Using Cannabidiol to Treat Diabetic Peripheral Neuropathy of the Feet
NCT ID: NCT04679545
Last Updated: 2021-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2020-12-10
2021-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CBD
Subject will receive a 28-day supply of 20 mg CBD sublingual tablets to be taken 3 times a day for 28 days.
CBD
A water-soluble sublingual tablet containing 20 mg of CBD.
Placebo Control
A placebo sublingual tablet to be taken three times a day for 28 days.
Placebo
An inactive compound.
Interventions
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CBD
A water-soluble sublingual tablet containing 20 mg of CBD.
Placebo
An inactive compound.
Eligibility Criteria
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Inclusion Criteria
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
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.
21 Years
ALL
No
Sponsors
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Pure Green
INDUSTRY
Responsible Party
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Principal Investigators
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Debra Kimless, M.D.
Role: PRINCIPAL_INVESTIGATOR
Pure Green Pharmaceuticals
Locations
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Pure Green Pharmaceuticals
Bloomfield Township, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Boulton AJ: Management of Diabetic Peripheral Neuropathy. Clinical Diabetes. 2005;23(1):9-15.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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PG-DPN-20WS-2020
Identifier Type: -
Identifier Source: org_study_id
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