UC San Diego researchers that are based at the Center for Medicinal Cannabis Research are recruiting eligible participants in ages 7 to 14, to determine whether cannabidiol, an extract of cannabis, can reduce behavioral symptoms of severe autism spectrum disorder (ASD). The clinical trial is conducted in partnership with the Wholistic Research and Education Foundation.
Cannabidiol (CBD), a compound originally derived from the cannabis plant but without the psychoactive effects found in cannabis, has been shown to be safe and effective in the treatment of children with severe epilepsy. Two non-controlled studies using CBD from local sources have demonstrated improvements in behavior in children with autism. Parents of autistic children have been using CBD products in an unregulated fashion with unknown dosing with anecdotal reports of improved behavior.
This clinical trial of UC San Diego researchers examine if and how cannabidiol (CBD), provides therapeutic benefit to children with severe autism spectrum disorder (ASD). The trial is funded by a grant from the Ray and Tye Noorda Foundation in partnership with and based on recommendations from the Wholistic Research and Education Foundation.
The goals of the study are to determine
1) if CBD is safe and tolerable and whether it helps with the symptoms of ASD;
2) whether and how CBD alters neurotransmitters and/or improves brain connectivity; and
3) whether biomarkers of neuro-inflammation, also associated with ASD, are altered by CBD.
The clinical trial consists of 30 children, ages eight to 12 years, with a confirmed diagnosis of moderate to severe autism. They must be free of other neurological conditions, such as epilepsy, and in general good health.
This study will use EPIDIOLEX (EPX), a purified CBD oral solution that was FDA approved in June 2018 to treat severe forms of pediatric epilepsy.
In the first phase of the study, half the children receive an oral dose of CBD and half placebo. In the second phase, the groups are switched and the half who originally received CBD receives placebo, while the initial placebo group receives CBD. Investigators are blinded to which children are receiving which treatment until after all of the testing is completed at the end of the study.
The study an Estimated Primary Completion Date is on December 31, 2022 and
Estimated Study Completion Date scheduled on March 31, 2023
For more information on the CBD-autism clinical trial, contact Lauren Smith at lmsmith@ucsd.edu or 619-627-1133.