HealthyPhase 1NCT02729623
The Pharmacokinetics, Safety, and Ease of Use of a Portable Metered-Dose Cannabis Inhaler
A Phase 1 study testing Kite Systems cannaHALER cannabis Inhaler. in people with Healthy, run by Kite Systems.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Kite Systems cannaHALER cannabis Inhaler.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Aug 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 30-70 years;
- healthy
- if applicable, negative pregnancy test (β human chorionic gonadotropin pregnancy test).
Who cannot join
- 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,
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- 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.
About this study
Official title: The Pharmacokinetics, Safety, and Ease of Use of a Portable Metered-Dose Cannabis Inhaler: A Phase 1a Study
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.
- Conditions
- Healthy
- Being tested
- Kite Systems cannaHALER cannabis Inhaler.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kite Systems cannaHALER cannabis Inhaler.Drug
| Study group | Role | What they receive |
|---|---|---|
| Single CannaHALER dose 10 ± 0.1 mg | Experimental | Single dose 10 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device. Receives: Drug: Kite Systems cannaHALER cannabis Inhaler. |
| Single CannaHALER dose 15 ± 0.1 mg | Experimental | Single dose 15 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device. Receives: Drug: Kite Systems cannaHALER cannabis Inhaler. |
| Single CannaHALER dose 20 ± 0.1 mg | Experimental | Single dose 20 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device. Receives: Drug: Kite Systems cannaHALER cannabis Inhaler. |
| Single CannaHALER dose 25 ± 0.1 mg | Experimental | Single dose 25 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device. Receives: Drug: Kite Systems cannaHALER cannabis Inhaler. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Δ9-tetrahydrocannabinol levels (THC)
Measured: 30 Minutes
Adverse event monitoring
Measured: 4 hours
Δ9 Carboxy-THC levels
Measured: 30 Minutes
Secondary outcomes (4)
Short Blessed cognitive Test
Measured: 30 Minutes
Blood pressure
Measured: 120 Minutes
Pulse rate
Measured: 120 Minutes
Oxygen saturation
Measured: 120 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2016 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kite Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rambam Health Care Campus
- Responsible party
- Sponsor
- Investigators
- Ofir Ben-Ishay, MD., Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729623
- Sponsor's protocol ID
- cannaHALER-1A
- Status last verified
- Jul 2016
- First submitted
- 27 Mar 2016
- Last updated
- 25 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetics, Safety, and Ease of Use of a Portable Metered-Dose Cannabis Inhaler: A Phase 1a Study
- ClinicalTrials.gov ID
- NCT02729623
- Acronym / sponsor ID
- cannaHALER-1A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Kite SystemsIndustry (pharma, biotech, devices)
- Collaborators
- Rambam Health Care Campus
- Study start
- Aug 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single CannaHALER dose 10 ± 0.1 mg | Experimental | Drug: Kite Systems cannaHALER cannabis Inhaler.Single dose 10 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device. |
| Single CannaHALER dose 15 ± 0.1 mg | Experimental | Drug: Kite Systems cannaHALER cannabis Inhaler.Single dose 15 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device. |
| Single CannaHALER dose 20 ± 0.1 mg | Experimental | Drug: Kite Systems cannaHALER cannabis Inhaler.Single dose 20 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device. |
| Single CannaHALER dose 25 ± 0.1 mg | Experimental | Drug: Kite Systems cannaHALER cannabis Inhaler.Single dose 25 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 30-70 years;
- healthy
- if applicable, negative pregnancy test (β human chorionic gonadotropin pregnancy test).
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kite Systems cannaHALER cannabis Inhaler. | Drug | Single CannaHALER dose 10 ± 0.1 mg, Single CannaHALER dose 15 ± 0.1 mg, Single CannaHALER dose 20 ± 0.1 mg, Single CannaHALER dose 25 ± 0.1 mg |
Primary outcome
Δ9-tetrahydrocannabinol levels (THC)
Time frame: 30 Minutes
Adverse event monitoring
Time frame: 4 hours
Δ9 Carboxy-THC levels
Time frame: 30 Minutes
4 secondary outcomes
Short Blessed cognitive Test
Time frame: 30 Minutes
Blood pressure
Time frame: 120 Minutes
Pulse rate
Time frame: 120 Minutes
Oxygen saturation
Time frame: 120 Minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ofir Ben-Ishay, MD. principal investigator
Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Kite Systems cannaHALER cannabis Inhaler. in people with Healthy, run by Kite Systems.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Δ9-tetrahydrocannabinol levels (THC) (time frame: 30 Minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2016.