Clinical trial NCT02735954: Colorado Marijuana Users Health Cohort
Official title: Colorado Marijuana Users Health Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Insomnia
Cannabis
Lead sponsor: National Jewish Health
Sponsor class: OTHER
Collaborators: name: Colorado Department of Public Health and Environment
First posted: 2016-04-13
Enrollment: 2000
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: Long term medical effects of marijuana use
timeFrame: measured at baseline visit
Secondary outcomes:
measure: Quality of sleep
timeFrame: measured at baseline visit
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
References: