Colorado Marijuana Users Health Cohort

NCT ID: NCT02735954

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2019-12-31

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.

Conditions

COPD; Insomnia; Cannabis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Marijuana Users

Individuals who use marijuana

Marijuana

Intervention Type: OTHER

This is an observational study looking at the effects of marijuana on health, including lung health and sleep.

Combined Marijuana and Tobacco Users

Individuals who use marijuana and also smoke cigarettes

Marijuana

Intervention Type: OTHER

This is an observational study looking at the effects of marijuana on health, including lung health and sleep.

Non-Marijuana Users

Individuals who do not use marijuana

No interventions assigned to this group

Interventions

Marijuana

This is an observational study looking at the effects of marijuana on health, including lung health and sleep.

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colorado Department of Public Health and Environment

OTHER_GOV

Sponsor Role: collaborator

National Jewish Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Jewish Health

Denver, Colorado, United States

Countries

United States

Other Identifiers

HS 2854

Identifier Type: -

Identifier Source: org_study_id