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

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)1114-1119
Number of pages6
JournalMovement Disorders Clinical Practice
Volume10
Issue number7
DOIs
StatePublished - Jul 2023

Keywords

  • Parkinson's disease
  • cannabis
  • pain
  • randomized clinical trial

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