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

NCT02729623 | Unknown Phase 1

• 1 other identifier: cannaHALER-1A
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Δ9-tetrahydrocannabinol levels (THC)

  30 Minutes

• Adverse event monitoring

  4 hours

• Δ9 Carboxy-THC levels

  30 Minutes

Secondary Outcomes (4)

• Short Blessed cognitive Test

  30 Minutes

• Blood pressure

  120 Minutes

• Pulse rate

  120 Minutes

• Oxygen saturation

  120 Minutes

Study Arms (4)

Single CannaHALER dose 10 ± 0.1 mg

EXPERIMENTAL

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

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.

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.

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.

Drug: Kite Systems cannaHALER cannabis Inhaler.

Interventions

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

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 30-70 years;
• healthy
• if applicable, negative pregnancy test (β human chorionic gonadotropin pregnancy test).

You may not qualify if:

• 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,

Sponsors & Collaborators

• Kite Systems: lead
• Rambam Health Care Campus: collaborator

Study Officials

• Ofir Ben-Ishay, MD.

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2016
• First Posted: April 6, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: August 1, 2017
• Last Updated: July 25, 2016

Record last verified: 2016-07