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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: Kite Systems cannaHALER cannabis Inhaler.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kite Systems
• Collaborators: Rambam Health Care Campus
• Investigators: Principal Investigator: Ofir Ben-Ishay, MD., Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: March 27, 2016
• First Submitted That Met QC Criteria: April 5, 2016
• First Posted (Estimate): April 6, 2016

Study Record Updates

• Last Update Posted (Estimate): July 25, 2016
• Last Update Submitted That Met QC Criteria: July 22, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse
• Other Study ID Numbers: cannaHALER-1A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided