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Colorado Marijuana Users Health Cohort

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02735954
Recruitment Status : Unknown
Verified October 2018 by National Jewish Health.
Recruitment status was:  Active, not recruiting
First Posted : April 13, 2016
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Colorado Department of Public Health and Environment
Information provided by (Responsible Party):
National Jewish Health

Tracking Information
First Submitted Date January 6, 2016
First Posted Date April 13, 2016
Last Update Posted Date March 13, 2019
Study Start Date September 2014
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 12, 2016)
Long term medical effects of marijuana use [ Time Frame: measured at baseline visit ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 12, 2016)
Quality of sleep [ Time Frame: measured at baseline visit ]
physiological parameter and questionnaires
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Colorado Marijuana Users Health Cohort
Official Title Colorado Marijuana Users Health Cohort
Brief Summary 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.
Detailed Description

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood and urine will be collected and retained for study purposes to look at biomarkers and correlated cannabinoid (THC) levels.
Sampling Method Non-Probability Sample
Study Population The Colorado investigators are recruiting 1,000 marijuana only users, 1,000 marijuana and tobacco users, and up to 250 non-marijuana users. The sleep sub-study will include up to 218 eligible participants.
Condition
  • COPD
  • Insomnia
  • Cannabis
Intervention Other: Marijuana
This is an observational study looking at the effects of marijuana on health, including lung health and sleep.
Study Groups/Cohorts
  • Marijuana Users
    Individuals who use marijuana
    Intervention: Other: Marijuana
  • Combined Marijuana and Tobacco Users
    Individuals who use marijuana and also smoke cigarettes
    Intervention: Other: Marijuana
  • Non-Marijuana Users
    Individuals who do not use marijuana
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 12, 2016)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02735954
Other Study ID Numbers HS 2854
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Jewish Health
Study Sponsor National Jewish Health
Collaborators Colorado Department of Public Health and Environment
Investigators Not Provided
PRS Account National Jewish Health
Verification Date October 2018