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

Abstract: Introduction: This decentralized, randomized, triple-blind, placebo-controlled study evaluated efficacy and safety of oral cannabigerol (CBG) in Veterans with sleep issues.Methods: After a two-week run-in phase, participants received CBG (25 mg daily for two weeks, then 50 mg daily for a further two weeks) or placebo. The primary endpoint was change in sleep quality via the Medical Outcomes Study Sleep Problems Index II questionnaire (MOS-SS SPI-II). Additional endpoints included change in quality of life measured via the World Health Organization Disability Assessment Schedule, version 2.0 instrument (WHODAS-2.0–12), post-traumatic stress disorder (PTSD) symptoms evaluated via the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5 (PCL-5), and sleep actigraphy data via Fitbit. Results: 63 participants were randomized to receive CBG (n=33) or placebo (n=30). 35 participants completed the study without major protocol deviations (CBG [n=18]; placebo [n=17]). MOS-SS SPI-II scores indicated improved sleep with no statistically significant difference between the CBG and placebo groups. Similar patterns were observed for WHODAS-2.0–12 and PCL-5 scores. CBG was well tolerated. Conclusion: While no firm conclusion on the efficacy of CBG in improving sleep can be made, the favorable safety profile supports future studies with CBG. ClinicalTrials.gov ID: NCT05088018

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