Clinical trial NCT02729623: The Pharmacokinetics, Safety, and Ease of Use of a Portable Metered-Dose Cannabis Inhaler
Official title: The Pharmacokinetics, Safety, and Ease of Use of a Portable Metered-Dose Cannabis Inhaler: A Phase 1a Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Kite Systems
Sponsor class: INDUSTRY
Collaborators: name: Rambam Health Care Campus
First posted: 2016-04-06
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* aged 30-70 years;
* healthy
* if applicable, negative pregnancy test (β human chorionic gonadotropin pregnancy test).

Exclusion Criteria:

* significant cardiac or pulmonary disease,
* history of a psychotic or anxiety disorder,
* pregnancy, pregnancy attempt or breastfeeding,
* presence of a neuropathic or non-neuropathic pain,
* low blood pressure, below 90 mm Hg (systolic)
* Diabetes is diagnosed,
* first degree family history of psychotic or anxiety disorder,
* history of drug addiction,
* history of drug misuse,
* using the following drugs: Rifampicin, Rifabutin, Carbamazepine, Phenobarbital, Primidone,
* using the following plants: Hypericum perforatum, troglitazone,
* Alcohol consumption up to 12 hours before the study,
* abnormal parameters such as Heart Rate above 100 BPM, Blood pressure, below 90 mm Hg (systolic), Saturation below 91 percent,
* Cannabis use up to 12 hours before the study,
* health condition which could affect or alter the experiment results,
* Volunteer has a legal guardian.
* Chronic use of drugs,
* age less than 30 or more than 70,
* a health condition that could affect the outcome of the trial or constitutes a risk factor for participation in the trial.
* The experiment will not include special populations such as pregnant women, children and without judgement.

Primary outcomes:
measure: Δ9-tetrahydrocannabinol levels (THC)
timeFrame: 30 Minutes
measure: Adverse event monitoring
timeFrame: 4 hours
measure: Δ9 Carboxy-THC levels
timeFrame: 30 Minutes
Secondary outcomes:
measure: Short Blessed cognitive Test
timeFrame: 30 Minutes
measure: Blood pressure
timeFrame: 120 Minutes
measure: Pulse rate
timeFrame: 120 Minutes
measure: Oxygen saturation
timeFrame: 120 Minutes
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Health Care Campus
name: Ofir Ben-Ishay, MD.
role: PRINCIPAL_INVESTIGATOR
References: