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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Kite Systems cannaHALER cannabis Inhaler.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single CannaHALER dose 10 ± 0.1 mg<br>Single dose 10 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device. | Drug: Kite Systems cannaHALER cannabis Inhaler.<br> <br> |
| Experimental: Single CannaHALER dose 15 ± 0.1 mg<br>Single dose 15 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device. | Drug: Kite Systems cannaHALER cannabis Inhaler.<br> <br> |
| Experimental: Single CannaHALER dose 20 ± 0.1 mg<br>Single dose 20 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device. | Drug: Kite Systems cannaHALER cannabis Inhaler.<br> <br> |
| Experimental: Single CannaHALER dose 25 ± 0.1 mg<br>Single dose 25 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device. | Drug: Kite Systems cannaHALER cannabis Inhaler.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Δ9-tetrahydrocannabinol levels (THC) |  | 30 Minutes | 
| Adverse event monitoring |  | 4 hours | 
| Δ9 Carboxy-THC levels |  | 30 Minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Blessed cognitive Test |  | 30 Minutes | 
| Blood pressure |  | 120 Minutes | 
| Pulse rate |  | 120 Minutes | 
| Oxygen saturation |  | 120 Minutes |