Clinical trial NCT05088018: Swallowable Cannabigerol Tablets for Sleep Quality In Veterans (Veterans Exploring Cannabigerol for Sleep)
Official title: A Placebo-controlled, Triple-blind, Pre-post Interventional Study of Swallowable Cannabigerol Tablets on Sleep Quality in Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Lead sponsor: Metta Medical, Inc
Sponsor class: INDUSTRY
Collaborators: name: Veterans Cannabis Group
name: Curebase Inc.
name: Santa Cruz Veterans Alliance
First posted: 2021-10-21
Enrollment: 68
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Medical Outcomes Study (MOS) Sleep Problems Index II
timeFrame: 4 weeks
Secondary outcomes:
measure: WHO-DAS-2.0-12
timeFrame: 4 weeks
Other outcomes:
measure: Sleep Biometric Activity
timeFrame: 4 weeks
measure: Activity Biometric Activity
timeFrame: 4 weeks
measure: Heart Rate Biometric Activity
timeFrame: 4 weeks
measure: Medical Outcomes Study (MOS) Sleep Problems Index II
timeFrame: 2 weeks
Locations:
city: Walnut
country: United States
facility: Virtual Site
state: California
Study officials:
References: