Clinical trial explores cannabinoids for improving sleep

The Radicle Discovery Sleep Study is the first to compare the effect of cannabinoids to melatonin on sleep quality.

Radicle Science and Open Book Extracts (OBX) have stated that the majority of participants in the trial receiving a cannabinoid product experienced significant improvement in sleep quality and duration.

The participants that received a cannabinoid product also did not experience one of melatonin’s most common side effects – grogginess.

Read more: CBN, CBC and CBDa – the cannabinoids to have on your radar

Radicle Science, an AI-driven healthtech B-corp, announced the results of the study which involved 1,800 participants across the US. The Radicle Discovery Sleep Study was an Institutional Review Board (IRB) approved, blinded, randomised, controlled clinical trial evaluating the effects of different cannabinoid products relative to melatonin. 

Exploring cannabinoids for sleep

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, one of the most researched and widely used non-prescription sleep aids, were compared against a control product containing 5mg of melatonin only.

Radicle Science studied products supplied by OBX, an NSF- and ISO 9001-certified manufacturer and distributor.

The companies have stated that four of the five products showed sleep improvement comparable to the melatonin control arm, and that there were no significant differences in frequency of total side effects of all types between any of the products studied.

OBX CEO Dave Neundorfer, commented: “This is fascinating data that is the first-of-its-kind. We have always been committed to industry-leading R&D, and this historic data further bolsters our endeavours 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.”

Trial results

The company has stated that the results found the onset of effects from all the cannabinoid products in the trial were similar to the melatonin control product, with most participants noticing an effect within one hour of taking them.

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

More than 60 per cent of participants across all study groups experienced meaningful improvements in their sleep. A total of 71 per cent of participants taking melatonin alone or melatonin in combination with CBD and CBN in a defined ratio also experienced meaningful improvement and 69 per cent of participants taking a combination of CBD, CBN, and CBC in a defined ratio experienced meaningful improvement as well.

According to the companies, the side effects were mostly mild in nature, and there were no significant differences in the frequency of reported side effects between all six study groups. 

However, the participants receiving products containing cannabinoids, including the product containing cannabinoids and melatonin, reported lower incidences of grogginess than those who received melatonin alone.

Additionally, 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. The companies states that this was greater than any other study product, including the melatonin control, butnot with a statistically significant difference.

Over all, the results revealed 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.

The 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.

Radicle Science’s CEO and co-founder, Dr Jeff Chen, commented: “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.”

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

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