Low Dose of Cannabidiol (CBD) to Treat Mild to Moderate Musculoskeletal Pain

Study Overview
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Brief Summary
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The purpose of the study is to evaluate whether Pure Green tablets is a better pain reliever for the treatment of mild to moderate musculoskeletal pain.

Official Title
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A Controlled-Dose Study Using A One Time Low Dose Cannabidiol Tablet For The Treatment of Mild to Moderate Musculoskeletal Pain

Conditions
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Musculoskeletal Pain

Intervention / Treatment
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* Drug: Cannabidiol (CBD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female at least 21 years of age; Subject has mild to moderate musculoskeletal pain; Pain for greater than or equal to 10 days of each month for 3 months prior to study entry for which the pain requires treatment. Has an Numeric Pain Rating Scale (NPRS) score of 3 or greater, If female, subject is practicing an approved method of birth control throughout the study; Subject is willing and able to comply with all protocol-specified requirements; Subject is willing to take Pure Green tablets only and will not take any other pain medications, Subject is willing to provide his/her written informed consent to participate in the study as stated in the informed consent document. Subject is willing to document pain scale scores in a diary. Exclusion Criteria: Subject has any condition for which the investigator does not feel the participant should be enrolled due to possible safety or compliance issues; Subject has received treatment with an investigational drug or therapy within 30 days or 5 half-lives (whichever is longer) prior to Day 1. Subject has a known allergy to active or inert ingredients of Pure Green tablets; Subject is taking a concomitant medication or treatment that would complicate use or interpretation of the study drug's effects (examples include: Cannabis (marijuana) or any cannabinoid products including Cannabidiol (CBD) or Tetrahydrocannabinol (THC); Any drug or herbal product that influences the endocannabinoid system (ECS)); Have serious cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study. Have a history of recurrent seizures other than febrile seizures. Have current or pending disability compensation or litigation issues that may compromise response to treatment, in the opinion of the investigator. Have a diagnosis of inflammatory arthritis (that is, rheumatoid arthritis) or an autoimmune disorder (excluding inactive Hashimoto's thyroiditis). Use of acupuncture, chiropractic maneuvers, transcutaneous electrical nerve stimulation (TENS), or similar procedures aimed to relieve any kind of pain. Patients who are anticipated by the investigator to require use of analgesic agents including but not limited to non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen/paracetamol, and opioids, or other excluded medication for the duration of the study. Are unwilling or unable to comply with the data collection method used to record their patient rated outcome data.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pure Green Tablet<br>A water-soluble sublingual tablet that contains 5 mg of cannabidiol (CBD). | Drug: Cannabidiol (CBD)<br>* A single dose of Cannabidiol (CBD) when patients experience musculoskeletal pain in the trial.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Pure Cannabidiol (CBD) tablets on safety in patient's with musculoskeletal pain using a self-reported pain scale score. | To evaluate the safety and efficacy of Pure Green Cannabidiol (CBD) sublingual tablets for the treatment of musculoskeletal pain by having patients evaluate their Numeric Pain Rating Scale (NPRS) score reported as 0-10 where 0 is no pain and 10 is the worst pain possible. | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate efficacy of a low dose of Cannabidiol (CBD) in the treatment of mild to moderate musculoskeletal pain. | To explore the impact of Pure Green sublingual tablets on patient self-reported Numeric Pain Rating Scale (NPRS), as a route of administration and reduction in baseline pain scores. | 1 Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBD, Cannabidiol, Musculoskeletal Pain, Pain