Radicle Science recently released its findings from the Radicle ACES (Advancing CBD Education and Science) study to determine the effectiveness of CBD products. The open label trial examined over a dozen US brands to determine whether botanical products containing CBD deliver therapeutic benefits across five health outcomes, including well-being, quality of life, longer-term pain, feelings of anxiety, and sleep quality.
Jeff Chen, MD, Co-founder and CEO of Radicle Science, told NutraIngredients-USA that the goal is to generate real world evidence indicative of the behavior and health outcomes of the tens of millions of Americans who use CBD regularly.
“Official clinical research on these CBD products is lacking due to decades of research restrictions and unclear regulations that continue to this day. The Radicle ACES study was a 4-week 14-arm open label randomized trial that involved nearly 3,000 participants, 13 products, and a waitlist control group. It is history’s largest randomized controlled trial ever done on CBD and was completed at the end of 2021.”
The brands that participated in the Radicle ACES study include: ALTWELL, Columbia Care, Healer, Lord Jones, Maven Hemp, MD FARMA, Peels (a citrus-derived brand), Prospect Farms, PURAURA Naturals from Enhanced Botanicals, Rae Wellness, Trokie, and Verséa Wellness.
“We sought intentional diversity in the attributes of these 13 products to reflect the thousands of different CBD products available in the US, and thus these products varied in formulation, dose, and form factor,” Chen added.
Of the participants who received any of the 13 CBD products:
- Participants experienced a 71% improvement in their well-being, on average
- 63% experienced a clinically meaningful improvement in anxiety
- 61% experienced a clinically meaningful improvement in sleep quality
- 47% experienced a clinically meaningful improvement in pain
- 61% reported an effect within one to four hours of taking their product
“When we looked at participants by their sex, by their age, or by prior CBD use, we saw no differences in the products’ effects between these groups,” said Chen. “We saw significant improvements in well-being, anxiety, sleep and pain in as little as four weeks, with most of those improvements appearing within the first week. This was a real world evidence study, so this may be indicative of what’s happening to the tens of millions of Americans who buy CBD products and begin to use them. Also higher dose products did not always outperform lower dose products–so more CBD may not always be necessarily better.”
Clinical trials reimagined
The key to success is rethinking clinical trials and systematically tackling limitations, which has led to studies that are 10x cheaper, faster, and greater in scale, the company said.
“We are at the dawn of a new era where we can, in record time, generate and disseminate rigorous data on health products for the benefit of consumers, healthcare providers and brands.”
Just getting started
This year Radicle Science is slated to launch several large-scale, blinded, placebo-controlled clinical trials on rare cannabinoids including THCV, CBN, CBG, and CBC. The focus will be on the rare cannabinoid’s effects on energy, focus, appetite, sleep disturbance, pain, stress, and anxiety. The studies will require more than 10,000 participants.
“Our audacious mission is to create the new standard of trust and transparency consumers deserve and healthcare providers demand on these widely accessible potential therapies. The large scale and the intentional heterogeneity of our studies pave the path forward to transforming these consumer health products into democratized, precision solutions. The findings of Radicle ACES are just the beginning,” said Pelin Thorogood, Co-founder and Executive Chair of Radicle Science.