Colorado Marijuana Users Health Cohort

• ClinicalTrials.gov Identifier: NCT02735954
• Recruitment Status: Active, not recruiting
• First Posted: April 13, 2016
• Last Update Posted: March 13, 2019
• Sponsor: National Jewish Health
• Collaborator: Colorado Department of Public Health and Environment
• Information provided by (Responsible Party): National Jewish Health

Study Description

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.

Condition or disease	Intervention/treatment
COPD; Insomnia; Cannabis	Other: Marijuana

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 Design

• Study Type: Observational
• Estimated Enrollment: 2000 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Colorado Marijuana Users Health Cohort
• Study Start Date: September 2014
• Estimated Primary Completion Date: May 2019
• Estimated Study Completion Date: December 2019

Groups and Cohorts

Group/Cohort	Intervention/treatment
Marijuana Users; Individuals who use marijuana	Other: Marijuana; 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	Other: Marijuana; 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

Outcome Measures

Primary Outcome Measures :

1. Long term medical effects of marijuana use [ Time Frame: measured at baseline visit ]

Secondary Outcome Measures :

1. Quality of sleep [ Time Frame: measured at baseline visit ]
   physiological parameter and questionnaires

Biospecimen Retention:   Samples With DNA

Blood and urine will be collected and retained for study purposes to look at biomarkers and correlated cannabinoid (THC) levels.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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.

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

Contacts and Locations

Locations

United States, Colorado

National Jewish Health

Denver, Colorado, United States, 80206

Sponsors and Collaborators

National Jewish Health

Colorado Department of Public Health and Environment

More Information

• Responsible Party: National Jewish Health
• ClinicalTrials.gov Identifier: NCT02735954 History of Changes
• Other Study ID Numbers: HS 2854
• First Posted: April 13, 2016
• Last Update Posted: March 13, 2019
• Last Verified: October 2018

Additional relevant MeSH terms:

Marijuana Abuse; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders