ANZCTR - Registration

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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

27/10/2021

Date data sharing statement initially provided

11/11/2019

Date results information initially provided

27/10/2021

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]

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

Condition category

Condition code

Injuries and Accidents

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]

Treatment: Drugs

Comparator / control treatment

Medium Chain Triglyceride Oil (Placebo)

Control group

Placebo

Outcomes

Primary outcome [1]

Standard deviation of lateral position (SDLP) on the simulated car driving performance test

Timepoint [1]

30- and 210-min post-drug administration.

Secondary outcome [1]

Mean speed on the simulated car driving performance tests.

Timepoint [1]

30- and 210-min post-drug administration

Secondary outcome [2]

Number of correct patterns and pattern accuracy on the digit symbol substitution test

Timepoint [2]

At Baseline and at ~30- and ~210 min post-drug administration

Secondary outcome [3]

Tracking error on the divided attention test.

Timepoint [3]

At Baseline and at ~30- and ~120 min post-drug administration

Secondary outcome [4]

Response accuracy and the total number of correct trials on the paced auditory serial addition test.

Timepoint [4]

At Baseline and at ~30- and ~120-min post-drug administration

Secondary outcome [5]

Heart rate (digital sphygmomanometer)

Timepoint [5]

At Baseline and at ~10-, 60-, 140-, 190- and 240-min post-drug administration.

Secondary outcome [6]

Score on the short (6-item) State and Train Anxiety Index (STAI)

Timepoint [6]

At Baseline and at ~10-, 60-, 140-, 190- and 240-min post-drug administration.

Secondary outcome [7]

Subjective drug effects (i.e. feeling stoned) on 100 mm visual analog scales

Timepoint [7]

At Baseline and at ~10-, 60-, 140-, 190- and 240-min post-drug administration.

Secondary outcome [8]

Impairment evaluation score on the DRUID Smart-Phone Application

Timepoint [8]

At Baseline and at ~20- and 200-min post-drug administration

Secondary outcome [9]

Reaction time and number of lapses on the psychomotor vigilance test

Timepoint [9]

~70- and 250-min post-drug administration

Secondary outcome [10]

Score on the Adelaide Driving Self-Efficacy Scale

Timepoint [10]

~30- and 210-min post-drug administration

Secondary outcome [11]

Score on the Simulator Sickness Questionnaire

Timepoint [11]

~60 and 240-min post-drug administration

Secondary outcome [12]

Plasma cannabinoid concentrations

Timepoint [12]

At Baseline and ~30-, 60-, 195- and 240-min post-drug administration.

Secondary outcome [13]

Oral fluid cannabinoid concentrations

Timepoint [13]

At Baseline and ~30-, 140- and 195-min post-drug administration.

Secondary outcome [14]

Result (Positive or Negative) of the Securetec DrugWipe® and Dräger DrugTest® 5000 drug tests

Timepoint [14]

At Baseline and ~30-, 140- and 195-min post-drug administration

Secondary outcome [15]

Standard deviation of speed on the simulated car driving performance tests.

Timepoint [15]

30- and 210-min post-drug administration

Secondary outcome [16]

Distance headway on the simulated car driving performance tests.

Timepoint [16]

30- and 210-min post-drug administration

Secondary outcome [17]

Standard deviation of distance headway on the simulated car driving performance tests.

Timepoint [17]

30- and 210-min post-drug administration

Secondary outcome [18]

Number of target numbers correctly identified on the divided attention test.

Timepoint [18]

At Baseline and at ~30- and ~120 min post-drug administration

Secondary outcome [19]

Response time on the divided attention test.

Timepoint [19]

At Baseline and at ~30- and ~120 min post-drug administration

Secondary outcome [20]

Blood pressure (digital sphygmomanometer)

Timepoint [20]

At Baseline and at ~10-, 60-, 140-, 190- and 240-min post-drug administration.

Secondary outcome [21]

Subjective drug effects (i.e. feeling sedated) on 100 mm visual analog scales

Timepoint [21]

At Baseline and at ~10-, 60-, 140-, 190- and 240-min post-drug administration.

Secondary outcome [22]

Subjective drug effects (i.e. feeling alert) on 100 mm visual analog scales

Timepoint [22]

At Baseline and at ~10-, 60-, 140-, 190- and 240-min post-drug administration.

Secondary outcome [23]

Subjective drug effects (i.e. feeling anxious) on 100 mm visual analog scales

Timepoint [23]

At Baseline and at ~10-, 60-, 140-, 190- and 240-min post-drug administration.

Secondary outcome [24]

Subjective drug effects (i.e. feeling sleepy) on 100 mm visual analog scales

Timepoint [24]

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

Sex

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

Completed

Date of first participant enrolment

Anticipated

18/11/2019

Actual

4/12/2019

Date of last participant enrolment

Anticipated

1/06/2020

Actual

2/12/2020

Date of last data collection

Anticipated

1/07/2020

Actual

20/01/2021

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Lambert Initiative for Cannabinoid Therapeutics

Address [1]

Brain and Mind Centre (Level 6)
94 Mallet Street
Camperdown
New South Wales
Australia
2050

Country [1]

Australia

Primary sponsor type

University

Name

University of Sydney

Address

Camperdown
New South Wales
Australia
2050

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Sydney Human Research Ethics Committee

Ethics committee address [1]

Administration Building (Level 3, F23)
University of Sydney
Camperdown
New South Wales
Australia
2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/04/2019

Approval date [1]

07/07/2019

Ethics approval number [1]

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

Prof Iain McGregor

Address

Brain and Mind Centre (Level 6)
94 Mallet Street
Camperdown
New South Wales
Australia
2050

Country

Australia

Phone

+61 02 9351 0883

Fax

[email protected]

Contact person for public queries

Name

Dr Danielle McCartney

Address

Brain and Mind Centre (Level 6)
94 Mallet Street
Camperdown
New South Wales
Australia
2050

Country

Australia

Phone

+61 02 9351 0783

Fax

[email protected]

Contact person for scientific queries

Name

Prof Iain McGregor

Address

Brain and Mind Centre (Level 6)
94 Mallet Street
Camperdown
New South Wales
Australia
2050

Country

Australia

Phone

+61 02 9351 0883

Fax

[email protected]

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 Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The effect of cannabidiol on simulated car driving performance: A randomised, double-blind, placebo-controlled, crossover, dose-ranging clinical trial protocol.	2020	https://dx.doi.org/10.1002/hup.2749
Embase	Orally administered cannabidiol does not produce false-positive tests for DELTA9-tetrahydrocannabinol on the Securetec DrugWipe 5S or Drager DrugTest 5000.	2022	https://dx.doi.org/10.1002/dta.3153
Embase	Effects of cannabidiol on simulated driving and cognitive performance: A dose-ranging randomised controlled trial.	2022	https://dx.doi.org/10.1177/02698811221095356

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically