The Safety and Effectiveness of Commercially Available Cannabidiol Products for Health and Well-Being: A Randomized, Multi-Arm, Open-Label Waitlist-Controlled Trial

Introduction: Over the past decade, use of cannabidiol (CBD) to manage common symptoms such as anxiety, sleep disturbance, and pain has expanded rapidly. However, few clinical trials have investigated CBD's safety or efficacy. Furthermore, whether effects vary by characteristics of the product or individual characteristics is largely unknown. Materials and Methods: The safety and health effects of 13 orally ingested, commercially available CBD products were evaluated using an open-label, randomized, waitlist controlled design. Participants (n = 2816; 94% female) residing in the United States and reporting symptoms of anxiety, sleep disturbance, or chronic pain were randomized to receive a 4-week supply of a CBD product or no product (waitlist control). CBD products varied by dose, form (e.g., capsules), and spectrum (isolate, broad, or full). Participants completed online surveys assessing well-being, anxiety, sleep disturbance, and pain using validated outcome measures weekly for 4 weeks. Linear mixed models were used to assess the effect of taking any product relative to waitlist control and the interaction effects of participant prior (prestudy) CBD use. Effects of CBD spectrum were investigated using post hoc analyses. Results: Well-being, anxiety, sleep disturbance, and pain significantly improved among those assigned to take a CBD product relative to waitlist control. Among those assigned to a CBD product, the percentage of individuals with a given condition who experienced an improvement which could be considered clinically meaningful or important was 46.6% for anxiety; 47.9% for sleep disturbance, and 35.2% for pain. No significant differences in effect were found as a function of spectrum or prior CBD use for any outcome. Approximately 9.5% of participants reported one or more side effects, the most common of which were gas/flatulence (1.6%), headache (1.4%), diarrhea (1.2%), and bloating (1.2%). No severe side effects were reported. Discussion: Our results suggest that the commercially available CBD products included in this study are safe and may serve as potentially effective complementary therapies for management of anxiety, sleep disturbance, and pain. These effects appear independent of the prior CBD use and product spectrum.