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

NCT03886753 | Terminated

• 1 other identifier: 18-015787
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Description and incidence of patient or caregiver reported side effects

  1 year

• Changes in drug concentrations

  2 years

• Rate of bioavailabilty

  2 years

• Volume of distribution

  2 years

• Report area under the plasma concentration versus time curve (AUC)

  2 years

Study Arms (4)

Ease

Subjects using Ease as standard treatment. Registry and PK sampling

Other: Registry; Other: PK microsampling of blood

Dream

Subjects using Dream as standard treatment. Registry and PK sampling

Other: Registry; Other: PK microsampling of blood

Soothe

Subjects using Soothe as standard treatment. Registry and PK sampling

Other: Registry; Other: PK microsampling of blood

Shine

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

Other: Registry; Other: PK microsampling of blood

Interventions

Registry OTHER

Collect data on subjects

Dream; Ease; Shine; Soothe

PK microsampling of blood OTHER

Obtain 5 microsamples of blood from subjects via a fingerstick.

Dream; Ease; Shine; Soothe

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Ilera Healthcare: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

We will ask patients if we can retain their specimens for future studies

MeSH Terms

Conditions

Autism Spectrum Disorder; Neoplasms; Muscle Spasticity; Dyskinesias; Epilepsy; Glaucoma; Huntington Disease; Inflammatory Bowel Diseases; Multiple Sclerosis; Parkinson Disease; Acquired Immunodeficiency Syndrome; Stress Disorders, Post-Traumatic; Pain, Intractable; Anemia, Sickle Cell

Interventions

Registries

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Movement Disorders; Central Nervous System Diseases; Brain Diseases; Ocular Hypertension; Eye Diseases; Basal Ganglia Diseases; Dementia; Chorea; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Parkinsonian Disorders; Synucleinopathies; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Pain; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Records; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Athena F Zuppa, MD MSCE

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: March 22, 2019
• Study Start: May 15, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: July 30, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)