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| Name | Class |
|---|---|
| Veterans Cannabis Group | UNKNOWN |
| Curebase Inc. | INDUSTRY |
| Santa Cruz Veterans Alliance | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Cannabigerol | Experimental | 25 mg daily swallowable Cannabigerol tablets for 2 weeks, immediately followed by 50 mg daily swallowable Cannabigerol tablets for 2 weeks |
|
| Placebo | Placebo Comparator | 25 mg daily swallowable placebo tablets for 2 weeks, immediately followed by 50 mg daily swallowable placebo tablets for 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabigerol | Other | Cannabigerol is a non-psychoactive cannabinoid obtained from the cannabis plant. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Biometric Activity | Change in sleep Duration and quality from baseline to 4 weeks post-treatment, captured using a Fitbit Physical Activity Tracking Device | 4 weeks |
| Activity Biometric Activity | Change in activity Duration and quality from baseline to 4 weeks post-treatment, captured using a Fitbit Physical Activity Tracking Device |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virtual Site | Walnut | California | 91789 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41574318 | Derived | Emerson CR, Webster CE, Daza EJ, Klamer BG, Tummalacherla M. Effect of Cannabigerol on Sleep and Quality of Life in Veterans: A Decentralized, Randomized, Placebo-Controlled Trial. Med Cannabis Cannabinoids. 2025 Dec 9;9(1):1-14. doi: 10.1159/000549902. eCollection 2026 Jan-Dec. |
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| ID | Term |
|---|---|
| C037036 | cannabigerol |
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| Placebo | Other | A placebo form of the same swallowable tablet with no cannabigerol |
|
| 4 weeks |
| Heart Rate Biometric Activity | Change in resting heart rate from baseline to 4 weeks post-treatment, captured using a Fitbit Physical Activity Tracking Device | 4 weeks |
| 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 2 weeks' treatment. Scores range from 0-100, with higher scores indicating a worse outcome. | 2 weeks |