- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04193631
Low Dose of Cannabidiol (CBD) to Treat Mild to Moderate Musculoskeletal Pain
March 23, 2020 updated by: Pure Green
A Controlled-Dose Study Using A One Time Low Dose Cannabidiol Tablet For The Treatment of Mild to Moderate Musculoskeletal Pain
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Chadds Ford, Pennsylvania, United States, 19317
- Dr. Kimless' Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Pure Green Tablet
A water-soluble sublingual tablet that contains 5 mg of cannabidiol (CBD).
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A single dose of Cannabidiol (CBD) when patients experience musculoskeletal pain in the trial.
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What is the study measuring?
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.
Time Frame: 1 Day
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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.
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1 Day
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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.
Time Frame: 1 Day
|
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.
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1 Day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Debra Kimless, MD, Chief Medical Officer
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Madden K, van der Hoek N, Chona S, George A, Dalchand T, Baldawi H, Mammen G, Bhandari M. Cannabinoids in the Management of Musculoskeletal Pain: A Critical Review of the Evidence. JBJS Rev. 2018 May;6(5):e7. doi: 10.2106/JBJS.RVW.17.00153. No abstract available.
- Hill KP, Palastro MD, Johnson B, Ditre JW. Cannabis and Pain: A Clinical Review. Cannabis Cannabinoid Res. 2017 May 1;2(1):96-104. doi: 10.1089/can.2017.0017. eCollection 2017.
- National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice; Committee on the Health Effects of Marijuana: An Evidence Review and Research Agenda. The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research. Washington (DC): National Academies Press (US); 2017 Jan 12. Available from http://www.ncbi.nlm.nih.gov/books/NBK423845/
- Ware MA, Wang T, Shapiro S, Collet JP; COMPASS study team. Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS). J Pain. 2015 Dec;16(12):1233-1242. doi: 10.1016/j.jpain.2015.07.014. Epub 2015 Sep 16.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 7, 2019
Primary Completion (ACTUAL)
December 9, 2019
Study Completion (ACTUAL)
December 9, 2019
Study Registration Dates
First Submitted
December 8, 2019
First Submitted That Met QC Criteria
December 8, 2019
First Posted (ACTUAL)
December 10, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 24, 2020
Last Update Submitted That Met QC Criteria
March 23, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PG-19-00A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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