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

An Observational, Population-Based Study of Pharmacogenetic Variation to Identify Genetic Factors That May Affect the Efficacy and Safety of Medical Marijuana

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.

Study Overview

• Status: Completed
• Conditions: New York Medical Marijuana Program Qualifying Conditions
• Intervention / Treatment: Other: DNA Genotek Oragene 600

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 Type: Observational
• Enrollment (Actual): 157

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • Columbia Care New York Dispensary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High daily dose users; Total Cannabinoid Daily Dose greater than 50 mg	Other: DNA Genotek Oragene 600; Saliva-based DNA sample collection kit
Control; Users that represent the median dose between "high daily dose users" and "low daily dose users" taking between 11-21 mg	Other: DNA Genotek Oragene 600; Saliva-based DNA sample collection kit
Low daily dose users; Total Cannabinoid Daily Dose less than 10 mg	Other: DNA Genotek Oragene 600; Saliva-based DNA sample collection kit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Columbia Care Inc.
• Investigators: Principal Investigator: Rosemary Mazanet, MD, Columbia Care Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2019
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: August 27, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Medical cannabis; Medical marijuana
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse
• Other Study ID Numbers: IRB Tracking Number: 20190945

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No