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

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ClinicalTrials.gov Identifier: NCT03886753
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
Ilera Healthcare
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment
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 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

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Study Type : Observational
Estimated Enrollment : 128 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetic and Pharmacodynamic Study of Ilera Medical Marijuana Products
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

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.




Primary Outcome Measures :
  1. Change in symptoms [ Time Frame: 1 year ]
    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


Secondary Outcome Measures :
  1. Description and incidence of patient or caregiver reported side effects [ Time Frame: 1 year ]
    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.

  2. Changes in drug concentrations [ Time Frame: 2 years ]
    The amount of a drug in a given volume of blood plasma, measured as the number of micrograms per milliliter

  3. Rate of bioavailabilty [ Time Frame: 2 years ]
    The degree and rate at which the medication is absorbed by the body's circulatory system, the systemic circulation.

  4. Volume of distribution [ Time Frame: 2 years ]
    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.

  5. Report area under the plasma concentration versus time curve (AUC) [ Time Frame: 2 years ]
    The area under the curve (AUC) is the definite integral in a plot of drug concentration in blood plasma vs. time

  6. Report half-life [ Time Frame: 2 years ]
    Half life is described as how long it takes for half of the dose to be metabolized and eliminated from the bloodstream.

  7. Assess therapeutic range [ Time Frame: 2 years ]
    Comparison of the amount of a therapeutic agent that causes the therapeutic effect to the amount that causes toxicity.


Biospecimen Retention:   Samples Without DNA
We will ask patients if we can retain their specimens for future studies


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

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): NCT03886753


Contacts
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Contact: Mary Ann DiLiberto, RN 2674265753 diliberto@email.chop.edu

Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Athena Zuppa, MD    267-426-7359    zuppa@email.chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
Ilera Healthcare
Investigators
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Principal Investigator: Athena F Zuppa, MD MSCE Childrens Hospital of Philadelphia

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03886753     History of Changes
Other Study ID Numbers: 18-015787
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Autism Spectrum Disorder
Parkinson Disease
Multiple Sclerosis
Inflammatory Bowel Diseases
Anemia, Sickle Cell
Huntington Disease
Pain, Intractable
Muscle Spasticity
Dyskinesias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies