SleepECS21NCT05088018
Swallowable Cannabigerol Tablets for Sleep Quality In Veterans (Veterans Exploring Cannabigerol for Sleep)
A study testing Cannabigerol in people with Sleep, run by Chris Emerson at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Cannabigerol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2021to 11 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sleep
- Being tested
- Cannabigerol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabigerolOther
Cannabigerol is a non-psychoactive cannabinoid obtained from the cannabis plant.
PlaceboOther
A placebo form of the same swallowable tablet with no cannabigerol
| Study group | Role | What they receive |
|---|---|---|
| Active Cannabigerol | Experimental | 25 mg daily swallowable Cannabigerol tablets for 2 weeks, immediately followed by 50 mg daily swallowable Cannabigerol tablets for 2 weeks Receives: Other: Cannabigerol |
| Placebo | Placebo comparator | 25 mg daily swallowable placebo tablets for 2 weeks, immediately followed by 50 mg daily swallowable placebo tablets for 2 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (1)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start11 Oct 2021
- Primary completion9 May 2022
- Study completion11 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chris Emerson
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Veterans Cannabis Group, Curebase Inc., Santa Cruz Veterans Alliance
- Responsible party
- Sponsor-investigator, Chris Emerson, Metta Medical, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088018
- Sponsor's protocol ID
- VetsECS21
- Acronym
- ECS21
- Status last verified
- Jun 2022
- First submitted
- 11 Oct 2021
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41574318
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Triple-blind, Pre-post Interventional Study of Swallowable Cannabigerol Tablets on Sleep Quality in Veterans
- ClinicalTrials.gov ID
- NCT05088018
- Acronym / sponsor ID
- ECS21 / VetsECS21
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Chris EmersonIndustry (pharma, biotech, devices)
- Collaborators
- Veterans Cannabis Group, Curebase Inc., Santa Cruz Veterans Alliance
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 9 May 2022 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Cannabigerol | Experimental | Other: Cannabigerol25 mg daily swallowable Cannabigerol tablets for 2 weeks, immediately followed by 50 mg daily swallowable Cannabigerol tablets for 2 weeks |
| Placebo | Placebo comparator | Other: Placebo25 mg daily swallowable placebo tablets for 2 weeks, immediately followed by 50 mg daily swallowable placebo tablets for 2 weeks |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabigerolCannabigerol is a non-psychoactive cannabinoid obtained from the cannabis plant. | Other | Active Cannabigerol |
| PlaceboA placebo form of the same swallowable tablet with no cannabigerol | Other | Placebo |
Primary outcome
Medical Outcomes Study (MOS) Sleep Problems Index II
Time frame: 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.
1 secondary outcome
WHO-DAS-2.0-12
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Derived from this study: PubMed 41574318Emerson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cannabigerol in people with Sleep, run by Chris Emerson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical Outcomes Study (MOS) Sleep Problems Index II (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05088018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022.