The Pharmacokinetics, Safety, and Ease of Use of a Portable Metered-Dose Cannabis Inhaler
Status:
Unknown status
Trial end date:
2017-08-01
Target enrollment:
Participant gender:
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.