The Effects of Medical Cannabis in Children With Autistic Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

Official title:

The Effects of Medical Cannabis in Children With Autistic Spectrum Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05212493
• Other study ID #: 0281-17-ASF
• Secondary ID: 20175083
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 14, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2023
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 128
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Marijuana Abuse

Intervention

Drug:
• Cannabis oil
Cannabis oil 20:1 CBD:THC ratio

Locations

Country	Name	City	State
Israel	Assaf Harofeh Medical Center	Zerifin

Sponsors (3)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center	Canndoc Ltd, Seach Sarid Ltd

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View 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. — View 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. Erratum In: JAMA. 2015 Aug 4;314(5):520. JAMA. 2015 Aug 25;314(8):837. JAMA. 2015 Dec 1;314(21):2308. JAMA. 2016 Apr 12;315(14):1522. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cannabinoids levels change	To compare CBD, THC their and metabolites blood levels before and after intervention	3 months
Primary	Changes in attention span	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
Primary	Changes in cognitive level	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
Primary	Comparison of efficacy between two different cannabis oil products	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
Primary	Changes in adaptive behavior	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
Primary	Changes in violent behavior	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	Side effects	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
Secondary	Therapeutic failure	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
Secondary	Changes in sleep problems	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
Secondary	Changes in eating problems	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
Secondary	Changes in hormonal profile	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
Secondary	Changes in biochemical parameters	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