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The Radicle Science Approach to CBD and Cannabis Research

Pelin Thorogood and Susan Hewlings discuss cannabinoid studies and how wellness brands can prove product efficacy.   

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By: Sheldon Baker

CEO, Baker Dillon Group

Pelin Thorogood is the co-founder and executive chair of Radicle Science, an AI-driven healthtech pioneer recognized as a “World Changing Idea” by Fast Company for powering the future of personalized wellness with proof. Her category-defining efforts earned her the INC 200 Female Founder award in 2023. Previously, Thorogood held pivotal C-level roles in both public and private companies, including CEO, establishing herself as a mar-tech trailblazer. Thorogood is a prolific writer and speaker on topics ranging from AI, analytics, entrepreneurship, women’s health and precision medicine, including in Fast Company, Forbes, SXSW, TEDx, Montgomery Summit, and Cornell Enterprise. Deeply committed to impact, education, and community, Thorogood serves as trustee and vice chair of the UC San Diego Foundation and as chair of the UC San Diego Chancellor’s Council for Innovation and Entrepreneurship. She holds a B.S., M.Eng and MBA, all from Cornell.

Susan Hewlings, PhD, RD, serves as the senior vice president of scientific affairs at Radicle Science. With a lifetime of dedication to health and fitness, Hewlings brings over two decades of extensive experience in research, teaching, and medical writing in nutrition, sports nutrition, and scientific consulting for both the dietary supplement and medical industries. Her academic achievements include a doctorate in nutrition, a master’s in exercise physiology, and a bachelor’s in nutrition from Florida State University. She has been instrumental in bridging the gap between science and product development, marketing, and sales for numerous leading brands in the supplement industry.

Area Code 420 (AC 420): What did you hope to accomplish (your goal) when forming Radicle Science?

Thorogood: When COVID hit and nearly all traditional trials came to a halt, we saw a massive opportunity to fix a broken system. We created a new model of virtualized, tech-enabled research — one that could be easily accessible for natural, non-pharmaceutical health products. Just as importantly, we saw how to bring much needed equity and diversity into medical research.

As we enable clinical trials at scale, everyone benefits from being able to make history’s first evidence-based decisions on wellness products. This includes not only consumers and physicians, but brands, ingredient suppliers, retailers and distributors to even insurers and healthcare systems.

Powered by clinical evidence, our goal is to transform natural health products into proven precision medicines, accessible by all.

AC 420: What is the state of the industry for non-intoxicating cannabinoids derived from hemp?

Hewlings: The industry for non-intoxicating cannabinoids derived from hemp, particularly cannabidiol (CBD), has experienced significant growth and transformation in recent years. As of 2023, the global market for hemp-derived CBD was valued at approximately $8.28 billion, according to Yahoo Finance, and is projected to reach $46.25 billion by 2034, reflecting a compound annual growth rate (CAGR) of 16.9% during this period.

The expansion of the CBD market is largely driven by increasing consumer interest in wellness and natural health products. This interest has driven the incorporation of CBD into a variety of products, including edibles, topicals and beverages, catering to diverse consumer preferences.

The regulatory environment for hemp-derived cannabinoids is complex and evolving. The 2018 Farm Bill legalized hemp cultivation and the production of non-intoxicating cannabinoids like CBD in the U.S. However, subsequent amendments and state-level regulations have introduced new definitions and restrictions, particularly concerning products that may have intoxicating effects. For instance, certain states have proposed or enacted laws imposing “total THC” limits on hemp products, affecting the legality of various cannabinoids. ​

Despite the growth, the industry faces challenges related to regulatory scrutiny and market saturation. The proliferation of products containing cannabinoids such as delta-8 THC has led to legal ambiguities and health concerns, prompting some states to restrict or ban these substances. Additionally, the market has seen an influx of products with varying quality standards, leading to consumer confusion and potential safety issues. ​

AC 420: What has your research uncovered regarding the health effects of cannabinoids derived from hemp, as well as cannabis?

Hewlings: Through our large-scale clinical trials on cannabinoids and sleep, we have generated clinical evidence that consumers need to make informed decisions about their sleep health.

In our trial on CBN on sleep quality, it was found to be comparable to the most studied and used dietary supplement sleep ingredient: melatonin. The CBN dosages studied (25, 50, and 100 mg) and the 4 mg melatonin groups all experienced clinically meaningful improvement in their sleep.

In our trial on CBD formulations, both CBD and melatonin improved sleep quality, with no significant differences between them. In addition, our results suggest that the combination of certain cannabinoids and melatonin may confer greater improvement in sleep duration than melatonin alone. Of note, participants receiving products with cannabinoids (including cannabinoids in combination with melatonin) reported lower incidences of grogginess relative to melatonin only. Therefore, cannabinoid products warrant further attention and research as effective alternatives or additions to melatonin that may avoid or reduce one of its most common unwanted side effects.

In our trial comparing two multi-ingredient supplements containing different levels of federally-legal THC and botanicals to a placebo, we found that the formulation with lower levels of THC, in combination with CBD, CBN, and higher levels of GABA, and GABA-elevating botanical oils from valerian and hops, significantly improved sleep disturbance, anxiety, stress, and well-being compared to placebo. The other formulation with higher levels of THC and lower levels of the other botanicals did not show significant differences. While further exploration is necessary, this research supports the idea of synergism between botanical compounds, allowing for variable amounts of them without additional side effects.

Overall, our trials show that CBD, melatonin, and certain cannabinoid formulations, particularly those containing CBN, could be safe and effective options for improving sleep quality in individuals with sleep disturbances.

AC 420: Was Radicle Science the first to perform CBD and cannabis studies?

Hewlings: No, we weren’t the first to do cannabis and CBD studies, but we have definitely performed some of the largest, most diverse virtual RCTs in healthy people across the U.S. on cannabis products that have ever been conducted. For example, we conducted the largest study on CBD in history, as well as the largest one ever investigating the effects of cannabinoids on sleep outcomes. We generated the first human data suggesting that CBN can significantly improve sleep, and our research marks the first IRB-approved blinded randomized controlled trial to compare cannabinoid products against melatonin.

AC 420: What type of cannabinoid studies do you perform? Do you have a specific approach?

Hewlings: All of the studies that Radicle Science conducts are gold standard clinical trials: double-blinded, randomized, placebo-controlled. Our trials are large scale and study Americans using validated outcome measures. They are virtual, where study products and any biomarker kits are mailed to each participant, and we leverage technology to monitor their changes. This allows participants from across the U.S. to be involved in research, ensuring the diversity and representativeness of our study population to all Americans. Further, we only study cannabinoids that are federally legal, which includes THC up to 0.3%.

AC 420: What do you feel the future of CBD regulation might be?

Hewlings: The future of the hemp-derived cannabinoid industry will likely be shaped by ongoing regulatory developments and consumer demand for safe, high-quality products. Stakeholders are advocating for clear and consistent regulations to ensure product safety and industry sustainability. As the market matures, companies that prioritize compliance, transparency, and consumer education are expected to thrive.

AC 420: Do you use the health impact tracker for cannabinoid wellness brands?

Thorogood: Journey by Radicle Science is a digital engagement and health tracking platform for brands, driving consumer repeat purchasing while delivering real-world insights to the brand. It can be used for any health product, including cannabinoid brands, to engage consumers post-purchase and demonstrate the product’s personalized health impact, boosting adherence and reducing churn.

In addition, given the competitive nature of the cannabinoid market, brands are certainly looking for innovative ways to grow their business. Journey empowers brands with aggregate health and behavioral data to inform R&D and optimize target marketing.

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