The Food and Drug Administration (FDA) has approved a first-of-its-kind human trials study by the Yale School of Medicine in conjunction with CT Pharma that will investigate the effectiveness of cannabis-based medicines.
CTPharma, US based company CTPharma that supplies cannabis products to dispensaries recently announced that it is collaborating with researchers at Yale University on a federally approved study of CBD and THC as treatments for pain and stress.
This appears to be the first time that the Food and Drug Administration (FDA) has signed off on a medical study involving U.S.-grown cannabis from a source other than the National Institute on Drug Abuse (NIDA), heretofore the only legal supplier of marijuana for research in the country.
The Drug Enforcement Administration (DEA), which for years refused to license additional suppliers of marijuana, changed its mind in 2016, the last year of the Obama administration when it announced that it would start accepting applications from would-be growers.
As of August, the DEA had received 33 applications, but so far it has not granted any licenses.
CTPharma is not licensed by the DEA to produce marijuana. In fact, its entire operation, like that of every other state-licensed marijuana supplier, remains illegal under the federal Controlled Substances Act. It is therefore rather surprising that Yale researchers were allowed to use CTPharma’s products—specifically, tablets containing plant-derived CBD and THC—in an FDA-approved Phase I clinical trial.
“All the formulations are in tablet form,” stated CTPharma COO Rino Ferrarese.
“The FDA wanted very specific formulations.”
The study will be conducted at the Yale Stress Center, which is part of the university’s medical school.
Ferrarese said the DEA would not let a pharmacist at Yale dispense the tablets but withdrew its objections after the researchers proposed a different plan: The subjects will pick up their tablets at Affinity Health & Wellness, and bring them to Yale for the study.
The first stage of the study involves recreational cannabis consumers who will be randomly assigned to receive either placebos or various doses of CBD, sometimes in combination with THC, over a six-week period.
The second stage involves people with chronic pain. The researchers will record subjective drug effects, stress and pain ratings, heart rate, blood pressure, and blood levels of CBD, THC, and their metabolites.
Depending on what they find, the researchers may decide to include subjects with other conditions, such as post-traumatic stress disorder.
“With increasing levels of use of medical marijuana products in the U.S. today,” lead researcher Rajita Sinha, a Yale professor of psychiatry and neurobiology, said that “it is imperative that we understand the science of how these products are working to alleviate patient symptoms.”