None listed
Conditions
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.
Interventions
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.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
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).
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
Outcome results
None listed