Healthy
Conditions
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.
Interventions
DRUGKite Systems cannaHALER cannabis Inhaler.
Sponsors
Rambam Health Care Campus
Kite Systems
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Δ9-tetrahydrocannabinol levels (THC) | 30 Minutes |
| Adverse event monitoring | 4 hours |
| Δ9 Carboxy-THC levels | 30 Minutes |
Secondary
| Measure | Time frame |
|---|---|
| Short Blessed cognitive Test | 30 Minutes |
| Oxygen saturation | 120 Minutes |
| Blood pressure | 120 Minutes |
| Pulse rate | 120 Minutes |
Outcome results
None listed