Cannabinoids for Behavioral Problems in Children With ASD

NCT02956226 | Completed Phase 2 DMC

• 1 other identifier: CBA
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the safety, tolerability and efficacy of cannabinoids mix \[cannabidiol (CBD), Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio, BOL Pharma, Israel\] for behavioral problems in children and youth with ASD.

Conditions

Autistic Disorder

Outcome Measures

Primary Outcomes (2)

• Change from baseline Home Situations Questionnaire-Autism Spectrum Disorder (HSQ-ASD) score, at three months. Within subject difference between the placebo condition and the whole plant extract condition.

  This is a 24-item parent-rated measure of noncompliant behavior in children with ASD

  At onset of each treatment period, at 1 month, 2 months and 3 months (end of treatment period)

• Clinical Global Impression-Improvement scores (CGI-I ) at three months. Within subject difference between the placebo condition and the whole plant extract condition.

  This is a 7-point scale designed to measure overall improvement from baseline (CGI-I).

  At 3 months (end of treatment period)

Secondary Outcomes (4)

• Clinical Global Impression-Improvement scores (CGI-I ) at three months. Within subject differences between the placebo condition and the pure cannabinoids condition and between the whole plant extract condition and the pure cannabinoids condition.

  At 3 months (end of treatment period)

• Change in Social Responsiveness Scale scores-2 (SRS-2, parent and teacher rated) at three months

  At onset of each treatment period and at 3 months (end of treatment period)

• Change in Autism Parenting Stress Index (APSI) score, at three months

  At onset of each treatment period, at 1 month, 2 months and 3 months (end of treatment period)

• Change from baseline Home Situations Questionnaire-Autism Spectrum Disorder (HSQ-ASD) score, at three months.

  At onset of each treatment period, at 1 month, 2 months and 3 months (end of treatment period)

Other Outcomes (1)

• Modified Liverpool Adverse Events Profile (LAEP)

  At onset of each treatment period, at 1 month, 2 months and 3 months (end of treatment period)

Study Arms (3)

Cannabinoids - 99% pure cannabinoids mix

EXPERIMENTAL

Oral cannabinoids mix \[cannabidiol (CBD), Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio\] at 1 mg/kg cannabidiol per day, up-titrated until intolerance or to a maximum dose of 10 mg/kg CBD per day, divided to 3 daily doses, for 3 months.

Drug: Cannabinoids - 99% pure cannabinoids mix

Placebo

PLACEBO COMPARATOR

Oral olive oil and flavors that mimic in texture and flavor the cannabinoids' solution.

Drug: Placebo

Cannabinoids - whole plant extract

EXPERIMENTAL

Oral cannabinoids mix \[cannabidiol (CBD), Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio\] at 1 mg/kg cannabidiol per day, up-titrated until intolerance or to a maximum dose of 10 mg/kg CBD per day, divided to 3 daily doses, for 3 months

Drug: Cannabinoids - whole plant extract

Interventions

Cannabinoids - 99% pure cannabinoids mix DRUG

99% pure cannabidiol (CBD) and 99% pure Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio (B.O.L Pharma, Israel), in a 160/8.0 mg per mL (CBD/THC) olive oil-based solution.

Cannabinoids - 99% pure cannabinoids mix

Placebo DRUG

Olive oil and flavors solution.

Placebo

Cannabinoids - whole plant extract DRUG

Whole plant extract enriched with cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC) to achieve 20:1 ratio (B.O.L Pharma, Israel), in a 160/8.0 mg per mL (CBD/THC) olive oil-based solution.

Cannabinoids - whole plant extract

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ASD diagnosis (Diagnostic and Statistical Manual of Mental Disorders \[Fifth Edition; DSM-V\]
• Moderate or greater behavioral problems as measured by a rating of moderate or higher (≥4) on the Clinical Global Impression-Severity (CGI-S)

You may not qualify if:

• Planned changes in existing interventions for the duration of the trial or such a change in the last 4 weeks.
• Current treatment with cannabis based therapy or such a treatment in the last 3 months.
• Heart, liver, renal or hematological disorders
• History of psychotic disorder in a first degree relative.

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Related Publications (1)

• Aran A, Harel M, Cassuto H, Polyansky L, Schnapp A, Wattad N, Shmueli D, Golan D, Castellanos FX. Cannabinoid treatment for autism: a proof-of-concept randomized trial. Mol Autism. 2021 Feb 3;12(1):6. doi: 10.1186/s13229-021-00420-2.

  PMID: 33536055 DERIVED

MeSH Terms

Conditions

Autistic Disorder

Interventions

Cannabinoids

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Adi Aran, MD

  Shaare Zedek Medical Center

  PRINCIPAL INVESTIGATOR

• Varda Gross

  Shaare Zedek Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Neuro-pediatric unit

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 7, 2016
• Study Start: January 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 27, 2018

Record last verified: 2018-12

Locations

IL (1)