Colorado Marijuana Users Health Cohort

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.

Study Overview

• Status: Unknown
• Conditions: Insomnia; Cannabis; COPD
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: National Jewish Health
• Collaborators: Colorado Department of Public Health and Environment

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (ANTICIPATED): May 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: January 6, 2016
• First Submitted That Met QC Criteria: April 12, 2016
• First Posted (ESTIMATE): April 13, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse
• Other Study ID Numbers: HS 2854