Children's Hospital of Philadelphia is pairing with an Australian biopharmaceutical company in what some advocates say could be the first major effort in the United States to study the effects of medical marijuana on children with autism.
Athena Zuppa, the director of the hospital's Center for Clinical Pharmacology, will lead a team researching current medical marijuana patients. The hospital will not provide any cannabis products to children.
"This is truly an observational study," Zuppa said. "We're not giving them anything. We're just gathering data to educate ourselves."
Research with children who are already covered under Pennsylvania's Safe Harbor provision is likely to begin in early 2018.
There is significant anecdotal evidence showing that cannabinoids, the active compounds in medical marijuana, can help with some of the symptoms of autism. Cannabis advocates say cannabinoids help improve social interaction and control repetitive behavior, and don't cause the side effects associated with antipsychotic drugs often given to autistic children.
The study at CHOP will build on data collected by the Australian company, Zelda Therapeutics, which is funding the research. Zelda, which completed another observational study on autism in Chile last year, is also set to start clinical trials in Australia to investigate the effectiveness of medical marijuana on chronic insomnia.
"For too long, patients and their families have been missing out on genuine therapeutic options with the potential to transform lives," Daniels said.
Zuppa said that little is known about how cannabis works in kids.
Standard drugs are marketed after going through a rigorous process by the FDA. Because the federal government considers marijuana to be a Schedule I drug, akin to heroin and LSD, there have been no clinical trials in the U.S. for any cannabis product.
One of the aims of the CHOP study will determine what parents in the region are giving their autistic children. Cannabidiol, known as CBD, is a substance in marijuana that, unlike THC, does not induce euphoria.
"We're trying to understand the landscape of what the kids are taking," Zuppa said. "Some kids are taking only CBD and some are taking a mixture of CBD and THC. I'm trying to understand how parents make their choices."
Pennsylvania's medical marijuana program is set to launch early next year.
For more information about the CHOP study, parents and caregivers can call 215-590-4924.