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Osteoarthritis of the Knee Pain Study Using a CBD and THC Sublingual Tablet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04195269
Recruitment Status : Recruiting
First Posted : December 11, 2019
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Pure Green

Brief Summary:
This study is a prospective Phase 2, drug controlled, open-label study to evaluate the safety and efficacy of Pure Green sublingual tablets for the treatment of pain associated with osteoarthritis of the knee.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Pain Drug: Test Article Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Osteoarthritis of the Knee Pain Study Using CBD and THC in Rapidly Dissolvable Sublingual Tablet
Estimated Study Start Date : April 20, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Pure Green Sublingual Tablet - Daily
Subjects will take 2 tablets daily, one in the morning and one in the evening, and are able to take up to 2 additional tablets per day as needed for pain.
Drug: Test Article
10 mg CBD, 10 mg of THC, and a proprietary blend of terpenes.




Primary Outcome Measures :
  1. Impact of Pure Green sublingual tablets on pain due to osteoarthritis of the knee using a daily self-reported pain scale score. [ Time Frame: 30 days ]
    To evaluate the safety and efficacy of Pure Green sublingual tablets for the treatment of pain due to osteoarthritis of the knee by having patients evaluate their daily pain scale score reported as 0-10 where 0 is no pain and 10 is the worst pain possible as self-reported with every dose taken by the patient in the smart phone app. The objective is to reduce the patients average daily pain scale score to less than 4.


Secondary Outcome Measures :
  1. Impact of Pure Green sublingual tablets on general health and well-being of Osteoarthritis of the knee patients. [ Time Frame: 30 Days ]
    To evaluate the impact of Pure Green sublingual tablets on the general health and well-being of osteoarthritis of the knee patiens. The objective is to examine quality of life metrics: overall quality of life and general health, physical health, and knee pain as measured on a 1-5 scale before and after the study

  2. Impact of Pure Green sublingual tablets on sleep improvement of patients with osteoarthritis of the knee. [ Time Frame: 30 Days ]
    The Pittsburgh Sleep Quality Index will be used to compare pre and post Pure Green sublingual tablet study on sleep changes. Patients will be asked questions before beginning of the study and after completion.

  3. Impact of Pure Green sublingual tablets on anxiety of patients with osteoarthritis if the knee [ Time Frame: 30 Days ]
    The Hamilton Anxiety rating scale questionnaire will be administered before the study begins and after completion to examine the impact of Pure Green sublingual tablets on anxiety in patients with osteoarthritis of the knee. The scale of 0-4 will be used where 0 is no anxiety present and 4 is very severe anxiety.

  4. Impact on the use of sublingual tablets as the route of administration. [ Time Frame: 30 Days ]
    To explore the impact of sublingual administration on patient compliance by evaluating the number of tablets taken per day as entered by the patients into the smart phone app.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is at least 21 years of age;
  2. Subject has a diagnosis of a pain related to osteoarthritis of the knee as determined by the subject's primary care physician or related health care provider.
  3. Subject has a mean pain scale score of ≥ 4 recorded in the 7 days prior to enrollment.
  4. If female, the subject is postmenopausal (> 1 year), surgically sterile (> 3 months), had a hysterectomy, or is currently using 2 effective forms of birth control.
  5. Subject has not taken marijuana (cannabis) in any form, chemicals or extracts or foods or beverages or topical creams, lotions, gels, patches containing marijuana (cannabinoids, or and cannabis derivatives) including synthetic marijuana and/or CBD for at least 14 days prior to this study, and promises to not take marijuana (cannabis) in any form, chemicals or extracts or foods or beverages or topical creams, lotions, gels, patches containing marijuana (cannabinoids, or and cannabis derivatives) including synthetic marijuana and/or CBD while participating in this study.
  6. Subject has not taken any pain medication, including NSAIDs, for at least 2 days before taking the first dose of study drug.
  7. Subject is willing to provide his/her written informed consent to participate in the study as stated in the informed consent document.
  8. Subject is willing to use an electronic diary to enter a pain scale score up to four times a day for 28 days.

Exclusion Criteria

  1. Subject is pregnant or lactating;
  2. Subject has an allergy to cannabis, the Cannabaceae plant family (e.g., hemp, hops), palmitoylethanolamide, or terpenes;
  3. Subject has a known allergy to active or inert ingredients of PG-OA-10:10-2020-B 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 or any cannabinoid products; Any drug or herbal product that influences the endocannabinoid system (ECS));
  5. Subject is taking marijuana (cannabis) in any form, chemicals or extracts or foods or beverages or topical creams, lotions, gels, patches containing marijuana (cannabinoids, or and cannabis derivatives) including synthetic marijuana and/or CBD for at least 14 days prior to this study, and does not promise that they will not take marijuana (cannabis) in any form, chemicals or extracts or foods or beverages or topical creams, lotions, gels, patches containing marijuana (cannabinoids, or and cannabis derivatives) including synthetic marijuana and/or CBD while participating in this study;
  6. Subject is currently being treated with antibiotics for sinus, throat, or lung infections;
  7. Subject has shortness of breath associated with allergies;
  8. Subject has uncontrolled asthma;
  9. Subject has a fever and/or productive cough;
  10. Subject has unstable angina, uncontrolled hypertension;
  11. Subject currently or has a history of congestive heart failure;
  12. Subject has any other unstable medical condition;
  13. Subject has a personal or family history of schizophrenia;
  14. Subject has a personal history or currently has suicidal ideation or attempted suicide;
  15. Subject has a major neurological disorder, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, history of traumatic brain injury/head injury, and seizures.
  16. Subject has taken pain medicine of any kind throughout the screening period, or has taken acetaminophen within 2 days of taking the first dose of study drug.
  17. Subject has an allergy to, or has an intolerance to, acetaminophen.
  18. Subject is currently taking any form of opioids.
  19. Subject has a history of alcohol or substance abuse
  20. Subject has clinically significant illness, including cardiovascular disorders.
  21. Subject has any condition in which the investigator believes will confound the data of the study or could put the subject at risk of harm.
  22. Subject does not have access to a smart phone or does not know how to use a smart phone application.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04195269


Contacts
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Contact: Matthew Caloura, C.C.R.P. (248) 802-4380 mcaloura@pure.green

Locations
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United States, Michigan
Pure Green, LLC Recruiting
West Bloomfield, Michigan, United States, 48323
Contact: Matthew Caloura    248-802-4380    mcaloura@pure.green   
Sponsors and Collaborators
Pure Green
Investigators
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Principal Investigator: Debra Kimless, M.D. Chief Medical Officer
Publications:
Australian Public Assessment Report for Nabiximols

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Responsible Party: Pure Green
ClinicalTrials.gov Identifier: NCT04195269    
Other Study ID Numbers: PG-OA-1010-19-004
First Posted: December 11, 2019    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pure Green:
CBD
THC
Cannabidiol
Tetrahydrocannabinol
Osteoarthritis
Knee
Pain
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases