Effectiveness of TruCBN for Improving Sleep, with Vaughn Hartung

In the first ever trial comparing the effect of CBN against placebo, results showed participants taking TruCBN had no significant differences in sleep improvement than participants taking melatonin.¹

TruCBN, a hemp-derived, THC-free, non-psychoactive cannabinol, is the first cannabinoid to be clinically validated for improving sleep quality.² Vaughn Hartung, BS, the founder and vice president of science and technology at FloraWorks, presented the data at SLEEP 2024, the 38th annual meeting of the Associated Professional Sleep Societies in Houston.¹

The randomized, double-blind, placebo-controlled trial found 3 groups of TruCBN—either taking 25, 50, or 100 mg—all showed significant improvements compared to placebo. Participants on 4 mg of melatonin also showed significant improvement in sleep compared to placebo.

Over half (53.6%) of participants receiving TruCBN 50 mg had clinically meaningful sleep improvements—the greatest percentage out any of the groups, including the melatonin group. However, the improvement seen in the melatonin group was not significantly different from the improvement seen in any of the TruCBN groups. The study also found the adverse events of both TruCBN and melatonin were mild to moderate with no significant differences.

In an interview with HCPLive at SLEEP 2024, Hartung discussed the study’s results and how CBN compares to melatonin in treating sleep issues.

HCPLive: How does the truCBN compare with other commonly used sleep treatments in terms of efficacy and safety?

Hartung: We're finding that truCBN is quite safe… [with] extremely low toxic and essentially minimum side effects. As far as efficacy goes, that's what we're studying today. We’re interested in studying how efficacious cannabinoids can be, and what the therapeutic effects of pedialytes are outside of psychoactivity.

HCPLive: What dosing recommendations would you recommend for the truCBN based on the study?

Hartung: For a clinician who's interested in trying a new dietary intervention, 50 milligrams was a clinically significant improvement over 25 milligrams, and we really didn't see further significance.

HCPLive: Given that both truCBN and melatonin showed significant improvements, how would you decide between prescribing truCBN versus melatonin?

Hartung: Like melatonin, we view truCBN as a dietary intervention. I should say, potentially, these are something for their patients to try where melatonin isn't functioning for them or working for them, or where they're looking for an alternative sleep aid.

HCPLive: How significant is the dose response relationship observed in the study?

Hartung: The dose response relationship is something we need to continue to follow up on. But as I said, we had a clinically significant finding with the dose response, where 50 milligrams appear to be the optimum dose.

HCPLive: What considerations would you have for the long-term use of truCBN in patients with chronic sleep issues?

Hartung: This is something for us to continue to further study. We're interested in studying this in different cohorts and understanding within even individual patient populations what sorts of different chronic effects might be exhibited. In the study that we ran, we found that there were no statistically significant clinical side effects to this for over a 4-week timeframe. We certainly have seen in other datasets that there don't appear to be long term side effects that's related to this.

HCPLive: What about adverse effects in general?

Hartung: We didn't see any statistically significant adverse effects… [only] at a very small percentage. The first effect that we saw was a drowsiness effect, at less than a 1% level within one of the populations, but again, not statistically significant for general side effects.

HCPLive: What additional research would you like to see further validated with the use of true CBN in clinical practice?

Hartung: We’d love to continue to study…different cohorts, but [also] truCBN in patients where melatonin may not be an option. We're extremely interested in studying patients with other neurological conditions because this might be a neurological basic effect. We're interested in studying this in dementia populations, for example, and in individuals with TBI, where melatonin is not an option and prescription sleep aids may exacerbate some of their some of their symptoms.

References

1. ^{Hartung, V. A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Effectiveness of TruCBN™ for Improving Sleep. Abstract presented at SLEEP 2024. Houston, TX. June 3, 2024.}
2. ^{Clinical Validation Data for FloraWorks' TruCBN to be Presented at SLEEP 2024. Newsfile. May 30, 2024. https://www.newsfilecorp.com/release/210996. Accessed June 11, 2024.}