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

New York Medical Marijuana Program Qualifying Conditions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04083261
• Other study ID #: IRB Tracking Number: 20190945
• Status: Completed
• Start date: July 11, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: July 2020
• Source: Columbia Care Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Marijuana Abuse
• New York Medical Marijuana Program Qualifying Conditions

Intervention

Other:
• DNA Genotek Oragene 600
Saliva-based DNA sample collection kit

Locations

Country	Name	City	State
United States	Columbia Care New York Dispensary	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia Care Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of genetic factors	Saliva-based DNA sample will be tested for known genes (e.g., the cytochrome P-450 superfamily)	Day 1
Secondary	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