time of in-person medical screening (post-enrolment).
Query!
Secondary outcome [29]
438813
0
Depression Anxiety and Stress Scale (DASS-21). This will be assessed as a composite outcome.
Query!
Assessment method [29]
438813
0
The DASS-21 is a self-report instrument that measures the negative emotional states of depression, anxiety, and stress. Each subscale consists of 7 items, and participants rate the extent to which they have experienced these symptoms over the past week. The DASS-21 is administered through a questionnaire.
Query!
Timepoint [29]
438813
0
Assessed at the time of in-person medical screening (post-enrolment).
Query!
Secondary outcome [30]
438814
0
Dula Dangerous Driving Index (DDDI)
Query!
Assessment method [30]
438814
0
The Dula Dangerous Driving Index (DDDI) assesses the likelihood of engaging in dangerous driving behaviours. It includes items that measure risky, aggressive, and negative emotional driving tendencies. The DDDI is administered through a self-report questionnaire.
Query!
Timepoint [30]
438814
0
Assessed at the time of in-person medical screening (post-enrolment).
Query!
Secondary outcome [31]
438815
0
Driving Behaviour Questionnaire (DBQ)
Query!
Assessment method [31]
438815
0
The Driving Behaviour Questionnaire (DBQ) is used to assess aberrant driving behaviours, such as errors, violations, and lapses. Participants report how frequently they engage in various types of driving behaviour on a scale. The DBQ is administered through a questionnaire.
Query!
Timepoint [31]
438815
0
Assessed at the time of in-person medical screening (post-enrolment).
Query!
Secondary outcome [32]
438816
0
Numerical Rating Scale (NRS)
Query!
Assessment method [32]
438816
0
The NRS is a simple scale (typically 0-10) where participants rate their pain intensity. The NRS is administered through questionnaires on an iPad or computer.
Query!
Timepoint [32]
438816
0
Assessed at the time of in-person medical screening (post-enrolment).
Query!
Secondary outcome [33]
438817
0
The Barratt Impulsiveness Scale (BIS)
Query!
Assessment method [33]
438817
0
The Barratt Impulsiveness Scale (BIS) is a widely used measure of impulsiveness. It includes 30 items that are scored to yield six first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and three second-order factors (attentional, motor, and non-planning impulsiveness). The BIS scale is administered through questionnaires on an iPad or computer.
Query!
Timepoint [33]
438817
0
Assessed at the time of in-person medical screening (post-enrolment).
Query!
Secondary outcome [34]
438818
0
Detectability of THC in oral fluid
Query!
Assessment method [34]
438818
0
The detectability of THC in oral fluid will be using a point-of-collection device (Drugwipe Twin or 6s). These devices use lateral-flow technology to provide a positive (detected) or negative (not detected) visual based on pre-determined device-specific thresholds for THC.
Query!
Timepoint [34]
438818
0
• Inhaled Cannabis: Assessed at T1 (pre-dose), T2 (15-minutes post-dose) and T3 (2-hours 15-minutes post-dose).
• Oral Cannabis: Assessed at T1 (pre-dose), T2 (1-hour 15-minutes post-dose), and T3 (3-hours 15-minutes post-dose).
Query!
Secondary outcome [35]
439144
0
Pupillary unrest index (PUI)
Query!
Assessment method [35]
439144
0
Pupillary unrest index (PUI) quantifies the spontaneous, small, fluctuations in pupil size that occur even in the absence of changes in lighting or visual stimuli. The PUI is often used to assess individual’s level of alertness or drowsiness, or autonomic nervous system activity.
Query!
Timepoint [35]
439144
0
• AARC/Inhaled Cannabis: Assessed following each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1-hour post-dose), and T3 (3-hours post-dose).
• AARC/Oral Cannabis: Assessed following each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (2-hours post-dose), and T3 (4-hours post-dose).
• METEC/Inhaled Cannabis: Assessed following each driving session at T1 (pre-dose), T2 (1-hour post-dose), and T3 (3-hours post-dose).
• METEC/Oral Cannabis: Assessed following each driving session at T1 (pre-dose), T2 (2-hours post-dose), and T3 (4-hours post-dose).
Query!
Secondary outcome [36]
439147
0
Pupillary light reflex (PLR)
Query!
Assessment method [36]
439147
0
Pupillary light reflex (PLR) refers to the automatic constriction (miosis) and dilation (mydriasis) of the pupil in response to changes in light intensity. The PLR is widely used to assess neurological function and autonomic nervous system health. A pupillometry device will be used to measure this outcome.
Query!
Timepoint [36]
439147
0
• AARC/Inhaled Cannabis: Assessed following each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (1-hour post-dose), and T3 (3-hours post-dose).
• AARC/Oral Cannabis: Assessed following each driving session at T0 (day prior) for baseline, T1 (pre-dose), T2 (2-hours post-dose), and T3 (4-hours post-dose).
• METEC/Inhaled Cannabis: Assessed following each driving session at T1 (pre-dose), T2 (1-hour post-dose), and T3 (3-hours post-dose).
• METEC/Oral Cannabis: Assessed following each driving session at T1 (pre-dose), T2 (2-hours post-dose), and T3 (4-hours post-dose).
Query!
Secondary outcome [37]
439152
0
Attitudes/behaviours related to driving under the influence of alcohol (DUIA)
Query!
Assessment method [37]
439152
0
A questionnaire designed specifically for this study with several items related to individuals attitudes towards DUIA and their perceived ability to DUIA.
Query!
Timepoint [37]
439152
0
Assessed at the time of in-person medical screening (post-enrolment).
Query!
Eligibility
Key inclusion criteria
-On a stable dose of medical cannabis (at least 3 months) with a minimum dose of 2 mg THC per administration.
-Prescription for medical cannabis for chronic pain, anxiety, or sleep disorder (insomnia) that has persisted for at least 6 months.
-Current and unrestricted Victorian driver’s licence.
-Be able to consume medical cannabis during the day as required for testing.
Query!
Minimum age
21
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
-On an unstable dose of medical cannabis or currently titrating their dose.
-Unstable use or titration of other medications that could impair driving, such as opioids or benzodiazepines (defined as infrequent use or dose titrating).
-Unable to attend the test facility for a full day and stay overnight the evening prior (AARC only).
-Pregnant or lactating.
-Currently under administrative or legal supervision.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
The study employs a baseline-controlled design where the intervention (medical cannabis) is compared against baseline (pre-dosing) performance.
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Safety/efficacy
Query!
Statistical methods / analysis
Sample Size Calculation:
A sample size of n = 72 will allow researchers to detect a small effect size (f=0.15) with 90% power assuming one group (i.e., all patients collapsed into a single group), 6 repeated measurements (3 drives over 2 days), an estimated correlation among repeated measures of 0.6 and a non-sphericity correction of 0.6.
Statistical Analysis:
Demographic information will be presented with summary statistic (mean, median, standard deviation, percentage and range) for age, sex, body mass index (kg/m2), and other related variables.
Linear mixed effects models will be used to examine the effect of time (baseline; T1; T2; T3) on target outcomes. Time will be entered into the model as a repeated measures factor, participant as random factor, and separate models will be built with driving outcomes, ocular parameters, and subjective drug effects as outcome variables. Where a main effect of time is observed, Bonferroni corrected post-hoc comparisons will be conducted to further explore main effect differences. Linear regression models will also be used to assess associations between (i) blood, (ii) subjective drug effects, and performance outcomes.
Finally, based on the findings from the linear mixed-effects models, thresholds for primary outcomes (e.g., SDLP) will be established to categorise driving performance. Dichotomised variables will be entered in logistic regression and receiver operating characteristic (ROC) curve analyses as dependent variables, with performance outcomes serving as independent variables. Separate models will be built for each condition to assess the predictive power of individual outcomes in relation to driving performance.
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
31/10/2024
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
6/04/2026
Query!
Actual
Query!
Date of last data collection
Anticipated
24/04/2026
Query!
Actual
Query!
Sample size
Target
72
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Funding & Sponsors
Funding source category [1]
317210
0
Government body
Query!
Name [1]
317210
0
Department of Transport and Planning (DTP)
Query!
Address [1]
317210
0
Query!
Country [1]
317210
0
Australia
Query!
Primary sponsor type
University
Query!
Name
Swinburne University of Technology
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
319529
0
None
Query!
Name [1]
319529
0
Query!
Address [1]
319529
0
Query!
Country [1]
319529
0
Query!
Ethics approval
Ethics application status
Submitted, not yet approved
Query!
Ethics committee name [1]
315948
0
Swinburne University of Technology Human Research Ethics Committee
Query!
Ethics committee address [1]
315948
0
https://www.swinburne.edu.au/research/ethics/human-research/
Query!
Ethics committee country [1]
315948
0
Australia
Query!
Date submitted for ethics approval [1]
315948
0
02/08/2024
Query!
Approval date [1]
315948
0
Query!
Ethics approval number [1]
315948
0
Query!
Summary
Brief summary
The CAN-TRACK study is a closed-circuit track trial designed to assess the impact of medical cannabis on driving performance. This study aims to evaluate the cognitive, behavioural, and driving-related risks associated with the use of THC-containing medical cannabis in patients who have been using their prescribed product containing 2mg or more of THC for at least 3 months. The findings are expected to provide valuable insights into how medical cannabis influences driving safety, informing public health policies and road safety regulations.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
136314
0
Prof Luke Downey
Query!
Address
136314
0
Advanced Technologies Centre, 427-451 Burwood Road, Hawthorn VIC 3122
Query!
Country
136314
0
Australia
Query!
Phone
136314
0
+61 03 9214 5781
Query!
Fax
136314
0
Query!
Email
136314
0
[email protected]
Query!
Contact person for public queries
Name
136315
0
Dr Thomas Arkell
Query!
Address
136315
0
Advanced Technologies Centre, 427-451 Burwood Road, Hawthorn VIC 3122
Query!
Country
136315
0
Australia
Query!
Phone
136315
0
+61 03 9214 3571
Query!
Fax
136315
0
Query!
Email
136315
0
[email protected]
Query!
Contact person for scientific queries
Name
136316
0
Dr Amie Hayley
Query!
Address
136316
0
Advanced Technologies Centre, 427-451 Burwood Road, Hawthorn VIC 3122
Query!
Country
136316
0
Australia
Query!
Phone
136316
0
+61 03 9214 5585
Query!
Fax
136316
0
Query!
Email
136316
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
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.
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