The federal Food and Drug Administration has given the Yale School of Medicine and medical marijuana supplier CT Pharma approval to begin a human drug trial that will study the effectiveness of marijuana-based medicine.
Yale University School of Medicine’s Dr. Rajita Sinha is the lead investigator for the clinical trial. She hopes the results will yield true scientific answers to a host of questions about medical marijuana.
“How does it work, who does it work for, and what doses do you need?” she said during a news conference about the trial. “Which symptoms can be alleviated, and is there a need for refinement? There are so many questions.”
Sinha said the study will focus on the effectiveness of cannabinoid medicine at alleviating stress and pain symptoms.
The trial will be the first of its kind on human subjects, according to CT Pharma, based in Portland, Connecticut. Researchers will use a double-blind, placebo controlled method, in which one group will be given an oral tablet of medical marijuana provided by CT Pharma, while the other group will receive a placebo.
CT Pharma board chair Michael Fedele, who served as the state’s lieutenant governor from 2007 to 2011, told reporters he hopes the study will yield the first FDA-approved marijuana-based medicine to be manufactured in the United States.
“Right now, a company in England has the only FDA-approved, plant-based medical marijuana product in our market,” he said. “That really shouldn’t be the case with respect to American companies.”
Cori Alicea, who has stage 4 glioblastoma — a type of brain cancer — has been a medical marijuana patient since 2014. Monday, she said she welcomes the study.
“It has helped me with every physical ability that I have,” she said. “My right side was completely numb from having the seizures and the surgeries. This medicine has made it so I’m able to live my daily life. It’s exciting to see all of the progress, and I just hope to help others.”