Challenging the Status Quo of Antiquated CBD Research

by Michelle L Shuffett, MD Chief Growth Officer for Radicle Science

Cannabis has been labeled as a Schedule I drug for half a century. For about 40 years, there has only been one regulated source for DEA-approved cannabis research–a farm at the University of Mississippi. The problem with that? The products–frozen dried flowers rolled into a cigarette–aren’t anything like what people are actually consuming.

Dr. Jeff Chen, MD/MBA, Co-founder, and CEO of Radicle Science and former founder and Executive Director of the UCLA Cannabis Research Initiative, said he too experienced this huge flaw in the research industry when it came to cannabis or cannabinoids, “In our case, we could not study a single one of the products that 50M plus Americans were using…so it was very frustrating, to say the least.”

The 2018 Farm Bill, which declassified hemp-derived CBD as a Schedule I drug, led to a proliferation of CBD crops and consumer package goods which sold CBD products sold more or less as dietary supplements. The FDA stepped in and declared that CBD couldn’t be sold as a dietary supplement because a pharmaceutical company had already begun substantial clinical research on CBD. This company had received FDA approval for their plant-derived CBD product as a drug before it was widely sold as a supplement. This has led to a lot of confusion and has limited research in this sector. Universities wouldn’t and still won’t touch it, because they believe CBD has to be studied as a drug. They usually don’t deviate from the norm because they rely on federal research funding.

For decades, the research community has been challenged when it comes to running meaningful studies due to these regulatory hurdles and more.

Until now. Radicle Science was born out of an innate belief that there is a better way. One of the health tech company’s first tasks was to conduct real-world evidence (RWE) research on CBD products already on the market. Radicle uses a real-world study approach, with products that participants take in their own homes in their daily lives for several weeks instead of administering products in a lab and asking participants on the spot “How do you feel right now?”

As Dr. Chen explained, “We wanted enough time to capture meaningful data, so four weeks seemed sufficient based on anecdotal evidence from consumers, who reported that the products were taking about a month to take effect.”

Radicle Science employs validated instruments to measure participant outcomes in their studies, for example, in the recently completed Radicle ACES (Advancing CBD Education and Science) study. Radicle ACES was a four-week, Institutional Review Board (IRB) approved randomized controlled trial (RCT) of nearly 3,000 participants assigned to different botanical products containing CBD.

Dr. Chen explains why these instruments were crucial to the study, “The beauty of using these validated survey instruments is that we can now compare this to other studies… using the exact same validation measures.” Radicle Science uses these gold standard outcome measures so that brands that participate in studies like Radicle ACES can compare their own products to any other product or treatment studied by that same measure/RWE approach.

Two of the thirteen brands who participated in the Radicle ACES study attended a recent webinar, hosted by Dr. Jeff Chen to explain why they joined in, as well as talk about how they will use the data to share meaningful insights about their products and their customers: Gavin Chandler, CFA, and CEO of Trokie? and Rosemary Mazanet, MD/Ph.D. and CSO of Columbia Care.

As Dr. Mazanet explained in the webinar, Columbia Care, like most other CBD brands, was relying on anecdotal reports from customers and reviews to glean which products were helping. But, as she said, “Actual quotes from actual customers beg for more. The sample feedback you get from your customers isn’t enough. That’s one of the reasons we were very interested in working with Radicle Science on the Radicle ACES study… We don’t just brand. We say: Take X product, and when.”

Dr. Mazanet went on to talk about how they wanted to learn about the taste, the timing of dosing, and the adverse effects. The Radicle ACES results for Columbia Care provided an interesting bit of information about GERD, or acid reflux in participants, specifically: “Some of the patients reported adverse effects if they took the [product] right before they went to sleep.”

Due to the Radicle ACES study, Columbia Care is able to recommend that customers should take their product a few hours before bed instead of immediately before.

Gavin Chandler from Trokie? took a product-development approach to the data the Radicle ACES study reported for Trokie?. As a relatively new brand, they were starting at ground zero. As Chandler explained, “Almost everything was going to be new for us… we had some thoughts and some theories and some propositions about how our unique route of administration would be beneficial for patients but we really didn’t have any data to support one way or another whether or not it was going to be a real differentiation.”

Trokie? was curious about dosing and reliance on other medications. They gleaned two things from the dataset: 1. Of 90 participants, 30% of those who reported all three conditions also reported a reduction in their reliance on other medications they took to alleviate those same conditions while in the trial (Trokie? does not recommend any medication changes without consulting a healthcare provider first); and 2. The self-administered dosage didn’t seem to have any correlation in terms of the BMI of participants, nor did BMI have anything to do with the perception of well-being.

The webinar closed with some inspiring comments from all three as to the future of clinical research in the health and wellness industry, kicking off with Gavin Chandler, who stated, “One of our partners said that the rule is any good clinical trial deserves three or four more. I think that’s the picture that’s being painted here. What I’m really excited about is the next step, using the Radicle Discovery platform to do randomized placebo-controlled blind trials.”

Dr. Mazanet added, “I think this is really helpful for brands to be able to perfect their product… It helps people home in on what they might want their product to look like in a perfect world and how they might want to do that before we do research… You can spend millions of dollars, tens of millions, hundreds of millions on research, but you have to ask the question ‘right’ first… I think that’s where we need to use this data, to try to help make the products the best that they can be… that’s what’s exciting to me.”

Dr. Jeff Chen closed the talk with this: “This is just the first shot across the bow. There is a lot of work that needs to be done… There's a half-century of research bans that need to be overcome. It’s amazing to be at the forefront of this and I’m excited to wake up every day and be a part of it.”

Stay tuned for more studies in early 2022!? Next up: a Radicle Discovery study called Radicle Sleep! If you are a consumer interested in participating in Radicle Sleep, you can learn more here. Recruitment will begin later this month.

If you are a brand interested in participating in a Radicle research study, you can schedule a strategy session at no cost to you.

Missed the webinar? That’s ok! You can still watch the recording and read more about the Radicle ACES results here!