• What is Radicle ACES?

Radicle ACES (Advancing CBD Education & Science) is history’s largest longitudinal real world evidence (RWE) study to determine effectiveness of botanical products containing CBD. It is the largest and most comprehensive randomized controlled trial (RCT) of its kind, collecting data on product effectiveness for 13 mission-driven CBD brands.

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.

• What was the overall design of the study and number of total participants?

Radicle ACES is a randomized, open-label RCT to evaluate the safety and effectiveness of commercially available botanical products containing CBD. Participants (2987 in total) were randomly assigned to one of 14 different study arms; 13 arms received one of a selection of CBD products, while 1 arm acted as a waitlist control (i.e., they acted as a comparison group and did not receive product until the conclusion of the study).

• What questions will Radicle ACES answer?

The objective of the study was to determine the effect of CBD on participants’ quality of life and well-being over the 4-week study period, compared to waitlist control. This open label RCT examined 13 U.S. 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. The study also aimed to evaluate whether certain CBD products and product attributes (composition, mode of use, dosage, frequency and timing of dosing) were associated with greater changes in health-related outcomes.

• How does Radicle ACES elevate the industry?

The Real-World evidence (RWE) collected with Radicle ACES will inform scientific understanding on dosing, usage patterns, user characteristics, effectiveness across conditions, and predictors and modifiers of treatment response from these products.

Radicle is applying science to understand the effectiveness of CBD products used by tens of millions of Americans every day by partnering with 13 leading CBD brands and collaborators across five top tier research universities to drive accurate, transparent, and actionable insights for all stakeholders.

• What makes Radicle ACES different from other CBD studies?

Innovative approach

Radicle ACES is Institutional Review Board (IRB) approved and will capture CBD effectiveness data directly from nearly 3,000 study participants, specifically tracking usage and health outcome data of orally ingested CBD products on well-being, quality of life, pain, sleep disturbance, and anxiety.

Radicle ACES is 100% virtual which allows a highly diverse participant population across a variety of ethnicities, age groups, geographies, behavioral habits, and pre-existing health conditions.

Reduced cost & time

Our transformative clinical trials and proprietary data analytics platform are 10x cheaper and faster compared to traditional clinical trials while maintaining scientific rigor. We achieve this by bypassing institutional bureaucracy, avoiding federal funding restrictions, eliminating all physical infrastructure, technology automation, and running our studies in a virtual direct-to-consumer (D2C) crowdsourced fashion.

Clinical trials can take several years from launch date to trial completion. The Radicle approach offers the first ever path to natural product validation at scale, and is able to generate meaningful health outcome data in a matter of months.

• How does Radicle ACES help consumers and brands?

The “trust gap” is one of the biggest barriers preventing the CBD and natural products industry from achieving its full potential. As recently shared by the Consumer Brand Association (CBA), a July 2021 Consumer Brands/Ipsos poll of 1,000 American adults found that Americans rated their knowledge of CBD as a 3.3 on a scale of 1 to 10. Our rigorous scientific studies into specific formulations of high-quality CBD and minor cannabinoids (of which there are >100 in cannabis and hemp) are helping bridge that gap.

The Radicle ACES study aims to answer lingering questions as to who should take CBD, how much and for what conditions, as well as differing dosage patterns.

Every participant receives a personalized Radicle Health Journey Report, empowering them with credible, scientific information to make informed choices about their health. Each brand received a Radicle Brand Insight Report, providing them with far richer data than ever before, data that is targeted, trusted, and inclusive.

• It’s great to see some of the aggregate results now, yet when will you release all of the results?

Initial results can be found here. Radicle will publish the anonymized, aggregate results of the study in a peer-reviewed journal article to enable everyone—from consumers and healthcare providers to businesses and regulators—the ability to make better health decisions regarding CBD.

Additional aggregate results will be shared in early 2022.