Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001118594
Ethics application status
Approved
Date submitted
28/08/2024
Date registered
17/09/2024
Date last updated
24/11/2024
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
Scientific title
A Closed-Circuit Track Trial to Assess Risk, Impairment and Performance from Medical Cannabis Among Patients
Secondary ID [1] 312778 0
Nil known
Universal Trial Number (UTN)
U1111-1312-6170
Trial acronym
CAN-TRACK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurological 334832 0
Condition category
Condition code
Eye 331390 331390 0 0
Normal eye development and function
Mental Health 331391 331391 0 0
Anxiety
Mental Health 331392 331392 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 329306 0
Treatment: Drugs
Intervention code [2] 329307 0
Behaviour
Comparator / control treatment
Participant performance during the experimental sessions will be compared against their baseline (pre-dosing) performance.
Control group
Active

Outcomes
Primary outcome [1] 339156 0
AARC: Standard deviation of lateral position (SDLP)
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).
Primary outcome [2] 339166 0
Primary for METEC Only: Frequency of lane excursions during driving.
Timepoint [2] 339166 0
• 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).
Secondary outcome [1] 438782 0
Steering variability (SV)
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.
Secondary outcome [2] 438783 0
Standard deviation of speed (SDS)
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).
Secondary outcome [3] 438784 0
Secondary for AARC Only: Frequency of lane excursions during driving.
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).
Secondary outcome [4] 438785 0
Drive terminations during driving.
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).
Secondary outcome [5] 438786 0
Adherence to instructed speeds during driving.
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).
Secondary outcome [6] 438787 0
Assessor-rated driving performance.
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).
Secondary outcome [7] 438788 0
Vehicle Telemetry Acceleration.
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).
Secondary outcome [8] 438789 0
Vehicle Telemetry Braking.
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).
Secondary outcome [9] 438790 0
Vehicle Telemetry Speeding.
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).
Secondary outcome [10] 438791 0
Gaze transition entropy (GTE)
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).
Secondary outcome [11] 438792 0
Stationary Gaze Entropy (SGE)
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).
Secondary outcome [12] 438793 0
Long Glance Away (LGA) events
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).
Secondary outcome [13] 438794 0
Visual Attention Time Sharing (VATS) Events
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).
Secondary outcome [14] 438795 0
Blink Rate
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).
Secondary outcome [15] 438796 0
Blink Duration
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).
Secondary outcome [16] 438797 0
Fixation Rate
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).
Secondary outcome [17] 438798 0
Fixation Duration
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).
Secondary outcome [18] 438799 0
Eye Closure (Percent of Time Spent with Eyes Closed)
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).
Secondary outcome [19] 438800 0
Microsleeps
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).
Secondary outcome [20] 438803 0
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Timepoint [20] 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).
Secondary outcome [21] 438804 0
NASA Task Load Index (NASA-TLX)
Timepoint [21] 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).
Secondary outcome [22] 438805 0
Subjective Driving Ability
Timepoint [22] 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).
Secondary outcome [23] 438806 0
Blood THC Levels
Timepoint [23] 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).
Secondary outcome [24] 438808 0
Percent Road Centre (PRC)
Timepoint [24] 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).
Secondary outcome [25] 438809 0
Karolinska Sleepiness Scale (KSS)
Timepoint [25] 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).
Secondary outcome [26] 438811 0
Brief Pain Inventory (BPI)
Timepoint [26] 438811 0
Assessed at the time of in-person medical screening (post-enrolment).
Secondary outcome [27] 438812 0
36-Item Short Form Health Survey (SF-36)
Timepoint [27] 438812 0
Assessed at the time of in-person medical screening (post-enrolment).
Secondary outcome [28] 438813 0
Depression Anxiety and Stress Scale (DASS-21). This will be assessed as a composite outcome.
Timepoint [28] 438813 0
Assessed at the time of in-person medical screening (post-enrolment).
Secondary outcome [29] 438814 0
Dula Dangerous Driving Index (DDDI)
Timepoint [29] 438814 0
Assessed at the time of in-person medical screening (post-enrolment).
Secondary outcome [30] 438815 0
Driving Behaviour Questionnaire (DBQ)
Timepoint [30] 438815 0
Assessed at the time of in-person medical screening (post-enrolment).
Secondary outcome [31] 438816 0
Numerical Rating Scale (NRS)
Timepoint [31] 438816 0
Assessed at the time of in-person medical screening (post-enrolment).
Secondary outcome [32] 438817 0
The Barratt Impulsiveness Scale (BIS)
Timepoint [32] 438817 0
Assessed at the time of in-person medical screening (post-enrolment).
Secondary outcome [33] 438818 0
Detectability of THC in oral fluid
Timepoint [33] 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).
Secondary outcome [34] 439144 0
Pupillary unrest index (PUI)
Timepoint [34] 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).
Secondary outcome [35] 439147 0
Pupillary light reflex (PLR)
Timepoint [35] 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).

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.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The study employs a baseline-controlled design where the intervention (medical cannabis) is compared against baseline (pre-dosing) performance.
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/10/2024
Actual
1/11/2024
Date of last participant enrolment
Anticipated
1/05/2026
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
72
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317210 0
Government body
Name [1] 317210 0
Department of Transport and Planning (DTP)
Country [1] 317210 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
Country
Australia
Secondary sponsor category [1] 319529 0
None
Name [1] 319529 0
Address [1] 319529 0
Country [1] 319529 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315948 0
Swinburne University of Technology Human Research Ethics Committee
Ethics committee address [1] 315948 0
Ethics committee country [1] 315948 0
Australia
Date submitted for ethics approval [1] 315948 0
02/08/2024
Approval date [1] 315948 0
24/10/2024
Ethics approval number [1] 315948 0
20248178-19868

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136314 0
Prof Luke Downey
Address 136314 0
Advanced Technologies Centre, 427-451 Burwood Road, Hawthorn VIC 3122
Country 136314 0
Australia
Phone 136314 0
+61 03 9214 5781
Fax 136314 0
Email 136314 0
ldowney@swin.edu.au
Contact person for public queries
Name 136315 0
Dr Thomas Arkell
Address 136315 0
Advanced Technologies Centre, 427-451 Burwood Road, Hawthorn VIC 3122
Country 136315 0
Australia
Phone 136315 0
+61 03 9214 3571
Fax 136315 0
Email 136315 0
tarkell@swin.edu.au
Contact person for scientific queries
Name 136316 0
Dr Amie Hayley
Address 136316 0
Advanced Technologies Centre, 427-451 Burwood Road, Hawthorn VIC 3122
Country 136316 0
Australia
Phone 136316 0
+61 03 9214 5585
Fax 136316 0
Email 136316 0
ahayley@swin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.