Musculoskeletal PainPhase 1NCT04193631
Low Dose of Cannabidiol (CBD) to Treat Mild to Moderate Musculoskeletal Pain
A Phase 1 study testing Cannabidiol (CBD) in people with Musculoskeletal Pain, run by Pure Green at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Cannabidiol (CBD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2019to 9 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dr. Kimless' Clinic
Chadds Ford, Pennsylvania, 19317
About this study
Official title: 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.
- Conditions
- Musculoskeletal Pain
- Being tested
- Cannabidiol (CBD)
- Keywords
- CBD, Cannabidiol, Musculoskeletal Pain, Pain
- Medical subject headings
- Musculoskeletal Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol (CBD)Drug
A single dose of Cannabidiol (CBD) when patients experience musculoskeletal pain in the trial.
| Study group | Role | What they receive |
|---|---|---|
| Pure Green Tablet | Experimental | A water-soluble sublingual tablet that contains 5 mg of cannabidiol (CBD). Receives: Drug: Cannabidiol (CBD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start7 Dec 2019
- Primary completion9 Dec 2019
- Study completion9 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pure Green
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Debra Kimless, MD, Principal investigator, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193631
- Sponsor's protocol ID
- PG-19-00A
- Status last verified
- Mar 2020
- First submitted
- 8 Dec 2019
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 29787450Hill 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 28861509Therapeutic 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled-Dose Study Using A One Time Low Dose Cannabidiol Tablet For The Treatment of Mild to Moderate Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT04193631
- Acronym / sponsor ID
- PG-19-00A
- Conditions
- Musculoskeletal Pain
- Keywords
- CBD, Cannabidiol, Musculoskeletal Pain, Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Pure GreenIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2019 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pure Green Tablet | Experimental | Drug: Cannabidiol (CBD)A water-soluble sublingual tablet that contains 5 mg of cannabidiol (CBD). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol (CBD)A single dose of Cannabidiol (CBD) when patients experience musculoskeletal pain in the trial. | Drug | Pure Green Tablet |
Primary outcome
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 secondary outcome
To evaluate efficacy of a low dose of Cannabidiol (CBD) in the treatment of mild to moderate musculoskeletal pain.
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Background: PubMed 29787450Madden 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.
- Background: PubMed 28861509Hill 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.
- BackgroundTherapeutic 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.
- Background: PubMed 26385201Ware 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra Kimless, MD principal investigator
Chief Medical Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cannabidiol (CBD) in people with Musculoskeletal Pain, run by Pure Green at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04193631, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.