(This story is part of the cover package in the July issue of MJBizMagazine.)
The goal of a cannabis research study doesn’t always have to be the creation of a drug approved by the U.S. Food and Drug Administration.
“I would argue that even though we’re not cranking out a drug on the other end, the arguments for doing something like this are multifold,” said Dr. Stephen Dahmer, chief medical officer at Vireo Health, a Minnesota-based multistate operator that, over the past several years, has partnered with universities on several studies exploring the therapeutic benefits of cannabis.
Dahmer said arguments for carrying out research studies include:
- Building consumer trust in a brand.
- Getting “buy-in” from the medical profession.
- Understanding how patients respond to cannabis treatments.
Vireo – whose parent company, Goodness Growth Holdings, agreed to be acquired by Verano Holdings – considered undertaking an FDA-approved study. But the process was too expensive, and finding a pharmaceutical company willing to partner with a marijuana business proved too difficult at the time.
“We certainly looked at an FDA path. An FDA path is an incredibly high bar. And in the early days, those companies (that we would have partnered with) wouldn’t even speak to us. And it’s a multimillion-dollar – some argue billion-dollar – path to try,” Dahmer said.
Dahmer, who spends much of his time networking with other physicians, met Dr. Chinazo Cunningham at a neurological conference. The conversation with Cunningham, a clinical professor at the Albert Einstein College of Medicine and commissioner of the New York State Office of Addiction Services and Supports, led to an observational clinical trial.
The study included patients enrolled in New York’s medical marijuana program who had chronic pain and also took opioids. The 250 patients in the study were instructed to consume cannabis products as they typically would and then answer questions such as:
- What cannabis products are you using?
- How does cannabis impact your opioid use?
- How does cannabis impact your pain?
These so-called “patient-reported outcomes” provide valuable insights for Vireo at a relatively low cost, because they are carried out by academic institutions that receive government and private funding. This study, for example, was funded by a $3.8 million National Institutes of Health grant in Cunningham’s name. In return, Vireo provided the products to subjects at a substantial discount, Dahmer said.
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Researchers began enrolling subjects in the 18-month study in August 2017, and the last subjects started in December 2021, meaning some patients are still in mid-study.
Researchers have started to analyze data and found that some patients need to consume cannabis daily for pain relief, while others’ consumption is less frequent, with factors including individual thresholds for pain.
“That speaks again to the complexity not only of human beings – each one of us are very different – but how pain or chronic pain is a very subjective experience. Not only is it different for each and every one of us, but it can fluctuate markedly even throughout the day or throughout a week,” Dahmer said.
After successfully undertaking the first study, Vireo felt confident enough to pursue the “gold standard” of studies, a randomized, double-blind, controlled trial.
“The patients, providers and the pharmacists are all blinded, so they don’t know what they’re getting,” Dahmer explained.
The second study involves New York medical marijuana patients with chronic pain who were given softgels in four formulations – a placebo plus three combinations of THC and CBD.
Study administrators aim to enroll 250 patients; through late May, they had enrolled about 80. Patients are enrolled for 14 weeks in the study, which is being funded by a private grant.
“The beauty of a randomized control trial is that the time period is much shorter,” Dahmer said.
While the first study was purely observational, researchers and Vireo officials haven’t ruled out the prospect of a cannabis-based drug with FDA approval.
“We’re already testing the waters, looking at three of our different products versus placebo, backing that up with longitudinal data to try to determine: Of the many SKUs and products that we offer in the market, is there one that does better and that supports patients more in their diagnosis of chronic pain and … decreasing opioid use?” Dahmer said.
The doctor noted the research team has submitted a pre-Investigational New Drug (IND) application – an early step that companies must take if they intend to conduct FDA-approved studies that could lead to FDA-approved drugs.
Vireo is now waiting to see which of the products it is testing offers the best results and which has the best chance of making it through the FDA process, Dahmer said.
Dahmer noted that when companies file an IND for a pharmaceutical product, it’s usually for a “single constituent.”
“If you file and receive an IND, you’re moving through that FDA process,” Dahmer said. “So you’d better be very certain that the product you choose to push down that pipeline is one that you hope will have success.”