Swallowable Cannabigerol Tablets for Sleep Quality In Veterans (Veterans Exploring Cannabigerol for Sleep)

A Placebo-controlled, Triple-blind, Pre-post Interventional Study of Swallowable Cannabigerol Tablets on Sleep Quality in Veterans

New methods for the treatment and support of Veterans experiencing sleep issues is critically needed. LEVEL's unique, targeted effects-based cannabis products provide a unique opportunity to study the therapeutic safety and efficacy of cannabigerol (a non-psychoactive cannabinoid) with a controlled dosage. Study participants will participate in an interventional, placebo-controlled, triple-blind pre-post study design. Participants will have a four-week run-in phase followed by an eight-week treatment phase with a CBG ProtabTM or placebo ProtabTM in a swallowable tablet form. During the study, participants will answer questions assessing their sleep, alcohol and drug use, and quality of life, among others. They will also wear a Fitbit Inspire 2 to collect biometric data.

Inclusion Criteria:

• Veteran status
• MOS Sleep Problems Index II > 30
• California resident
• Participants must own their own smartphone device to use for the study. Devices must meet the following criteria:
• Participants must be comfortable reading study instructions in English and communicating with study team in English
• Be willing to commit to study dosing, completing evaluation instruments, and following study protocol activities.
• If female and of childbearing potential, agree to use an effective form of birth control during study participation.

Exclusion Criteria:

• If using sleep medications, medication and dosage have not been changed in the past month and will remain unchanged for the duration of the study
• If using other psychotropic medications, medication and dosage have not been changed in the past 2 months, and will remain unchanged for the duration of the study
• Prior observation that the prospective participant has stopped breathing or observed choking/gasping during their sleep
• Previous diagnosis of sleep apnea (participant reported) without use of a CPAP (or similar PAP device) for at least the prior 4 weeks
• Currently in a Cognitive Behavioral Therapy for Insomnia (CBTI) program
• Women who are currently pregnant, trying to become pregnant, or breastfeeding
• Currently using CBG on a regular basis
• Participant has already participated in this study