The Food and Drug Administration has granted approval to the Yale School of Medicine and CT Pharma for human drug trials to study the efficacy of cannabis-based medicines, according to a Connecticut Public Radio report. The study will be the first with FDA approval to test cannabis on human subjects.
Yale University School of Medicine’s Dr. Rajita Sinha, the lead researcher for the clinical trial, said the studies will attempt to figure out how medical cannabis works, who it works for, what symptoms can be alleviated, dosages, and whether there is “a need for refinement.”
Michael Fedele, board chair of the Portland, Connecticut-based CT Pharma, told CPR that he hopes the study will result in the first FDA-approved cannabis-based medicine to be manufactured in the U.S.
“Right now, a company in England (GW Pharma) has the only FDA-approved, plant-based medical marijuana product (Epidiolex) in our market. That really shouldn’t be the case with respect to American companies.” – Fedele, via CPR
According to the FDA, the agency “is aware that there is considerable interest in the use of marijuana to attempt to treat a number of medical conditions” and does support “research into the medical use of marijuana and its constituents through cooperation with other federal agencies involved in marijuana research.”
According to a Hartford Business Journal report, Yale indicated the first phase will examine men and women between the ages of 21 to 45 who use cannabis recreationally but do not qualify for medicinal use. The second phase will focus on men and women ages 21 to 60 with chronic pain. Each participant will receive a placebo, CBD and THC. Side effects such as vital signs of heart rate, systolic and diastolic blood pressure and clinical symptoms will be assessed.
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