The Effects of Cannabidiol (CBD) on Symptoms of Severe Autism (PI: Doris Trauner, MD)

This clinical trial will examine if and how cannabidiol (CBD), a chemical found in the cannabis plant, provides therapeutic benefit to children with severe autism spectrum disorder (ASD). The trial, scheduled to launch in approximately one year, 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.

ASD affects an estimated one in 68 children in the United States, primarily boys. CBD is a major chemical compound found in cannabis. It does not produce the “highness” caused by THC but interacts with the body’s endocannabinoid system; a network that regulates diverse physiological and cognitive processes.

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 will consist 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.

In the first phase of the study, half the children will receive an oral dose of CBD and half placebo. In the second phase, the groups will be switched and the half who originally received CBD will receive placebo, while the initial placebo group will receive CBD. Investigators will be blinded to which children are receiving which treatment until after all of the testing is completed at the end of the study.

For more information about the CMCR, click here.

The study will not begin until the end of the year. Click here to sign up to receive information when the study is getting closer to beginning.

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