History's Largest Clinical Trial on Cannabinoids and Sleep Finds Meaningful Improvements

Radicle Science and Open Book Extracts release results of history's first clinical trial comparing cannabinoids to melatonin, with the majority of participants receiving a cannabinoid product experiencing significant improvement in sleep quality and duration as well as less of one of melatonin's most common and cumbersome side effects: grogginess

SAN DIEGO, Sept. 27, 2022 /PRNewswire/ -- Radicle Science, an AI-driven healthtech B-corp offering the first easy path for health and wellness products to prove their true effects, announced today the results of history's first clinical trial comparing cannabinoids to melatonin for sleep outcomes.  Studying 1,800 participants across the U.S., the Radicle Discovery™ Sleep Study, conducted exclusively with Open Book Extracts (OBX), is history's largest clinical trial researching cannabinoids for sleep outcomes—and the largest trial of cannabinol (CBN) containing products.  

Radicle Science studied products supplied by OBX, an NSF- and ISO 9001-certified manufacturer and distributor known for the industry's most innovative and highest quality cannabinoid ingredients and finished wellness and self-care products.  

All products examined in the study demonstrated meaningful improvements in sleep quality and duration. Four of the five products showed sleep improvement comparable (i.e. no statistically significant difference) to the melatonin control arm. There were no significant differences in frequency of total side effects of all types between any of the products studied.

The Radicle Discovery™ Sleep Study was an Institutional Review Board (IRB) approved, blinded, randomized, controlled clinical trial evaluating the effects of different cannabinoid products relative to melatonin. Five cannabinoid products that all contained CBD, with some containing additional rare cannabinoids such as cannabinol (CBN) and cannabichromene (CBC)—and one containing additional 5mg of melatonin, were compared against a control product containing 5mg of melatonin only. Melatonin is one of the most researched and widely used non-prescription sleep aids.

One thousand eight hundred (1,800) participants (56% female, 44% male) across the United States were enrolled and then randomized to take one of the cannabinoid products or melatonin only daily for four weeks. Participants reported regularly on their usage, side effects, sleep quality and other health outcomes, including pain and anxiety.  

Participants in all study groups saw significant improvements in sleep quality, well-being, anxiety and pain. The onset of effects from all cannabinoid products were similar to the melatonin control product, with most participants noticing an effect within one hour of taking their product.

Throughout the study, the amount of average increased sleep that participants experienced from each different product ranged from 34 - 76 additional minutes nightly, though there was not a statistically significant difference between products. 

The majority (>60%) of participants across all study groups experienced meaningful improvements (defined by "clinically important difference" thresholds) in their sleep. Seventy-one percent (71%) of participants taking melatonin alone or melatonin in combination with CBD and CBN in a defined ratio also experienced meaningful improvement and 69% of participants taking a combination of CBD, CBN, and CBC in a defined ratio experienced meaningful improvement as well.  

All study products exhibited a favorable safety profile. Side effects were mostly mild in nature, and there were no significant differences in the frequency (~10%) of reported side effects between all six study groups. However, the participants receiving products containing cannabinoids (including the product containing cannabinoids + melatonin) reported lower incidences of grogginess than those who received melatonin alone.   

Of those who also reported pain and anxiety in addition to sleep disturbance at the start of the study, the greatest proportion of participants who experienced a meaningful improvement in their pain and anxiety were those taking the combination of CBD, CBN, and CBC. This was greater than any other study product (including the melatonin control), though not with a statistically significant difference.

History's first IRB-approved blinded, randomized controlled trial to compare cannabinoid products against melatonin finds meaningful improvements in sleep across all products. Results reveal no significant differences in sleep improvement between melatonin compared to all of the cannabinoid-containing products (including those with only cannabinoids and no melatonin) with the exception of one that performed significantly worse than melatonin.

Study results suggest that the combination of certain cannabinoids and melatonin may confer greater improvement in sleep duration than melatonin alone, calling for further research into these combinations—especially given animal studies suggesting interplay between the endocannabinoid system and the pineal gland that produces melatonin.  

While the cannabinoid study products had similar incidence of total side effects relative to melatonin, the participants receiving products with cannabinoids (including cannabinoids in combination with melatonin) reported lower incidences of grogginess relative to melatonin only. Therefore, cannabinoid products warrant further attention and research as effective alternatives or additions to melatonin that may avoid or reduce one of its most common and cumbersome side effects.

Moreover, the combination of CBD, CBN and CBC in a defined ratio may be a particularly promising alternative to melatonin, especially in those who have concurrent pain or anxiety in addition to their sleep disturbance, warranting further exploration.  

"This is fascinating data that is the first-of-its-kind," said OBX CEO Dave Neundorfer. "We have always been committed to industry-leading R&D, and this historic data further bolsters our endeavors to create the most effective formulations that enhance wellbeing.  What's especially interesting is that cannabinoid formulations for sleep can also help people who also experience pain or anxiety. Instead of having to take several products to address their ailments, they may be able to take just one."  

"With sleep issues impacting 50 to 70 million Americans, scientifically-validated research is needed more than ever on how to help improve rest. Sleep is among one of the most popular therapeutic usages for cannabinoids, and we're excited to have begun this groundbreaking work in researching formulations and dosages to discover those with greatest effect," shared Dr. Jeff Chen, Radicle Science's CEO and co-founder.    

Radicle Science and OBX's next study will be a blinded, randomized controlled trial on formulations containing the cannabinoid THCV to explore effects on energy, focus and appetite.  

Radicle Science is an AI-driven healthtech B-corp offering history's first easy path for non-pharmaceutical products to prove their true effects. Radicle Science leverages a crowdsourced, virtual, direct-to-consumer (D2C) approach enabling research across diverse populations and conditions at unprecedented affordability, speed and scale. The company's Radicle vision is an abundant future where democratized access to clinical trials transforms non-pharmaceutical products into proven personalized medicines that are accessible to all without gatekeepers. To learn more about Radicle Science, visit www.RadicleScience.com. 

Headquartered in Roxboro, NC, Open Book Extracts is a cGMP-certified manufacturer of premium plant-based cannabinoid products aiming to be the industry's true north by delivering premium products, exceptional service and industry-leading transparency. With control of the entire supply chain, a state-of-the-art extraction campus near North Carolina's Research Triangle, proprietary refinement and conversion methods backed by a growing IP portfolio and a team of PhD chemists and seasoned business leaders, OBX is the trusted partner for global brands seeking to enter the marketplace. Learn more at www.OpenBookExtracts.com. 

SOURCE Radicle Science