Sleep
Conditions
Brief summary
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.
Interventions
OTHERCannabigerol
Cannabigerol is a non-psychoactive cannabinoid obtained from the cannabis plant.
OTHERPlacebo
A placebo form of the same swallowable tablet with no cannabigerol
Sponsors
Veterans Cannabis Group
Curebase Inc.
Santa Cruz Veterans Alliance
Chris Emerson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medical Outcomes Study (MOS) Sleep Problems Index II | 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WHO-DAS-2.0-12 | 4 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sleep Biometric Activity | 4 weeks | Change in sleep Duration and quality from baseline to 4 weeks post-treatment, captured using a Fitbit Physical Activity Tracking Device |
| Activity Biometric Activity | 4 weeks | Change in activity Duration and quality from baseline to 4 weeks post-treatment, captured using a Fitbit Physical Activity Tracking Device |
| Heart Rate Biometric Activity | 4 weeks | Change in resting heart rate from baseline to 4 weeks post-treatment, captured using a Fitbit Physical Activity Tracking Device |
| Medical Outcomes Study (MOS) Sleep Problems Index II | 2 weeks | 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. |
Countries
United States
Outcome results
None listed