NCT05088018

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

October 11, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 21, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2022

Completed
Last Updated

June 7, 2022

Status Verified

June 1, 2022

Enrollment Period

7 months

First QC Date

October 11, 2021

Last Update Submit

June 4, 2022

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • WHO-DAS-2.0-12

    4 weeks

Other Outcomes (4)

  • Sleep Biometric Activity

    4 weeks

  • Activity Biometric Activity

    4 weeks

  • Heart Rate Biometric Activity

    4 weeks

  • +1 more other outcomes

Study Arms (2)

Active Cannabigerol

EXPERIMENTAL

25 mg daily swallowable Cannabigerol tablets for 2 weeks, immediately followed by 50 mg daily swallowable Cannabigerol tablets for 2 weeks

Other: Cannabigerol

Placebo

PLACEBO COMPARATOR

25 mg daily swallowable placebo tablets for 2 weeks, immediately followed by 50 mg daily swallowable placebo tablets for 2 weeks

Other: Placebo

Interventions

CannabigerolOTHER

Cannabigerol is a non-psychoactive cannabinoid obtained from the cannabis plant.

Active Cannabigerol
PlaceboOTHER

A placebo form of the same swallowable tablet with no cannabigerol

Placebo

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virtual Site

Walnut, California, 91789, United States

Location

Related Publications (1)

  • Emerson CR, Webster CE, Daza EJ, Klamer BG, Tummalacherla M. Effect of Cannabigerol on Sleep and Quality of Life in Veterans: A Decentralized, Randomized, Placebo-Controlled Trial. Med Cannabis Cannabinoids. 2025 Dec 9;9(1):1-14. doi: 10.1159/000549902. eCollection 2026 Jan-Dec.

    PMID: 41574318DERIVED

MeSH Terms

Interventions

cannabigerol

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
CEO & Founder

Study Record Dates

First Submitted

October 11, 2021

First Posted

October 21, 2021

Study Start

October 11, 2021

Primary Completion

May 9, 2022

Study Completion

May 11, 2022

Last Updated

June 7, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)