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

Primary Purpose

Osteoarthritis, Knee, Pain

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Test Article
Sponsored by
Pure Green
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring CBD, THC, Cannabidiol, Tetrahydrocannabinol, Osteoarthritis, Knee, Pain

Eligibility Criteria

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

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.

Sites / Locations

  • Pure Green, LLCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pure Green Sublingual Tablet - Daily

Arm Description

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.

Outcomes

Primary Outcome Measures

Impact of Pure Green sublingual tablets on pain due to osteoarthritis of the knee using a daily self-reported pain scale score.
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

Impact of Pure Green sublingual tablets on general health and well-being of Osteoarthritis of the knee patients.
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
Impact of Pure Green sublingual tablets on sleep improvement of patients with osteoarthritis of the knee.
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.
Impact of Pure Green sublingual tablets on anxiety of patients with osteoarthritis if the knee
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.
Impact on the use of sublingual tablets as the route of administration.
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.

Full Information

First Posted
December 9, 2019
Last Updated
April 10, 2020
Sponsor
Pure Green
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1. Study Identification

Unique Protocol Identification Number
NCT04195269
Brief Title
Osteoarthritis of the Knee Pain Study Using a CBD and THC Sublingual Tablet
Official Title
Osteoarthritis of the Knee Pain Study Using CBD and THC in Rapidly Dissolvable Sublingual Tablet
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2020 (Anticipated)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
July 15, 2020 (Anticipated)

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Pain
Keywords
CBD, THC, Cannabidiol, Tetrahydrocannabinol, Osteoarthritis, Knee, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pure Green Sublingual Tablet - Daily
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Test Article
Intervention Description
10 mg CBD, 10 mg of THC, and a proprietary blend of terpenes.
Primary Outcome Measure Information:
Title
Impact of Pure Green sublingual tablets on pain due to osteoarthritis of the knee using a daily self-reported pain scale score.
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Impact of Pure Green sublingual tablets on general health and well-being of Osteoarthritis of the knee patients.
Description
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
Time Frame
30 Days
Title
Impact of Pure Green sublingual tablets on sleep improvement of patients with osteoarthritis of the knee.
Description
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.
Time Frame
30 Days
Title
Impact of Pure Green sublingual tablets on anxiety of patients with osteoarthritis if the knee
Description
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.
Time Frame
30 Days
Title
Impact on the use of sublingual tablets as the route of administration.
Description
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.
Time Frame
30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is at least 21 years of age; 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. Subject has a mean pain scale score of ≥ 4 recorded in the 7 days prior to enrollment. 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. 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. Subject has not taken any pain medication, including NSAIDs, for at least 2 days before taking the first dose of study drug. 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 use an electronic diary to enter a pain scale score up to four times a day for 28 days. Exclusion Criteria Subject is pregnant or lactating; Subject has an allergy to cannabis, the Cannabaceae plant family (e.g., hemp, hops), palmitoylethanolamide, or terpenes; Subject has a known allergy to active or inert ingredients of PG-OA-10:10-2020-B tablets; 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)); 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; Subject is currently being treated with antibiotics for sinus, throat, or lung infections; Subject has shortness of breath associated with allergies; Subject has uncontrolled asthma; Subject has a fever and/or productive cough; Subject has unstable angina, uncontrolled hypertension; Subject currently or has a history of congestive heart failure; Subject has any other unstable medical condition; Subject has a personal or family history of schizophrenia; Subject has a personal history or currently has suicidal ideation or attempted suicide; Subject has a major neurological disorder, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, history of traumatic brain injury/head injury, and seizures. 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. Subject has an allergy to, or has an intolerance to, acetaminophen. Subject is currently taking any form of opioids. Subject has a history of alcohol or substance abuse Subject has clinically significant illness, including cardiovascular disorders. 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. Subject does not have access to a smart phone or does not know how to use a smart phone application.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Caloura, C.C.R.P.
Phone
(248) 802-4380
Email
mcaloura@pure.green
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra Kimless, M.D.
Organizational Affiliation
Chief Medical Officer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pure Green, LLC
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48323
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Caloura
Phone
248-802-4380
Email
mcaloura@pure.green

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24294303
Citation
Brown JP, Boulay LJ. Clinical experience with duloxetine in the management of chronic musculoskeletal pain. A focus on osteoarthritis of the knee. Ther Adv Musculoskelet Dis. 2013 Dec;5(6):291-304. doi: 10.1177/1759720X13508508.
Results Reference
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16282192
Citation
Blake DR, Robson P, Ho M, Jubb RW, McCabe CS. Preliminary assessment of the efficacy, tolerability and safety of a cannabis-based medicine (Sativex) in the treatment of pain caused by rheumatoid arthritis. Rheumatology (Oxford). 2006 Jan;45(1):50-2. doi: 10.1093/rheumatology/kei183. Epub 2005 Nov 9.
Results Reference
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Citation
Australian Public Assessment Report for Nabiximols
Results Reference
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PubMed Identifier
29635215
Citation
O'Brien M, McDougall JJ. Cannabis and joints: scientific evidence for the alleviation of osteoarthritis pain by cannabinoids. Curr Opin Pharmacol. 2018 Jun;40:104-109. doi: 10.1016/j.coph.2018.03.012. Epub 2018 Apr 7.
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22727500
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Huggins JP, Smart TS, Langman S, Taylor L, Young T. An efficient randomised, placebo-controlled clinical trial with the irreversible fatty acid amide hydrolase-1 inhibitor PF-04457845, which modulates endocannabinoids but fails to induce effective analgesia in patients with pain due to osteoarthritis of the knee. Pain. 2012 Sep;153(9):1837-1846. doi: 10.1016/j.pain.2012.04.020. Epub 2012 Jun 21.
Results Reference
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PubMed Identifier
25115332
Citation
Fukuda S, Kohsaka H, Takayasu A, Yokoyama W, Miyabe C, Miyabe Y, Harigai M, Miyasaka N, Nanki T. Cannabinoid receptor 2 as a potential therapeutic target in rheumatoid arthritis. BMC Musculoskelet Disord. 2014 Aug 12;15:275. doi: 10.1186/1471-2474-15-275.
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Citation
Krustev E, Reid A, McDougall JJ. Tapping into the endocannabinoid system to ameliorate acute inflammatory flares and associated pain in mouse knee joints. Arthritis Res Ther. 2014 Sep 27;16(5):437. doi: 10.1186/s13075-014-0437-9.
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PubMed Identifier
9610941
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Smith FL, Fujimori K, Lowe J, Welch SP. Characterization of delta9-tetrahydrocannabinol and anandamide antinociception in nonarthritic and arthritic rats. Pharmacol Biochem Behav. 1998 May;60(1):183-91. doi: 10.1016/s0091-3057(97)00583-2.
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Schuelert N, McDougall JJ. Cannabinoid-mediated antinociception is enhanced in rat osteoarthritic knees. Arthritis Rheum. 2008 Jan;58(1):145-53. doi: 10.1002/art.23156.
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Schuelert N, Johnson MP, Oskins JL, Jassal K, Chambers MG, McDougall JJ. Local application of the endocannabinoid hydrolysis inhibitor URB597 reduces nociception in spontaneous and chemically induced models of osteoarthritis. Pain. 2011 May;152(5):975-981. doi: 10.1016/j.pain.2010.11.025. Epub 2010 Dec 24.
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Osteoarthritis of the Knee Pain Study Using a CBD and THC Sublingual Tablet

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