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

Overview

Journal Mov Disord Clin Pract

Publisher Wiley

Specialty Neurology

Date 2023 Jul 21

PMID 37476317

Authors

Daniel G Di Luca

Gabriela S Gilmour

Conor Fearon

Emily Swinkin

Eliza Freitas

Greg Kuhlman

Susan H Fox

Tiago Mestre

Affiliations

Soon will be listed here.

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.

Citing Articles

Advice to People with Parkinson's in My Clinic: Cannabis.

de Freitas M, Fox S J Parkinsons Dis. 2024; 14(4):873-881.

PMID: 38759024 PMC: 11191450. DOI: 10.3233/JPD-230358.

Short-Term Cannabidiol with Δ-9-Tetrahydrocannabinol in Parkinson's Disease: A Randomized Trial.

Liu Y, Bainbridge J, Sillau S, Rajkovic S, Adkins M, Domen C Mov Disord. 2024; 39(5):863-875.

PMID: 38487964 PMC: 11102313. DOI: 10.1002/mds.29768.

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