None listed
Conditions
Brief summary
Autism spectrum disorder (ASD) is a highly prevalent neurodevelopmental disorder with no validated biomedical treatments for the core social and behavioural symptoms. The current study is a randomised crossover trial to assess whether cannabidiol (CBD) can promote behavioural and neurophysiological improvements in 5- to 12-year-old children. Several recent studies have investigated acute CBD administration on neurophysiological processes in the adult autistic brain (Pretzsch, Freyberg, Voinescu, et al., 2019a; Pretzsch, Voinescu, Lythgoe, et al., 2019a, 2019b; Pretzsch et al., 2021a). Others have documented behavioural outcomes following chronic (long-term) administration of the compound (Aran et al., 2019, 2021; Bar-Lev Schleider et al., 2019). To date, no investigation has explored effects of long-term CBD administration on glutamate and GABA concentrations alongside social communication outcomes. With a specific focus on the Research Domain Criteria (RDoC) ‘social processes’ domain (Cuthbert & Insel, 2013), which is heavily implicated in ASD, this study will utilise electroencephalography (EEG) to measure neurophysiological changes after chronic administration of CBD over a 12-week period. EEG will be used to acquire resting-state, social task-related processing, and mismatch negativity (MMN) data. MMN is a recognised measure of glutamatergic NMDA receptor function, and thus, neuronal excitation (Kompus et al., 2015). The study is designed to address the following aims: Behavioural: to measure the effect of CBD on the RDoC social processes domain in children with autism. More specifically, to observe a change in Social Responsiveness Scale (SRS) scores from baseline to Week 12. Neurophysiological: to observe whether CBD ‘shifts’ cortical excitation/inhibition during a social task, measured using EEG.
Interventions
Weight-based dosing of 10 mg/kg/day of cannabidiol (Medigrowth CBD100) for 12 weeks (delivered sublingually via syringe dispenser).
Washout period: 8 weeks.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
5 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed