search
Back to results

Using Cannabidiol to Treat Diabetic Peripheral Neuropathy of the Feet

Primary Purpose

Diabetic Peripheral Neuropathic Pain

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CBD
Placebo
Sponsored by
Pure Green
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathic Pain focused on measuring Cannabidiol, CBD, DPN, Diabetic Peripheral Neuropathy

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pure Green PharmaceuticalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CBD

Placebo Control

Arm Description

Subject will receive a 28-day supply of 20 mg CBD sublingual tablets to be taken 3 times a day for 28 days.

A placebo sublingual tablet to be taken three times a day for 28 days.

Outcomes

Primary Outcome Measures

Incidence of treatment-related adverse events as assessed by CTCAE v4.0
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.

Secondary Outcome Measures

Pain as assessed by Numerical Pain Rating Scale (NPRS)
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.
Anxiety as assessed by the Zung Self-Rating Anxiety Scale (SAS)
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.
Sleep Quality as assessed by Pittsburgh Sleep Quality Index (PSQI)
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.
Subject's Response to Treatment as assessed by Patient's Global Impression of Change (PGIC)
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.

Full Information

First Posted
December 10, 2020
Last Updated
February 1, 2021
Sponsor
Pure Green
search

1. Study Identification

Unique Protocol Identification Number
NCT04679545
Brief Title
Using Cannabidiol to Treat Diabetic Peripheral Neuropathy of the Feet
Official Title
A Randomized, Double-Blind, Placebo-Controlled Trial Using Cannabidiol for the Treatment of Painful Diabetic Peripheral Neuropathy of the Feet
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
April 1, 2021 (Anticipated)

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathic Pain
Keywords
Cannabidiol, CBD, DPN, Diabetic Peripheral Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
There are 2 groups in this trial: interventional group (active drug) and control group (placebo).
Masking
ParticipantInvestigator
Masking Description
Subjects will be randomized at a 1:1 ratio.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBD
Arm Type
Experimental
Arm Description
Subject will receive a 28-day supply of 20 mg CBD sublingual tablets to be taken 3 times a day for 28 days.
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm Description
A placebo sublingual tablet to be taken three times a day for 28 days.
Intervention Type
Drug
Intervention Name(s)
CBD
Intervention Description
A water-soluble sublingual tablet containing 20 mg of CBD.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
An inactive compound.
Primary Outcome Measure Information:
Title
Incidence of treatment-related adverse events as assessed by CTCAE v4.0
Description
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.
Time Frame
Four Weeks
Secondary Outcome Measure Information:
Title
Pain as assessed by Numerical Pain Rating Scale (NPRS)
Description
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.
Time Frame
Four Weeks
Title
Anxiety as assessed by the Zung Self-Rating Anxiety Scale (SAS)
Description
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.
Time Frame
Four Weeks
Title
Sleep Quality as assessed by Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
Four Weeks
Title
Subject's Response to Treatment as assessed by Patient's Global Impression of Change (PGIC)
Description
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.
Time Frame
Four 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 diabetic neuropathic pain of the feet determined by the subject's primary care physician or related health care provider. Subject has a mean pain scale score of ≥ 5 recorded in the 7 days prior to randomization. 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. 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. 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. Subject has not taken any NSAIDs and/or acetaminophen for at least 2 days prior to randomization. Subject is willing to provide his/her written informed consent to participate in the study as stated in the informed consent document. Subject is willing to use an electronic diary to enter trial information for 29 days. Exclusion Criteria: Subject is pregnant or lactating; Subject has an allergy to cannabis, the Cannabaceae plant family (e.g., hemp, hops), palmitoylethanolamide, or terpenes; Subject has a known allergy to active or inert ingredients of the investigational product; 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 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; Subject currently resides in the state of Nebraska, Idaho, Iowa, or South Dakota. 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 has unstable angina, uncontrolled hypertension; Subject currently or has a history of congestive heart failure; Subject has any other unstable medical condition; Subject has a personal or family history of schizophrenia; Subject has a personal history or currently has suicidal ideation or attempted suicide; Subject has a major neurological disorder, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, history of traumatic brain injury/head injury, and seizures. Subject has taken pharmaceutical pain medicine of any kind, or has taken a NSAID and/or acetaminophen, within 2 days of randomization. Subject has taken gabapentin, pregabalin, or duloxetine within 7 days prior to randomization or is unwilling to stop these medications. Subject has an allergy to, or has an intolerance to, NSAIDs or acetaminophen. Subject is currently taking any form of opioids. Subject has a history of substance or alcohol abuse. Subject has clinically significant illness, including cardiovascular disorders. 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. Subject does not have access to a smart phone or does not know how to use a smart phone application.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Caloura
Phone
(248) 802-4380
Email
mcaloura@pgpharma.co
First Name & Middle Initial & Last Name or Official Title & Degree
Debra Kimless, M.D.
Phone
(248) 920-8761
Email
dkimlessmd@pgpharma.co
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra Kimless, M.D.
Organizational Affiliation
Pure Green Pharmaceuticals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pure Green Pharmaceuticals
City
Bloomfield Township
State/Province
Michigan
ZIP/Postal Code
48323
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Caloura
Phone
248-802-4380
Email
mcaloura@pgpharma.co
First Name & Middle Initial & Last Name & Degree
Debra Kimless, M.D.
Phone
(248) 920-8761
Email
dkimlessmd@pgpharma.co
First Name & Middle Initial & Last Name & Degree
Debra Kimless, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12577252
Citation
Quattrini C, Tesfaye S. Understanding the impact of painful diabetic neuropathy. Diabetes Metab Res Rev. 2003 Jan-Feb;19 Suppl 1:S2-8. doi: 10.1002/dmrr.360.
Results Reference
background
PubMed Identifier
22608666
Citation
Callaghan BC, Cheng HT, Stables CL, Smith AL, Feldman EL. Diabetic neuropathy: clinical manifestations and current treatments. Lancet Neurol. 2012 Jun;11(6):521-34. doi: 10.1016/S1474-4422(12)70065-0. Epub 2012 May 16.
Results Reference
background
PubMed Identifier
16608048
Citation
Argoff CE, Cole BE, Fishbain DA, Irving GA. Diabetic peripheral neuropathic pain: clinical and quality-of-life issues. Mayo Clin Proc. 2006 Apr;81(4 Suppl):S3-11. doi: 10.1016/s0025-6196(11)61474-2.
Results Reference
background
PubMed Identifier
25498300
Citation
Sadosky A, Mardekian J, Parsons B, Hopps M, Bienen EJ, Markman J. Healthcare utilization and costs in diabetes relative to the clinical spectrum of painful diabetic peripheral neuropathy. J Diabetes Complications. 2015 Mar;29(2):212-7. doi: 10.1016/j.jdiacomp.2014.10.013. Epub 2014 Nov 8.
Results Reference
background
PubMed Identifier
12766111
Citation
Gordois A, Scuffham P, Shearer A, Oglesby A, Tobian JA. The health care costs of diabetic peripheral neuropathy in the US. Diabetes Care. 2003 Jun;26(6):1790-5. doi: 10.2337/diacare.26.6.1790.
Results Reference
background
PubMed Identifier
24373831
Citation
Singh R, Kishore L, Kaur N. Diabetic peripheral neuropathy: current perspective and future directions. Pharmacol Res. 2014 Feb;80:21-35. doi: 10.1016/j.phrs.2013.12.005. Epub 2013 Dec 25.
Results Reference
background
Citation
Boulton AJ: Management of Diabetic Peripheral Neuropathy. Clinical Diabetes. 2005;23(1):9-15.
Results Reference
background
PubMed Identifier
25843054
Citation
Wallace MS, Marcotte TD, Umlauf A, Gouaux B, Atkinson JH. Efficacy of Inhaled Cannabis on Painful Diabetic Neuropathy. J Pain. 2015 Jul;16(7):616-27. doi: 10.1016/j.jpain.2015.03.008. Epub 2015 Apr 3.
Results Reference
background
PubMed Identifier
11399676
Citation
Bridges D, Ahmad K, Rice AS. The synthetic cannabinoid WIN55,212-2 attenuates hyperalgesia and allodynia in a rat model of neuropathic pain. Br J Pharmacol. 2001 Jun;133(4):586-94. doi: 10.1038/sj.bjp.0704110.
Results Reference
background
PubMed Identifier
15140913
Citation
De Vry J, Denzer D, Reissmueller E, Eijckenboom M, Heil M, Meier H, Mauler F. 3-[2-cyano-3-(trifluoromethyl)phenoxy]phenyl-4,4,4-trifluoro-1-butanesulfonate (BAY 59-3074): a novel cannabinoid Cb1/Cb2 receptor partial agonist with antihyperalgesic and antiallodynic effects. J Pharmacol Exp Ther. 2004 Aug;310(2):620-32. doi: 10.1124/jpet.103.062836. Epub 2004 May 12.
Results Reference
background
PubMed Identifier
17296917
Citation
Abrams DI, Jay CA, Shade SB, Vizoso H, Reda H, Press S, Kelly ME, Rowbotham MC, Petersen KL. Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled trial. Neurology. 2007 Feb 13;68(7):515-21. doi: 10.1212/01.wnl.0000253187.66183.9c.
Results Reference
background
PubMed Identifier
20805210
Citation
Ware MA, Wang T, Shapiro S, Robinson A, Ducruet T, Huynh T, Gamsa A, Bennett GJ, Collet JP. Smoked cannabis for chronic neuropathic pain: a randomized controlled trial. CMAJ. 2010 Oct 5;182(14):E694-701. doi: 10.1503/cmaj.091414. Epub 2010 Aug 30.
Results Reference
background
PubMed Identifier
23237736
Citation
Wilsey B, Marcotte T, Deutsch R, Gouaux B, Sakai S, Donaghe H. Low-dose vaporized cannabis significantly improves neuropathic pain. J Pain. 2013 Feb;14(2):136-48. doi: 10.1016/j.jpain.2012.10.009. Epub 2012 Dec 11.
Results Reference
background
PubMed Identifier
18403272
Citation
Wilsey B, Marcotte T, Tsodikov A, Millman J, Bentley H, Gouaux B, Fishman S. A randomized, placebo-controlled, crossover trial of cannabis cigarettes in neuropathic pain. J Pain. 2008 Jun;9(6):506-21. doi: 10.1016/j.jpain.2007.12.010. Epub 2008 Apr 10.
Results Reference
background
PubMed Identifier
19896326
Citation
Johnson JR, Burnell-Nugent M, Lossignol D, Ganae-Motan ED, Potts R, Fallon MT. Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related pain. J Pain Symptom Manage. 2010 Feb;39(2):167-79. doi: 10.1016/j.jpainsymman.2009.06.008. Epub 2009 Nov 5.
Results Reference
background
PubMed Identifier
30157131
Citation
De Gregorio D, McLaughlin RJ, Posa L, Ochoa-Sanchez R, Enns J, Lopez-Canul M, Aboud M, Maione S, Comai S, Gobbi G. Cannabidiol modulates serotonergic transmission and reverses both allodynia and anxiety-like behavior in a model of neuropathic pain. Pain. 2019 Jan;160(1):136-150. doi: 10.1097/j.pain.0000000000001386.
Results Reference
background

Learn more about this trial

Using Cannabidiol to Treat Diabetic Peripheral Neuropathy of the Feet

We'll reach out to this number within 24 hrs