New York Medical Marijuana Program Qualifying ConditionsNCT04083261
Pharmacogenetic Variation: Factors That May Affect the Efficacy and Safety of Medical Marijuana
An observational study of New York Medical Marijuana Program Qualifying Conditions, run by Columbia Care Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- New York Medical Marijuana Program Qualifying Conditions
- What is being tested?
- DNA Genotek Oragene 600
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2019to 30 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Unwillingness to participate and consent to a DNA analysis
- Unwillingness to answer a survey/questionnaire on patient satisfaction as related to product efficacy
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia Care New York Dispensary
New York, New York, 10003
About this study
Official title: 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.
Read the 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.
- Being tested
- DNA Genotek Oragene 600
- Keywords
- Medical cannabis, Medical marijuana
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA Genotek Oragene 600Other
Saliva-based DNA sample collection kit
| Study group | Role | What they receive |
|---|---|---|
| High daily dose users | Total Cannabinoid Daily Dose greater than 50 mg Receives: Other: DNA Genotek Oragene 600 | |
| Control | Users that represent the median dose between "high daily dose users" and "low daily dose users" taking between 11-21 mg Receives: Other: DNA Genotek Oragene 600 | |
| Low daily dose users | Total Cannabinoid Daily Dose less than 10 mg Receives: Other: DNA Genotek Oragene 600 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of genetic factors
Saliva-based DNA sample will be tested for known genes (e.g., the cytochrome P-450 superfamily)
Measured: Day 1
Secondary outcomes (1)
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start11 Jul 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for New York Medical Marijuana Program Qualifying ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia Care Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosemary Mazanet, MD, Principal investigator, Columbia Care Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083261
- Sponsor's protocol ID
- IRB Tracking Number: 20190945
- Status last verified
- Jul 2020
- First submitted
- 27 Aug 2019
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Population-Based Study of Pharmacogenetic Variation to Identify Genetic Factors That May Affect the Efficacy and Safety of Medical Marijuana
- ClinicalTrials.gov ID
- NCT04083261
- Acronym / sponsor ID
- IRB Tracking Number: 20190945
- Keywords
- Medical cannabis, Medical marijuana
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Columbia Care Inc.University, hospital or other
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High daily dose users | – | Other: DNA Genotek Oragene 600Total Cannabinoid Daily Dose greater than 50 mg |
| Control | – | Other: DNA Genotek Oragene 600Users that represent the median dose between "high daily dose users" and "low daily dose users" taking between 11-21 mg |
| Low daily dose users | – | Other: DNA Genotek Oragene 600Total Cannabinoid Daily Dose less than 10 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Unwillingness to participate and consent to a DNA analysis
- Unwillingness to answer a survey/questionnaire on patient satisfaction as related to product efficacy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA Genotek Oragene 600Saliva-based DNA sample collection kit | Other | Control, High daily dose users, Low daily dose users |
Primary outcome
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)
1 secondary outcome
Satisfaction with therapy and adverse effects: survey
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosemary Mazanet, MD principal investigator
Columbia Care Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of New York Medical Marijuana Program Qualifying Conditions, run by Columbia Care Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of genetic factors (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2020.