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

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ClinicalTrials.gov Identifier: NCT02729623
Recruitment Status : Unknown
Verified July 2016 by Kite Systems.
Recruitment status was:  Enrolling by invitation
First Posted : April 6, 2016
Last Update Posted : July 25, 2016
Sponsor:
Collaborator:
Rambam Health Care Campus
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Kite Systems cannaHALER cannabis Inhaler. Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Pharmacokinetics, Safety, and Ease of Use of a Portable Metered-Dose Cannabis Inhaler: A Phase 1a Study
Study Start Date : August 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

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.



Primary Outcome Measures :
  1. Δ9-tetrahydrocannabinol levels (THC) [ Time Frame: 30 Minutes ]
  2. Adverse event monitoring [ Time Frame: 4 hours ]
  3. Δ9 Carboxy-THC levels [ Time Frame: 30 Minutes ]

Secondary Outcome Measures :
  1. Short Blessed cognitive Test [ Time Frame: 30 Minutes ]
  2. Blood pressure [ Time Frame: 120 Minutes ]
  3. Pulse rate [ Time Frame: 120 Minutes ]
  4. Oxygen saturation [ Time Frame: 120 Minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729623


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

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Responsible Party: Kite Systems
ClinicalTrials.gov Identifier: NCT02729623     History of Changes
Other Study ID Numbers: cannaHALER-1A
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders