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GI Medical Cannabis Study on IBD (GIMEDCAN)

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ClinicalTrials.gov Identifier: NCT03886532
Recruitment Status : Not yet recruiting
First Posted : March 22, 2019
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief Summary:

Create a registry that will described the natural history and landscape of medical cannabis product use in patients with chronic abdominal pain or inflammatory bowel disease.

Quantitatively describe the pharmacokinetic (PK) profile of select medical cannabis products in patients with chronic neuropathic (abdominal) pain or inflammatory bowel disease.

To create an educational program for families that have participated in the research for those families who opt for this component. Although these are not research in nature, they are a direct result of the proposed research and are included in the protocol to demonstrate the study's deliverables.


Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Neuropathic Pain Other: Medical Marijuana

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Detailed Description:

Although the state-level legalization of cannabis for medical use allows access for patients, its use closely resembles the dietary supplement market. In 1994, the Dietary Supplement Health and Education Act (DSHEA) was passed, allowing dietary supplements to be available to consumers without prior proof of quality, safety, or efficacy. The goal of the legislation was to allow consumer access to potentially beneficial therapies without the delay from research and regulatory body approval. Unfortunately, the research did not follow, and now the dietary supplement market is an unregulated industry that is fraught with fraudulent claims and unsafe, contaminated, and/or adulterated products, many of which have unknowingly harmed individuals. Similar to dietary supplements, cannabis as a therapy is largely unstudied, with over 100 active constituents, each of which has its own potential pharmacologic actions. Different blends of these constituents have the potential to reap significant therapeutic benefits. Unfortunately, the traditional drug development paradigm has not been performed for these products.

Objectives:

The overall goal of this research is to characterize the current use and disposition of medical cannabis including cannabidiol (CBD) products being administered to children and adults as standard of care, and to understand the pharmacokinetics (PK) and pharmacodynamics (PD) of compounds in these medical cannabis products. An additional component of this study is to provide educational feedback to families and care providers to provide evidenced-based dosing guidance for these products to patients with qualifying gastrointestinal disorders.

  1. The primary objective is to describe the natural history and landscape of medical cannabis including CBD use in patients with qualifying gastrointestinal disorders, specifically chronic abdominal pain and inflammatory bowel disease. There will be a specific focus on the variability of products and routes of administration.
  2. The secondary objective is to quantitatively describe the PK profile of select medical cannabis products in patients with these gastrointestinal disorders.
  3. Another secondary objective is to create an educational program for families that have participated in the research, for those families who opt for this component.

Study Design:

This is a prospective observational cohort study.

Setting/Participants:

Persons who are receiving medical cannabis as therapy, who have a diagnosis of chronic abdominal pain or inflammatory bowel disease.

Study Interventions and Measures:

  1. Investigators will collect demographics, data regarding utilization, formulation, indications, and concomitant medications. Investigators will do an initial intake and perform follow-up to inquire about any changes in medications or medical history on a monthly basis.
  2. Once four subjects have been recruited who are taking the same formulation of a cannabis product, the study team will contact them for consent for the PK portion of the study. Investigators will collect five samples with a microsampling technique. If at any point there is a change in symptoms and/or product, Investigators will collect another five samples. The purpose of the collection is to assay for cannabis-related compounds [(e.g. Tetrahydrocannabinol (THC), CBD)] to quantitatively describe the PK profile.
  3. Educational sessions will be created for research subjects and families who opt to participate. Investigators will hold meetings which may be in person or online and invite those interested participants to learn about our findings. This will be done at approximately six-month intervals throughout the study, or when it is deemed appropriate by the study team to share than information.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: GI Medical Cannabis Registry and Pharmacology
Estimated Study Start Date : September 1, 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
Medical Marijuana
Those subject taking only medical marijuana as standard of care. Will collect registry data and collect blood samples.
Other: Medical Marijuana
registry and blood samples

CBD only products
Those subjects taking only CBD products as standard of care. Will collect registry data and collect blood samples.
Other: Medical Marijuana
registry and blood samples




Primary Outcome Measures :
  1. Change in symptoms [ Time Frame: 1 year ]
    Relief of primary indication (perceived therapeutic benefit of product) reported via parent or caregiver on a 1-10 Lichert scale with 1 being minimally effective and 10 being extremely effective.


Secondary Outcome Measures :
  1. Patient or caregiver reported side effects [ Time Frame: 1 year ]
    There is no particular scale or instrument being used to collect this data. Patients and caregivers are reporting on any perceived side effects from the medication.

  2. Changes in drug concentrations [ Time Frame: 1 year ]
    To assess changes in pharmacokinetic levels in the blood


Biospecimen Retention:   Samples Without DNA
We will consent subjects to retain microsampling samples.


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:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are diagnosed with inflammatory bowel disease (IBD) and are taking medical marijuana or cannabidiol (CBD) legally
Criteria

Inclusion Criteria:

  1. Individuals who consume cannabis products in a state which has legalized medical cannabis for the treatment of inflammatory bowel disease and chronic neuropathic (abdominal) pain.
  2. Individuals who have a diagnosis of Inflammatory Bowel Disease or chronic neuropathic (abdominal) pain.

Exclusion Criteria:

  1. Consumption of cannabis products that are not obtained from a state-sanctioned dispensary.
  2. Non English speaking individuals.

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): NCT03886532


Contacts
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Contact: Mary Ann DiLiberto, RN 2674265753 diliberto@email.chop.edu
Contact: Naylor Brownell, MD brownellj@email.chop.edu

Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
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Principal Investigator: Athena F Zuppa, MD MSCE Childrens Hospital of Philadelphia

Additional Information:

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03886532     History of Changes
Other Study ID Numbers: 18-015221
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: June 26, 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: Yes
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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Inflammatory Bowel Diseases
Neuralgia
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms