The largest clinical trial in history on cannabinoids and sleep finds significant improvements
Radicle Science and Open Book Extracts release the results of the first clinical trial in history comparing cannabinoids to melatonin, with the majority of participants receiving a cannabinoid product experiencing a significant improvement in the quality and duration of sleep , and even less of one of the most common and cumbersome side effects of melatonin: grogginess
Radicle Science, an AI-driven health B-corp offering the first easy path for health and wellness products to prove their true effects, today announced the results of the first-ever clinical trial comparing cannabinoids to melatonin for sleep results. Studying 1,800 participants across the United States, the The discovery of the rootTM sleep study, carried out exclusively with Open Book Abstracts (OBX), is the largest clinical trial in history researching cannabinoids for sleep outcomes – and the largest trial of products containing cannabinol (CBN).
Radicle Science has researched products provided 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 the products examined in the study showed significant improvements in the quality and duration of sleep. Four of the five products showed comparable sleep improvement (ie no statistically significant difference) to the melatonin control arm. There were no significant differences in the frequency of total side effects of all types between any of the products studied.
CLINICAL TRIAL METHODOLOGY
U The discovery of the rootTM Sleep study was an Institutional Review Board (IRB)-approved randomized controlled clinical trial that evaluated the effects of various cannabinoid products in relation to melatonin. Five cannabinoid products all containing CBD, with some containing additional rare cannabinoids such as cannabinol (CBN) and cannabichromene (CBC), and one containing an additional 5mg of melatonin, were compared with a control product containing only 5mg of melatonin. Melatonin is one of the most researched and used over-the-counter 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 alone every day for four weeks. Participants regularly reported on their use, side effects, sleep quality and other health outcomes, including pain and anxiety.
STUDY RESULTS ON SLEEP QUALITY, DURATION, SIDE EFFECTS AND WELL-BEING
Participants in all study groups saw significant improvements in sleep quality, well-being, anxiety and pain. The onset of effects of all cannabinoid products were similar to the melatonin control product, with most participants noticing an effect within an hour of taking their product.
Throughout the study, the amount of average increased sleep that participants experienced from each different product ranged from 34 to 76 additional minutes each night, although there was no statistically significant difference between the products.
The majority (>60%) of participants in all study groups experienced significant 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 significant improvement and 69% of participants taking a combination of CBD, CBN and CBC in a defined report have experienced significant. also improve.
All study products show a favorable safety profile. Side effects were mostly mild in nature, and there were no significant differences in the frequency (~10%) of side effects reported between all six study groups. However, participants receiving products containing cannabinoids (including the product containing cannabinoids + melatonin) reported lower incidence of grogginess than those who received melatonin alone.
Of those who also reported pain and anxiety in addition to sleep disturbances at the start of the study, the largest proportion of participants who experienced a significant improvement in their pain and anxiety were those who take the combination of CBD, CBN and CBC. This was greater than any other study product (including the melatonin control), but not with a statistically significant difference.
KEY POINTS AND FUTURE STUDIES
The first blinded randomized controlled trial, approved by the IRB in history to compare cannabinoid products with melatonin finds significant improvements in sleep in all products. The results did not reveal significant differences in the improvement of sleep between melatonin compared to all products containing cannabinoids (including those with only cannabinoids and without melatonin) with the exception of the one that did significantly worse than melatonin.
The results of studies suggest that the combination of certain cannabinoids and melatonin can confer a greater improvement in sleep duration than melatonin alone, calling for more research into these combinations, especially animal studies that suggest the interaction between the endocannabinoid system and the pineal gland that produces melatonin.
While the cannabinoid study products had a similar incidence of total side effects relative to melatonin, participants receiving products with cannabinoids (including cannabinoids in combination with melatonin) reported lower incidences of grogginess compared to melatonin alone. Therefore, cannabinoid products warrant more attention and research as effective alternatives or additions to melatonin that can avoid or reduce one of its most common and cumbersome side effects.
In addition, the combination of CBD, CBN and CBC in a defined ratio can be a particularly promising alternative to melatonin, especially in those who have pain or simultaneous anxiety in addition to their sleep disturbance, which warrants further exploration .
“This is fascinating data that is the first of its kind,” said OBX CEO Dave Neundorfer. “We have always been engaged in industry-leading R&D, and this historical data further strengthens our efforts to create the most effective formulations that increase well-being. What is particularly interesting is that the formulations of cannabinoids for sleep can also help people who also have pain or anxiety. Instead of having to take several products to face their illnesses, they may be able to take just one.”
“With sleep problems impacting 50 to 70 million Americans, scientifically validated research is needed more than ever to help improve sleep. Sleep is one of the most popular therapeutic uses for cannabinoids, and we are excited to begin this groundbreaking work in researching formulations and dosages to discover the ones with the most effect,” shared Dr. Jeff Chen, CEO and co-founder of Radicle Science. .
The next study by Radicle Science and OBX will be a blinded, randomized controlled trial on formulations containing the cannabinoid THCV to explore the effects on energy, focus and appetite.
Radicle Science is an AI-driven healthcare B-corp offering the first easy path in history for non-pharmaceutical products to prove their true effects. Radicle Science leverages a crowdsourced, virtual, direct-to-consumer (D2C) approach that enables research in diverse populations and conditions at unprecedented accessibility, 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 that aims to be the industry’s true north by offering 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 refining and conversion methods supported by a growing IP portfolio and a team of PhD chemists and executives of experienced companies, OBX is the trust. partner for global brands looking to enter the market. Learn more at www.OpenBookExtracts.com.