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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05088018
Recruitment Status : Completed
First Posted : October 21, 2021
Last Update Posted : June 7, 2022
Sponsor:
Collaborators:
Veterans Cannabis Group
Curebase Inc.
Santa Cruz Veterans Alliance
Information provided by (Responsible Party):
Chris Emerson, Metta Medical, Inc

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sleep Other: Cannabigerol Other: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-controlled, Triple-blind, Pre-post Interventional Study of Swallowable Cannabigerol Tablets on Sleep Quality in Veterans
Actual Study Start Date : October 11, 2021
Actual Primary Completion Date : May 9, 2022
Actual Study Completion Date : May 11, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Active Cannabigerol
25 mg daily swallowable Cannabigerol tablets for 2 weeks, immediately followed by 50 mg daily swallowable Cannabigerol tablets for 2 weeks
 Other: Cannabigerol
Cannabigerol is a non-psychoactive cannabinoid obtained from the cannabis plant.
Placebo Comparator: Placebo
25 mg daily swallowable placebo tablets for 2 weeks, immediately followed by 50 mg daily swallowable placebo tablets for 2 weeks
 Other: Placebo
A placebo form of the same swallowable tablet with no cannabigerol


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. WHO-DAS-2.0-12 [ Time Frame: 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 Outcome Measures:
  1. Sleep Biometric Activity [ Time Frame: 4 weeks ]
    Change in sleep Duration and quality from baseline to 4 weeks post-treatment, captured using a Fitbit Physical Activity Tracking Device

  2. Activity Biometric Activity [ Time Frame: 4 weeks ]
    Change in activity Duration and quality from baseline to 4 weeks post-treatment, captured using a Fitbit Physical Activity Tracking Device

  3. Heart Rate Biometric Activity [ Time Frame: 4 weeks ]
    Change in resting heart rate from baseline to 4 weeks post-treatment, captured using a Fitbit Physical Activity Tracking Device

  4. Medical Outcomes Study (MOS) Sleep Problems Index II [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05088018


Locations
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United States, California
Virtual Site
Walnut, California, United States, 91789
Sponsors and Collaborators
Chris Emerson
Veterans Cannabis Group
Curebase Inc.
Santa Cruz Veterans Alliance
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Chris Emerson, CEO & Founder, Metta Medical, Inc
ClinicalTrials.gov Identifier: NCT05088018    
Other Study ID Numbers: VetsECS21
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: June 7, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No