Trial of Cannabidiol to Treat Severe Behavior Problems in Children With Autism
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 behaviors and severe hyperactivity. This study is being conducted to determine whether cannabidiol can reduce any or all of these problem behaviors.
A Double-Blind, Crossover Trial of Cannabidiol to Treat Severe Behavior Problems in Children With Autism
Children with autism spectrum disorders (ASD) may have severe behavior problems, including aggression, self-injurious behaviors, severe and persistent stereotypic behaviors, and extreme hyperactivity, which limit their ability to function socially and academically and are often disruptive to family life as well. 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 study will use EPIDIOLEX (EPX), a purified CBD oral solution that was FDA approved in June 2018 to treat severe forms of pediatric epilepsy. Study subjects will be 30 boys between 7 and 14 years of age with autism who have severe behavior problems. Every child will undergo baseline clinical evaluation, neuropsychological, behavioral, cognitive, and language testing, will have a test of brain wave activity (EEG) and a brain MRI scan. parents will complete questionnaires on various aspects of their child’s behavior. Fifteen children will receive CBD for 8 weeks and 15 will receive a placebo that looks and tastes similar to the CBD (Period 1). All of the baseline tests and questionnaires will then be repeated. After a 4 week washout period, behavioral and cognitive tests and questionnaires will be repeated and then the treatments will be reversed (Period 2). At the end of 8 weeks, all of the baseline tests and questionnaires will be repeated. Study personnel and parents will be blinded to the treatment status of each child. Statistical analyses will be used to determine whether there are significant differences between baseline testing and results after placebo or CBD treatment. Types and severities of adverse events will be tracked to provide information about the safety and tolerability of CBD in this population. If CBD is found to be safe and effective in treating the behavioral problems associated with autism, this would be a major new tool in the treatment of those children that could lead to improved functioning and quality of life for the affected individuals and their families.
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CBD For Autism
Supporting someone with Autism is a struggle for millions of people every day. CBD for Autism may help control difficult behaviors, symptoms and give the people who are diagnosed with Autism a chance to live a more normal and productive life.
What Is Autism?
Autism spectrum disorder (ASD) is a developmental disorder characterized by difficulty with communication, socialization, and behavior control. According to the CDC, ASD is diagnosed in an average of one in every 54 American adults with the rates increasing yearly. Autism is known as a spectrum disorder because it can manifest in a number of different forms, with varying levels of severity. Some people diagnosed with Autism have intense interests and difficulty making social connections; others are nonverbal through adulthood and present with an amplified reaction to outside stimulation.
Some of the primary characteristics of Autism include:
- Delayed language and verbal abilities
- Difficulty making and maintaining eye contact
- Engaging in repetitive behavior
- Intensity involving personal interests
- Sensitivity to sensory stimuli
- Lack of emotional awareness
- Engaging in impulsive or compulsive behavior
There is no genetic or lab testing available to diagnose ASD. Instead, developmental screening and evaluation is used to determine whether the individual may be somewhere on the Autism spectrum, as well as how to best treat them.
Why CBD may help Autism.
CBD for Autism are connected largely through the endocannabinoid system, the network in the human body that, among other things, regulates the way the body responds to sensory stimuli. It essentially acts as a pathway between the mind and body. In people with ASD, the link between their disorder and the endocannabinoid system might be a valuable connection for Autism researchers to explore. CB receptors, which interact with cannabinoids on a cellular level, are in cell membranes all over the body.
Another recent study showed CBD to be effective in mice displaying the social symptoms of Autism. Mice without the characteristics of ASD showed a strong preference for interacting with other mice over nearby inanimate objects, while mice who did present with the social characteristics of Autism were indifferent.
While studying the link between CBD for Autism, researchers administered a dose of CBD to some of the mice who were less enthusiastic about social interaction. In short time, they became much more socially involved after being treated with CBD. Because the medical community is loath to perform clinical trials to explore the benefits of connecting CBD for Autism for humans, only a few trials are currently in progress.
What Products Work Best
People on the Autism spectrum can use CBD and it may help with symptoms of their ASD. Products to use can include brownies infused with CBD, as well as treats like cookies, or muffins. Specially infused honey sticks are also available as a deliciously sweet way to help Autism symptoms with CBD. CBD for Autism drinks are also a popular choice. CBD oil can be used to mix up a batch of infused treats like tea (hot or iced), lemonade, soda, and juice.
CBD capsules may be a quick and easy choice. There are also CBD pills on the market, that can be taken along with any other medications or supplements. Tinctures are also an option but do taste more unpleasant. CBD Oils and CBD lotions can also be used topically for any issues related to skin picking. They can also ease muscular pain.
Finding the right dosage for CBD for Autism can be challenging. Each individual has their own level of dosage that works therapeutically for them and finding it can largely be a matter of trial and error. As a baseline measure, it’s worth noting that during a recent study assessing the link between Autism and CBD, participants were given a dose of 10 mg (though it’s unclear how often the CBD dose was administered). Most medical professionals advise starting at 10 mg two or three times per day and assess symptoms for two weeks. If unimproved, each dosage can be raised to 15 or even 20 mg.