The Effects of Cannabidiol (CBD) on Symptoms of Severe Autism

INVESTIGATORS: Doris Trauner, MD

STUDY LOCATION: University of California, San Diego

PROJECT TITLE: The Effects of Cannabidiol (CBD) on Symptoms of Severe Autism

FUNDING SOURCE: Wholistic Research and Education Foundation

PROJECT TYPE: Clinical Study

STATUS: PENDING

ABSTRACT:

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 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.

We anticipate that this study will begin enrollment within the next few months. Click here to sign up to receive information when the study is getting closer to beginning.

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Regulators hungry for evidence as FDA weighs allowing CBD in food, dietary supplements

Angelica LaVito, CNBC, May 31, 2019

Food and Drug Administration regulators grilled manufacturers and advocates Friday for evidence that CBD actually does anything they claim it does.

Companies are adding CBD, short for cannabidiol, to just about everything, including makeup, tea, pet treats and soft drinks — even though there's little data to support the many claims of its benefits. FDA regulators trying to learn more about the cannabis compound held the agency's first hearing on it Friday.

More than 100 people testified at the hearing. Speakers pushed the FDA to set up a regulatory framework to legally add CBD to food products and dietary supplements. They praised CBD and the purported benefits — and FDA panelists repeatedly asked for data. Scientists warned of the little research and many potential risks CBD brings.

Read the story here


Three years into legal cannabis and California still doesn’t have a reliable test for driving while high

Brooke Staggs, Orange County Register, May 31, 2019

Nearly three years after California voters approved a cannabis legalization bill that promised, among other things, to clarify the issue of driving while high, researchers and law enforcement have few concrete answers about a potentially deadly problem.

It’s unclear, for example, if marijuana-related arrests or car crashes have increased statewide. It’s up to each county to track that data, and many still don’t distinguish between cannabis and other drugs in their arrest and accident reports.

There also aren’t yet any reliable methods for testing whether drivers were actually impaired by marijuana when they’re behind the wheel. Research in this area is hampered by federal law and left scrambling to catch up with the wave of marijuana legalization that continues to sweep the country.

Read the rest of the article here


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