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

Phase 1

• Conditions: Healthy
• Interventions: Drug: Kite Systems cannaHALER cannabis Inhaler.

• Registration Number: NCT02729623
• Lead Sponsor: Kite Systems

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-27
• Study First Submitted QC: 2016-04-05
• Study First Posted: 2016-04-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-22
• Last Update Posted: 2016-07-25
• Study Start: 2016-08
• Primary Completion: 2016-12
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single CannaHALER dose 25 ± 0.1 mg	Kite Systems cannaHALER cannabis Inhaler.	Single dose 25 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device.
Single CannaHALER dose 10 ± 0.1 mg	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	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	Kite Systems cannaHALER cannabis Inhaler.	Single dose 20 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device.

Primary Outcome Measures

Name	Time	Method
Δ9 Carboxy-THC levels	30 Minutes
Δ9-tetrahydrocannabinol levels (THC)	30 Minutes
Adverse event monitoring	4 hours

Secondary Outcome Measures

Name	Time	Method
Short Blessed cognitive Test	30 Minutes
Blood pressure	120 Minutes
Pulse rate	120 Minutes
Oxygen saturation	120 Minutes