Cannabinoids for Behavioral Problems in Children With ASD (CBA)
ClinicalTrials.gov Identifier : NCT02956226
Recruitment Status : Completed
First Posted : November 7, 2016
Last Update Posted : December 27, 2018
https://clinicaltrials.gov/ct2/show/NCT02956226?term=cannabidiol&cond=Autism+Spectrum+Disorder
Sponsor : Shaare Zedek Medical Center
Information provided by (Responsible Party) : Dr. Adi Aran, Shaare Zedek Medical Center
Study Description
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 mixDrug: PlaceboDrug: Cannabinoids – whole plant extract |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual 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 |
| Actual Primary Completion Date : | October 2018 |
| Actual Study Completion Date : | December 2018 |
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures :
- 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
- 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 :
- 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
- 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
- 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.
- 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 :
- 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.
| 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.