Pharmacogenetic Variation: Factors That May Affect the Efficacy and Safety of Medical Marijuana

Columbia Care Inc.

Status

Completed

Conditions

New York Medical Marijuana Program Qualifying Conditions

Treatments

Other: DNA Genotek Oragene 600

Study type

Observational

Funder types

Other

Identifiers

NCT04083261

IRB Tracking Number: 20190945

Details and patient eligibility

About

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.

Full description

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.

Enrollment

157 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males and Females age 18 and older
Currently obtaining medical marijuana products from Columbia Care LLC
Willing to participate and consent to a DNA analysis
Purchased product from Columbia Care for three consecutive encounters spanning a 6-month period

Exclusion criteria

Unwillingness to participate and consent to a DNA analysis
Unwillingness to answer a survey/questionnaire on patient satisfaction as related to product efficacy