The Use of a Water Soluble Under the Tongue (Sublingual) CBD Tablet for Treating Pain Associated With Diabetic Peripheral Neuropathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04088929|
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : September 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Neuropathies||Drug: CBD||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Dose Controlled Diabetic Neuropathic Pain Study Using Non-Intoxicating Cannabidiol in a Rapidly Dissolvable Sublingual Tablet|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||June 2020|
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.
A water-soluble sublingual tablet containing 20 mg of cannabidiol (CBD) and 0.1 mg of a proprietary blend of terpenes.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088929
|Contact: Heather Denham||(228) email@example.com|
|Contact: Debra Kimless, M.D.||(248) firstname.lastname@example.org|
|United States, Michigan|
|Dr. Nakadar's Office||Recruiting|
|Sterling Heights, Michigan, United States, 48310|
|Contact: Heather Denham 228-327-6339 email@example.com|
|Contact: Matthew Caloura (248) 802-4380 firstname.lastname@example.org|
|Sub-Investigator: Saqib Nakadar, D.O.|
|Principal Investigator:||Debra Kimless, M.D.||Pure Green, LLC|