A Randomized, Double-Blind, Placebo Controlled Trial to Assess the Effectiveness and Safety of Melatonin and Three Formulations of Floraworks Proprietary TruCBN™ for Improving Sleep

Abstract

AbstractIntroduction: Prescription sleep aids often have side effects, making alternative solutions necessary. Melatonin is an efficacious sleep aid and is often the comparator for alternatives. The phytocannabinoid cannabinol (CBN), has a potential mechanism of action but minimal evidence to support its effectiveness. Methods: TruCBN™ is a hemp-derived cannabinol (CBN) sleep aid. The primary aim of this randomized, double-blind, placebo-controlled study was to assess the safety and effects of three formulations of TruCBN™ [25 mg (n=206), 50 mg (n=205), 100 mg (n=203)], on sleep quality measured by PROMIS Sleep Disturbance 8A scale, relative to placebo (n=204). As a secondary aim, the effectiveness and safety of these formulations relative to a 4 mg melatonin (n=202) were assessed. Exploratory measures were stress (PROMIS Stress 4A), anxiety (Anxiety 4A), pain (PROMIS™ PEG) and well-being (WHO 5). Results: All treatment groups (25, 50 and 100 mg TruCBN™) and the 4 mg melatonin group experienced significant improvement in sleep quality relative to placebo. There were no significant differences between any of the TruCBN™ groups and melatonin for improving sleep. Participants taking 100 mg TruCBN™ showed a larger decrease in stress compared to the placebo group. There were no significant differences in anxiety, pain, well-being or frequency of side effects between any TruCBN™ group and placebo. There was no significant difference in improvements in sleep quality between any of the treatment groups and 4mg melatonin. Discussion: Orally ingested TruCBN™, 25 mg, 50 mg and 100 mg, is a safe and effective alternative for the improvement of sleep.Sterling Institutional Review Board (SIRB) approved the study [10147-EKPauli]. The study was registered onClinicalTrials.gov[NCT05511818] on August 21, 2023.