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Completed

NCT Number: NCT05212493

The Effects of Medical Cannabis in Children With Autistic Spectrum Disorder

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.

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Key information

Conditions

Autism Spectrum Disorder Autistic Disorder Chemically-Induced Disorders Child Development Disorders, Pervasive Marijuana Abuse Mental Disorders Neurodevelopmental Disorders Substance-Related Disorders

Age range

5 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cannabis oil

Drug

Cannabis oil 20:1 CBD:THC ratio

Primary outcomes

  1. Cannabinoids levels change

    Time frame: 3 months

    To compare CBD, THC their and metabolites blood levels before and after intervention

  2. Changes in attention span

    Time frame: 6 months

    To characterize the effect of medical cannabis treatment on the attention span using Conners teacher questionnaires. Significant change is defined as a change of 10% in questionnaire score between baseline and 6 months.

  3. Changes in cognitive level

    Time frame: 6 months

    To examine the effect of cannabis treatment on cognitive level using part of Wechsler test. Significant change is defined as a change of 10% in questionnaire score between baseline and 6 months.

  4. Comparison of efficacy between two different cannabis oil products

    Time frame: 6 months

    To compare efficacy of medical cannabis products with the same CBD: THC ratio in terms of communication skills using ADOS test. Significant change is defined as a change of 10% in raw questionnaire score between baseline and 6 months.

  5. Changes in adaptive behavior

    Time frame: 6 months

    To examine the effect of cannabis treatment on adaptive behavior as per ADOS test. Significant change is defined as a change of 10% in raw questionnaire score between baseline and 6 months.

  6. Changes in violent behavior

    Time frame: 6 months

    To examine the effect of cannabis treatment on violent behavior as per specific trial-designed questionnaire. Significant change is defined as a change of 10% in questionnaire score between baseline and 6 months.

Secondary outcomes

  1. Side effects

    Time frame: 6 months

    To identify side effects as per parents report in a specific trial-designed questionnaire. Significant change is defined as a change of 10% in new side effects as examined by questionnaire score between baseline and 6 months.

  2. Therapeutic failure

    Time frame: 6 months

    To identify therapeutic failure reasons as per Professional expert opinion. Significant reason is defined as reason that will effect at least 20% of therapeutic failure cases.

  3. Changes in sleep problems

    Time frame: 6 months

    To examine whether high concentration CBD cannabis oil is effective in improving sleep as per Sleep questionnaire. Significant change is defined as a change of 10% in raw questionnaire score between baseline and 6 months.

  4. Changes in eating problems

    Time frame: 6 months

    To examine whether high concentration CBD cannabis oil is effective in improving eating as per eating questionnaire. Significant change is defined as a change of 10% in raw questionnaire score between baseline and 6 months.

  5. Changes in hormonal profile

    Time frame: 3 months

    To compare hormonal profile measured as per by Hospital Lab SOP before and during treatment. measured hormones are: TSH, FT4, 17OH-testosterone, LH, prolactine. Significant change is defined as a clinically significant diversion from lab defined normal ranges, according to age and sex, between baseline and 3 months.

  6. Changes in biochemical parameters

    Time frame: 3 months

    To compare liver enzymes measured as per by Hospital Lab SOP before and during treatment. Measured enzymes are: ALT, AST, GGT, Bilirubin. Significant change is defined as a clinicaly significant diversion (more than twice the Upper Limit of Noraml for each enzyme) from lab defined normal ranges, between baseline and 3 months.

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Collaborators

  • Canndoc Ltd
  • Seach Sarid Ltd

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Jan 28, 2022
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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