Radicle Science, a healthtech B-corp validating natural products, has launched the Radicle Advancing CBD Education and Science (ACES) study.
Using a virtual, direct-to-consumer approach, Radicle ACES is the largest and most comprehensive randomized controlled trial of its kind, collecting data on 13 U.S. CBD brands, including 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, and Verséa Wellness.
“A rigorous scientific study of this magnitude has never before been conducted in the CBD market,” said Pelin Thorogood, co-founder and executive chair of Radicle Science. “Radicle ACES is driven by our deep commitment to contribute to the body of evidence to support growing demand from consumers and healthcare providers. Given the scale, the diversity of the participant population and the wide range of high-quality commercial brands included, Radicle ACES promises to deliver rich, objective health outcome data for a variety of common health conditions, with the potential to offer unprecedented guidance on CBD effectiveness based on demographic or behavioral differences.”
Radicle ACES is Institutional Review Board approved and will capture CBD effectiveness data directly from nearly 3,000 study participants. During the four-week study, participants will use the Radicle Science platform to track consumption and effectiveness of orally ingested CBD products on well-being, quality of life, pain, sleep disturbance, and anxiety. Radicle ACES will use validated, standardized health indices to gather health outcome data from a diverse population across a variety of ethnicities, age groups, geographies, behavioral habits, and pre-existing health conditions.
“We’re applying science to understand the effectiveness of CBD products used by tens of millions of Americans every day,” said Jeff Chen, MD/MBA, co-founder and CEO of Radicle Science. “We’re partnering with 13 leading CBD brands and collaborators across five top-tier research universities to drive accurate, transparent, and actionable insights for all stakeholders.”
Radicle ACES is led by Principal Investigator Kelsey Laird, PhD, and Co-Investigator Jessica Saleska, PhD/MPH. Academic collaborators include Miroslav Backonja, MD (Clinical Professor, University of Washington), Chris Colwell, PhD (Professor, UCLA), Derek Loewy, PhD (Director of Behavioral Sleep Medicine at Scripps Clinic Sleep Center), Ethan Russo, MD (Founder and CEO of CReDO Science), Kate Taylor, PhD (Associate Professor, UCLA), Jill Waalen, MD/MPH (Co-Director of Biostatistics at Scripps Research), and more.
The real world evidence collected will inform scientific understanding on dosing, usage patterns, user characteristics, effectiveness across conditions, and predictors and modifiers of treatment response.
Radicle ACES findings will address the top two barriers to CBD usage identified in a 2019 Nielsen study: 1) difficulty gauging effectiveness of specific products, and 2) lack of research data on health benefits.
“The Radicle ACES study aims to answer lingering questions as to who should take cannabidiol, how much and for what conditions, as well as differing dosage patterns,” said Ethan Russo, MD, scientific expert for Radicle Science and founder and CEO of CReDO Science. “CBD is much more subtle in its effects and quite benign compared to THC. Patients are unclear on what product to choose and healthcare providers don’t yet have the data to counsel on proper dosage.”
Anonymized aggregate results will be released in October 2021. For more background on Radicle ACES methodology and additional insights from collaborators and experts involved in the study, see these Radicle Resources articles.