The Effects of Medical Cannabis in Children With Autistic Spectrum Disorder

July 30, 2024 updated by: Assaf-Harofeh Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / 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

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Zerifin, Israel, 70300
        • Assaf Harofeh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Seach CBD:THC 20:1 cannabis oil
cannabis oil containing CBD:THC ratio of 20:1. plant material is grown by Seach LTD and oil manufactured by Nextar Pharma LTD.
Drug: Cannabis oil
Cannabis oil 20:1 CBD:THC ratio
Active Comparator: Candoc CBD:THC 20:1 cannabis oil
cannabis oil containing CBD:THC ratio of 20:1. plant material is grown by Candoc LTD and oil manufactured by Panaxia LTD.
Drug: Cannabis oil
Cannabis oil 20:1 CBD:THC ratio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cannabinoids levels change
Time Frame: 3 months
To compare CBD, THC their and metabolites blood levels before and after intervention
3 months
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.
6 months
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.
6 months
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.
6 months
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 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months
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.
6 months
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.
6 months
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.
3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Collaborators

Seach Sarid Ltd
Canndoc Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2019

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

December 12, 2021

First Submitted That Met QC Criteria

January 16, 2022

First Posted (Actual)

January 28, 2022

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0281-17-ASF
  • 20175083 (Registry Identifier: Israeli MOH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

the study protocol to be sahared upon request

IPD Sharing Time Frame

during the duration of the trial

IPD Sharing Access Criteria

for interested colleagues

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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