Medical Marijuana Study Ready To Roll

Yale researchers have the permissions they need to begin using homegrown cannabis in two clinical trials — in what could be a boon to Connecticut’s budding medical marijuana industry.

A team of researchers, drug-makers and regulators announced that they have gotten their protocol to test marijuana on human subjects past the U.S. Food & Drug Administration and the Connecticut Department of Consumer Protection, at a Friday morning press conference in a boardroom at the Yale School of Medicine on Cedar Street.

Rajita Sinha, a psychiatrist who directs the Yale Interdisciplinary Stress Center, will be conducting two studies.

“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,” Sinha said. ​“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 first will test safety and dosing, by trying out six double-blind combinations of CBD (cannabidiol) and THC (tetrahydrocannabinol) — or a placebo — on a group of adults, ages 21 to 45, who already toke recreationally.

Researchers will look at heart rate, blood pressure and other physiological changes, while they watch how the drug moves through the body, from the high to the comedown.

The second will test pain relief, by giving a a group of adults, ages 21 to 60, with chronic pain repeated dosing for a week.

Researchers will ask about stress and pain, while looking at hormone responses and cardiovascular measures during regular visits to the lab. Based on how the first study goes, they might also look at the drug’s effect on post-traumatic stress disorder or opioid use disorder.

“There are so many questions, and we have to acknowledge the State of Connecticut was very proactive and thoughtful in acknowledging that the research will be ongoing,” Sinha said. ​“We know from our colleagues on other campuses across the country that is not necessarily the case in other states.”

Connecticut — unlike the 11 states that have legalized recreational pot, where bud-tenders can sell pre-rolled joints and vape-pens to any adult — has focused on building up its medical marijuana industry.

“We believe Connecticut really has the best medical marijuana program in the country,” said Michelle Seagull, the state’s consumer protection commissioner. ​“It’s because, from the beginning, we really were determined to have a true medical program, and we feel really good we’ve succeeded in doing that.”

Most importantly for the state’s drug-markers, regulators have allowed locally grown weed to be used in clinical trials.

Researchers in most other states have trouble using their own ganja supply.

Because the federal government still lists marijuana as a controlled substance with ​“high potential for abuse,” ​“no currently accepted medical use” and a ​“lack of accepted safety,” it limits the drug’s availability, even for pharmacological research.

It usually makes scientists buy boxes of years-old, frozen buds from the University of Mississippi, the government’s only approved grower.

But Sinha, after two-and-a-half years of negotiations with regulators, got a pass. The U.S. Food & Drug Administration will allow her team to use cannabis from a grow facility near Middletown run by CTPharma.

“We were really interested in what people are using here,” Sinha said. ​“We did not even try to go the other route.”

Eventually, that could make it easier for CTPHarma to go to market, as they’ll already have a specific strain of cannabis vetted in early clinical trials.

“America has set the world’s pharmaceutical standards for the past century,” said Rino Farrarese, CTPharma’s chief operating officer. ​“Today, an English company has the only FDA-approved plant-based medical marijuana product in our market. CTPharma has the knowledge and discipline to use plant-derived cannabinoid formulations and to prove their safety and efficacy to any standards, including the FDA’s, right here in America.”

Just as the clinical trial is set to begin, another Connecticut drug-maker — Purdue Pharma, the Stamford-based OxyContin manufacturer — has filed for bankruptcy, amid thousands of lawsuits over its role in kicking off a deadly opioid epidemic.

Sinha, who previously conducted several studies on addiction, said researchers have learned from what went wrong with opioids, especially when it comes to the right dosage.

Cori Alicea, a Milford resident who’s used marijuana for the last five years to treat her glioblastoma, an aggressive form of brain cancer, said that marijuana is different, as she hoped clinical studies like this would prove.

“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,” Alicea said. ​“Being able just to sit here and talk with you was not an option prior to using this medicine.”