Effect of cannabigerol on sleep and quality of life in Veterans: A decentralized, randomized, placebo-controlled trial

Background/ObjectiveThis decentralized, randomized, triple-blind, placebo-controlled study evaluated the efficacy and safety of an oral cannabigerol (CBG) formulation in Veterans with sleep issues. MethodsAfter inclusion, randomization and a two-week run-in phase, participants received CBG (25 mg daily for two weeks, escalated to 50 mg daily for a further two weeks) or placebo. The primary endpoint was change in sleep quality, assessed via the Medical Outcomes Study Sleep Problems Index II (MOS-SS SPI-II). Additional endpoints included change in quality of life (WHODAS-2.0-12), post-traumatic stress disorder symptoms (PCL-5) and sleep actigraphy data. Safety was assessed based on adverse event reporting. ResultsA total of 63 participants were randomized to receive CBG (n=33) or placebo (n=30) and formed the intention-to-treat (ITT) population. Of these, 35 completed the study without major protocol deviations (CBG [n=18]; placebo [n=17]) and formed the per-protocol (PP) population. During active treatment (between day 14 and day 42) MOS-SS SPI-II scores declined numerically (indicating improved sleep) in both treatment groups (in both the ITT and the PP populations) with no statistically discernible difference between the CBG and placebo groups. Similar patterns were observed for WHODAS-2.0-12 and PCL-5 scores. Actigraphy data indicated no discernible difference in sleep patterns between the treatment groups. Five mild, nonserious, adverse events were reported with CBG. ConclusionsBoth CBG and placebo tended towards sleep and QoL improvement in Veterans. While no firm conclusion on the efficacy of CBG in improving sleep can be made, the favorable safety profile supports future studies to investigate the benefit of CBG.