Marijuana’s medicinal benefits are undeniable, now demonstrated by decades of studies published in highly respected medical journals and there is a plethora of scientific research establishing its safety and efficacy, the federal government and federal agencies are blocking the clinical trials necessary to turn the marijuana plant into an FDA-approved prescription drug. Many state legislatures have sidestepped the FDA, permitting the use of marijuana and CBD for medical conditions with physician “approval.” Eleven states and Washington, DC, have now legalized marijuana for recreational use for adults over 21. and 33 states have legalized medical marijuana.
America has finally modernized its attitude towards cannabis. 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.
The study will be the first with FDA approval to test cannabis on human subjects.
A Portland company, CT Pharma, that supplies cannabis products to dispensaries under that state’s medical marijuana program, has announced it’s collaboration with researchers at Yale on a federally approved study of cannabinoids for treatment of of pain and stress – specifically THC and CBD in tablet form.
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.”
CTPharma is not a DEA federally licensed entity, its entire operation like that of every other state-licensed marijuana supplier, remains illegal under the federal Controlled Substances Act. Due to this it’s came as a shock that Yale researchers were allowed by the FDA to use CTPharma’s tablets containing cannabis derived CBD and THC in a Phase I clinical trial. “All the formulations are in tablet,” says CTPharma COO Rino Farrarese. “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 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 in a press release, “it is imperative that we understand the science of how these products are working to alleviate patient symptoms.”
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. Since NIDA grown cannabis can’t be used for commercial purposes it also means it can’t be used in phase III clinical trials which is the last step before the FDA approves any new medicine as the drug used in that last phase must be an exact replication of the drug that will be sold. This has created a scenario in which research could be done using the government grown ganja but there was no way for researchers to make it through the type of trials necessary to get cannabinoid medicine – namely those that include THC – through the rigorous requirements and laws that surround conducting clinical trials – or any research on humans.
The Drug Enforcement Administration (DEA), which for years has refused to license additional suppliers of medicinal marijuana, changed its mind in 2016, the last year of the Obama administration – when at that time announced it would start accepting applications from potential future growers – but it never happened. As of this summer, 2019, a total of 33 applications have been received by the DEA yet not one has been granted these licenses to provide the government with more up to date strains and more. In essence the promise to allow U.S. growers to supply the government with cannabis for research was empty – and up until this announcement there’s been no availability to study without using the government model of cannabis – but that just changed.
Farrarese noted that “an English company has the only FDA-approved plant-based medical marijuana product in our market”: Epidiolex, an oral CBD solution made by GW Pharmaceuticals from cannabis the company grows in the U.K. Last year it gained FDA approval as a treatment for two rare forms of epilepsy. CTPharma hopes to follow in the British company’s footsteps, although the process may take anywhere from three to seven years.” .
Meanwhile, CTPharma seems to have accomplished a first of its own. Farrarese says he is not aware of any other FDA-approved study using marijuana produced in the United States that does not come from NIDA. “I’m pretty sure it’s the first one,” he says.