New York Medical Marijuana Program Qualifying Conditions
Conditions
Keywords
Medical cannabis, Medical marijuana
Brief summary
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.
Detailed 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.
Interventions
OTHERDNA Genotek Oragene 600
Saliva-based DNA sample collection kit
Sponsors
Columbia Care Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of genetic factors | Day 1 | Saliva-based DNA sample will be tested for known genes (e.g., the cytochrome P-450 superfamily) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with therapy and adverse effects: survey | Day 1 | Survey tool will examine patient satisfaction with current dose as a covariate and evaluate adverse outcomes (e.g., mental health indications, reported unintended effects) based on varying doses and mode of exposure of cannabis within our analyses. |
Countries
United States
Outcome results
None listed