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| Name | Class |
|---|---|
| Rambam Health Care Campus | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single CannaHALER dose 10 ± 0.1 mg | Experimental | Single dose 10 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device. |
|
| Single CannaHALER dose 15 ± 0.1 mg | Experimental | Single dose 15 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device. |
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| Single CannaHALER dose 20 ± 0.1 mg | Experimental | Single dose 20 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device. |
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| Single CannaHALER dose 25 ± 0.1 mg | Experimental | Single dose 25 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kite Systems cannaHALER cannabis Inhaler. | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Δ9-tetrahydrocannabinol levels (THC) | 30 Minutes | |
| Adverse event monitoring | 4 hours | |
| Δ9 Carboxy-THC levels | 30 Minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Short Blessed cognitive Test | 30 Minutes | |
| Blood pressure | 120 Minutes | |
| Pulse rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ofir Ben-Ishay, MD. | Rambam Health Care Campus | Principal Investigator |
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| 120 Minutes |
| Oxygen saturation | 120 Minutes |