A randomised crossover trial examining behavioural and neurophysiological effects of cannabidiol (CBD) in children with autism

Deakin University0 sites34 target enrollmentStarted: March 18, 2022Last updated: August 2, 2023

Conditions

Trial Snapshot

No summary available.

•1. Male or female children aged between and including 5 to 12.
•2. Diagnosis of Autism Spectrum Disorder (ASD) confirmed by The Autism Diagnostic Observation Schedule 2nd edition (ADOS-2). Children with autism will be identified in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V; APA, 2013) criteria.
•3. Stable pharmacologic, educational, behavioural, and/or dietary interventions for 4 weeks prior to randomisation and for the duration of the study;
•4. Presence of a parent/guardian who can provide consent for the participation of their child and complete assessments regarding the child's development and behaviour throughout the study;
•5. Normal/corrected to normal hearing and vision.
•6. IQ of 40 or higher.

•1. Exposure to any investigational agent in the 30 days prior to randomization;
•2. Prior chronic treatment with CBD, CBDV or an endocannabinoid treatment;
•3. Diagnosis of a known genetic disorder (e.g., Prader-Willi Syndrome, Angelman Syndrome, Tuberous Sclerosis);
•4. A known diagnosis of Rett Syndrome or Childhood Disintegrative Disorder, or marked sensory impairment such as deafness or blindness;
•5. A primary psychiatric diagnosis other than ASD, including bipolar disorder, psychosis, schizophrenia, Post-Traumatic Stress Disorder (PTSD) or Major Depressive Disorder (MDD). These patients will be excluded due to potential confounding results;
•6. A medical condition that severely impacts the participant’s ability to participate in the study, interferes with the conduct of the study, confounds interpretation of study results, or endangers the participant’s well-being;
•7. Changes in allied health therapies, behavioural, or educational interventions within 4 weeks prior to randomisation other than those associated with school holidays;
•8. Changes in medications or medication doses within four weeks of randomisation.
•9. Contraindications to CBD100: hypersensitivity to cannabinoids, liver, kidney or cardiovascular disease, hypersensitivity to the excipient (MCT) or coconut allergy
•10. Currently taking benzodiazepines, antiepileptic medications (e.g., sodium valproate, clobazam), and barbiturates.
•11. IQ below 40 or severe intellectual disability.

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