The University of California San Diego (UCSD) Center for Medicinal Cannabis Research received a $4.7 million grant in April 2018 that may help shed some light on whether cannabidiol can help alleviate the symptoms of severe autism in children.
“It’s potentially extremely important … there really are very limited options for treating those negative behaviors for children with severe autism,” said Dr. Doris Trauner, a pediatric neurologist at UCSD’s School of Medicine and lead investigator for the study. “It’s got huge implications.”
An estimated one in 68 children in the United States are affected by autism spectrum disorder, according to the Center for Medicinal Cannabis Research (CMCR) website. The Linden, Utah-based Ray and Tye Noorda Foundation awarded the private gift to the CMCR in April based on recommendations from the Wholistic Research and Education Foundation, a San Diego-based nonprofit with a focus of exploring the health benefits of CBD, according to the CMCR.
With cannabis currently listed as a drug deemed to have no medicinal benefitson the federal level, research has been limited.
“It’s made it extremely difficult because it is Schedule I,” said Trauner. “It requires a very rigid monitoring, and very rigid procedures. … It has made the research extremely difficult to do.”
And the lack of funding sources increases those challenges as well.
“It’s the first study of this type,” said Trauner.
The study, which Trauner said will begin in about nine to 12 months, has three key goals. The first is to determine whether CBD is safe for use in autistic children, and whether it can help relieve symptoms in severe cases.
The three symptom categories the researchers will look at are: self-injurious behaviors, where children hurt themselves through scratching, biting and other harmful behavior aggression toward others by hitting, spitting, biting, and other actions; and severe stereotypic, or repetitive, behaviors that can include spinning around or flapping their hands repeatedly, according to Trauner. The researchers will be looking for 30 children from ages 8 to 12 with moderate to severe autism who have severe behaviors in one or more of the three symptom categories.
“The most important, immediate issue is whether CBD helps to improve the functioning of the child,” she said.
She said some animal studies have shown that CBD can improve social reward responsiveness, reduce anxiety, enhance certain neurotransmitter receptors and increase serotonin availability – essentially helping reduce symptoms of autism. There have also been anecdotal reports of improvements seen in children after CBD use.
“All of those have led to the idea that CBD may be effective in treating the symptoms of autism,” said Trauner.
She said there was also a recent retrospective study of children with autism who were treated with CBD. Some improvement in various behaviors were noted, she said.
However, she added, “It wasn’t controlled. It wasn’t looking at any objective measures … it’s a nice first pass at providing some information but it needs to be followed up with a very good carefully controlled study.”
The new study will also look at whether and how CBD affects certain neurotransmitters. Researchers will do this by studying brain wave activity, as well as imaging the brain by using magnetic resonance spectroscopy. The third study goal is to determine whether biomarkers of neuro-inflammation are affected by CBD – in other words, whether there is a change in the immune system, said Trauner.
“We’re looking at markers of inflammation of the blood,” she said, adding that one study doctor will be looking at skin biopsies from the children to determine whether those cells change in regards to inflammation with the use of CBD.
The study will use synthetic 100 percent CBD without any THC.
“I thought it was important to start with pure CBD to see what it affect it has,” said Trauner, adding that if it works, then a future study may look at a combination of CBD and THC. “That’s totally depending on what we find with the initial study.”
The multidisciplinary study will use a double-blind crossover protocol, meaning the children will be given CBD or a placebo for 12 weeks, then the doses will be flipped for 12 weeks..
“Neither the parents nor the people testing them will know which they’re on … this takes away the subjectivity,” she said. “It’s a really important way to do a study like this, because you want to try and minimize bias as much as possible.”