Colorado Marijuana Users Health Cohort

COPD Clinical Trial

Official title:

Colorado Marijuana Users Health Cohort

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02735954
• Other study ID #: HS 2854
• Status: Active, not recruiting
• Start date: September 2014
• Est. completion date: December 2019

Study information

• Verified date: October 2018
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: December 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis
• COPD
• Insomnia

Intervention

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

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
National Jewish Health	Colorado Department of Public Health and Environment

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long term medical effects of marijuana use		measured at baseline visit
Secondary	Quality of sleep	physiological parameter and questionnaires	measured at baseline visit