09.27.22
Radicle Science, a health technology B-Corp which conducts contract research for health and wellness products, recently completed history’s first clinical trial evaluating the effects of cannabinoids in comparison to melatonin for sleep-related outcomes, which is pending publication.
The cannabinoid products investigated were supplied by Open Book Extracts (OBX), a manufacturer and distributor for cannabinoid ingredients and finished products in the wellness and self-care markets.
The study, which was approved by the International Review Board, evaluated five cannabinoid ingredients. All products contained cannabidiol (CBD), while some contained additional rare cannabinoids such as cannabinol (CBN), and cannabichromene (CBC) in defined ratios. One contained CBD in combination with 5 mg of melatonin, while a control product contained only 5 mg of melatonin.
A total of 1,800 adults (56% female, 44% male) were enrolled into the study, and divided into one of five groups for each product that was assessed, taking the product nightly for four weeks. The participants regularly reported on their usage, side effects, sleep quality, and other health outcomes, including pain and anxiety.
Significant Improvements Across the Board
Across the board, there were no significant differences in the performances of the products on domains that were reported. Significant improvements were reported for the users of all five products when it came to self-reported sleep quality, well-being, anxiety, and pain assessments.
Throughout the study, the amount of average increased sleep that participants experienced from each different product ranged from 34-76 additional minutes nightly, with no significant differences between products.
Over 60% of the participants, across all study groups, experienced improvements that crossed “clinically important difference” thresholds in their sleep. 71% of participants who took either melatonin alone or melatonin in combination with CBD and CBN in a defined ratio experienced meaningful improvement, while 69% of participants taking a combination of CBD, CBN, and CBC in defined ratios experienced meaningful improvements as well.
Safety Data
All of the products used in the study exhibited favorable safety profiles – all side effects were mostly mild in nature, and there were no significant differences in the frequency of reported side effects for each product studied. No product caused more than 10% of participants to experience any side effects.
The participants who received products containing cannabinoids, including cannabinoids and melatonin combined, reported lower incidences of grogginess than those who received melatonin alone.
Those who reported pain and anxiety in addition to sleep disturbance at the start of the study were most likely to experience a meaningful improvement in pain and anxiety when taking the combination of CBD, CBN, and CBC, though the difference wasn’t clinically significant.
An Important Foothold for Cannabis in the Sleep Market
The study results suggest that the combination of certain cannabinoids and melatonin may confer greater improvement in sleep duration than melatonin alone, opening the opportunity to investigate this relationship further, according to Radicle Science. Further, animal studies suggest there is an interplay between the endocannabinoid system (a cell-signaling system involving cannabinoid receptors which is expressed through the central and peripheral nervous systems) and the production of melatonin in the pineal gland.
Cannabinoid products also warrant further attention as melatonin alternatives in order to reduce grogginess, one of melatonin’s common and cumbersome side effects, the company reports. The results also suggest that those with concurrent pain or anxiety might benefit more from CBD, CBN, and CBC in a defined ratio than melatonin, warranting further exploration, according to Radicle Science.
“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 experience pain or anxiety. Instead of having to take several products to address their ailments, they may be able to take just one.”
The cannabinoid products investigated were supplied by Open Book Extracts (OBX), a manufacturer and distributor for cannabinoid ingredients and finished products in the wellness and self-care markets.
The study, which was approved by the International Review Board, evaluated five cannabinoid ingredients. All products contained cannabidiol (CBD), while some contained additional rare cannabinoids such as cannabinol (CBN), and cannabichromene (CBC) in defined ratios. One contained CBD in combination with 5 mg of melatonin, while a control product contained only 5 mg of melatonin.
A total of 1,800 adults (56% female, 44% male) were enrolled into the study, and divided into one of five groups for each product that was assessed, taking the product nightly for four weeks. The participants regularly reported on their usage, side effects, sleep quality, and other health outcomes, including pain and anxiety.
Significant Improvements Across the Board
Across the board, there were no significant differences in the performances of the products on domains that were reported. Significant improvements were reported for the users of all five products when it came to self-reported sleep quality, well-being, anxiety, and pain assessments.
Throughout the study, the amount of average increased sleep that participants experienced from each different product ranged from 34-76 additional minutes nightly, with no significant differences between products.
Over 60% of the participants, across all study groups, experienced improvements that crossed “clinically important difference” thresholds in their sleep. 71% of participants who took either melatonin alone or melatonin in combination with CBD and CBN in a defined ratio experienced meaningful improvement, while 69% of participants taking a combination of CBD, CBN, and CBC in defined ratios experienced meaningful improvements as well.
Safety Data
All of the products used in the study exhibited favorable safety profiles – all side effects were mostly mild in nature, and there were no significant differences in the frequency of reported side effects for each product studied. No product caused more than 10% of participants to experience any side effects.
The participants who received products containing cannabinoids, including cannabinoids and melatonin combined, reported lower incidences of grogginess than those who received melatonin alone.
Those who reported pain and anxiety in addition to sleep disturbance at the start of the study were most likely to experience a meaningful improvement in pain and anxiety when taking the combination of CBD, CBN, and CBC, though the difference wasn’t clinically significant.
An Important Foothold for Cannabis in the Sleep Market
The study results suggest that the combination of certain cannabinoids and melatonin may confer greater improvement in sleep duration than melatonin alone, opening the opportunity to investigate this relationship further, according to Radicle Science. Further, animal studies suggest there is an interplay between the endocannabinoid system (a cell-signaling system involving cannabinoid receptors which is expressed through the central and peripheral nervous systems) and the production of melatonin in the pineal gland.
Cannabinoid products also warrant further attention as melatonin alternatives in order to reduce grogginess, one of melatonin’s common and cumbersome side effects, the company reports. The results also suggest that those with concurrent pain or anxiety might benefit more from CBD, CBN, and CBC in a defined ratio than melatonin, warranting further exploration, according to Radicle Science.
“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 experience pain or anxiety. Instead of having to take several products to address their ailments, they may be able to take just one.”
