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Cannabinoids for Behavioral Problems in Children With ASD (CBA)

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ClinicalTrials.gov Identifier: NCT02956226
Recruitment Status : Active, not recruiting
First Posted : November 7, 2016
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Adi Aran, Shaare Zedek Medical Center

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.

Condition or disease Intervention/treatment Phase
Autistic Disorder Drug: Cannabinoids - 99% pure cannabinoids mix Drug: Placebo Drug: Cannabinoids - whole plant extract Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cannabinoids for Behavioral Problems in Autism Spectrum Disorder: A Double Blind, Randomized, Placebo-controlled Trial With Crossover.
Study Start Date : January 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cannabinoids - 99% pure cannabinoids mix
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
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.

Placebo Comparator: Placebo
Oral olive oil and flavors that mimic in texture and flavor the cannabinoids' solution.
Drug: Placebo
Olive oil and flavors solution.

Experimental: Cannabinoids - whole plant extract
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
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.




Primary Outcome Measures :
  1. 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. [ Time Frame: At onset of each treatment period, at 1 month, 2 months and 3 months (end of treatment period) ]
    This is a 24-item parent-rated measure of noncompliant behavior in children with ASD

  2. Clinical Global Impression-Improvement scores (CGI-I ) at three months. Within subject difference between the placebo condition and the whole plant extract condition. [ Time Frame: At 3 months (end of treatment period) ]
    This is a 7-point scale designed to measure overall improvement from baseline (CGI-I).


Secondary Outcome Measures :
  1. 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. [ Time Frame: At 3 months (end of treatment period) ]
    This is a 7-point scale designed to measure overall improvement from baseline

  2. Change in Social Responsiveness Scale scores-2 (SRS-2, parent and teacher rated) at three months [ Time Frame: At onset of each treatment period and at 3 months (end of treatment period) ]
    This is a 65 item, caregiver (pSRS) or teacher (tSRS) questionnaire, used to determine the severity of social deficit exhibited by participants with ASD. The SRS contains five subscales: Social Awareness, Social Cognition, Social Communication, Social Motivation, and Autistic Mannerisms, which respectively measure the ability to recognize social cues, the ability to interpret social cues, the ability to use expressive verbal and nonverbal language skills, the ability to engage in social-interpersonal behaviors, and the tendency to display stereotypical behaviors and restricted interests characteristic of autism

  3. Change in Autism Parenting Stress Index (APSI) score, at three months [ Time Frame: At onset of each treatment period, at 1 month, 2 months and 3 months (end of treatment period) ]
    This is a 13-item parent rated measure designed to assess the effect of interventions to control disruptive behavior in children with ASD on parenting stress.

  4. Change from baseline Home Situations Questionnaire-Autism Spectrum Disorder (HSQ-ASD) score, at three months. [ Time Frame: At onset of each treatment period, at 1 month, 2 months and 3 months (end of treatment period) ]
    This is a 24-item parent-rated measure of noncompliant behavior in children with ASD. Within subject differences between the placebo condition and the pure cannabinoids condition and between the whole plant extract condition and the pure cannabinoids condition.


Other Outcome Measures:
  1. Modified Liverpool Adverse Events Profile (LAEP) [ Time Frame: At onset of each treatment period, at 1 month, 2 months and 3 months (end of treatment period) ]
    Tolerability and adverse effects will be assessed using this modified Liverpool Adverse Events Profile (LAEP) that includes all 19 items of the original LAEP and another 15 items to cover all reported significant side effects of CBD and THC in former studies.



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Ages Eligible for Study:   5 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: (both are needed)

  • 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)

Exclusion Criteria:

  • 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.

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): NCT02956226


Locations
Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Adi Aran, MD Shaare Zedek Medical Center
Principal Investigator: Varda Gross Shaare Zedek Medical Center

Responsible Party: Dr. Adi Aran, Director, Neuro-pediatric unit, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02956226     History of Changes
Other Study ID Numbers: CBA
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Autistic Disorder
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Problem Behavior
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Behavioral Symptoms
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists