On March 31, Kentucky’s governor, Andy Beshear, signed Senate Bill 47, and, with a flick of his pen, Kentucky became the 38th US state to legalize medical cannabis.
This wasn’t the first cannabis bill Beshear had signed, though. A year earlier, he had put his signature to House Bill 604, which legislated a Kentuckian cannabis research center.
Now, the state’s first legal medical cannabis dispensaries aren’t expected to open until 2025. The cannabis research center, however, is alive and researching. Several studies are already underway, and their findings may just help inform the state’s eventual medical cannabis policies.
To find out more, Analytical Cannabis spoke to the center’s director, Shanna Babalonis.
A blue-grass research center
“The center was funded and established by House Bill 604, a piece of legislation that appropriated $2 million to the University of Kentucky to create the center of cannabis research,” explains Babalonis, “with the overall overreaching goal of enacting controlled trials in cannabis science to determine the risks and benefits of cannabis for certain medical conditions.”
“And we are focusing on the health conditions which are most relevant to the state of Kentucky,” she adds.
With the maladies of Kentuckians in mind, Babalonis and her team have received grants for studies to investigate whether cannabis can benefit cancer patients, obese people, and older adults already using opioids and benzodiazepines.
“Kentucky, unfortunately, in the United States is number one in cancer rates,” Babalonis says. “So we are conducting one of the first placebo-controlled, randomized trials of cannabis for cancer patients.”
“We will enroll patients for several months and give them different doses of cannabis to determine whether it impacts their quality of life, their sleep, their appetite, and nausea and vomiting – their overall, what we call, cancer burden.”
“How much does cancer affect someone’s life?” she posits. “We’re really interested in that, and that [study] will be one of the first of its kind.”
“We are also doing a study where we’re looking at daily doses of cannabis versus placebo for metabolic health and obesity,” she continues. “Kentucky ranks anywhere between two and number five in the United States in rates of metabolic health disease and obesity.”
“And then I have an NIH [National Institutes of Health] award to look at cannabis for outcomes related to opioid use disorder, so opioid withdrawal syndrome, opioid drug taking, and then opioid safety. What happens when you put opioids and cannabinoids together? Is that a safe combination? Or is that something that we should worry about physiologically?”
“And so those three are the focus on the center, and all [are] highly relevant to Kentucky.”
None of the studies are completely unique, of course; there have been dozens of studies charting the relationship between cannabis and different cancers, for instance, and many papers published concerning opioid use and obesity, too. What marks the Kentucky studies out, as Babalonis says, is their rigor.
“We are doing placebo-controlled trials,” she tells Analytical Cannabis. “[Many other] studies are not controlled dosing, and they’re not placebo-controlled trials.”
“You can ask people, are you using cannabis, yes or no? How is it helping your cancer burden? But to actually conduct a randomized, placebo-controlled dosing trial to identify doses which may or may not help and to look at the side effects of those doses? That is knew.”
“And so that is our capability at our center,” she says. “I have a Schedule one drug license and a Schedule one import license. Those things allow us to do these controlled dosing studies, where other studies are just looking at survey work or post-hoc work – which is very important work to be done – but if we are going to as a society, and as a medical field, start looking at cannabis as medicine, we have to start levelling up and doing clinical trials and determining what dose is effective. And what are the side effects of those doses? And are they effective? What is the risk benefit profile of various doses or medical health conditions? I think that’s where we come in and are trying to make our mark.”
To make the center’s studies more relevant to Kentucky’s forthcoming medical cannabis market, Babalonis and her team have tried to ensure the doses of cannabis used in their studies are fairly representative of what a medical marijuana patient might be able to buy from a dispensary.
“There are not many options for avenues for supply,” she says. “That being said, we are getting a supply of cannabis for the cancer trial that will be in an edible form. And it’s a full-spectrum distillate that we feel closely approximates what patients would be taking in medical dispensary. And [for] our studies where we administer smoked cannabis, we’ve been successful at obtaining 18% THC cannabis, which closely approximates what’s available in dispensaries.”
“Of course, people can get more potent cannabis,” she concedes.
Yet potency doesn’t necessarily equate to dosing, according to Babalonis.
“Even if we’re giving 18% cannabis, some folks will come back at us and say, ‘Well, it’s not 26% Because that’s what they have in California and Colorado and other places,’” she says.
“And that’s absolutely true. But you can increase the quantity of 18% cannabis that you give somebody to get an achievable dose that’s comparable to 26%. And so we feel like we are approximating what people would buy in a recreational or medical dispensary.”
With these considerations in place, the only thing left for the researchers to do is gather their results. And that could take a while, given the length and rigor of their studies. So, to keep Kentuckians informed of medical cannabis science in the meantime, Babalonis and her colleagues have also organized several educational platforms at the center.
“We also have several other points of collaboration and research going on,” she says. “And so we have a speaker series where we bring in national and international experts on cannabis science, and invite them for webinars to our center. And we make those free and open to the public to increase medical literacy among the population in Kentucky, and then also to inform our experts about the work that's being done.”