Smokeless consumption of medical cannabis pharmacokinetics, safety and feasibility of the CannaHALER© a phase 1a study

BACKGROUND: Substantial advancements were achieved in the management of postoperative pain, however the need for further improvement remains. This study explores the pharmacokinetics and safety of the CannaHaler, a metered dose inhaler for plant material made by Kite-Systems situated in Tel-Aviv, Israel. METHODS: The study was conducted on 12 healthy adult volunteers divided into four arms (each arm/group holds 3 volunteers) with the evaporated plant material being Alaska strain provided by “Tikun Olam”. This strain is a hybrid of 70% Sativa and 30% Indika strains, consisting of 20–22% THC and 0% CBD. Each arm received a single dose and groups were divided in an ascending dose fashion: Group I-IV receiving 10, 15, 20, 25 mg of THC respectively. The volunteers inhaled a single dose of THC using the CannaHaler, device. Blood samples for Δ(9) – Tetrahydrocannabinol (THC) and 9-THCCOOH were taken at base line and up to 30 min after dosing. Adverse events were monitored following the inhalation. Pharmacokinetics profile was obtained for each patient in all arms. RESULTS: Ascending doses of THC produced a linear increase in the maximum concentration 10, 15, 20 and 25 mg of THC. (35.43 ± 5.97, 51.47 ± 13.79, 72.37 ± 15.93, 88.63 ± 14.75 respectively) with the same linear increase in the dimension of the AUC (441.59 ± 88.49, 624 ± 123.56, 698.35 ± 174.98, 971.36 ± 310.4 respectively) both with no change in the time needed to reach such concentration. No adverse events were recorded in all of study subjects. The CannaHaler achieved high C(max) (35.43–88.63 ng/mL) values and low coefficient of variations (16.64–26.79%) in comparison to both smoking and oral preparations, thus reaching the potential of a pharmaceutical grade device for inhaled substance. CONCLUSIONS: The current study showed that the use of Kite-Systems CannaHaler as a smokeless medical cannabis inhalation device is feasible and efficient. The low coefficient of variation together with the high C(max) values, suggest the potential use of the CannaHaler device as a pharmaceutical cannabis dosing administrator.