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

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.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Other: Cannabigerol; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Walnut, California, United States, 91789
      • Virtual Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Chris Emerson
• Collaborators: Curebase Inc.; Veterans Cannabis Group; Santa Cruz Veterans Alliance

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2021
• Primary Completion (Actual): May 9, 2022
• Study Completion (Actual): May 11, 2022

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 4, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: VetsECS21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No