A Phase Ib, Double Blind, Randomized Study of Cannabis Oil for Pain in Parkinson's Disease.
Mov Disord Clin Pract
; 10(7): 1114-1119, 2023 Jul.
Article
em En
| MEDLINE
| ID: mdl-37476317
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 (180, 1010, and 120). 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 (120).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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Base de dados:
MEDLINE
Tipo de estudo:
Clinical_trials
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article