Thomas R. Collins is a freelance medical writer based in Florida.
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September 2019Simple Study Not So Simple When It’s Marijuana
After noticing that patients who said they used marijuana seemed to do better with radiation and chemotherapy than those who did not, Rafi Kabarriti, MD, a rare researcher doing work involving marijuana and otolaryngology, thought it was time to collect some hard data on the topic. He wanted to see how easy it was for patients to obtain and stay on a dosing plan for medical marijuana and how it affected the tolerability of their chemoradiation.
It proved to be a much more challenging process than any other trial on which he has worked. “This one took three to four times the effort,” said Dr. Kabarriti.
He preferred to randomize patients to either receive New York State-approved medical marijuana or not, but that was not feasible. The only way to randomize would be to obtain medical marijuana from the National Institute on Drug Abuse, a process that can take years, he said. So, he settled for a pilot study of just 30 patients, with no randomization.
Also, because marijuana is classified as a Schedule I drug—meaning that, in the eyes of the federal government, it has “no currently accepted medical use and a high potential for abuse,” the same category as heroin, LSD, and ecstasy—he wouldn’t be able to dispense any medical marijuana on site, and no university personnel could do any of the dispensing regardless. Instead, university researchers had to collaborate with pharmacists at dispensaries outside their institution, confirming with them that patients were in fact obtaining and taking their medical marijuana in tincture or pill form. They settled on those forms to avoid the possible side effects of smoking or vaping.
“We had multiple hurdles to be able to get our trial up and started,” he said. “It was a big challenge, but we were persistent, and that’s why we’re probably one of the few ones in the country to have it [a medical marijuana study] open.”
It’s no wonder so few clinical studies are being performed on medical marijuana, even as public interest in medical marijuana and CBD skyrockets.
After a large-scale review of the available literature on cannabis and its cannabinoids, the National Academies of Science, Engineering, and Medicine urged public, philanthropic, private, and clinical research groups to support cannabis research, and urged federal authorities to develop research standards and benchmarks to produce high-quality research.