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The Pharmacokinetics, Safety, and Ease of Use of a Portable Metered-Dose Cannabis Inhaler

Healthy Clinical Trial

Official title:
The Pharmacokinetics, Safety, and Ease of Use of a Portable Metered-Dose Cannabis Inhaler: A Phase 1a Study

Clinical Trial Summary

Growing evidence supports the use of inhaled cannabis for neuropathic pain; the lack of standard inhaled dosing holds a major obstacle in cannabis becoming a pharmacological treatment for neuropathic pain. The objective of this study is to explore the pharmacokinetics, safety, tolerability, and ease of use of a portable metered-dose inhaler, (i.e. CannaHALER) for cannabis in a cohort of 12 healthy volunteers. In a single escalating dose methodology, open-label study, patients will inhale a single 10 ± 0.1 mg / 15 ± 0.1 mg / 20 ± 0.1 mg / 25 ± 0.1 mg dose of cannabis using the Kite Systems cannaHALER cannabis Inhaler device. Blood samples will be taken at baseline and up to 30 minutes. Adverse events will be monitored following the inhalation.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02729623
Study type Interventional
Source Kite Systems
Contact
Status Enrolling by invitation
Phase Phase 1
Start date August 2016
Completion date August 2017
View Details
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