TY - JOUR
T1 - A Phase Ib, Double Blind, Randomized Study of Cannabis Oil for Pain in Parkinson's Disease
AU - Di Luca, Daniel G.
AU - Gilmour, Gabriela S.
AU - Fearon, Conor
AU - Swinkin, Emily
AU - Freitas, Eliza
AU - Kuhlman, Greg
AU - Fox, Susan H.
AU - Mestre, Tiago
N1 - Publisher Copyright:
© 2023 International Parkinson and Movement Disorder Society.
PY - 2023/7
Y1 - 2023/7
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.
AB - 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.
KW - Parkinson's disease
KW - cannabis
KW - pain
KW - randomized clinical trial
UR - http://www.scopus.com/inward/record.url?scp=85158143094&partnerID=8YFLogxK
U2 - 10.1002/mdc3.13754
DO - 10.1002/mdc3.13754
M3 - Article
C2 - 37476317
AN - SCOPUS:85158143094
SN - 2330-1619
VL - 10
SP - 1114
EP - 1119
JO - Movement Disorders Clinical Practice
JF - Movement Disorders Clinical Practice
IS - 7
ER -