It’s becoming a broken record among physicians asked about the benefits and risks of medical marijuana: “More research is needed,” they say. For decades, federal restrictions on marijuana research have hampered inquiries into how marijuana interacts with the human body.
Now, the U.S. Food and Drug Administration has approved medical marijuana research trials using human subjects. Researchers from the Yale School of Medicine say the green light is a first, and the breakthrough could expand understanding of medical marijuana’s power to ease pain and treat illnesses.
Under the study, Yale researchers will team with medical marijuana producer CTPharma to test cannabis’ effectiveness in treating such conditions as stress and pain.
“There’s obviously a big movement going on across the country to assess and think about how medical marijuana products could be useful to alleviate patients’ symptoms,” said researcher Rajita Sinha. “We wanted to see if we could understand it better: How does it work? Who does it work for? What doses do we need? Can we learn more about it? Which symptoms can be alleviated?”
The Connecticut Department of Consumer Protection also okayed the studies.
Researchers say the studies will examine safety and dosing by looking at:
- Heart rate, blood pressure, and other physiological changes as marijuana moves though the body. The study will try six double-blind combinations of cannabidiol (CBD) and tetrahydrocannabinol (THC) or a placebo on adults ages 21 to 45. Participants will be men and women who have already used marijuana recreationally.
- Marijuana’s effectiveness at easing pain. The test will administer doses to adults ages 21 to 60 enduring chronic pain that’s not effectively treated by opioids. Like the other test subjects, participants will be assigned to receive placebos or doses of CBD and THC.
By focusing on stress and pain, the trials zero in on debilitating symptoms associated with many of the conditions approved for medical marijuana use, said Sinha. Pennsylvania’s Medical Marijuana Program director recently reported that 60 percent of the state’s medical marijuana users are seeking pain relief – a finding that mirrors usage in other states.
Results from the Yale tests could lead to separate studies into medical marijuana’s effect on PTSD or opioid use disorder – both, like chronic pain, among Pennsylvania’s 23 serious medical conditions that can qualify patients for medical marijuana ID cards.
The Yale studies also mark a first because the FDA has always required researchers to buy inferior-quality marijuana from a single approved grower. That product cannot be used for commercial purposes, which creates a roadblock on the final Phase III of clinical trials of new meds, because the prescription marketed must be the same formula that was tested. Sinha said she conducted two and a half years of negotiations to win approval for use of marijuana grown in Connecticut by CTPharma.
CTPharma officials, who hope to develop the first cannabis-based medicine to be manufactured in the U.S., say the eased restriction will simplify the route from test to marketplace, especially because they have already identified a strain that shows promise.
A CTPharma official noted that the only cannabinoid-based prescription drug on the market, the anti-seizure Epidiolex, comes from an English company. His company “has the knowledge and discipline to use plant-based cannabinoid formulations and to prove their safety and efficacy to any standards, including the FDA’s, right here in America.”
At a news conference announcing the initiative, a patient with the aggressive brain cancer known as glioblastoma said her medical marijuana use, supplied by CTPharma and complementing her chemo and radiation, has helped her stay alert and manage her pain.
“I can be with my kids, and I can drive them to school,” said Cori Alicea, of Milford, CT. Alicea said she hopes the study will reveal the marijuana’s ability to deliver a different kind or remedy, for expanded treatment options.
“My right side was completely numb after having seizures from surgeries and craniotomies, and this medicine has made it so I am able to live my daily life,” she said. “Being able just to sit here and talk with you was not an option prior to using this medicine.”
Researchers expect to complete the study by April 2022.