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Trial registered on ANZCTR


Registration number
ACTRN12619001552178
Ethics application status
Approved
Date submitted
22/10/2019
Date registered
11/11/2019
Date last updated
11/11/2019
Date data sharing statement initially provided
11/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of cannabidiol (CBD) on simulated driving performance.
Scientific title
A randomised, double-blinded, crossover trial investigating the dose-dependent effects of purified oral cannabidiol (CBD) on simulated driving performance in healthy volunteers.
Secondary ID [1] 299191 0
CT-2019-CTN-04227-1
Universal Trial Number (UTN)
U1111-1239-7155
Trial acronym
CBDdrive
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Road Trauma 314292 0
Condition category
Condition code
Injuries and Accidents 312646 312646 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Oral Cannabidiol in Medium Chain Triglyceride Oil (Schedule 4 Drug); 15 mg (single dose)
Arm 2: Oral Cannabidiol in Medium Chain Triglyceride Oil (Schedule 4 Drug); 300 mg (single dose)
Arm 3: Oral Cannabidiol in Medium Chain Triglyceride Oil (Schedule 4 Drug); 1500 mg (single dose)

All trials will be separated by a washout period of at least 7 days.

As this is an ‘acute dosing’ trial (i.e. using a single dose of CBD per research session) compliance does not need to be monitored.
Intervention code [1] 315488 0
Treatment: Drugs
Comparator / control treatment
Medium Chain Triglyceride Oil (Placebo)
Control group
Placebo

Outcomes
Primary outcome [1] 321296 0
Standard deviation of lateral position (SDLP) on the simulated car driving performance test
Timepoint [1] 321296 0
30- and 210-min post-drug administration.
Secondary outcome [1] 374560 0
Mean speed on the simulated car driving performance tests.
Timepoint [1] 374560 0
30- and 210-min post-drug administration
Secondary outcome [2] 374568 0
Number of correct patterns and pattern accuracy on the digit symbol substitution test
Timepoint [2] 374568 0
At Baseline and at ~30- and ~210 min post-drug administration
Secondary outcome [3] 374569 0
Tracking error on the divided attention test.
Timepoint [3] 374569 0
At Baseline and at ~30- and ~120 min post-drug administration
Secondary outcome [4] 374570 0
Response accuracy and the total number of correct trials on the paced auditory serial addition test.
Timepoint [4] 374570 0
At Baseline and at ~30- and ~120-min post-drug administration
Secondary outcome [5] 374571 0
Heart rate (digital sphygmomanometer)
Timepoint [5] 374571 0
At Baseline and at ~10-, 60-, 140-, 190- and 240-min post-drug administration.
Secondary outcome [6] 374572 0
Score on the short (6-item) State and Train Anxiety Index (STAI)
Timepoint [6] 374572 0
At Baseline and at ~10-, 60-, 140-, 190- and 240-min post-drug administration.
Secondary outcome [7] 374573 0
Subjective drug effects (i.e. feeling stoned) on 100 mm visual analog scales
Timepoint [7] 374573 0
At Baseline and at ~10-, 60-, 140-, 190- and 240-min post-drug administration.
Secondary outcome [8] 374574 0
Impairment evaluation score on the DRUID Smart-Phone Application
Timepoint [8] 374574 0
At Baseline and at ~20- and 200-min post-drug administration
Secondary outcome [9] 374575 0
Reaction time and number of lapses on the psychomotor vigilance test
Timepoint [9] 374575 0
~70- and 250-min post-drug administration
Secondary outcome [10] 374576 0
Score on the Adelaide Driving Self-Efficacy Scale
Timepoint [10] 374576 0
~30- and 210-min post-drug administration
Secondary outcome [11] 376105 0
Score on the Simulator Sickness Questionnaire
Timepoint [11] 376105 0
~60 and 240-min post-drug administration
Secondary outcome [12] 376107 0
Plasma cannabinoid concentrations
Timepoint [12] 376107 0
At Baseline and ~30-, 60-, 195- and 240-min post-drug administration.
Secondary outcome [13] 376108 0
Oral fluid cannabinoid concentrations
Timepoint [13] 376108 0
At Baseline and ~30-, 140- and 195-min post-drug administration.
Secondary outcome [14] 376110 0
Result (Positive or Negative) of the Securetec DrugWipe® and Dräger DrugTest® 5000 drug tests
Timepoint [14] 376110 0
At Baseline and ~30-, 140- and 195-min post-drug administration
Secondary outcome [15] 376449 0
Standard deviation of speed on the simulated car driving performance tests.
Timepoint [15] 376449 0
30- and 210-min post-drug administration
Secondary outcome [16] 376450 0
Distance headway on the simulated car driving performance tests.
Timepoint [16] 376450 0
30- and 210-min post-drug administration
Secondary outcome [17] 376451 0
Standard deviation of distance headway on the simulated car driving performance tests.
Timepoint [17] 376451 0
30- and 210-min post-drug administration
Secondary outcome [18] 376452 0
Number of target numbers correctly identified on the divided attention test.
Timepoint [18] 376452 0
At Baseline and at ~30- and ~120 min post-drug administration
Secondary outcome [19] 376453 0
Response time on the divided attention test.
Timepoint [19] 376453 0
At Baseline and at ~30- and ~120 min post-drug administration
Secondary outcome [20] 376454 0
Blood pressure (digital sphygmomanometer)
Timepoint [20] 376454 0
At Baseline and at ~10-, 60-, 140-, 190- and 240-min post-drug administration.
Secondary outcome [21] 376455 0
Subjective drug effects (i.e. feeling sedated) on 100 mm visual analog scales
Timepoint [21] 376455 0
At Baseline and at ~10-, 60-, 140-, 190- and 240-min post-drug administration.
Secondary outcome [22] 376456 0
Subjective drug effects (i.e. feeling alert) on 100 mm visual analog scales
Timepoint [22] 376456 0
At Baseline and at ~10-, 60-, 140-, 190- and 240-min post-drug administration.
Secondary outcome [23] 376457 0
Subjective drug effects (i.e. feeling anxious) on 100 mm visual analog scales
Timepoint [23] 376457 0
At Baseline and at ~10-, 60-, 140-, 190- and 240-min post-drug administration.
Secondary outcome [24] 376458 0
Subjective drug effects (i.e. feeling sleepy) on 100 mm visual analog scales
Timepoint [24] 376458 0
At Baseline and at ~10-, 60-, 140-, 190- and 240-min post-drug administration.

Eligibility
Key inclusion criteria
(a) Between 18 and 65 years of age;
(b) No reported use of cannabis within the past 3 months; to be confirmed by a negative urine drug screen at the medical screening;
(c) In possession of full (unrestricted) Australian driver’s license for at least 1 y;
(d) Proficient in English (i.e. must not require an English translator).
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(a) Cannabis dependence or any other drug or alcohol dependence, as per the International Statistical Classification of Diseases 10th Revision criteria or at the medical officer’s discretion;
(b) Contraindications to cannabinoids, including clinically significant prior adverse response to cannabis, cannabinoid products or synthetic cannabinoids (e.g. panic, anxiety attacks, arrhythmia, falls, seizures or other);
(c) History of a major psychiatric disorder within the previous 12 months (except clinically managed mild depression) as per the Diagnostic and Statistical Manual of Mental Disorders-V criteria or at the medical officer’s discretion;
(d) History of attempted suicide or current suicide ideation as determined by a score >0 on Question 9 of the Patient Health Questionnaire-9;
(e) A diagnosed sleep disorder, as per the International Classification of Sleep Disorders Diagnostic and Coding manual or at the medical officer’s discretion;
(f) Pregnant or lactating. All female volunteers of childbearing potential will be required to complete a human chorionic gonadotrophin (hCG) urine screen to rule out pregnancy at the medical screening; females of childbearing potential and males with a female partner must agree to use a reliable form of contraception during and one month following their participation in this project;
(g) Inability to refrain from alcohol consumption 24 h prior to each experimental trial;
(h) Inability to refrain from using other central nervous system active drugs (e.g. opioids, benzodiazepines) while participating in this project;
(i) Use of medications that may influence CBD metabolism, such as inducers or inhibitors of the CYP450 enzyme system;
(j) Use of medications handled by transporter proteins or CYP enzymes that are inhibited by CBD, such as anticoagulants, calcium channel blockers, beta-blockers and sulfonylureas;
(k) Use of anticonvulsive medications, such as clobazam or valproate;
(l) Required to complete mandatory drug testing for cannabis (e.g. workplace testing; court order);
(m) A high habitual caffeine (i.e. >300 mg·d-1);
(n) At risk for developing driving simulator sickness, as determined at the medical screening using the Simulator Sickness Questionnaire;
(o) Body mass index (BMI) >30 kg·m2

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using a random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This trial will use non-inferiority analyses to test the hypothesis that CBD, at doses of 15, 300 and 1500 mg, is not “inferior” to- (i.e., more impairing than-) placebo by more than the non-inferiority margin, delta. The delta has been set at a Cohen’s d effect of 0.52 on SDLP. This value was selected on the basis that: (1) delta should reflect the smallest “acceptable” level of impairment; and (2) data from several comprehensive, dose-ranging studies suggest that (on average) a blood alcohol concentration of 50 mg·dL-1 would have an effect of this size on a ~15–60 min highway driving test.

Recruitment
Recruitment status
Not yet 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)
NSW

Funding & Sponsors
Funding source category [1] 303732 0
Charities/Societies/Foundations
Name [1] 303732 0
Lambert Initiative for Cannabinoid Therapeutics
Address [1] 303732 0
Brain and Mind Centre (Level 6)
94 Mallet Street
Camperdown
New South Wales
Australia
2050
Country [1] 303732 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Camperdown
New South Wales
Australia
2050
Country
Australia
Secondary sponsor category [1] 303855 0
None
Name [1] 303855 0
Address [1] 303855 0
Country [1] 303855 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304256 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 304256 0
Administration Building (Level 3, F23)
University of Sydney
Camperdown
New South Wales
Australia
2050
Ethics committee country [1] 304256 0
Australia
Date submitted for ethics approval [1] 304256 0
04/04/2019
Approval date [1] 304256 0
07/07/2019
Ethics approval number [1] 304256 0
2019/474

Summary
Brief summary
This study is a randomised, crossover, double-blinded, single-dose experimental trial investigating the dose-dependent effects of purified, oral cannabidiol (CBD) on simulated car driving performance in healthy individuals. Participants will complete four experimental sessions involving different CBD treatments: (1) Placebo (0mg); (2) Low dose (15mg); (3) Moderate dose (300mg); and (4) High dose (1500mg). Trials will be conducted at the Woolcock Institute of Medical Research. We hypothesise that no dose of CBD will affect simulated car driving performance. Findings may assist to inform the development of guidelines and/or laws relating to the use of CBD drug therapies by drivers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96306 0
Prof Iain McGregor
Address 96306 0
Brain and Mind Centre (Level 6)
94 Mallet Street
Camperdown
New South Wales
Australia
2050
Country 96306 0
Australia
Phone 96306 0
+61 02 9351 0883
Fax 96306 0
Email 96306 0
iain.mcgregor@sydney.edu.au
Contact person for public queries
Name 96307 0
Dr Danielle McCartney
Address 96307 0
Brain and Mind Centre (Level 6)
94 Mallet Street
Camperdown
New South Wales
Australia
2050
Country 96307 0
Australia
Phone 96307 0
+61 02 9351 0783
Fax 96307 0
Email 96307 0
danielle.mccartney@sydney.edu.au
Contact person for scientific queries
Name 96308 0
Prof Iain McGregor
Address 96308 0
Brain and Mind Centre (Level 6)
94 Mallet Street
Camperdown
New South Wales
Australia
2050
Country 96308 0
Australia
Phone 96308 0
+61 02 9351 0883
Fax 96308 0
Email 96308 0
iain.mcgregor@sydney.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?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication (via request), no end date.
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Contacting the Principle Investigator (corresponding authour).
What supporting documents are/will be available?
No other documents available
Summary results
No Results