The Use of a Water Soluble Under the Tongue (Sublingual) CBD Tablet for Treating Pain Associated With Diabetic Peripheral Neuropathy

Overview

Use of Cannabidiol for the treatment of Diabetic Neuropathic Pain.

Full Title of Study: “A Dose Controlled Diabetic Neuropathic Pain Study Using Non-Intoxicating Cannabidiol in a Rapidly Dissolvable Sublingual Tablet”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2020

Interventions

  • Drug: CBD
    • A water-soluble sublingual tablet containing 20 mg of cannabidiol (CBD) and 0.1 mg of a proprietary blend of terpenes.

Arms, Groups and Cohorts

  • Experimental: CBD for Treatment of Diabetic Neuropathic Pain
    • Patients are instructed to take 3 total tablets a day, under the tongue, six hours apart for three weeks. Patients are to enter their pain scale score into the smartphone app as instructed during the initial site visit. Patients are to enter into the notes section of the app any additional information such as side effects (positive or negative), medication changes.

Clinical Trial Outcome Measures

Primary Measures

  • Impact of Pure Green CBD tablets on diabetic neuropathy pain using a daily self-reported pain scale score.
    • Time Frame: Three Weeks
    • To evaluate the safety and efficacy of Pure Green CBD sublingual tablets for the treatment of chronic diabetic neuropathic pain patients by evaluating 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 5.

Secondary Measures

  • Impact of Pure Green CBD tablets on the quality of life of Diabetic Neuropathy Patients
    • Time Frame: Three Weeks
    • To evaluate the impact of Pure Green CBD sublingual tablets on the quality of life of diabetic neuropathy patients measured by World Health Organization’s quality of life questionnaire, . The objective is to examine quality of life metrics: overall quality of life and general health, physical health, psychological, social, and environment as measured on a 1-5 scale before and after the study.
  • Impact of Pure Green CBD tablets on sleep improvement of Diabetic Neuropathy Patients
    • Time Frame: Three weeks
    • The Pittsburgh Sleep Quality Index will be used to compare pre and post Pure Green CBD tablet study on sleep changes. Patients will be asked questions before beginning the study and after completion.
  • Impact of Pure Green CBD tablets on anxiety of Diabetic Neuropathy Patients
    • Time Frame: Three Weeks
    • The Hamilton Anxiety rating scale questionnaire will be administered before the study begins and after completion to examine the impact of Pure Green CBD tablets on anxiety in diabetic neuropathy pain patients. 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
    • Time Frame: Three Weeks
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

1. Subject is at least 21 years of age;

2. Subject has a diagnosis of chronic diabetic neuropathic pain condition as determined by the subject's health care or allied health provider for which medications other than cannabis, cannabinoids, or cannabis-based medicines are currently utilized;

3. Subject has a 7-day average pain scale score (recorded during the screening period) of ≥ 5;

4. If female, subject is postmenopausal (> 1 year), surgically sterile, or practicing an approved method of birth control throughout the study and for 5 months (150 days) after the last dose of study drug;

5. If female and of childbearing potential, subject has a denied pregnancy and has no desire to become pregnant throughout the duration of the study;

6. Subject is willing and able to provide his/her written informed consent to participate in the study as stated in the informed consent document;

7. Subject has access to a smart phone and knows how to use smart phone applications.

Exclusion Criteria

1. Subject is pregnant or lactating;

2. Subject has an allergy to cannabis, the Cannabaceae plant family (e.g., hemp, hops, hackberry), PEA, terpenes, peppermint;

3. Subject has a known allergy to active or inert ingredients of Pure Green tablets;

4. Subject is currently treating their pain with cannabis, cannabinoids, cannabis-base medicine;

5. 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));

6. 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 30 days prior to this study., and does not promise 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;

7. Subject is currently being treated with antibiotics for sinus, throat, or lung infections;

8. Subject has shortness of breath associated with allergies;

9. Subject has uncontrolled asthma;

10. Subject has a fever and/or productive cough;

11. Subject does not have access to a smart phone or does not know how to use a smart phone application.

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pure Green
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Debra Kimless, M.D., Principal Investigator, Pure Green, LLC
  • Overall Contact(s)
    • Heather Denham, (228) 327-6339, hdenham@pure.green

References

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Argoff CE, Cole BE, Fishbain DA, Irving GA. Diabetic peripheral neuropathic pain: clinical and quality-of-life issues. Mayo Clin Proc. 2006 Apr;81(4 Suppl):S3-11. Review.

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