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

NCT ID: NCT04083261

Last Updated: 2020-07-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 157 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-11
• Study Completion Date: 2020-03-30

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.

Conditions

New York Medical Marijuana Program Qualifying Conditions

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

High daily dose users

Total Cannabinoid Daily Dose greater than 50 mg

DNA Genotek Oragene 600

Intervention Type: OTHER

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

DNA Genotek Oragene 600

Intervention Type: OTHER

Saliva-based DNA sample collection kit

Low daily dose users

Total Cannabinoid Daily Dose less than 10 mg

DNA Genotek Oragene 600

Intervention Type: OTHER

Saliva-based DNA sample collection kit

Interventions

DNA Genotek Oragene 600

Saliva-based DNA sample collection kit

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia Care Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rosemary Mazanet, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia Care Inc.

Locations

Columbia Care New York Dispensary

New York, New York, United States

Countries

United States

Other Identifiers

IRB Tracking Number: 20190945

Identifier Type: -

Identifier Source: org_study_id