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Tetrahydrocannabinol/Cannabidiol Oromucosal Spray in Patients With Multiple Sclerosis: A Pilot Study on the Plasma Concentration-Effect Relationship.
Clin Neuropharmacol. 2018 Sep/Oct; 41(5):171-176.CN

Abstract

OBJECTIVES

We aimed to assess the potential relationship between intrasubject 9-tetrahydrocannabinol/cannabidiol (THC/CBD) oromucosal spray plasma profiles and clinical effects elicited by subacute dosing in chronically treated patients with multiple sclerosis (MS).

METHODS

The study design was pilot, single center, open, and prospective. The patients were challenged with a morning test dose of 2 THC/CBD sprays at a 15-minute interval. Venous blood samples were collected before the first spray administration and every 30 minutes after the second spray, until 240 minutes postdosing. Patients rated their spasticity by the Numerical Rating Scale (NRS) simultaneously with blood drawings. Postural and motor tests were performed before the first spray and 90 and 180 minutes thereafter.

RESULTS

Twelve patients were recruited. Peak plasma concentrations of THC/CBD largely varied among patients, from 0.60 to 13.29 ng/mL for THC and 0.55 to 11.93 ng/mL for CBD. Time to peak plasma concentrations ranged from 150 to 240 minutes for THC and 90 to 240 minutes for CBD. Patients' NRS serial scores decreased after dosing, from a median value of 6 to 3.5 (P < 0.001). A significant inverse correlation was observed between median intrasubject repeated NRS scores and corresponding median values of both THC (P < 0.01) and CBD (P < 0.002) plasma concentrations. No significant effect of cannabinoids dosing could be appreciated according to posturographic and motor tests.

CONCLUSIONS

Our kinetic dynamic findings from THC/CBD oromucosal spray are the first obtained in real MS patients. Although preliminary, they suggest that subacute dosing might elicit a subjective clinically significant effect on MS-related spasticity, paralleling cannabinoids measurable plasma concentrations.

Authors+Show Affiliations

No affiliation info availableNo affiliation info availableIRCCS, Institute of Neurological Sciences of Bologna, and.IRCCS, Institute of Neurological Sciences of Bologna, and.IRCCS, Institute of Neurological Sciences of Bologna, and.IRCCS, Institute of Neurological Sciences of Bologna, and.Department of Biomedical and Neuromotor Sciences, University of Bologna Bologna, Italy.Department of Biomedical and Neuromotor Sciences, University of Bologna Bologna, Italy.No affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article

Language

eng

PubMed ID

30024443

Citation

Contin, Manuela, et al. "Tetrahydrocannabinol/Cannabidiol Oromucosal Spray in Patients With Multiple Sclerosis: a Pilot Study On the Plasma Concentration-Effect Relationship." Clinical Neuropharmacology, vol. 41, no. 5, 2018, pp. 171-176.
Contin M, Mancinelli L, Perrone A, et al. Tetrahydrocannabinol/Cannabidiol Oromucosal Spray in Patients With Multiple Sclerosis: A Pilot Study on the Plasma Concentration-Effect Relationship. Clin Neuropharmacol. 2018;41(5):171-176.
Contin, M., Mancinelli, L., Perrone, A., Sabattini, L., Mohamed, S., Scandellari, C., Foschi, M., Vacchiano, V., Lugaresi, A., & Riva, R. (2018). Tetrahydrocannabinol/Cannabidiol Oromucosal Spray in Patients With Multiple Sclerosis: A Pilot Study on the Plasma Concentration-Effect Relationship. Clinical Neuropharmacology, 41(5), 171-176. https://doi.org/10.1097/WNF.0000000000000294
Contin M, et al. Tetrahydrocannabinol/Cannabidiol Oromucosal Spray in Patients With Multiple Sclerosis: a Pilot Study On the Plasma Concentration-Effect Relationship. Clin Neuropharmacol. 2018;41(5):171-176. PubMed PMID: 30024443.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Tetrahydrocannabinol/Cannabidiol Oromucosal Spray in Patients With Multiple Sclerosis: A Pilot Study on the Plasma Concentration-Effect Relationship. AU - Contin,Manuela, AU - Mancinelli,Luca, AU - Perrone,Alessandro, AU - Sabattini,Loredana, AU - Mohamed,Susan, AU - Scandellari,Cinzia, AU - Foschi,Matteo, AU - Vacchiano,Veria, AU - Lugaresi,Alessandra, AU - Riva,Roberto, PY - 2018/7/20/pubmed PY - 2018/12/12/medline PY - 2018/7/20/entrez SP - 171 EP - 176 JF - Clinical neuropharmacology JO - Clin Neuropharmacol VL - 41 IS - 5 N2 - OBJECTIVES: We aimed to assess the potential relationship between intrasubject 9-tetrahydrocannabinol/cannabidiol (THC/CBD) oromucosal spray plasma profiles and clinical effects elicited by subacute dosing in chronically treated patients with multiple sclerosis (MS). METHODS: The study design was pilot, single center, open, and prospective. The patients were challenged with a morning test dose of 2 THC/CBD sprays at a 15-minute interval. Venous blood samples were collected before the first spray administration and every 30 minutes after the second spray, until 240 minutes postdosing. Patients rated their spasticity by the Numerical Rating Scale (NRS) simultaneously with blood drawings. Postural and motor tests were performed before the first spray and 90 and 180 minutes thereafter. RESULTS: Twelve patients were recruited. Peak plasma concentrations of THC/CBD largely varied among patients, from 0.60 to 13.29 ng/mL for THC and 0.55 to 11.93 ng/mL for CBD. Time to peak plasma concentrations ranged from 150 to 240 minutes for THC and 90 to 240 minutes for CBD. Patients' NRS serial scores decreased after dosing, from a median value of 6 to 3.5 (P < 0.001). A significant inverse correlation was observed between median intrasubject repeated NRS scores and corresponding median values of both THC (P < 0.01) and CBD (P < 0.002) plasma concentrations. No significant effect of cannabinoids dosing could be appreciated according to posturographic and motor tests. CONCLUSIONS: Our kinetic dynamic findings from THC/CBD oromucosal spray are the first obtained in real MS patients. Although preliminary, they suggest that subacute dosing might elicit a subjective clinically significant effect on MS-related spasticity, paralleling cannabinoids measurable plasma concentrations. SN - 1537-162X UR - https://www.unboundmedicine.com/medline/citation/30024443/Tetrahydrocannabinol/Cannabidiol_Oromucosal_Spray_in_Patients_With_Multiple_Sclerosis:_A_Pilot_Study_on_the_Plasma_Concentration_Effect_Relationship_ L2 - http://dx.doi.org/10.1097/WNF.0000000000000294 DB - PRIME DP - Unbound Medicine ER -