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

Primary Purpose

Healthy

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Kite Systems cannaHALER cannabis Inhaler.

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

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

Arm Description

Single dose 10 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device.

Single dose 15 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device.

Single dose 20 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device.

Single dose 25 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device.

Outcomes

Primary Outcome Measures

Δ9-tetrahydrocannabinol levels (THC)

Adverse event monitoring

Δ9 Carboxy-THC levels

Secondary Outcome Measures

Short Blessed cognitive Test

Blood pressure

Pulse rate

Oxygen saturation

Full Information

NCT ID

NCT02729623

First Posted

March 27, 2016

Last Updated

July 22, 2016

Sponsor

Kite Systems

Collaborators

Rambam Health Care Campus

1. Study Identification

Unique Protocol Identification Number

NCT02729623

Brief Title

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

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Unknown status

Study Start Date

August 2016 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kite Systems

Collaborators

Rambam Health Care Campus

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single CannaHALER dose 10 ± 0.1 mg

Arm Type

Experimental

Arm Description

Single dose 10 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device.

Arm Title

Single CannaHALER dose 15 ± 0.1 mg

Arm Type

Experimental

Arm Description

Single dose 15 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device.

Arm Title

Single CannaHALER dose 20 ± 0.1 mg

Arm Type

Experimental

Arm Description

Single dose 20 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device.

Arm Title

Single CannaHALER dose 25 ± 0.1 mg

Arm Type

Experimental

Arm Description

Single dose 25 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device.

Intervention Type

Drug

Intervention Name(s)

Kite Systems cannaHALER cannabis Inhaler.

Primary Outcome Measure Information:

Title

Δ9-tetrahydrocannabinol levels (THC)

Time Frame

30 Minutes

Title

Adverse event monitoring

Time Frame

4 hours

Title

Δ9 Carboxy-THC levels

Time Frame

30 Minutes

Secondary Outcome Measure Information:

Title

Short Blessed cognitive Test

Time Frame

30 Minutes

Title

Blood pressure

Time Frame

120 Minutes

Title

Pulse rate

Time Frame

120 Minutes

Title

Oxygen saturation

Time Frame

120 Minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ofir Ben-Ishay, MD.

Organizational Affiliation

Rambam Health Care Campus

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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