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Trial record 1 of 1 for:    cannabidiol | Autism
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Cannabinoids for Behavioral Problems in Children With ASD (CBA)

This study is currently recruiting participants.
Verified June 2017 by Dr. Adi Aran, Shaare Zedek Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02956226
First Posted: November 7, 2016
Last Update Posted: June 27, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Adi Aran, Shaare Zedek Medical Center
  Purpose
This study aims to assess the safety, tolerability and efficacy of cannabinoids mix [cannabidiol (CBD), Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio] for behavioral problems in children and youth with ASD.

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

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Dr. Adi Aran, Shaare Zedek Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Change in Clinical Global Impression scores (CGI, improvement and efficacy index items) at three months [ Time Frame: At onset of each treatment period and at 3 months (end of treatment period) ]
    This is a 7-point scale designed to measure severity of illness (CGI-S), overall improvement from baseline (CGI-I) and the drug effects (both therapeutic effect and side effects, CGI-D).

  • 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

  • Comparison between Child Behavior Checklist (CBCL)- externalizing section score and 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) ]
    The CBCL generates 3 broad band results—an internalizing score (summing up anxious/depressed scale, somatic complaints scale and withdrawn scale) an externalizing score (summing up non-compliant scale and aggressive behavior scale) and a total score. For this study we will use the externalizing section only.

  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: January 2017
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

Disruptive behaviors are very common in children and youth with autism spectrum disorder (ASD). Behavioral problems increase social impairment in children with ASD, make interventions more difficult and place considerable strain on families and caregivers. Current treatment is based on behavioral interventions combined with atypical antipsychotics which often have low tolerability and questionable efficacy.

Cannabis exerts profound effects on human social behavior. Research using animal models of ASD indicate a possible dysregulation of the endocannabinoid system, and stress that it may be a novel target for pharmacological interventions. Anecdotal evidence suggest efficacy of various phytocannabinoids in resistant behavioral problems. However controlled human studies are lacking.

Objective: To assess the safety, tolerability and efficacy of cannabinoids mix [cannabidiol (CBD), Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio] for behavioral problems in children and youth with ASD.

Setting: A double blind randomized placebo-controlled trial with crossover. Methods: One hundred and twenty participants ages 6-30 years, with established ASD diagnosis and moderate to severe refractory behavioral problems will be treated with placebo and cannabinoids mix in a randomized cross-over trial. Each intervention period will be 12 weeks with additional 4 weeks for gradual dose decrease and wash-out. Baseline evaluations will include: Autism diagnostic observation schedule (ADOS-2), Social Communication Questionnaire (SCQ), Vineland II (interview based), Childhood Autism Rating Scale (CARS-2, observation based). Primary outcome measures: Home Situations Questionnaire-Autism Spectrum Disorder (HSQ-ASD), Child Behavior Checklist (CBCL, parent-rated), and Autism Parenting Stress Index (APSI) will be assessed every 4 weeks. Secondary outcome measures: Clinical Global Impression (CGI, improvement and efficacy index items, clinician-rated) and Social Responsiveness Scale (SRS, parent and teacher rated) will be assessed at baseline and termination of each treatment period. Adverse events will be taped every 4 weeks.

  Eligibility

Information from the National Library of Medicine

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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.
  Contacts and Locations
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


Contacts
Contact: Sara Shaked 972-26555414 neuropedm@szmc.org.il
Contact: Nava Badichi 972-26666239 navabad@szmc.org.il

Locations
Israel
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel
Contact: Nava Badichi    97226666239    navabad@szmc.org.il   
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
  More Information

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 Submitted: November 1, 2016
First Posted: November 7, 2016
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Autistic Disorder
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
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists