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

Status

Completed

Conditions

Intervention / Treatment

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

  • United States
    • Pennsylvania
      • Chadds Ford, Pennsylvania, United States, 19317
        • Dr. Kimless' Clinic

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:

  1. Male or female at least 21 years of age;
  2. Subject has mild to moderate musculoskeletal pain;
  3. 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.
  4. Has an Numeric Pain Rating Scale (NPRS) score of 3 or greater,
  5. If female, subject is practicing an approved method of birth control throughout the study;
  6. Subject is willing and able to comply with all protocol-specified requirements;
  7. Subject is willing to take Pure Green tablets only and will not take any other pain medications,
  8. Subject is willing to provide his/her written informed consent to participate in the study as stated in the informed consent document.
  9. Subject is willing to document pain scale scores in a diary.

Exclusion Criteria:

  1. Subject has any condition for which the investigator does not feel the participant should be enrolled due to possible safety or compliance issues;
  2. Subject has received treatment with an investigational drug or therapy within 30 days or 5 half-lives (whichever is longer) prior to Day 1.
  3. Subject has a known allergy to active or inert ingredients of Pure Green tablets;
  4. 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));
  5. 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.
  6. Have a history of recurrent seizures other than febrile seizures.
  7. Have current or pending disability compensation or litigation issues that may compromise response to treatment, in the opinion of the investigator.
  8. Have a diagnosis of inflammatory arthritis (that is, rheumatoid arthritis) or an autoimmune disorder (excluding inactive Hashimoto's thyroiditis).
  9. Use of acupuncture, chiropractic maneuvers, transcutaneous electrical nerve stimulation (TENS), or similar procedures aimed to relieve any kind of pain.
  10. 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.
  11. 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).
Drug: Cannabidiol (CBD)
A single dose of Cannabidiol (CBD) when patients experience musculoskeletal pain in the trial.

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
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.
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.
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pure Green

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

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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