Citation

Di Luca DG, Gilmour GS, Fearon C, Swinkin E, Freitas E, Kuhlman G, Fox SH, Mestre T. Mov. Disord. Clin. Pract. (Hoboken) 2023; 10(7): 1114-1119.

Copyright

(Copyright © 2023, John Wiley and Sons)

DOI

10.1002/mdc3.13754

PMID

unavailable

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. © 2023 International Parkinson and Movement Disorder Society.

Language: en

Keywords

human; female; male; cannabis; randomized controlled trial; scoring system; pain; controlled study; clinical article; double blind procedure; somnolence; drug safety; drug efficacy; drug tolerability; Parkinson disease; visual analog scale; drug formulation; dizziness; drug dose reduction; Parkinson's disease; Article; maximum tolerated dose; Epworth sleepiness scale; dronabinol; drug dose comparison; Unified Parkinson Disease Rating Scale; medication compliance; cannabidiol; Columbia suicide severity rating scale; pain severity; randomized clinical trial; phase 1 clinical trial; king parkinson disease pain scale