Clinical trial NCT04083261: Pharmacogenetic Variation: Factors That May Affect the Efficacy and Safety of Medical Marijuana
Official title: An Observational, Population-Based Study of Pharmacogenetic Variation to Identify Genetic Factors That May Affect the Efficacy and Safety of Medical Marijuana
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: New York Medical Marijuana Program Qualifying Conditions
Keywords: Medical cannabis
Medical marijuana
Lead sponsor: Columbia Care Inc.
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Identification of genetic factors
timeFrame: Day 1
Secondary outcomes:
measure: Satisfaction with therapy and adverse effects: survey
timeFrame: Day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia Care New York Dispensary
state: New York
Study officials:
affiliation: Columbia Care Inc.
name: Rosemary Mazanet, MD
role: PRINCIPAL_INVESTIGATOR
References: