The Veterans ECS21 (Exploring Cannabigerol for Sleep) Study: A protocol for the first randomized clinical trial of Cannabigerol (CBG), a decentralized study designed for U.S. Veterans in California
Webster, C. E.; Emerson, C. R.; Daza, E. J.
Show abstract
The Veterans ECS21 (Exploring Cannabigerol for Sleep) Study is the first clinical trial of Cannabigerol (CBG), a non-psychoactive cannabinoid (ClinicalTrials.gov Identifier: NCT05088018). This study investigates if CBG improves sleep for U.S. Veterans in California using a fully remote (decentralized), randomized, placebo-controlled, triple-blind, pre-post study design. Over 100 participants will be recruited through Veterans advocacy organizations, email campaigns, and point-of-sale displays at cannabis dispensaries. Participants will be provided with a study application to assess sleep quality, quality of life, and PTSD-related symptoms. A Fitbit Inspire 2 will be used to collect sleep, activity, and cardiovascular biometrics. After a two-week run-in phase, participants will begin a four-week treatment phase with a dose escalation from 25 mg daily CBG (CBG Protab by LEVEL) up to 50 mg CBG daily. The present paper describes how we designed this study to overcome specific challenges. We held participant insight panels to learn Veterans lived experience and design ways to lower their obstacles to clinical research participation. We designed digital engagement strategies to maintain high participation and retention for a fully remote (decentralized) study, selected fit-for-purpose passive data collection mechanisms, and addressed common reproducibility issues in cannabis research.
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