Actively Recruiting
Chronic Cannabis Smoking, Oxidative Stress and the Pulmonary Innate Immune Response
Led by University of Colorado, Denver · Updated on 2024-10-10
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Center for Advancing Translational Sciences (NCATS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of chronic cannabis smoking on lung health, particularly focusing on lung function, pulmonary health, and the role of alveolar macrophages, which are immune cells in the lungs. This research addresses concerns that frequent cannabis use may increase oxidative stress in the lungs and impair immune responses, potentially raising the risk of respiratory infections. The study aims to fill gaps left by previous research, especially considering that modern cannabis contains higher THC levels than in past decades. The study compares two groups: one consisting of adults aged 18 to 55 who have never used cannabis or tobacco, and another group of daily or near daily cannabis smokers with at least 20 joint years of use and minimal tobacco exposure. Participants will undergo procedures including bronchoscopy to collect lung cell samples, chest X-rays to check for lung diseases, and blood draws for analysis. These tests help researchers assess lung function, oxidative stress, and immune cell activity related to cannabis use. During the study, participants will be evaluated at baseline and at 18 hours for changes in alveolar macrophage function, including their ability to engulf harmful particles. Lung function tests and measures of oxidative stress in lung fluid collected by bronchoalveolar lavage will also be performed. The study includes detailed interviews to assess cannabis use patterns. Participants' safety and health will be monitored throughout the research, which is expected to continue until July 2027.
CONDITIONS
Brief Title
Chronic Cannabis Smoking, Oxidative Stress and the Pulmonary Innate Immune Response
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Daily or near daily cannabis use equivalent to at least 20 joint years by self-report and urine test (for cannabis users)
- Less than one pack-year of tobacco use by self-report and negative cotinine urine test (for cannabis users)
- Ability to answer screening questions and provide informed consent
- No cannabis use ever and never tobacco users (for control group)
- Age between 18 and 55 years
- Not pregnant
- Not decisionally challenged
- Not prisoners
You will not qualify if you...
- Cannabis use less than near daily or fewer than 20 joint years, or negative urine drug screen (for cannabis users)
- Tobacco exposure exceeding one pack-year or positive cotinine urine screen
- Elevated alcohol use disorder screening score
- History of liver disease, myocardial infarction, congestive heart failure, or end-stage renal disease
- History of illicit drug use (opiates or cocaine)
- History of diabetes mellitus
- Uncontrolled asthma or COPD
- Uncontrolled HIV infection
- Low white blood cell count (less than 3000)
- Recent worsening of respiratory symptoms or low oxygen levels
- Recent use of systemic antibiotics
- Nutritional risk index less than 95
- Age under 21 or over 55
- Pregnancy
- Decisionally challenged
- Prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo diagnostic procedures including chest X-ray, bronchoscopy with bronchoalveolar lavage and specimen collection, venipuncture, and intravenous catheter placement to evaluate lung health and collect samples.
1 visit (in-person)
Duration - Up to 18 hours post-baseline
Participants are observed for changes in lung function and alveolar macrophage activity related to cannabis use over time.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
University of Colorado, Denver
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
J
Jeffrey D McKeehan, MSN
E
Ellen L Burnham, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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