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

Sleep Clinical Trial

— ECS21  

Official title:

A Placebo-controlled, Triple-blind, Pre-post Interventional Study of Swallowable Cannabigerol Tablets on Sleep Quality in Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05088018
• Other study ID #: VetsECS21
• Status: Completed
• Phase: N/A
• Start date: October 11, 2021
• Est. completion date: May 11, 2022

Study information

• Verified date: June 2022
• Source: Metta Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 11, 2022
• Est. primary completion date: May 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

Other:
• Cannabigerol
Cannabigerol is a non-psychoactive cannabinoid obtained from the cannabis plant.
• Placebo
A placebo form of the same swallowable tablet with no cannabigerol

Locations

Country	Name	City	State
United States	Virtual Site	Walnut	California

Sponsors (4)

Lead Sponsor	Collaborator
Chris Emerson	Curebase, Santa Cruz Veterans Alliance, Veterans Cannabis Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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