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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sleep

Intervention / Treatment
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* Other: Cannabigerol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Cannabigerol<br>25 mg daily swallowable Cannabigerol tablets for 2 weeks, immediately followed by 50 mg daily swallowable Cannabigerol tablets for 2 weeks | Other: Cannabigerol<br>* Cannabigerol is a non-psychoactive cannabinoid obtained from the cannabis plant.<br>|
| Placebo Comparator: Placebo<br>25 mg daily swallowable placebo tablets for 2 weeks, immediately followed by 50 mg daily swallowable placebo tablets for 2 weeks | Other: Placebo<br>* A placebo form of the same swallowable tablet with no cannabigerol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Outcomes Study (MOS) Sleep Problems Index II | Change in sleep quality from baseline scores as measured by the Medical Outcomes Study (MOS) Sleep Problems Index II after 4 weeks. Scores range from 0-100, with higher scores indicating a worse outcome. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WHO-DAS-2.0-12 | Change in qualify of life from baseline scores on the World Health Organization Disability Assessment Schedule, Version 2.0 after 4 weeks. Scores range from 12-60, with higher scores indicating a worse outcome. | 4 weeks |