Effect of Cannabigerol on Sleep and Quality of Life in Veterans: A Decentralized, Randomized, Placebo-Controlled Trial.

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 2-week run-in phase, participants received CBG (25 mg daily for 2 weeks, then 50 mg daily for a further 2 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

A total of 63 participants were randomized to receive CBG (n = 33) or placebo (n = 30). A total of 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.