The Effects of Medical Cannabis in Children With Autistic Spectrum Disorder

Shamir Medical Center (Assaf-Harofeh)

Status and phase

Completed

Phase 3

Conditions

Autism Spectrum Disorder

Treatments

Drug: Cannabis oil

Study type

Interventional

Funder types

Other

Identifiers

NCT05212493

20175083 (Registry Identifier)

0281-17-ASF

Details and patient eligibility

About

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.

Full 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

Enrollment

128 patients

Sex

All

Ages

5 to 25 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

diagnosed with ASD by DSM
IQ below 70. The investigator can include patients with IQ above 70 if they have significant ASD or comorbid symptoms.
With significant behavior problems in for at least 6 months before recruitment

Exclusion Criteria:

Epilepsy with clinical symptoms
Current or previous treatment with cannabis
Genetic disorder that can cause ASD symptoms
Metabolic disorder
immunologic disorder
liver cancer
Participants who, in the researcher's opinion, will not cooperate in the various research procedures
Women which are pregnant or breastfeeding.
Psychosis or schizophrenia or past or present schizoaffective disorder, in first-degree relatives
History of substance abuse or abuse (including cannabis use disorder or alcohol addiction) in first-degree relatives
Hypersensitivity to coconut oil / palm oil