GI Medical Cannabis Study on IBD
GI Medical Cannabis Study on IBD
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.
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.
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.