None listed
Conditions
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.
Interventions
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. Testi
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.
Sponsors
Cannvalate (Australia)
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
21 Years to 60 Years
Healthy volunteers
Yes
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
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
Outcome results
None listed