Using Cannabidiol to Treat Diabetic Peripheral Neuropathy of the Feet

February 1, 2021 updated by: Pure Green

A Randomized, Double-Blind, Placebo-Controlled Trial Using Cannabidiol for the Treatment of Painful Diabetic Peripheral Neuropathy of the Feet

The purpose of the study is to evaluate whether PG-DN-20WS is a better pain reliever in patients with diabetic neuropathic pain of the feet than a placebo.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Subjects will be enrolled in the study for a maximum of 43 days, including an optional 14-day screening period, 28 days of active product administration, and followed by a post-treatment follow-up within 1 day.

The primary objective of this study is:

  • To evaluate the safety of PG-DN-20WS for the treatment of painful DPN of the feet compared to a placebo control, including emergence of suicidal thoughts.

The secondary objectives of this study are:

  • To evaluate the impact of PG-DN-20WS on subject's neuropathic pain, anxiety, and sleep quality compared to a placebo control.
  • To evaluate the impact of PG-DN-20WS on the subject's impression of their response to the treatment compared to a placebo control.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Bloomfield Township, Michigan, United States, 48323
        • Recruiting
        • Pure Green Pharmaceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is at least 21 years of age;
  2. Subject has a diagnosis of diabetic neuropathic pain of the feet determined by the subject's primary care physician or related health care provider.
  3. Subject has a mean pain scale score of ≥ 5 recorded in the 7 days prior to randomization.
  4. If female, the subject is postmenopausal (> 1 year), surgically sterile (> 3 months), had a hysterectomy, or is currently using 2 effective forms of birth control.
  5. Subject has not taken 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 14 days prior to this study, and agrees 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.
  6. If subject is currently taking gabapentin, pregabalin, or duloxetine, subject must be willing to and completes a 7-day washout of these medications prior to randomization.
  7. Subject has not taken any NSAIDs and/or acetaminophen for at least 2 days prior to randomization.
  8. Subject is willing to provide his/her written informed consent to participate in the study as stated in the informed consent document.
  9. Subject is willing to use an electronic diary to enter trial information for 29 days.

Exclusion Criteria:

  1. Subject is pregnant or lactating;
  2. Subject has an allergy to cannabis, the Cannabaceae plant family (e.g., hemp, hops), palmitoylethanolamide, or terpenes;
  3. Subject has a known allergy to active or inert ingredients of the investigational product;
  4. 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));
  5. 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 14 days prior to this study, and does not promise that they will 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;
  6. Subject currently resides in the state of Nebraska, Idaho, Iowa, or South Dakota.
  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 has unstable angina, uncontrolled hypertension;
  12. Subject currently or has a history of congestive heart failure;
  13. Subject has any other unstable medical condition;
  14. Subject has a personal or family history of schizophrenia;
  15. Subject has a personal history or currently has suicidal ideation or attempted suicide;
  16. Subject has a major neurological disorder, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, history of traumatic brain injury/head injury, and seizures.
  17. Subject has taken pharmaceutical pain medicine of any kind, or has taken a NSAID and/or acetaminophen, within 2 days of randomization.
  18. Subject has taken gabapentin, pregabalin, or duloxetine within 7 days prior to randomization or is unwilling to stop these medications.
  19. Subject has an allergy to, or has an intolerance to, NSAIDs or acetaminophen.
  20. Subject is currently taking any form of opioids.
  21. Subject has a history of substance or alcohol abuse.
  22. Subject has clinically significant illness, including cardiovascular disorders.
  23. Subject has any condition in which the investigator believes will confound the data of the study or could put the subject at risk of harm.
  24. Subject does not have access to a smart phone or does not know how to use a smart phone application.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CBD
Subject will receive a 28-day supply of 20 mg CBD sublingual tablets to be taken 3 times a day for 28 days.
Drug: CBD
A water-soluble sublingual tablet containing 20 mg of CBD.
PLACEBO_COMPARATOR: Placebo Control
A placebo sublingual tablet to be taken three times a day for 28 days.
Drug: Placebo
An inactive compound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: Four Weeks
To evaluate the safety of PG-DN-20WS for the treatment of painful DPN of the feet compared to a placebo control assessed by Common Terminology Criteria For Adverse Events (CTCAE) v4.0.
Four Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain as assessed by Numerical Pain Rating Scale (NPRS)
Time Frame: Four Weeks
To evaluate the impact of PG-DN-20WS on the subject's neuropathic pain as assessed by utilizing a Numeric Pain Rating Scale (NPRS). NPRS is from 0-10, where higher scores indicate worse pain and lower scores indicate less pain reported by the subject.
Four Weeks
Anxiety as assessed by the Zung Self-Rating Anxiety Scale (SAS)
Time Frame: Four Weeks
To evaluate the impact of PG-DN-20WS on the subject's anxiety as assessed by the Zung Self-Rating Anxiety Scale (SAS). Subjects are given scores from 1-4 based on their responses to the survey, where a higher global score indicates a more severe form of anxiety and a lower global score indicates either a less severe form of anxiety or no anxiety presented by the subject.
Four Weeks
Sleep Quality as assessed by Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Four Weeks
To evaluate the impact of PG-DN-20WS on the subject's anxiety as assessed by the Pittsburgh Sleep Quality Index (PSQI). Subjects are given scores from 0-3 based on their responses to the survey, where a higher global score indicates poor sleep quality and a lower global score indicates good sleep quality reported by the subject.
Four Weeks
Subject's Response to Treatment as assessed by Patient's Global Impression of Change (PGIC)
Time Frame: Four Weeks
To evaluate the impact of PG-DN-20WS on the subject's impression of their response to the treatment compared to a placebo control as assessed by Patient's Global Impression of Change (PGIC). Subjects indicate their overall impression of their response to treatment on 0-10 scale, where a higher number represents the subject feeling worse than before the intervention, and a lower number represents the subject feeling better than before the intervention.
Four Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pure Green

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 10, 2020

Primary Completion (ANTICIPATED)

March 1, 2021

Study Completion (ANTICIPATED)

April 1, 2021

Study Registration Dates

First Submitted

December 10, 2020

First Submitted That Met QC Criteria

December 17, 2020

First Posted (ACTUAL)

December 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PG-DPN-20WS-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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