Status:
ACTIVE_NOT_RECRUITING
Trial of Cannabidiol to Treat Severe Behavior Problems in Children With Autism
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Wholistic Research and Education Foundation
Center for Medicinal Cannabis Research
Conditions:
Autism
Autism Spectrum Disorder
Eligibility:
MALE
7-14 years
Phase:
PHASE2
Brief Summary
There are very few treatments that are effective in reducing severe behavioral problems associated with autism. These behaviors include aggressive and self-harm behaviors, frequent repetitive behavior...
Detailed Description
Children with autism spectrum disorders (ASD) may have severe behavior problems, including aggression, self-injurious behaviors, severe and persistent stereotypic behaviors, and extreme hyperactivity,...
Eligibility Criteria
Inclusion
- Boys ages 7-14 years
- Confirmed diagnosis of autism based on ADOS testing
- Autism severity assessed as severe with substantial behavioral problems
- Severity of symptoms will be based on a number of criteria:
- Aggressive and/or self-injurious (SIBs) behaviors occur almost daily (more than 6 times per week) in any situation (home, school, clinic, etc.).
- Frequent (daily), persistent (lasting at least 5-10 minutes and repeated through the day) stereotypies (repetitive behaviors such as hand flapping, running in circles, jumping repeatedly, waving fingers in front of eyes)
- Pervasive hyperactivity (child is so physically active that he cannot sit for meals or school work, is moving all the time, jumping off furniture, climbing onto furniture, etc.)
- One of more of the above activities is deemed to contribute significantly to child's inability to function by parental report and with clinician agreement based on history and/or direct observation
Exclusion
- the presence of epilepsy
- a known genetic condition such as tuberous sclerosis
- other significant health issues such as cardiac disease, presence of known congenital brain malformation, or a history of central nervous system infection.
- children who are on anticonvulsant medications such as clobazam or valproic acid will also be excluded because of potential drug-drug interactions. At the time of screening, each child's medication list will be checked for drugs that are known to cause interactions with cannabidiol.
- children with an allergy to any components of the study drug
- children who are taking CBD from another source, unless parents are willing to stop the treatment for at least 4 weeks prior to entering the study. CBD and other cannabinoid blood levels will be performed at baseline and if CBD is detected in the blood, the child will be not be included in the study.
- children who might travel out of the area for a significant time during the study
- children who recently participated in another investigational drug trial may be excluded
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04517799
Start Date
June 1 2020
End Date
December 31 2025
Last Update
September 30 2025
Active Locations (1)
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1
University of California San Diego
La Jolla, California, United States, 92093