Pharmacokinetic (PK) and Pharmacodynamics (PD) Study of Ilera Specific Products (Ilera)

Pharmacokinetic and Pharmacodynamic Study of Ilera Medical Marijuana Products

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.

Study Overview

• Status: Terminated
• Conditions: Epilepsy; Multiple Sclerosis; Glaucoma; Cancer; Parkinson Disease; HIV/AIDS; ALS; Autism Spectrum Disorder; Sickle Cell Disease; Spasticity, Muscle; Huntington Disease; Opioid Use; Neuropathy; Terminal Illness; Inflammatory Bowel Disease (IBD); Intractable Pain; Ptsd; Dyskinetic Syndrome
• Intervention / Treatment: Other: Registry; Other: PK microsampling of blood

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

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ease; Subjects using Ease as standard treatment. Registry and PK sampling	Other: Registry; Collect data on subjects; Other: PK microsampling of blood; Obtain 5 microsamples of blood from subjects via a fingerstick.
Dream; Subjects using Dream as standard treatment. Registry and PK sampling	Other: Registry; Collect data on subjects; Other: PK microsampling of blood; Obtain 5 microsamples of blood from subjects via a fingerstick.
Soothe; Subjects using Soothe as standard treatment. Registry and PK sampling	Other: Registry; Collect data on subjects; Other: PK microsampling of blood; Obtain 5 microsamples of blood from subjects via a fingerstick.
Shine; Those subjects using Shine as standard treatment. Registry and PK sampling	Other: Registry; Collect data on subjects; Other: PK microsampling of blood; Obtain 5 microsamples of blood from subjects via a fingerstick.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in symptoms	Relief of primary indication (perceived therapeutic benefit of product)as reported by parent or caregiver on a 1-10 Lichert scale with 1 being minimally effective and 10 being extremely effective	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description and incidence of patient or caregiver reported side effects	There is no particular instrument used in collecting this data. It is an open ended question where by patients and caregivers report possible side effects from the medical marijuana. Investigators will report the incidence in percentages.	1 year
Changes in drug concentrations	The amount of a drug in a given volume of blood plasma, measured as the number of micrograms per milliliter	2 years
Rate of bioavailabilty	The degree and rate at which the medication is absorbed by the body's circulatory system, the systemic circulation.	2 years
Volume of distribution	The volume of medication that would be necessary to contain the total amount of the administered drug at the same concentration that it is observed in the blood plasma.	2 years
Report area under the plasma concentration versus time curve (AUC)	The area under the curve (AUC) is the definite integral in a plot of drug concentration in blood plasma vs. time	2 years
Report half-life	Half life is described as how long it takes for half of the dose to be metabolized and eliminated from the bloodstream.	2 years
Assess therapeutic range	Comparison of the amount of a therapeutic agent that causes the therapeutic effect to the amount that causes toxicity.	2 years

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: Ilera Healthcare

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2019
• Primary Completion (ACTUAL): June 30, 2020
• Study Completion (ACTUAL): June 30, 2020

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (ACTUAL): March 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Pain; Neurologic Manifestations; Neurocognitive Disorders; Hematologic Diseases; Gastrointestinal Diseases; Genetic Diseases, Inborn; Musculoskeletal Diseases; Gastroenteritis; Muscular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Intestinal Diseases; Neuromuscular Manifestations; Anemia; Dyskinesias; Heredodegenerative Disorders, Nervous System; Dementia; Cognition Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Muscle Hypertonia; Chorea; Multiple Sclerosis; Parkinson Disease; Inflammatory Bowel Diseases; Autism Spectrum Disorder; Anemia, Sickle Cell; Muscle Spasticity; Huntington Disease; Pain, Intractable
• Other Study ID Numbers: 18-015787

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No