The Effects of Medical Cannabis in Children With Autistic Spectrum Disorder
Status:
Active, not recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Children with autism spectrum disorder (ASD) commonly exhibit comorbid symptoms such as
aggression, hyperactivity and anxiety. Data on the effects of cannabidiol rich cannabis
extract use for ASD is promising but still limited. The aim of this study is to investigate
if oral cannabinoids treatment to children and young adults with ASD affect the comorbidities
of autism, including sleep and eating problems, anxiety and violence.
The main objectives of the study are: 1) to characterize the effect of treatment with
cannabis oil on comorbid symptoms of ASD; 2) to compare safety and efficacy of different
cannabis products with identical CBD:THC ratio; 3) to investigate the effect of treatment on
cognitive and adaptive behavior; and 4) to measure THC and CBD and metabolites levels in the
blood of the patients.
In this study, patients diagnosed with ASD will be treated with cannabidiol-rich cannabis oil
(CBD:THC ratio of 20:1). The researchers will collect parental reports on ASD comorbid
symptoms before and bi-weekly during 6 months of the study period. Blood tests will be
performed before and after three months of treatment. Blood tests include blood count, blood
chemistry, hormones profile, phyto- and endo- cannabinoids and metabolites. Cognitive
evaluation will be done before and after six months of treatment. Electroencephalogram (EEG)
to exclude epilepsy will be performed before and after six months of treatment.