NCT05212493

The Effects of Medical Cannabis in Children With Autistic Spectrum Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Assaf-Harofeh Medical Center · Other Government
• Sex: All
• Age: 5 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants will be screened by the PI, a specialist neurologist. For those passing screening, license for Cannabis will be obtained at MOH. Participants will pass tests such as ADOS (communication skills) and Wechsler (IQ), parents will fill questionnaires. Treatment will start in a titration mode till improvement in some parameters is seen or till treatment failure decision is made. Participants will be called for a check-up by mid-time (after 3 months) and their parents will fill questionnaires. Participants will be called for a last check-up after 6 months from treatment beginning and pass again ADOS and Wechsler tests. Parents will fill questionnaires. Secondary purposes of the trial: To detect side-effects To assess treatment failure To assess treatment effect on sleep, motor restlessness and behavior. To examine treatment effect on hormonal profile

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Cannabis oil	Cannabis oil 20:1 CBD:THC ratio

Timeline

• Start date: 2019-11-14
• Primary completion: 2021-12-31
• Completion: 2023-12-31
• First posted: 2022-01-28
• Last updated: 2024-07-31

Locations

1 site across 1 country: Israel