Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04083261
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
New York Medical Marijuana Program Qualifying Conditions 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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: An Observational, Population-Based Study of Pharmacogenetic Variation to Identify Genetic Factors That May Affect the Efficacy and Safety of Medical Marijuana
Actual Study Start Date : July 11, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

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




Primary Outcome Measures :
  1. Identification of genetic factors [ Time Frame: Day 1 ]
    Saliva-based DNA sample will be tested for known genes (e.g., the cytochrome P-450 superfamily)


Secondary Outcome Measures :
  1. Satisfaction with therapy and adverse effects: survey [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083261


Contacts
Layout table for location contacts
Contact: Michelle L Shuffett, MD 310-995-6075 mshuffett@col-care.com

Locations
Layout table for location information
United States, New York
Columbia Care New York Dispensary Recruiting
New York, New York, United States, 10003
Contact: Tricia Reed, PharmD    646-453-7178    treed@col-care.com   
Sponsors and Collaborators
Columbia Care Inc.
Investigators
Layout table for investigator information
Principal Investigator: Rosemary Mazanet, MD Columbia Care Inc.

Layout table for additonal information
Responsible Party: Columbia Care Inc.
ClinicalTrials.gov Identifier: NCT04083261     History of Changes
Other Study ID Numbers: IRB Tracking Number: 20190945
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Columbia Care Inc.:
Medical cannabis
Medical marijuana
Additional relevant MeSH terms:
Layout table for MeSH terms
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders