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

被引：5

作者：

Di Luca, Daniel G. ^{[1
,6
]}

Gilmour, Gabriela S. ^{[1
]}

Fearon, Conor ^{[1
]}

Swinkin, Emily ^{[1
]}

Freitas, Eliza ^{[2
]}

Kuhlman, Greg ^{[3
]}

Fox, Susan H. ^{[1
]}

Mestre, Tiago ^{[4
,5
]}

机构：

[1] Toronto Western Hosp, Krembil Brain Inst, Edmond J Safra Program Parkinsons Dis, Movement Disorders Clin, Toronto, ON, Canada

[2] McMaster Univ, Div Neurol, Hamilton, ON, Canada

[3] Univ Cincinnati, Gardner Family Ctr Parkinsons Dis & Movement Disor, Dept Neurol & Rehabil Med, Cincinnati, OH USA

[4] Univ Ottawa Brain, Ottawa Hosp Res Inst, Mind Res Inst, Ottawa, ON, Canada

[5] Ottawa Hosp, Dept Med, Div Neurol, Ottawa, ON, Canada

[6] Toronto Western Hosp, Edmond J Safra Program Parkinsons Dis, Movement Disorders Clin, 399, Bathurst St, 416 603 5207, Toronto, ON M5T 2S8, Canada

来源：

MOVEMENT DISORDERS CLINICAL PRACTICE | 2023年 / 10卷 / 07期

关键词：

Parkinson's disease; pain; cannabis; randomized clinical trial; MEDICAL MARIJUANA; DYSKINESIA;

D O I：

10.1002/mdc3.13754

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

BackgroundPain is common in Parkinson's disease (PD), but effective therapies are limited. ObjectivesTo determine the maximum tolerated dose (MTD) and safety of formulations of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) for pain in PD. MethodsIn 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. ResultsEight 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). ConclusionsIn 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.

引用

页码：1114 / 1119

页数：6

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