GI Medical Cannabis Registry and Pharmacology

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: