New York Medical Marijuana Program Qualifying Conditions Clinical Trial
Official title:
An Observational, Population-Based Study of Pharmacogenetic Variation to Identify Genetic Factors That May Affect the Efficacy and Safety of Medical Marijuana
The primary purpose of this research is to identify genetic factors that may affect the efficacy and safety of medical marijuana, regardless of condition. The pharmacogenomics test detects DNA variants, which may affect the way drugs work and are metabolized in the body and/or detect potential side effects.
This observational, population-based study will examine genetic differences between
ultra-rapid, intermediate and poor metabolizers of various formulations of Columbia Care's
medical cannabis products in order to identify genetic factors that may affect the efficacy
and safety of medical marijuana, regardless of condition. The goal of the research is to
establish relationships between cannabis consumers, cannabinoids, and consumer outcomes. The
study is expected to enroll 150 subjects across three cohorts, high daily dose users (poor
metabolizers) that take more than 50 mg of cannabinoids daily (n=50), low daily dose users
(ultra-rapid metabolizers) that take less than 10 mg of cannabinoids daily (n=50), and a
control group (intermediate metabolizers) that represents the median daily dose user taking
between 11-21 mg of cannabinoids daily (n=50).
Columbia Care Inc. has identified trends amongst its medical cannabis users suggesting that
there are some patients who are "high daily dose users" and others who are "low daily dose
users", with both groups assumed to have similar satisfaction with the products. The
complexity of the endocannabinoid system combined with individual genetic predisposition and
gene-environment interactions likely result in the variation in response seen with
cannabinoid treatment.
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