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

Primary Purpose

Musculoskeletal Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cannabidiol (CBD)
Sponsored by
Pure Green
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Pain focused on measuring CBD, Cannabidiol, Musculoskeletal Pain, Pain

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dr. Kimless' Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pure Green Tablet

Arm Description

A water-soluble sublingual tablet that contains 5 mg of cannabidiol (CBD).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 8, 2019
Last Updated
March 23, 2020
Sponsor
Pure Green
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1. Study Identification

Unique Protocol Identification Number
NCT04193631
Brief Title
Low Dose of Cannabidiol (CBD) to Treat Mild to Moderate Musculoskeletal Pain
Official Title
A Controlled-Dose Study Using A One Time Low Dose Cannabidiol Tablet For The Treatment of Mild to Moderate Musculoskeletal Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 7, 2019 (Actual)
Primary Completion Date
December 9, 2019 (Actual)
Study Completion Date
December 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pure Green

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain
Keywords
CBD, Cannabidiol, Musculoskeletal Pain, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pure Green Tablet
Arm Type
Experimental
Arm Description
A water-soluble sublingual tablet that contains 5 mg of cannabidiol (CBD).
Intervention Type
Drug
Intervention Name(s)
Cannabidiol (CBD)
Intervention Description
A single dose of Cannabidiol (CBD) when patients experience musculoskeletal pain in the trial.
Primary Outcome Measure Information:
Title
Impact of Pure Cannabidiol (CBD) tablets on safety in patient's with musculoskeletal pain using a self-reported pain scale score.
Description
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.
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
To evaluate efficacy of a low dose of Cannabidiol (CBD) in the treatment of mild to moderate musculoskeletal pain.
Description
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.
Time Frame
1 Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra Kimless, MD
Organizational Affiliation
Chief Medical Officer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Kimless' Clinic
City
Chadds Ford
State/Province
Pennsylvania
ZIP/Postal Code
19317
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29787450
Citation
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.
Results Reference
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PubMed Identifier
28861509
Citation
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.
Results Reference
background
Citation
Therapeutic Effects of Cannabis and Cannabinoids, 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. Washington (DC): National Academies Press (US); 2017 Jan 12.
Results Reference
background
PubMed Identifier
26385201
Citation
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.
Results Reference
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Low Dose of Cannabidiol (CBD) to Treat Mild to Moderate Musculoskeletal Pain

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