Please note the ANZCTR will be unattended from Friday 20 December 2019 for the holidays. The Registry will re-open on Tuesday 07 January 2020. Submissions and updates will not be processed during that time.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000932167p
Ethics application status
Not yet submitted
Date submitted
14/06/2019
Date registered
4/07/2019
Date last updated
4/07/2019
Date data sharing statement initially provided
4/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of medicinal cannabis on driving performance, sedation and mood
Scientific title
A randomised controlled trial investigating the effect of high CBD/low dose THC versus placebo on driving performance, sedation and mood in healthy volunteers
Secondary ID [1] 298448 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Driving performance 313188 0
Sedation 313189 0
Mood 313190 0
Cognitive function 313191 0
Condition category
Condition code
Injuries and Accidents 311649 311649 0 0
Other injuries and accidents
Mental Health 311650 311650 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 311651 311651 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Over the two week testing period, at each of the two testing visits, participants will be given a 1ml palatable bearer oil containing either (i) oil vehicle only, with no CBD/THC (placebo) or (ii) CannEpil. 20:1 cannabidiol (CBD) to (-) -trans-9-tetrahydrocannabinol (THC) in an oil vehicle (active) by mouth. The oil will be delivered in a one-off dose of 1ml liquid aliquot for each study session using CannEpil™ enclosed 3 mL syringe (or placebo equivalent) connected directly to the bottle. Testing visits will be scheduled at least one week apart to allow for a one-week washout.
The active treatment, CannEpil, is a phytocannabinoid based product containing a ratio of 20:1 cannabidiol (CBD) to (-) -trans-9-tetrahydrocannabinol (THC) in an oil vehicle. It also contains triglycerides as inactive ingredients. The proposed dose of 1ml CannEpil contains 100mg of CBD and 5mg of THC, and is significantly less than the recommended total daily dose for patient titration.
Participants will be asked to consume a standardised breakfast before attending each testing visits. There will be no restrictions on what they may eat (except caffeine is not permitted). On attendance at the first testing session the researcher will record what the participant had for breakfast. The participant will receive a reminder phone call and email the day before the next session and will be reminded of what they ate before the first session and asked to consume an identical breakfast.
Intervention code [1] 314694 0
Treatment: Drugs
Comparator / control treatment
The placebo treatment will consist of an oil vehicle only and will contain no active ingredients. The placebo will be identical in taste and appearance to the active treatment.
Control group
Placebo

Outcomes
Primary outcome [1] 320355 0
Difference in standard deviation of the lateral position (SDLP) measured using the Forum 8 driving simulator between CDB/THC and placebo
Timepoint [1] 320355 0
Approx. 80 minutes post-dose
Secondary outcome [1] 371329 0
Difference in global mood measured using the profile of mood states (POMS) between CBD/THC and placebo
Timepoint [1] 371329 0
Approx. 1 hour post-dose
Secondary outcome [2] 371330 0
Difference in standard deviation of speed (SDS) measured using the Forum 8 driving simulator between CBD/THC and placebo
Timepoint [2] 371330 0
Approx. 80 minutes post-dose
Secondary outcome [3] 371331 0
Difference in lapses (change in mean lateral position of the car greater than 100cm, lasting for at least 8 seconds) measured using the Forum 8 driving simulator between CBD/THC and placebo
Timepoint [3] 371331 0
Approx. 80 minutes post-dose
Secondary outcome [4] 371332 0
Difference in change in global cognition from pre-driving simulator to post-driving simulator between CBD/THC and placebo, measured using the CogTrack cognitive testing system.
Timepoint [4] 371332 0
2 hours post-dose
Secondary outcome [5] 371333 0
Difference in concentration of CBD in the blood between CBD/THC and placebo
Timepoint [5] 371333 0
30 minutes post-dose
Secondary outcome [6] 371334 0
Difference in presence of CBD in oral fluid between CBD/THC and placebo measured using the Securatec DrugWipe.
Timepoint [6] 371334 0
30 minutes post-dose
Secondary outcome [7] 371335 0
Difference in concentration of CBD in the blood between CBD/THC and placebo
Timepoint [7] 371335 0
2.5 hours post-dose
Secondary outcome [8] 371336 0
Difference in presence of CBD in oral fluid between CBD/THC and placebo measured using the Securatec DrugWipe.
Timepoint [8] 371336 0
2.5 hours post-dose
Secondary outcome [9] 371337 0
Difference in perceived driving ability and mental effort between CBD/THC and placebo measured using the perceived driving ability/mental effort scale
Timepoint [9] 371337 0
Approx. 2 hours post-dose
Secondary outcome [10] 371338 0
Difference in motion sickness between CBD/THC and placebo measured using the Simulator Sickness Questionnaire
Timepoint [10] 371338 0
Approx. 2 hours post-dose
Secondary outcome [11] 371339 0
Difference in subjective symptoms between CBD/THC and placebo measured using the Subjective Symptoms Visual Analogue Scale
Timepoint [11] 371339 0
Approx. 2 hours post dose
Secondary outcome [12] 371803 0
Safety measured by the number and type of adverse events reported by trial participants. Adverse events include all untoward medical occurrences whether related to the study treatment or not. It is unlikely that the investigational product will lead to any adverse reactions, however some participants may experience dizziness, increased heart rate or a dry mouth.
Timepoint [12] 371803 0
Throughout the duration of the trial.
Secondary outcome [13] 371813 0
Difference in concentration of THC in the blood between CBD/THC and placebo
Timepoint [13] 371813 0
30 minutes post-dose
Secondary outcome [14] 371814 0
Difference in presence of THC in oral fluid between CBD/THC and placebo measured using the Securatec DrugWipe.
Timepoint [14] 371814 0
30 minutes post-dose
Secondary outcome [15] 371815 0
Difference in concentration of THC in the blood between CBD/THC and placebo
Timepoint [15] 371815 0
2.5 hours post-dose
Secondary outcome [16] 371816 0
Difference in presence of THC in oral fluid between CBD/THC and placebo measured using the Securatec DrugWipe.
Timepoint [16] 371816 0
2.5 hours post-dose

Eligibility
Key inclusion criteria
Individuals will be screened to ensure they are deemed eligible to participate in the study. Subjects who meet the following eligibility criteria will be enrolled in the trial:
• Aged between 21 and 60 years
• Hold a full drivers licence (no ‘P’ plates)
• Are regular drivers (> 4,000 km/year) with three years of driving experience
• Have experimented with cannabinoids previously (self-disclosure). This includes any cannabis product (marijuana, skunk, ‘weed’).
• No known allergic reaction to cannabis products with previous use
• Ability to speak and read English
• Have no history of past substance abuse or current abuse of illicit drugs
• Have no pre-existing neurological conditions, no previous or current history of severe psychiatric, cardiac, renal, endocrine, gastrointestinal, or bleeding disorders
• Not currently pregnant or lactating
• Not taken any form of medication within 5 days of admission (except for prophylactic antibiotics, or other routine medications to treat benign conditions, such as antibiotics to treat acne).
• Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial
• Be willing and able to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol
Minimum age
21 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects presenting with any of the following will not be included in the trial:
• Aged under 21 years or over 60 years.
• Does not hold full drivers licence
• Inability to speak or read English
• History of drug or substance abuse or current illicit drug abuse
• History of neurological conditions or previous or current history of severe psychiatric, cardiac, endocrine, renal, gastrointestinal, or bleeding disorders
• Currently pregnant or breastfeeding
• Currently taking medication (except for prophylactic antibiotics, or other routine medications to treat benign conditions, such as antibiotics to treat acne)
• Severe depression (a cut off of 20 and higher on the Beck Depression Inventory)
• Severe anxiety (a cut off of 16 and higher on the Beck Anxiety Inventory).
• No previous experience with cannabinoids
• Current participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed by sealed opaque envelopes, which are to be kept in a locked filing cabinet in the Principal Investigator's office and will only be opened in the case of an emergency. In addition, the full randomisation list will be kept in a password protected document in a restricted access confidential folder on a secure server. Only the person who is responsible for generating the randomisation list (a disinterested third party) will have the password to access this document.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of the order of treatment visits will be determined by random allocation by a disinterested third party. All consenting participants will be assigned a participant number. The randomisation order that has been placed next to the participants’ number will be the allocated treatment order for that individual using publicly available randomisation software (Research Randomiser Software Version 4.0).
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 / Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
All statistical tests will be performed two tailed at the 5% significance level and performed using IBM SPSS statistical package. Z scores for the distribution will be calculated for each variable and displayed in histogram form. Out of range values will be recoded as missing values.
Results for the driving simulator (SDLP, SPS and lapses) and from the mood/sedation measures will also be compared using a mixed design analysis of variance (MANCOVA), with treatment group as the between-subject variable, time as the within-subjects variable, and baseline score as the covariate.
A secondary outcome to be measured will be the results from the drug screening device as a function of treatment group and will be presented as a binary outcome (detection yes/no). A binary logistic regression model will be used, with detection status (present/absent) as the outcome, and treatment group (high CBD/ low THC or placebo) used as the categorical predictor variable. Baseline data and demographic information will be entered sequentially to assess for possible effect-modification.

Results for the dose-relative concentration of CBD and THC in blood will be analysed using mixed design analysis of covariance (ANCOVA), with treatment order as the between-subject variable, time (individual sessions) as the within-subjects variable, and baseline score as the covariate.

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)
VIC

Funding & Sponsors
Funding source category [1] 302995 0
Commercial sector/Industry
Name [1] 302995 0
Cannvalate (Australia)
Address [1] 302995 0
C2 Level 1/459 Toorak Rd,
Toorak VIC 3142
Country [1] 302995 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cannvalate (Australia)
Address
C2 Level 1/459 Toorak Rd,
Toorak VIC 3142
Country
Australia
Secondary sponsor category [1] 302961 0
None
Name [1] 302961 0
Address [1] 302961 0
Country [1] 302961 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 303544 0
Swinburne University Human Research Ethics Committee [EC00240]
Ethics committee address [1] 303544 0
Research Ethics Officer,
Swinburne Research (H68),
Swinburne University of Technology,
P O Box 218,
Hawthorn, Victoria, 3122.
Ethics committee country [1] 303544 0
Australia
Date submitted for ethics approval [1] 303544 0
17/07/2019
Approval date [1] 303544 0
Ethics approval number [1] 303544 0

Summary
Brief summary
The purpose of this trial is to assess whether a high CBD/low THC medicinal cannabis oil product [CannEpil. 20:1 cannabidiol (CBD) to (-) -trans-9-tetrahydrocannabinol (THC)] causes driving impairment using a high fidelity driving simulator. In particular the study will assess whether this medicinal cannabis product causes changes in the standard deviation of the lateral position (SDLP) variable obtained from the driving simulator compared to placebo.
Additionally, the project aims will explore the subjective mood and sedative effects of this medicinal cannabis product compared to placebo.
31 participants will undergo a screening and practice visit followed by two testing visits spaced at least one week apart. At each testing visit they will receive either CBD/THC treatment or placebo in a crossover design. Participants will be instructed to consume a standardised breakfast prior to each testing session. During each testing visit participants will complete a driving simulation, cognitive tasks and questionnaires as well as having blood and saliva samples taken.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94034 0
Prof Con Stough
Address 94034 0
Centre for Human Psychopharmacology
Swinburne University of Technology
Mail H24
PO Box 218
Hawthorn
VIC 3122
Country 94034 0
Australia
Phone 94034 0
+61 3 9214 8167
Fax 94034 0
Email 94034 0
cstough@gmail.com
Contact person for public queries
Name 94035 0
Dr Sarah Catchlove
Address 94035 0
Centre for Human Psychopharmacology
Swinburne University of Technology
Mail H24
PO Box 218
Hawthorn
VIC 3122
Country 94035 0
Australia
Phone 94035 0
+61 3 9214 8930
Fax 94035 0
Email 94035 0
scatchlove@swin.edu.au
Contact person for scientific queries
Name 94036 0
Prof Con Stough
Address 94036 0
Centre for Human Psychopharmacology
Swinburne University of Technology
Mail H24
PO Box 218
Hawthorn
VIC 3122
Country 94036 0
Australia
Phone 94036 0
+61 3 9214 8167
Fax 94036 0
Email 94036 0
cstough@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is expected that the results of this trial will be disseminated via peer-reviewed publications and at academic conferences. For these purposes the data will be collated and analysed as group data. If required by the publishing journal, de-identified raw data will be uploaded to an appropriate repository. Otherwise, as the Intellectual Property of this study are owned by the sponsor and may be used for the purposes of commercialisation of the study product, the trial data will not be made available.
What supporting documents are/will be available?
No other documents available
Summary results
No Results