Cannabis-Based Products in a Neurological Setting: A Clinical and Pharmacokinetic Survey.

cannabidiol cannabis oil cannabis oromucosal spray delta-9-tetrahydrocannabinol medical cannabis neurology pharmacokinetics

Journal

Frontiers in neurology
ISSN: 1664-2295
Titre abrégé: Front Neurol
Pays: Switzerland
ID NLM: 101546899

Informations de publication

Date de publication:
2022
Historique:
received: 28 09 2021
accepted: 27 01 2022
entrez: 14 4 2022
pubmed: 15 4 2022
medline: 15 4 2022
Statut: epublish

Résumé

Limited data are available in clinical settings on the pharmacokinetics of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). We investigated the use of cannabis-based products in neurological practice, monitoring patients' steady-state cannabinoids (CBs) plasma concentrations matched with different preparations. This was a prospective, single-center, observational study. Patients underwent venous blood withdrawal before the CBs' morning dose and then 2.5 h post-dosing. Spasticity or pain were patient self-assessed by the Numeric Rating Scale (NRS) before the morning CB's administration and 2.5 h post-dosing. Thirty-three patients were enrolled. Main indications for CBs were spasticity and chronic pain. Sixteen patients were treated with oromucosal spray formulation Sativex® and 17 with oil-based solutions. Both CBs trough plasma concentrations were ≤ limit of detection (0.1 ng/ml) in 45% of patients. Intrasubject CB's plasma levels significantly increased over baseline values in patients treated with Bediol® oil ( This is the first study investigating CB's plasma concentrations of oral and oromucosal preparations in real-world neurological practice. Findings of similar bioavailability for both CBD and THC after galenic oil compared with oromucosal spray dosing may be clinically relevant and deserve additional research in larger cohorts.

Sections du résumé

Background and Aim UNASSIGNED
Limited data are available in clinical settings on the pharmacokinetics of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). We investigated the use of cannabis-based products in neurological practice, monitoring patients' steady-state cannabinoids (CBs) plasma concentrations matched with different preparations.
Methods UNASSIGNED
This was a prospective, single-center, observational study. Patients underwent venous blood withdrawal before the CBs' morning dose and then 2.5 h post-dosing. Spasticity or pain were patient self-assessed by the Numeric Rating Scale (NRS) before the morning CB's administration and 2.5 h post-dosing.
Results UNASSIGNED
Thirty-three patients were enrolled. Main indications for CBs were spasticity and chronic pain. Sixteen patients were treated with oromucosal spray formulation Sativex® and 17 with oil-based solutions. Both CBs trough plasma concentrations were ≤ limit of detection (0.1 ng/ml) in 45% of patients. Intrasubject CB's plasma levels significantly increased over baseline values in patients treated with Bediol® oil (
Conclusion UNASSIGNED
This is the first study investigating CB's plasma concentrations of oral and oromucosal preparations in real-world neurological practice. Findings of similar bioavailability for both CBD and THC after galenic oil compared with oromucosal spray dosing may be clinically relevant and deserve additional research in larger cohorts.

Identifiants

pubmed: 35418935
doi: 10.3389/fneur.2022.784748
pmc: PMC8997238
doi:

Types de publication

Journal Article

Langues

eng

Pagination

784748

Informations de copyright

Copyright © 2022 Mohamed, Lopane, Sabattini, Scandellari, Zardi, Donadio, Rizzo, Perrone, Lugaresi and Contin.

Déclaration de conflit d'intérêts

AL has served as a Biogen, Merck Serono, Novartis, Roche, Sanofi/Genzyme Bristol-Myers- Squibb Celgene, and Teva Advisory Board Member. She received congress, and travel/accommodation expense compensations or speaker honoraria from Biogen, Merck, Mylan, Novartis, Sanofi/Genzyme, Teva and Fondazione Italiana Sclerosi Multipla (FISM). Her institutions received research grants from Novartis. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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Auteurs

Susan Mohamed (S)

IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.

Giovanna Lopane (G)

IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.

Loredana Sabattini (L)

IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.

Cinzia Scandellari (C)

IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.

Diletta Zardi (D)

Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.

Vincenzo Donadio (V)

IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.

Giovanni Rizzo (G)

IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.

Alessandro Perrone (A)

IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.

Alessandra Lugaresi (A)

IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.
Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.

Manuela Contin (M)

IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.
Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.

Classifications MeSH