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临床试验/NCT02735954
NCT02735954Unknown不适用

Colorado Marijuana Users Health Cohort

National Jewish Health1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,000
试验地点
1
主要终点
Long term medical effects of marijuana use

研究概览

简要总结

In Colorado, marijuana is currently used for both recreational and medicinal purposes.To learn more about the positive and negative long term medical effects of marijuana use. Information obtained during this study may identify new markers that influence the development of lung diseases such as COPD. The Investigators are also interested in learning more about the effects of marijuana use for insomnia and how it may or may not affect sleep.

详细描述

In Colorado, marijuana is currently used for both recreational and medicinal purposes. The major active drug is tetrahydrocannabinol (THC). The most common route of use is through inhalation of the combustion products of the dried, buds/flowers from the female plant either rolled in paper (joint) or burned through a screen in a dry or water filled pipe (bong). Increasingly THC is consumed.

The side effects of the inhalation of burned leaves are controversial. The purpose of this proposal is to establish a prospective cohort of heavy marijuana users to evaluate positive and negative long term medical effects of marijuana use. As marijuana has also been reported for use to help treat insomnia, a sub-study will focus on how marijuana is used for sleep disorders and disturbances.

This study will enroll individuals that use marijuana to learn more about long-term health effects. The study involves one visit where participants will complete questionnaires, breathing tests, blood and urine collection. There is a sub-study where eligible participants will also complete an at-home sleep monitoring test. Participants will be contacted multiple times a year for long-term follow-up.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Colorado-only study
  • Age 21-80 years and one of the categories below
  • Marijuana use: use of any cannabis (smoked, vaped, edible, etc.) on average more than 3 days per week for at least 1 year
  • Combined marijuana use and Tobacco use (current or former): ≥ 30 pack year cigarette smoking history
  • Non-marijuana users
  • Sleep sub-study:
  • Enrollment in the main cohort building study and a qualifying score on the Insomnia Severity Index questionnaire

排除标准

  • Respiratory disorder other than COPD or asthma
  • Lung surgery with removal of a lobe or more or lung volume reduction surgery
  • Lung cancer or other cancer under active treatment during past 12 months
  • ≥ 30 pack year cigarette smoking history for combined marijuana and cigarette users
  • Pregnancy
  • Use of antibiotics and/or systemic steroids for any lung infection within the last month
  • Inability to use albuterol
  • Subject enrolled in COPDGene or SPIROMICS
  • Sleep sub-study:
  • Inability to complete home sleep study

结局指标

主要结局

Long term medical effects of marijuana use

时间窗: measured at baseline visit

次要结局

  • Quality of sleep(measured at baseline visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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