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OpenTrials
Completed

NCT Number: NCT05088018

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

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.

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Key information

Conditions

Sleep

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virtual Site

Walnut, California, 91789, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cannabigerol

Other

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

Placebo

Other

A placebo form of the same swallowable tablet with no cannabigerol

Primary outcomes

  1. Medical Outcomes Study (MOS) Sleep Problems Index II

    Time frame: 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 outcomes

  1. WHO-DAS-2.0-12

    Time frame: 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.

Other outcomes

  1. Sleep Biometric Activity

    Time frame: 4 weeks

    Change in sleep Duration and quality from baseline to 4 weeks post-treatment, captured using a Fitbit Physical Activity Tracking Device

  2. Activity Biometric Activity

    Time frame: 4 weeks

    Change in activity Duration and quality from baseline to 4 weeks post-treatment, captured using a Fitbit Physical Activity Tracking Device

  3. Heart Rate Biometric Activity

    Time frame: 4 weeks

    Change in resting heart rate from baseline to 4 weeks post-treatment, captured using a Fitbit Physical Activity Tracking Device

  4. Medical Outcomes Study (MOS) Sleep Problems Index II

    Time frame: 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

Chris Emerson

Industry

Collaborators

  • Curebase Inc.
  • Santa Cruz Veterans Alliance
  • Veterans Cannabis Group

Registry information

Official study title

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

Acronym: ECS21

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 21, 2021
Registry last updated
Jun 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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