CTPharma, a Connecticut company that supplies cannabis products to dispensaries under that state’s medical marijuana program, 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 this country.
Researchers have long complained about the quality and variety of Uncle Sam’s cannabis, which is grown at the University of Mississippi under an exclusive contract with NIDA. They have also noted that NIDA marijuana cannot be used for commercial purposes, which means it cannot be used in Phase III clinical trials, the last step before FDA approval of a new medicine. The drug that subjects take at that stage has to be the same as the drug that will be sold to patients once the medication is approved.
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. But under the Trump administration, the DEA has dragged its feet in fulfilling that promise. As of August, Mike Riggs noted, 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,” says 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 says 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, a dispensary in New Haven, and bring them to Yale for the study.
The first stage of