The Effects of Medical Cannabis in Children With Autistic Spectrum Disorder

NCT05212493 | Completed Phase 3 DMC

• 2 other identifiers: 0281-17-ASF20175083
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism; Cannabis; co-morbid symptoms; ASD; Cannabidiol

Outcome Measures

Primary Outcomes (6)

• Cannabinoids levels change

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

  3 months

• 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

• 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

• 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

• 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

• 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 Outcomes (6)

• Side effects

  6 months

• Therapeutic failure

  6 months

• Changes in sleep problems

  6 months

• Changes in eating problems

  6 months

• Changes in hormonal profile

  3 months

Study Arms (2)

Seach CBD:THC 20:1 cannabis oil

ACTIVE COMPARATOR

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

Candoc CBD:THC 20:1 cannabis oil

ACTIVE COMPARATOR

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

Interventions

Cannabis oil DRUG

Cannabis oil 20:1 CBD:THC ratio

Candoc CBD:THC 20:1 cannabis oil; Seach CBD:THC 20:1 cannabis oil

Eligibility Criteria

• Age: 5 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead
• Seach Sarid Ltd: collaborator
• Canndoc Ltd: collaborator

Study Sites (1)

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

Related Publications (3)

• 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.

  PMID: 25667194 BACKGROUND

• 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.

  PMID: 26103030 BACKGROUND

• 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.

  PMID: 30687090 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Marijuana Abuse

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: January 28, 2022
• Study Start: November 14, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2023
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: during the duration of the trial
• Access Criteria: for interested colleagues

Locations

IL (1)