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

NCT05088018 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2022-06-07

No results posted yet for this study

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.

Conditions

  • Sleep

Interventions

OTHER

Cannabigerol

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

OTHER

Placebo

A placebo form of the same swallowable tablet with no cannabigerol

Sponsors & Collaborators

  • Veterans Cannabis Group

    collaborator UNKNOWN

  • Curebase Inc.

    collaborator INDUSTRY

  • Santa Cruz Veterans Alliance

    collaborator UNKNOWN

  • Chris Emerson

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-11
Primary Completion
2022-05-09
Completion
2022-05-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05088018 on ClinicalTrials.gov