Radicle Science recently published its findings from the Radicle ACES (Advancing CBD Education and Science) study to determine the effectiveness of CBD products. An open-label study examined more than a dozen U.S. brands to determine whether botanical products containing CBD bring therapeutic benefits in five health outcomes, including well-being, quality of life, long-term pain, anxiety and sleep quality.
Said Jeff Chen, MD, co-founder and CEO of Radicle Science NutraIngredients-USAthat the goal is to gather real-world evidence that indicates the behavior and health outcomes of tens of millions of Americans who use CBD regularly.
“Official clinical research on these CBD products is lacking due to decades of research limitations and unclear regulations that continue to this day. The Radicle ACES study was a 4-week open-label, randomized trial of 14 groups that included nearly 3,000 participants, 13 products, and a control group on a waiting list. It is the largest randomized controlled trial ever conducted on CBD in history and was completed in late 2021.
Brands that participated in the Radicle ACES study include: ALTWELL, Columbia Care, Healer, Lord Jones, Maven Hemp, MD FARMA, Peels (citrus brand), Prospect Farms, PURAURA Naturals from Enhanced Botanicals, Rae Wellness, Trokie, and Wellness version.
“We sought deliberate diversity in the properties of these 13 products to reflect the thousands of different CBD products available in the U.S., so these products differed in formulation, dosage, and form factor,”Chen added.
From participants who received any of the 13 CBD products:
- Participants experienced an average improvement of their well-being of 71%.
- 63% experienced a clinically significant improvement in anxiety
- 61% experienced a clinically significant improvement in sleep quality
- 47% experienced clinically significant improvement in pain
- 61% reported an effect within one to four hours after taking their product
“When we looked at respondents by gender, age, or previous use of CBD, we saw no difference in product effects between these groups,” said Chen. “We saw significant improvements in well-being, anxiety, sleep and pain in just four weeks, and most of those improvements appeared within the first week. This was a real-world study of evidence, so this may indicate what is happening to tens of millions of Americans who buy CBD products and start using them. Also, higher-dose products have not always been better than lower-dose products – so more CBD may not always be better. ”
Redesigned clinical trials
The key to success is rethinking clinical trials and systematically addressing limitations, leading to studies that are 10x cheaper, faster and larger in scale, the company said.
“We are in the dawn of a new era in which we can, in record time, generate and disseminate rigorous data on health products for the benefit of consumers, healthcare providers and brands.”
I just started
This year, Radicle Science is set to launch several large, blind, placebo-controlled clinical trials of rare cannabinoids, including THCV, CBN, CBG and CBC. The focus will be on the effects of rare cannabinoids on energy, focus, appetite, sleep disturbance, pain, stress and anxiety. The studies will require more than 10,000 participants.
“Our bold mission is to create the new standard of trust and transparency that consumers deserve, and healthcare providers are demanding these widely available potential therapies. The large scope and deliberate heterogeneity of our studies pave the way for the transformation of these consumer health products into democratized, precise solutions. The findings of Radicle ACES are just the beginning, ”said Pelin Thorogood, co-founder and executive chairman of Radicle Science.