Colorado Marijuana Users Health Cohort

Study Overview
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Brief Summary
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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
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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.

Official Title
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Colorado Marijuana Users Health Cohort

Conditions
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COPD, Insomnia, Cannabis

Intervention / Treatment
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* Other: Marijuana


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Marijuana Users<br>Individuals who use marijuana | Other: Marijuana<br>* This is an observational study looking at the effects of marijuana on health, including lung health and sleep.<br>|
| Combined Marijuana and Tobacco Users<br>Individuals who use marijuana and also smoke cigarettes | Other: Marijuana<br>* This is an observational study looking at the effects of marijuana on health, including lung health and sleep.<br>|
| Non-Marijuana Users<br>Individuals who do not use marijuana | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term medical effects of marijuana use |  | measured at baseline visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of sleep | physiological parameter and questionnaires | measured at baseline visit |