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临床试验/NCT04083261
NCT04083261已完成不适用

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

Columbia Care Inc.1 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2019年7月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
157
试验地点
1
主要终点
Identification of genetic factors

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Unwillingness to participate and consent to a DNA analysis
  • Unwillingness to answer a survey/questionnaire on patient satisfaction as related to product efficacy

结局指标

主要结局

Identification of genetic factors

时间窗: Day 1

Saliva-based DNA sample will be tested for known genes (e.g., the cytochrome P-450 superfamily)

次要结局

  • Satisfaction with therapy and adverse effects: survey(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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