Key Findings From the Largest Clinical Trial Conducted on CBD Products

While the effects of CBD on people are just starting to be studied, the effects of individual products have been mostly anecdotal. But a recent study has attempted to shed light on individual products and the cannabinoid as a whole.

Radicle ACES (Advancing CBD Education & Science), an Institutional Review Board (IRB)-approved a study conducted by Radicle Science that included 13 different CBD brands, concluded late last year. Radicle Science is led by Dr. Jeffrey Chen MD/MBA, founder and former director of the UCLA Cannabis Research Initiative, and Pelin Thorogood, president and co-founder of the Wholistic Research and Education Foundation.

The study took place over four weeks and included nearly 3,000 participants who were randomly assigned to take one of 13 CBD products, each from a different brand, in order to analyze the products’ effects on quality of life, well-being, anxiety, sleep quality and pain. (Meanwhile, one control group did not take any CBD products).

Overall, the study showed CBD had a significant impact on the participants–those taking a CBD product experienced “statistically significant improvement” across all health outcomes, Jessica Saleska, who led the research, said in an email. 

“The Radicle ACES study represents the largest clinical trial ever conducted on commercially-available CBD products and provides first-of-its-kind real-world evidence into what conditions users may experience benefit from CBD usage, whether these benefits are clinically meaningful, what attributes of CBD products may impact health outcomes, and what side effects may occur,” Saleska said. “This study will arm the American public and healthcare providers with critical data to make more informed choices about these products.”

Key Findings

Researchers measured the five different outcomes using questionnaires that asked participants to score the severity of each health indication.

“We looked at how this score changed throughout time and compared this change among those taking product to those who did not take product,” Saleska said. “We also looked at the proportion of people taking product who experienced ‘clinically meaningful improvement,’ meaning that their score improved so much that if a clinician were to evaluate them as a patient, they would conclude that the participant experienced a distinct and palpable improvement in their quality of life.”  

Notably, Saleska said, the study did not find any significant differences in effects produced by CBD products with various spectrums (e.g. full, broad, or isolate). “The lack of difference by spectrum was interesting. We had hypothesized that other Cannabis compounds would have some impact on the effect of CBD,” Saleska said.

Other key findings from the study include:

• The largest improvements experienced by participants across all health incomes took place within the first week of using a particular product.
• While about 10% of participants reported experiencing side effects, “nearly all” were mild, Saleska said.
• The greatest effects were reported within one hour (30%) or between one and four hours (31%) of taking the product.

 

 

Study Implications

While the study provided insights on the potential for CBD usage as a whole, it also gave participating companies a chance to identify how their own individual products worked.

The 13 brands that participated were:

• ALTWELL
• Charlotte’s Web
• Columbia Care
• Healer
• Lord Jones
• Maven Hemp
• MD FARMA
• Peels (a citrus-derived brand)
• Prospect Farms
• PURAURA Naturals from Enhanced Botanicals
• Rae Wellness
• Trokie
• Verséa Wellness

Maven Hemp, for example, submitted its original CBD tincture formula to “get a baseline on just straight CBD,” says CEO Zev Barnett.

“We haven’t had access to any kind of data like this before,” Barnett adds.

Radicle is currently in the process of submitting the study for peer review. Looking ahead, Saleska says other studies are in the works for 2022, “including the largest blinded, placebo-controlled trials ever conducted on minor cannabinoids” like tetrahydrocannabivarin (THCV), cannabinol (CBN), cannabigerol (CBG), and cannabichromene (CBC). The study will look at these cannabinoids’ effects on energy, focus, appetite, sleep disturbance, pain, stress, and anxiety, and will aim to include about 10,000 participants.

It’s another study that will loop in existing brands and products on the market as well.

“The idea [behind] working with Radicle is to challenge the lack of transparent and meaningful regulations by the FDA and publish, to the extent available, real science about [hemp] compounds and try to make a meaningful difference,” Barnett says.