Observational CBD Safety Study Is Now Underway
Enrollment has been initiated on the national clinical trial by ValidCare measuring the potential liver effects in healthy adults ingesting either full/broad-spectrum, hemp-derived CBD or CBD isolate. This Institutional Review Board (IRB) approved study is led by co-principal investigators Keith Aqua MD and Jeff Lombardo PharmD, BCOP. The study was designed to respond to the FDA’s repeated request, including the agency’s March 5, 2020 report to Congress for science-based data, so it can confidently determine the appropriate regulatory path(s) for hemp-derived CBD products.
Participant recruitment began the first week of August and is expected to continue through mid-September 2020.
“There are already over 300 participants actively engaged in the study and building each day,” said Dr. Lombardo. “The protocol has an 80.6% power score based on less than 700 participants. We are excited at the potential to enroll over 1,000 participants. This sample size provides increased reliability in understanding multiple variables across populations, products and lifestyles for researchers, product companies and the FDA.”
Thirteen product companies are now sponsoring this research including: Asterra Labs, Boulder Botanical & Bioscience Labs, Care by Design, CBDistillery, CBD American Shaman, Charlotte’s Web, Columbia Care, Global Widget, HempFusion, Infinite CBD, Kannaway, Medterra CBD and SunMed CBD. Each company provides lot-specific product information for the study and recruits up to 100 consumers to participate. Consumers are then screened to ensure they meet Inclusion/Exclusion criteria before they are approved and enrolled.
This decentralized/virtual, observational research is powered by ValidCare Study, which collects Real World Evidence (RWE) from consumers across the United States in accordance with the 21st Century Cures Act.
“ValidCare Study is a game-changer for clinical research; especially in light of COVID-19. Now we can remotely recruit, screen, consent, monitor, and obtain intra-study feedback from participants in real-time,” said Dr. Aqua. “Participants only need to be physically present once during the study to provide a blood sample at a lab close to their home.”
Results of the study will be shared with the FDA and are expected to be published in a peer-reviewed journal in early 2021.