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

Daniel G Di Luca; Gabriela S Gilmour; Conor Fearon; Emily Swinkin; Eliza Freitas; Greg Kuhlman; Susan H Fox; Tiago Mestre

doi:10.1002/mdc3.13754

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

Mov Disord Clin Pract. 2023 May 8;10(7):1114-1119. doi: 10.1002/mdc3.13754. eCollection 2023 Jul.

Authors

Daniel G Di Luca¹, Gabriela S Gilmour¹, Conor Fearon¹, Emily Swinkin¹, Eliza Freitas², Greg Kuhlman³, Susan H Fox¹, Tiago Mestre^{4

5}

Affiliations

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

Background: Pain is common in Parkinson's disease (PD), but effective therapies are limited.

Objectives: To determine the maximum tolerated dose (MTD) and safety of formulations of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) for pain in PD.

Methods: In 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.

Results: Eight 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).

Conclusions: In 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.

Keywords: Parkinson's disease; cannabis; pain; randomized clinical trial.