This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Rambam Health Care Campus
Information provided by (Responsible Party):
Kite Systems
ClinicalTrials.gov Identifier:
NCT02729623
First received: March 27, 2016
Last updated: July 22, 2016
Last verified: July 2016
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.
| Healthy | Drug: Kite Systems cannaHALER cannabis Inhaler. | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | The Pharmacokinetics, Safety, and Ease of Use of a Portable Metered-Dose Cannabis Inhaler: A Phase 1a Study |
- Δ9-tetrahydrocannabinol levels (THC) [ Time Frame: 30 Minutes ] [ Designated as safety issue: No ]
- Adverse event monitoring [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]
- Δ9 Carboxy-THC levels [ Time Frame: 30 Minutes ] [ Designated as safety issue: No ]
- Short Blessed cognitive Test [ Time Frame: 30 Minutes ] [ Designated as safety issue: No ]
- Blood pressure [ Time Frame: 120 Minutes ] [ Designated as safety issue: No ]
- Pulse rate [ Time Frame: 120 Minutes ] [ Designated as safety issue: No ]
- Oxygen saturation [ Time Frame: 120 Minutes ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 12 |
| Study Start Date: | August 2016 |
| Estimated Study Completion Date: | August 2017 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Experimental: Single CannaHALER dose 10 ± 0.1 mg
Single dose 10 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device. |
Drug: Kite Systems cannaHALER cannabis Inhaler. |
| Experimental: Single CannaHALER dose 15 ± 0.1 mg
Single dose 15 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device. |
Drug: Kite Systems cannaHALER cannabis Inhaler. |
| Experimental: Single CannaHALER dose 20 ± 0.1 mg
Single dose 20 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device. |
Drug: Kite Systems cannaHALER cannabis Inhaler. |
| Experimental: Single CannaHALER dose 25 ± 0.1 mg
Single dose 25 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device. |
Drug: Kite Systems cannaHALER cannabis Inhaler. |
| Ages Eligible for Study: | 30 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02729623
Kite Systems
Rambam Health Care Campus
| Principal Investigator: | Ofir Ben-Ishay, MD. | Rambam Health Care Campus |
| Responsible Party: | Kite Systems |
| ClinicalTrials.gov Identifier: | NCT02729623 History of Changes |
| Other Study ID Numbers: | cannaHALER-1A |
| Study First Received: | March 27, 2016 |
| Last Updated: | July 22, 2016 |
| Health Authority: | Israel: Ministry of Health |
| Individual Participant Data | |
| Plan to Share IPD: | Undecided |
ClinicalTrials.gov processed this record on September 13, 2016