Clinical trial NCT05212493: The Effects of Medical Cannabis in Children With Autistic Spectrum Disorder
Official title: The Effects of Medical Cannabis in Children With Autistic Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autism Spectrum Disorder
Keywords: Autism
Cannabis
co-morbid symptoms
ASD
Cannabidiol
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Seach Sarid Ltd
name: Canndoc Ltd
First posted: 2022-01-28
Enrollment: 128
Sex: ALL
Minimum age (years): 5
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility 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

Primary outcomes:
measure: Cannabinoids levels change
timeFrame: 3 months
measure: Changes in attention span
timeFrame: 6 months
measure: Changes in cognitive level
timeFrame: 6 months
measure: Comparison of efficacy between two different cannabis oil products
timeFrame: 6 months
measure: Changes in adaptive behavior
timeFrame: 6 months
measure: Changes in violent behavior
timeFrame: 6 months
Secondary outcomes:
measure: Side effects
timeFrame: 6 months
measure: Therapeutic failure
timeFrame: 6 months
measure: Changes in sleep problems
timeFrame: 6 months
measure: Changes in eating problems
timeFrame: 6 months
measure: Changes in hormonal profile
timeFrame: 3 months
measure: Changes in biochemical parameters
timeFrame: 3 months
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
References:
citation: Iseger TA, Bossong MG. A systematic review of the antipsychotic properties of cannabidiol in humans. Schizophr Res. 2015 Mar;162(1-3):153-61. doi: 10.1016/j.schres.2015.01.033. Epub 2015 Feb 7.
citation: Whiting PF, Wolff RF, Deshpande S, Di Nisio M, Duffy S, Hernandez AV, Keurentjes JC, Lang S, Misso K, Ryder S, Schmidlkofer S, Westwood M, Kleijnen J. Cannabinoids for Medical Use: A Systematic Review and Meta-analysis. JAMA. 2015 Jun 23-30;313(24):2456-73. doi: 10.1001/jama.2015.6358.
citation: Barchel D, Stolar O, De-Haan T, Ziv-Baran T, Saban N, Fuchs DO, Koren G, Berkovitch M. Oral Cannabidiol Use in Children With Autism Spectrum Disorder to Treat Related Symptoms and Co-morbidities. Front Pharmacol. 2019 Jan 9;9:1521. doi: 10.3389/fphar.2018.01521. eCollection 2018.