Pharmacokinetic (PK) and Pharmacodynamics (PD) Study of Ilera Specific Products
Stopped early
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT03886753
- Run by
- Children's Hospital of Philadelphia
- People needed
- 10
- Starts
- 2019-05-15
- Expected to finish
- 2020-06-30
- Last updated by the study team
- 2020-07-30
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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