Colorado Marijuana Users Health Cohort

NCT02735954 | Unknown

• 1 other identifier: HS 2854
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Insomnia; Cannabis

Outcome Measures

Primary Outcomes (1)

• Long term medical effects of marijuana use

  measured at baseline visit

Secondary Outcomes (1)

• Quality of sleep

  measured at baseline visit

Study Arms (3)

Marijuana Users

Individuals who use marijuana

Other: Marijuana

Combined Marijuana and Tobacco Users

Individuals who use marijuana and also smoke cigarettes

Other: Marijuana

Non-Marijuana Users

Individuals who do not use marijuana

Interventions

Marijuana OTHER

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

Combined Marijuana and Tobacco Users; Marijuana Users

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Jewish Health: lead
• Colorado Department of Public Health and Environment: collaborator

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Sleep Initiation and Maintenance Disorders; Marijuana Abuse

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: April 13, 2016
• Study Start: September 1, 2014
• Primary Completion: May 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 13, 2019

Record last verified: 2018-10

Locations

US (1)