Colorado Marijuana Users Health Cohort

• Conditions: COPD; Insomnia; Cannabis
• Interventions: Other: Marijuana

• Registration Number: NCT02735954
• Lead Sponsor: National Jewish Health

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 Timeline

• Study Start: 2014-09
• Study First Submitted: 2016-01-06
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-13
• Status Verified: 2018-10
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-13
• Primary Completion: 2019-05
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Marijuana Users	Marijuana	Individuals who use marijuana
Combined Marijuana and Tobacco Users	Marijuana	Individuals who use marijuana and also smoke cigarettes

Primary Outcome Measures

Name	Time	Method
Long term medical effects of marijuana use	measured at baseline visit

Secondary Outcome Measures

Name	Time	Method
Quality of sleep	measured at baseline visit	physiological parameter and questionnaires

Trial Locations

Locations (1)

National Jewish Health; 🇺🇸 Denver, Colorado, United States