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

Pure Green Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Diabetic Neuropathies

Treatments: Drug: CBD

Study type: Interventional

Funder types: Industry

Identifiers

NCT04088929

PG-19-002

Details and patient eligibility

About

Use of Cannabidiol for the treatment of Diabetic Neuropathic Pain.

Enrollment: 32 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

CBD for Treatment of Diabetic Neuropathic Pain

Experimental group

Description:

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.

Treatment:

Drug: CBD