Swallowable Cannabigerol Tablets for Sleep Quality In Veterans (Veterans Exploring Cannabigerol for Sleep) (ECS21)

Metta Medical

Status: Completed

Conditions: Sleep

Treatments: Other: Cannabigerol; Other: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05088018

VetsECS21

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 2 patient groups, including a placebo group

Active Cannabigerol

Experimental group

Description:

25 mg daily swallowable Cannabigerol tablets for 2 weeks, immediately followed by 50 mg daily swallowable Cannabigerol tablets for 2 weeks

Treatment:

Other: Cannabigerol

Placebo

Placebo Comparator group

Description:

25 mg daily swallowable placebo tablets for 2 weeks, immediately followed by 50 mg daily swallowable placebo tablets for 2 weeks

Treatment:

Other: Placebo