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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
12
Δ9-tetrahydrocannabinol levels (THC)
Time frame: 30 Minutes
Adverse event monitoring
Time frame: 4 hours
Δ9 Carboxy-THC levels
Time frame: 30 Minutes
Short Blessed cognitive Test
Time frame: 30 Minutes
Blood pressure
Time frame: 120 Minutes
Pulse rate
Time frame: 120 Minutes
Oxygen saturation
Time frame: 120 Minutes
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