Clinical trial NCT03886753: Pharmacokinetic (PK) and Pharmacodynamics (PD) Study of Ilera Specific Products
Official title: Pharmacokinetic and Pharmacodynamic Study of Ilera Medical Marijuana Products
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: ALS
Autism Spectrum Disorder
Cancer
Spasticity, Muscle
Dyskinetic Syndrome
Epilepsy
Glaucoma
Huntington Disease
Inflammatory Bowel Disease (IBD)
Multiple Sclerosis
Neuropathy
Opioid Use
Parkinson Disease
HIV/AIDS
Ptsd
Intractable Pain
Sickle Cell Disease
Terminal Illness
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Ilera Healthcare
First posted: 2019-03-22
Enrollment: 10
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients \> 2 years old who are being treated with Dream, Shine, Ease or Soothe products manufactured by Ilera Healthcare for a state approved qualifying medical condition under the PA State Medical Marijuana Program.

Brief summary: This is an observational study of medical marijuana manufactured and dispensed by Ilera and given as standard treatment for a variety of approved serious medical conditions as defined by individual state law. All patients who are receiving one of the four formulations (Dream, Soothe, Shine and Ease) of medical marijuana will be provided a study flyer and asked to contact the study team via phone or email. Once the study team confirms eligibility, the study team will meet the subject face-to-face most likely at their dispensary (or other mutually agreeable location) and obtain informed consent, and assent when appropriate. Initial baseline demographic information, medical history and medication inventory will be completed. Also, since it is possible that the Investigators will enroll subjects across the region, Investigators anticipate the need to seek consent over the phone for many patients. This will be done via Skype, Go to Meeting, Facetime or similar platforms so that the Investigators can have a face to face interaction with the potential subjects. Regardless of where this discussion takes place (i.e., in person or via the web), all reasonable safeguards to ensure patient privacy will be taken. Patients or their legally authorized representative (LAR) will be given sufficient (i.e., up to several hours/days) to make a decision to participate in this study. Study staff will fax or email the consent form for their signature and no study procedures will begin until the signed consent form is received by the study team. The subjects or their LARs will be instructed on obtaining the blood samples. Blood draws will be completed in the subjects' home after one of their standard doses is taken.

Detailed description: This is a prospective PK/PD study that will include patients who are currently legally consuming one of the four medical marijuana formulations (Dream, Soothe, Shine and Ease) from Ilera Healthcare as part of their standard therapy for one of the state approved serious medical conditions.

Part 1 of the study consists of intake data of select subjects.

* The patients will be identified at a dispensary that offers Ilera products.
* Patients be given a flyer about the study by either study staff or dispensary staff.
* Eligible patients will be asked to contact the study team if they are interested in the study.
* If the patient is interested, a face-to-face (in person at the dispensary or in the patients home or other agreed upon location) consent/assent will be obtained.
* Also, since it is possible that Investigators will enroll subjects across the region, Investigators anticipate the need to seek consent over the phone for many patients. This will be done via Skype, Go to Meeting, Facetime or similar platforms so that the investigators can have a face to face interaction with the potential subjects. Investigators will obtain written consent in all cases. Investigators will have them sign and fax or email/scan the signed consent form back to the study team.
* Once consent is obtained demographic information will be collected as well as a medical and medication history and several questions related specifically to the medical marijuana product and its perceived effectiveness.
* The data will be recorded in the REDCAP database. Part 2 of the study consists of pharmacokinetic evaluation of select subjects.
* Parents/ care providers/ patients when appropriate will undergo education regarding PK sample acquisition
* PK blood samples will be obtained and sent to the Children's Hospital of Philadelphia (CHOP) for determination of cannibidiol/ Tetrahydrocannabinol/ cannabinol (CBD/THC/CBN) concentrations
* PK and PD analysis will occur

Eligibility criteria: Inclusion Criteria:

* Individuals who consume either Dream, Shine, Soothe or Ease medical marijuana manufactured by Ilera Heath care in a state which has legalized medical marijuana for state specified serious medical conditions.
* Written informed consent and assent (if applicable)
* Patients greater than 2 years of age

Exclusion Criteria:

* Consumption of marijuana products that are not obtained from a state licensed dispensary
* Non English speaking individuals
* Have consumed a CBD/THC containing product other than the product under study within the 7 days prior to the PK study

Primary outcomes:
measure: Change in symptoms
timeFrame: 1 year
Secondary outcomes:
measure: Description and incidence of patient or caregiver reported side effects
timeFrame: 1 year
measure: Changes in drug concentrations
timeFrame: 2 years
measure: Rate of bioavailabilty
timeFrame: 2 years
measure: Volume of distribution
timeFrame: 2 years
measure: Report area under the plasma concentration versus time curve (AUC)
timeFrame: 2 years
measure: Report half-life
timeFrame: 2 years
measure: Assess therapeutic range
timeFrame: 2 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Athena F Zuppa, MD MSCE
role: PRINCIPAL_INVESTIGATOR
References: