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

Children's Hospital of Philadelphia (CHOP)

Status: Terminated

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

Treatments: Other: PK microsampling of blood; Other: Registry

Study type: Observational

Funder types: Other

Identifiers

NCT03886753

18-015787

Details and patient eligibility

About

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.

Full 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

Enrollment: 10 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 4 patient groups

Ease

Description:

Subjects using Ease as standard treatment. Registry and PK sampling

Treatment:

Other: Registry

Other: PK microsampling of blood

Dream

Description:

Subjects using Dream as standard treatment. Registry and PK sampling

Treatment:

Other: Registry

Other: PK microsampling of blood

Soothe

Description:

Subjects using Soothe as standard treatment. Registry and PK sampling

Treatment:

Other: Registry

Other: PK microsampling of blood

Shine

Description:

Those subjects using Shine as standard treatment. Registry and PK sampling

Treatment:

Other: Registry

Other: PK microsampling of blood