A Phase Ib, Double Blind, Randomized Study of Cannabis Oil for Pain in Parkinson's Disease-Reference-Cited by-同舟云学术

A Phase Ib, Double Blind, Randomized Study of Cannabis Oil for Pain in Parkinson's Disease

Published:2023-05-08 Issue:7 Volume:10 Page:1114-1119
ISSN:2330-1619
Container-title:Movement Disorders Clinical Practice
language:en
Short-container-title:Movement Disord Clin Pract

Author:

Di Luca Daniel G.¹^ORCID,Gilmour Gabriela S.¹,Fearon Conor¹^ORCID,Swinkin Emily¹,Freitas Eliza²^ORCID,Kuhlman Greg³,Fox Susan H.¹,Mestre Tiago⁴⁵^ORCID

Affiliation:

1. Edmond J. Safra Program in Parkinson's Disease, Movement Disorders Clinic Krembil Brain Institute, Toronto Western Hospital Toronto Ontario Canada

2. Division of Neurology McMaster University Hamilton Ontario Canada

3. Department of Neurology and Rehabilitation Medicine Gardner Family Center for Parkinson's Disease and Movement Disorders, University of Cincinnati Cincinnati Ohio USA

4. Ottawa Hospital Research Institute; University of Ottawa Brain and Mind Research Institute Ottawa Ontario Canada

5. Division of Neurology, Department of Medicine The Ottawa Hospital Ottawa Ontario Canada

Abstract

ABSTRACTBackgroundPain is common in Parkinson's disease (PD), but effective therapies are limited.ObjectivesTo determine the maximum tolerated dose (MTD) and safety of formulations of delta‐9‐tetrahydrocannabinol (THC) and cannabidiol (CBD) for pain in PD.MethodsIn this phase 1b, double‐blind, randomized, single‐center study, participants were randomized to three formulations of THC/CBD (18:0, 10:10, and 1:20). The MTD, adverse events (AE), and tolerability are described for each formulation.ResultsEight participants were randomized. The MTD was similar among groups (0.8–0.9 mL/daily), and there were no serious AE or study drop‐outs. The most common AE were drowsiness and dizziness (three participants). Epworth sleepiness scale scores were higher in the high CBD formulation (1:20).ConclusionsIn patients with pain and PD, mixed formulations of THC/CBD were tolerated with no serious AE. Considering the safety profile, future phase II studies should be considered.

Funder

Parkinson Canada

Publisher

Wiley

Subject

Neurology (clinical),Neurology

Reference19 articles.

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