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The Effects of Medical Cannabis in Children With Autistic Spectrum Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05212493
Recruitment Status : Active, not recruiting
First Posted : January 28, 2022
Last Update Posted : February 23, 2022
Sponsor:
Collaborators:
Seach Sarid Ltd
Canndoc Ltd
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center

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.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Drug: Cannabis oil Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Medical Cannabis in Children With Autistic Spectrum Disorder
Actual Study Start Date : November 14, 2019
Actual Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05212493


Locations
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Israel
Assaf Harofeh Medical Center
Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Seach Sarid Ltd
Canndoc Ltd
  Study Documents (Full-Text)

Documents provided by Assaf-Harofeh Medical Center:
Study Protocol  [PDF] August 23, 2020

Publications:
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Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT05212493    
Other Study ID Numbers: 0281-17-ASF
20175083 ( Registry Identifier: Israeli MOH )
First Posted: January 28, 2022    Key Record Dates
Last Update Posted: February 23, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: the study protocol to be sahared upon request
Supporting Materials: Study Protocol
Time Frame: during the duration of the trial
Access Criteria: for interested colleagues

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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
Keywords provided by Assaf-Harofeh Medical Center:
Autism
Cannabis
co-morbid symptoms
ASD
Cannabidiol
Additional relevant MeSH terms:
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Marijuana Abuse
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders