CClinicalTrials.gg
CompletedNCT04193631Updated Mar 24, 2020

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

A Phase 1 interventional study of Cannabidiol (CBD) in Musculoskeletal Pain, sponsored by Pure Green. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2020-03-24.

Sponsored by Pure Green · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Musculoskeletal Pain

Browse trials for

Keywords

  • CBD
  • Cannabidiol
  • Musculoskeletal Pain
  • Pain
03

In context

Musculoskeletal Pain

494 studies on the registry are indexed under Musculoskeletal Pain; 113 are open to participants now.

This study's enrollment of 16 is below the median of 68 across 347 interventional studies indexed under Musculoskeletal Pain.

Browse Musculoskeletal Pain studies →

Lead sponsor

Pure Green is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Pure Green Tablet

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

    Drug: Cannabidiol (CBD)

Interventions

  • DrugCannabidiol (CBD)

    A single dose of Cannabidiol (CBD) when patients experience musculoskeletal pain in the trial.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 Day

Secondary outcomes

  1. 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.

    Time frame: 1 Day

07

Study locations

1 site
  • Dr. Kimless' Clinic
    Chadds Ford, Pennsylvania 19317, United States
08

References and documents

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. PubMed 29787450 ↗
  • 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. PubMed 28861509 ↗
  • 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.
  • 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. PubMed 26385201 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04193631
Lead sponsor
Pure Green
Responsible party
Sponsor
First posted
Dec 10, 2019
Start date
Dec 7, 2019
Primary completion
Dec 9, 2019
Completion
Dec 9, 2019
Last update
Mar 24, 2020

Study contacts

Debra Kimless, MD
principal investigator · Chief Medical Officer

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion