TY - JOUR
PY - 2023//
TI - A phase 1b, double blind, randomized study of cannabis oil for pain in Parkinson's disease
JO - Movement disorders clinical practice
A1 - Di Luca, D.G.
A1 - Gilmour, G.S.
A1 - Fearon, C.
A1 - Swinkin, E.
A1 - Freitas, E.
A1 - Kuhlman, G.
A1 - Fox, S.H.
A1 - Mestre, T.
SP - 1114
EP - 1119
VL - 10
IS - 7
N2 - 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
LA - en SN - 2330-1619 UR - http://dx.doi.org/10.1002/mdc3.13754 ID - ref1 ER -