It is an interesting time to be a biomedical researcher in Colorado. In 2000, voters in the state made it legal to sell marijuana for medical use in adults; then in 2014, recreational marijuana was legalized for those over 21. For many years, some Colorado families who struggle to control their child’s epileptic seizures used cannabidiol, or CBD, as a medical treatment. (CBD is a naturally occurring cannabinoid constituent of cannabis that is non-intoxicating.) In addition, just a few months ago, the Food and Drug Administration approved the very first cannabidiol prescription drug, Epidiolex, the use of which is limited to two rare forms of childhood epilepsy.
Yet researchers understand very little of how CBD is absorbed in the body, distributed and metabolized—in other words, the pharmacokinetics of it. Human studies on the efficacy of CBD on epilepsy are few and limited. And because physicians know that a significant number of Colorado children with epilepsy regularly use CBD oil, there is an enormous need and an opportunity to study it.
Enter Dr. Sam Wang, emergency medicine physician at Children’s Hospital Colorado, and principal investigator of an observational study on Cannabidiol (CBD) and Pediatric Epilepsy, that has been taking place in the CCTSI’s Pediatric Clinical and Translational Research Center (CTRC) since 2015.
“We have been enrolling children with seizures or epilepsy who are using CBD oils for their seizures. We are trying to determine how CBD is absorbed, distributed and metabolized in children,” says Dr. Wang. “They come in for a 10-hour stay where they get blood draws; we determine CBD concentrations and look at the interactions with other anti-seizure medications.”
Wang says the study is observational for several reasons. Rules on the use of marijuana on the Anschutz Medical Campus, which includes Children’s Hospital Colorado, are very tightly regulated. Therefore, the easiest and most real-world applicable way to do the research is to assess the CBD the pediatric patients are already taking. Participants take the CBD oil before they arrive on campus. “We measure it while they are here, getting data about how it is processed in these children so we can get an idea of how it behaves in the child’s body,” Wang says.
The study just stopped enrollment, and is now in the analysis phase. Wang and his team have another six to nine months to complete the assays and analysis, and perform the analytic work and writing. In this phase of the research, Wang is collaborating with pharmacists, the ic42 toxicology lab and the department of neurology.
“From a medical perspective, it is important to get more data on CBD oil. What we learn will be so important for those who are using it,” Wang says. “Right now kids are on a lot of different doses, frequencies, and there is not a lot of data behind how they should be taking it, and if it may be affecting other drugs.”
Perhaps most significantly, CBD oils have not been studied for safety or efficacy. He says that we need to better understand the risks and potential benefits associated with CBD oil use, including the pediatric population. The presence of the Pediatric CTRC and its research nursing staff at Children’s Hospital Colorado allows for the performance of these important studies.