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Published on: September 20, 2019
A Phase Ib, Double Blind, Randomized Study of Cannabis Oil for Pain in Parkinson's Disease
Daniel G Di Luca1, Gabriela S Gilmour1, Conor Fearon1
1Edmond J. Safra Program in Parkinson's Disease, Movement Disorders Clinic Krembil Brain Institute, Toronto Western Hospital Toronto Ontario Canada.
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.
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