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

Not Applicable

Completed

• Conditions: Sleep
• Interventions: Other: Cannabigerol; Other: Placebo

• Registration Number: NCT05088018
• Lead Sponsor: Chris Emerson

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-11
• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-10-11
• Study First Posted: 2021-10-21
• Primary Completion: 2022-05-09
• Study Completion: 2022-05-11
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-04
• Last Update Posted: 2022-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Cannabigerol	Cannabigerol	25 mg daily swallowable Cannabigerol tablets for 2 weeks, immediately followed by 50 mg daily swallowable Cannabigerol tablets for 2 weeks
Placebo	Placebo	25 mg daily swallowable placebo tablets for 2 weeks, immediately followed by 50 mg daily swallowable placebo tablets for 2 weeks

Primary Outcome Measures

Name	Time	Method
Medical Outcomes Study (MOS) Sleep Problems Index II	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

Name	Time	Method
WHO-DAS-2.0-12	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.

Trial Locations

Locations (1)

Virtual Site; 🇺🇸 Walnut, California, United States