The US Food and Drug Administration (FDA) has just given the Yale University School of Medicine approval to begin clinical trials that could pave the way for the first American-made cannabis-based treatment for pain and stress.
The new study, which was also approved by the Connecticut Department of Consumer Protection, will research how different strains of medical cannabis could be used to alleviate chronic pain or stress. The study may also explore how and if pot can help treat other conditions like PTSD, or to help individuals wean themselves off of opioids. This is one of the first FDA-approved double-blind studies on medical marijuana to be conducted on humans.
Rather than relying on the low-quality “ditch weed” that the US government provides to researchers, Yale will be partnering with CT Pharmaceutical Solutions Inc., a medical cannabis producer based in Portland, Connecticut. CT Pharma has been working on this study in partnership with Yale's Dr. Rajita Sinha since 2016, but it's taken three years to receive all of the necessary regulatory approvals to begin the trial.
“With increasing levels of use of medical marijuana products in the US today, it is imperative that we understand the science of how these products are working to alleviate patient symptoms,” said Sinha in a press release, according to the Hartford Business Journal. The new study intends to explore “how medical marijuana may alleviate pain and stress symptoms and contribute to developing new cannabinoid based treatments.”
In the first phase of the trial, researchers will recruit recreational cannabis users between the ages of 21 and 45 who do not qualify for Connecticut's medical marijuana program. In the second phase, the subject pool will include adults aged 21 to 60 who are suffering from chronic pain. Subjects in both phases of the trial will randomly receive either THC, CBD, or a placebo. In addition to observing the effects of these cannabinoids on pain and other conditions, researchers will monitor the subjects' heart rate, blood pressure, and other vital signs.
Gallery — These Athletes Believe in the Power of Medical Cannabis
CT Pharma board chair Michael Fedele said that if these trials are successful, his company intends to bring this new cannabis medicine to market in the US.
“Right now, a company in England has the only FDA-approved, plant-based medical marijuana product in our market,” said Fedele, according to the Connecticut Mirror. “That really shouldn’t be the case with respect to American companies.”
The first cannabis drug to be approved by the FDA, the anti-epilepsy drug Epidiolex, is made by UK company GW Pharmaceuticals.
In order to approve the drug for the US market, the FDA would require another round of trials, which could take another 3 to 7 years. But if all of these trials succeed, doctors anywhere in the US would be legally able to prescribe this cannabis product to their patients, even in states that do not have medical marijuana programs.