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

Completed

• Conditions: New York Medical Marijuana Program Qualifying Conditions
• Interventions: Other: DNA Genotek Oragene 600

• Registration Number: NCT04083261
• Lead Sponsor: Columbia Care Inc.

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.

Study Timeline

• Study Start: 2019-07-11
• Study First Submitted: 2019-08-27
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-10
• Primary Completion: 2020-03-30
• Study Completion: 2020-03-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-09
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low daily dose users	DNA Genotek Oragene 600	Total Cannabinoid Daily Dose less than 10 mg
Control	DNA Genotek Oragene 600	Users that represent the median dose between "high daily dose users" and "low daily dose users" taking between 11-21 mg
High daily dose users	DNA Genotek Oragene 600	Total Cannabinoid Daily Dose greater than 50 mg

Primary Outcome Measures

Name	Time	Method
Identification of genetic factors	Day 1	Saliva-based DNA sample will be tested for known genes (e.g., the cytochrome P-450 superfamily)

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Columbia Care New York Dispensary; 🇺🇸 New York, New York, United States