What this study is
This study plans to evaluate the effects of chronic cannabis smoking on lung health by evaluating its effects on pulmonary health, lung physiology and alveolar macrophage function.
What's being tested
- Bronchoscopy
Intervention · PROCEDURE
Passage of a thin flexible tube through the mouth, into the windpipe and then into the bronchial tubes so that the study doctor can look into the lungs to perform Bronchoalveolar lavage (BAL), cytologic brushing, and protected specimen brushing.
- Chest X-ray
Intervention · RADIATION
To identify any previously undiagnosed lung disease that will either increase the risk of bronchoscopy or confound results of the study.
- Venipuncture
Intervention · PROCEDURE
To collect blood cells and serum for analyses.
- Intravenous Catheter
Intervention · PROCEDURE
To administer the appropriate medications for the bronchoscopy procedure.
Study details
- Sponsor
- University of Colorado, Denver
- Conditions
- Cannabis Smoking · Oxidative Stress
- Enrolling
- 100 people
- Starts
- 2015-11-11
- Est. completion
- 2027-07
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 55 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- Daily or near daily cannabis use (inhaled via joint/cigarette or pipe) equivalent to AT LEAST 20 "joint years" (number of joints/cigarettes per day multiplied by number of years during which cannabis was smoked) by self-report and validated through urine drug screen.
- Never or limited exposure to inhaled tobacco products (equivalent to LESS THAN one "pack year" in a lifetime) by selfreport and validated through negative urine cotinine screen.
- Capacity to answer screening questions and provide informed consent at time of interview, along with contact information INCLUSION CRITERIA for CONTROL patient: Subjects will be eligible if they meet all of the following:; No cannabis use ever by self-report, and validated through urine drug screen.; Never users of tobacco/cigarettes; Capacity to answer screening questions and provide informed consent at time of interview, along with contact information.
You can't join if
- LESS THAN near daily cannabis use (inhaled via joint/cigarette or pipe) equivalent to LESS THAN 20 "joint years" (number of joints/cigarettes per day multiplied by number of years during which cannabis was smoked) or a negative urine drug screen (for cannabis)
- Inhaled tobacco product exposure EXCEEDING one "pack year" or a positive urine cotinine screen
- Elevated AUDIT-C score: A 3 item questionnaire to identify subjects with alcohol use disorders.
- Prior medical history of liver disease: cirrhosis, total bilirubin > 2.0 mg/dL or albumin <3
- Prior medical history of myocardial infarction or congestive heart failure
- Prior medical history of end-stage renal disease or serum creatinine >3 mg/dL
- Prior history of or current use of illicit drug use defined as a positive toxicology screen for opiates or cocaine
- Prior history of diabetes mellitus
- Prior history of chronic obstructive pulmonary disease (COPD) or asthma that is not clinically controlled (have not required systemic corticosteroids in the past month)
- Prior history of HIV, not controlled or on medication
- Peripheral white blood cell count of less than 3000
- Acute worsening (<7 days) in respiratory symptoms (such as change in cough frequency or sputum production, fever, dyspnea, abnormal chest radiograph), or room air pulse oximetry of < 92% at rest or spirometry of < 50% predicted for FEV1 and FVC
- Use of systemic antibiotics for any reason in the past month (4 weeks)
- Failure of a subject or the subject's substance abuse counselor to provide assent
- Nutritional risk index of less than 95
- Age < 21 or > 55 (using an age of 55 limits the likelihood of comorbid conditions that may increase the risk of adverse events with bronchoscopy)
- Pregnancy
- Decisionally challenged
- Prisoners. EXCLUSION CRITERIA for CONTROL patient: Subjects will be ineligible to participate if they meet ANY of the following criteria:; History of inhaled cannabis exposure EXCEEDING one "joint year" or positive urine toxicology screen (for cannabis); History of inhaled tobacco product exposure EXCEEDING one "pack year" or a positive urine cotinine screen; Elevated AUDIT-C score: A 3 item questionnaire to identify subjects with alcohol use disorders.; Prior medical history of liver disease: cirrhosis, total bilirubin > 2.0 mg/dL or albumin <3; Prior medical history of myocardial infarction or congestive heart failure; Prior medical history of end-stage renal disease or serum creatinine >3 mg/dL; Prior history of or current use of illicit drug use defined as a positive toxicology screen for opiates or cocaine; Prior history of diabetes mellitus; Prior history of chronic obstructive pulmonary disease (COPD) or asthma that is not clinically controlled (have not required systemic corticosteroids in the past month); Prior history of HIV, not controlled or on medication; Peripheral white blood cell count of less than 3000; Acute worsening (<7 days) in respiratory symptoms (such as change in cough frequency or sputum production, fever, dyspnea, abnormal chest radiograph), or room air pulse oximetry of < 92% at rest or spirometry of < 50% predicted for FEV1 and FVC; Use of systemic antibiotics in the past month (4 weeks); Failure of a subject or the subject's substance abuse counselor to provide assent; Nutritional risk index of less than 95; Age < 21 or > 55; Pregnancy; Decisionally challenged; Prisoners.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openUniversity of Colorado, Denver
Aurora, Colorado, United States
Recruiting
Study team
Sponsor
University of Colorado, Denver
Study ID 14-1957
Principal investigator
Ellen L Burnham, MD
University of Colorado, Denver
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.