Clinical trial NCT04088929: The Use of a Water Soluble Under the Tongue (Sublingual) CBD Tablet for Treating Pain Associated With Diabetic Peripheral Neuropathy
Official title: A Dose Controlled Diabetic Neuropathic Pain Study Using Non-Intoxicating Cannabidiol in a Rapidly Dissolvable Sublingual Tablet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Neuropathies
Keywords: Pain
Neuropathy
Neuropathic Pain
Diabetes
Lead sponsor: Pure Green
Sponsor class: INDUSTRY
First posted: 2019-09-13
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Use of Cannabidiol for the treatment of Diabetic Neuropathic Pain.


Eligibility criteria: 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.

Primary outcomes:
measure: Impact of Pure Green CBD tablets on diabetic neuropathy pain using a daily self-reported pain scale score.
timeFrame: Three Weeks
Secondary outcomes:
measure: Impact of Pure Green CBD tablets on the quality of life of Diabetic Neuropathy Patients
timeFrame: Three Weeks
measure: Impact of Pure Green CBD tablets on sleep improvement of Diabetic Neuropathy Patients
timeFrame: Three weeks
measure: Impact of Pure Green CBD tablets on anxiety of Diabetic Neuropathy Patients
timeFrame: Three Weeks
measure: Impact on the use of sublingual tablets as the route of administration
timeFrame: Three Weeks
Other outcomes:
Locations:
city: Sterling Heights
country: United States
facility: Dr. Nakadar's Office
state: Michigan
Study officials:
affiliation: Pure Green, LLC
name: Debra Kimless, M.D.
role: PRINCIPAL_INVESTIGATOR
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