Cognitive Safety Data from a Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase IIb Study of the Effects of a Cannabidiol and Δ9-Tetrahydrocannabinol Drug on Parkinson's Disease-Related Motor Symptoms.
Christopher H Domen, Stefan Sillau, Ying Liu, Michelle Adkins, Sarah Rajkovic, Jacquelyn Bainbridge, Cristina Sempio, Jost Klawitter, Maureen A Leehey
Movement Disorders July 2023 DOI: 10.1002/mds.29447 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized, double-blind, parallel-group, placebo-controlled study Longitudinal Peer reviewed |
|---|---|
| Sample size | 58 |
| Population | People with Parkinson's disease |
| Dose | CBD 100 mg and THC 3.3 mg, escalating to twice per day |
| Duration | 16.3 (SD: 4.2) days of treatment; neuropsychological tests at baseline and 1-1½ hours after final dose |
| Measures | Animal Verbal Fluency, cognitive adverse events |
| Topics | Cannabis CBD |
| Keywords | Parkinson's disease Cognition Δ9-tetrahydrocannabinol |
| Key points | The CBD/THC drug showed a small detrimental effect on cognition after acute or short-term use in Parkinson's disease: the CBD/THC group performed worse than placebo on Animal Verbal Fluency after adjustment for age and education, and reported cognitive adverse events at least twice as often as the placebo group. |
Abstract
Cannabis is increasingly available worldwide but its impact on cognition in Parkinson's disease (PD) is unknown. Present cognitive safety data from study of an oral high-dose cannabidiol (CBD; 100 mg) and low-dose Δ9-tetrahydocannabinol (THC; 3.3 mg) drug in PD. Randomized, double-blind, parallel-group, placebo-controlled study of a CBD/THC drug administered for 16.3 (SD: 4.2) days, with dosage escalating to twice per day. Neuropsychological tests were administered at baseline and 1-1½ hours after final dose; scores were analyzed with longitudinal regression models (alpha = 0.05). Cognitive adverse events were collected. When adjusted for age and education, the CBD/THC group (n = 29) performed worse than the placebo group (n = 29) on Animal Verbal Fluency. Adverse cognitive events were reported at least twice as often by the CBD/THC than the placebo group. Data suggest this CBD/THC drug has a small detrimental effect on cognition following acute/short-term use in PD. © 2023 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.
Comparable studies
Other randomized controlled trials on CBD, most cited first.
Citations in the library
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and 3 more in the library