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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High daily dose users | Total Cannabinoid Daily Dose greater than 50 mg |
| |
| Control | Users that represent the median dose between "high daily dose users" and "low daily dose users" taking between 11-21 mg |
| |
| Low daily dose users | Total Cannabinoid Daily Dose less than 10 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNA Genotek Oragene 600 | Other | Saliva-based DNA sample collection kit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identification of genetic factors | Saliva-based DNA sample will be tested for known genes (e.g., the cytochrome P-450 superfamily) | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with therapy and adverse effects: survey | 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. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be identified from the Columbia Care database (prescription fills/refills and invoice data) and stratified into 3 groups, with n=50 participants in each cohort (total N=150).
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| Name | Affiliation | Role |
|---|---|---|
| Rosemary Mazanet, MD | Columbia Care Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia Care New York Dispensary | New York | New York | 10003 | United States |
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