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

Cancer Clinical Trial

— Ilera  

Official title:

Pharmacokinetic and Pharmacodynamic Study of Ilera Medical Marijuana Products

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03886753
• Other study ID #: 18-015787
• Status: Terminated
• Start date: May 15, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ALS
• Anemia, Sickle Cell
• Autism Spectrum Disorder
• Cancer
• Dyskinetic Syndrome
• Epilepsy
• Glaucoma
• HIV/AIDS
• Huntington Disease
• Inflammatory Bowel Disease (IBD)
• Inflammatory Bowel Diseases
• Intractable Pain
• Multiple Sclerosis
• Muscle Spasticity
• Neuropathy
• Opioid Use
• Pain, Intractable
• Parkinson Disease
• Ptsd
• Sickle Cell Disease
• Spasticity, Muscle
• Terminal Illness

Intervention

Other:
• Registry
Collect data on subjects
• PK microsampling of blood
Obtain 5 microsamples of blood from subjects via a fingerstick.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Ilera Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Rate of bioavailabilty	The degree and rate at which the medication is absorbed by the body's circulatory system, the systemic circulation.	2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	Assess therapeutic range	Comparison of the amount of a therapeutic agent that causes the therapeutic effect to the amount that causes toxicity.	2 years