Back to resultsThe Use of a Water Soluble Under the Tongue (Sublingual) CBD Tablet for Treating Pain Associated With Diabetic Peripheral Neuropathy
Primary Purpose
Diabetic Neuropathies
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CBD
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathies focused on measuring Pain, Neuropathy, Neuropathic Pain, Diabetes
Eligibility Criteria
Inclusion Criteria:
- Subject is at least 21 years of age;
- 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;
- Subject has a 7-day average pain scale score (recorded during the screening period) of ≥ 5;
- 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;
- If female and of childbearing potential, subject has a denied pregnancy and has no desire to become pregnant throughout the duration of the study;
- Subject is willing and able to provide his/her written informed consent to participate in the study as stated in the informed consent document;
- Subject has access to a smart phone and knows how to use smart phone applications.
Exclusion Criteria:
- Subject is pregnant or lactating;
- Subject has an allergy to cannabis, the Cannabaceae plant family (e.g., hemp, hops, hackberry), PEA, terpenes, peppermint;
- Subject has a known allergy to active or inert ingredients of Pure Green tablets;
- Subject is currently treating their pain with cannabis, cannabinoids, cannabis-base medicine;
- 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 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;
- 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 does not have access to a smart phone or does not know how to use a smart phone application.
Sites / Locations
- Dr. Nakadar's Office
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CBD for Treatment of Diabetic Neuropathic Pain
Arm 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.
Outcomes
Primary Outcome Measures
Impact of Pure Green CBD tablets on diabetic neuropathy pain using a daily self-reported pain scale score.
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 Outcome Measures
Impact of Pure Green CBD tablets on the quality of life of Diabetic Neuropathy Patients
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
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
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
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
1. Study Identification
Unique Protocol Identification Number
NCT04088929
Brief Title
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
November 22, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
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
Use of Cannabidiol for the treatment of Diabetic Neuropathic Pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies
Keywords
Pain, Neuropathy, Neuropathic Pain, Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBD for Treatment of Diabetic Neuropathic Pain
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
CBD
Intervention Description
A water-soluble sublingual tablet containing 20 mg of cannabidiol (CBD) and 0.1 mg of a proprietary blend of terpenes.
Primary Outcome Measure Information:
Title
Impact of Pure Green CBD tablets on diabetic neuropathy pain using a daily self-reported pain scale score.
Description
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.
Time Frame
Three Weeks
Secondary Outcome Measure Information:
Title
Impact of Pure Green CBD tablets on the quality of life of Diabetic Neuropathy Patients
Description
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.
Time Frame
Three Weeks
Title
Impact of Pure Green CBD tablets on sleep improvement of Diabetic Neuropathy Patients
Description
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.
Time Frame
Three weeks
Title
Impact of Pure Green CBD tablets on anxiety of Diabetic Neuropathy Patients
Description
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.
Time Frame
Three Weeks
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
Three Weeks
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 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;
Subject has a 7-day average pain scale score (recorded during the screening period) of ≥ 5;
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;
If female and of childbearing potential, subject has a denied pregnancy and has no desire to become pregnant throughout the duration of the study;
Subject is willing and able to provide his/her written informed consent to participate in the study as stated in the informed consent document;
Subject has access to a smart phone and knows how to use smart phone applications.
Exclusion Criteria:
Subject is pregnant or lactating;
Subject has an allergy to cannabis, the Cannabaceae plant family (e.g., hemp, hops, hackberry), PEA, terpenes, peppermint;
Subject has a known allergy to active or inert ingredients of Pure Green tablets;
Subject is currently treating their pain with cannabis, cannabinoids, cannabis-base medicine;
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 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;
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 does not have access to a smart phone or does not know how to use a smart phone application.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra Kimless, M.D.
Organizational Affiliation
Pure Green, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Nakadar's Office
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48310
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Citation
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The Use of a Water Soluble Under the Tongue (Sublingual) CBD Tablet for Treating Pain Associated With Diabetic Peripheral Neuropathy
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