Novel Water-Solubilized CBD-based Sublingual Tablets Treat Diabetic Neuropathic Pain - Debra Kimless

Tags: Diabetic Peripheral Neuropathy Treatment, DPN, PEA, CBD, Palmitoylethanolamide, Clinical Trial, Cannabis Research Studies, Medicine

Debra Kimless, MD, presents, "Novel Water-Solubilized CBD-based Sublingual Tablets Treat Diabetic Neuropathic Pain" at CannMed 23.

0:00 Intro
0:12 Disclosures
0:46 CannMed Conference
3:00 Sublingual CBD/PEA for the Treatment of Painful Diabetic Peripheral Neuropathy (DPN) of the Feet
3:58 Current Rx
4:18 Cannabidiol & Palmitoylethanolamide
4:57 Steps to Improve Bioavailability
5:40 Trial Participants
6:12 Pain Response
7:10 Anxiety Response
7:32 Sleep Response
8:07 Randomized, Double-Blind Placebo-Controlled Trial
8:23 Endpoints
8:33 Participants
9:06 Treatments
9:24 Pain Response
11:35 Anxiety
12:05 Sleep
12:18 Patient Global Impression of Change
12:45 Safety
13:12 Summary
15:00 Q&A

Prove the hypothesis that the water-solubilized CBD tablets were an effective treatment for Diabetic Neuropathic Pain (pDPN) and submit an IND to the FDA for approval of this novel pain relief therapy.

Conducting first a proof-of-concept open label trial (21 days) and then a double blind, placebo controlled randomized trial (28 days) using water-solubilized CBD sublingual tablets for the treatment of diabetic neuropathic pain of the feet (pDPN). Both clinical trials were conducted remotely using a web-based platform. The participants completed the trials without leaving their homes. This novel approach was developed and initiated prior to the onset of the pandemic and continued uninterrupted. The goals for both studies were safety, and efficacy of the tablets for the treatment of pDPN, poor sleep, and anxiety, and to assess the patient’s global impression of change (PGIC). Participants who received active drug were taking water solubilized 20mg CBD sublingually three times a day.

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