Researchers from UC San Diego are currently planning a clinical trial to determine how effectively cannabidiol (CBD) can treat symptoms of severe autism in children. The goal of the study “is to determine whether CBD reduces the problem behaviors that we see in children with severe autism,” Dr. Doris Trauner reportedly said.
Trauner is the study’s principal investigator. She is also a pediatric neurologist and professor of neuroscience at UCSD’s School of Medicine.
Trauner told local media that the study will target behaviors that “are specifically aggressive behaviors, self-injurious behavior [and] persistent repetitive behaviors, what are called stereotypic behaviors.” This reportedly could include shaking or other repetitive movement that “interferes with their ability to function.”
“What we’re trying to identify is whether CBD reduces the problem with behaviors and then, in turn, whether that could improve their ability to function,” Trauner reportedly said.
How the study works
Researchers intend to identify this by giving participants either CBD or a placebo to take orally every day for eight weeks. Then, the participants will have a four-week break. Following the break, the participants who took the CBD will take the placebo, and the participants who took the placebo will take the CBD.
It is a double blind study, which means that the researchers, children and parents do not know when a participant has been provided CBD and when they have been provided the placebo. Only the study’s research pharmacist will know when each child is taking the CBD.
“Everyone will be taking CBD, but they won’t know when,” Trauner said.
Boys and girls will participate separately
As exciting as this research is, the study is still in the planning phase. Currently, researchers are looking for 30 boys ages 7-14 who have autism spectrum disorder.
At the moment, only boys are needed for the study. Researchers plan to have a second phase of the study for girls. Trauner reportedly explained that girls on the spectrum tend to have different symptoms than boys on the spectrum have.
“The feeling was that if we did a study that included boys and girls together and looked at the same endpoints, we might not see what the benefit would be because I think there are different endpoints for the girls than there are for the boys,” she reportedly explained.
Additional safety measures
Once the study’s participants are found, they must undergo several tests to determine how severe their autism symptoms are before the study begins. These preliminary tests include an autism diagnostic screen, language testing, a nonverbal IQ test and an MRI scan of the brain. In addition, parents will reportedly be asked to fill out questionnaires about their children’s behaviors.
While the study is underway, the children will continue to be monitored for any potential side effects or toxicity. They will receive regular medical exams, electrocardiograms and blood tests.
This is important to ensure the safety of the participants but also to address a legitimate concern that could affect the success of CBD as a treatment option. Reportedly, the few drugs that have already been approved to treat severe autism do have side effects, and some of these side effects can be harsh. Parents and doctors must be aware of the long-term side effects of any autism treatment because a child may need to take it for many years or even throughout their lifetime.
Trauner reportedly said that she hopes CBD can help reduce some of the more debilitating symptoms associated with autism “to allow the children to be more socially available.”
“I’m really excited about the study,” she reportedly added. “If we can show that for the majority of children it has a significant benefit, it would be a whole new area [of] very exciting treatment.”