RECRUITING

Chronic Cannabis Smoking, Oxidative Stress and the Pulmonary Innate Immune Response

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Chronic Cannabis Smoking, Oxidative Stress and the Pulmonary Innate Immune Response

Quick Facts

Study Start:2015-11-11

Study Completion:2027-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02480283

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. 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. 2. 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. 3. Capacity to answer screening questions and provide informed consent at time of interview, along with contact information 1. No cannabis use ever by self-report, and validated through urine drug screen. 2. Never users of tobacco/cigarettes 3. Capacity to answer screening questions and provide informed consent at time of interview, along with contact information.	1. 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) 2. Inhaled tobacco product exposure EXCEEDING one "pack year" or a positive urine cotinine screen 3. Elevated AUDIT-C score: A 3 item questionnaire to identify subjects with alcohol use disorders. 4. Prior medical history of liver disease: cirrhosis, total bilirubin \> 2.0 mg/dL or albumin \<3 5. Prior medical history of myocardial infarction or congestive heart failure 6. Prior medical history of end-stage renal disease or serum creatinine \>3 mg/dL 7. Prior history of or current use of illicit drug use defined as a positive toxicology screen for opiates or cocaine 8. Prior history of diabetes mellitus 9. Prior history of chronic obstructive pulmonary disease (COPD) or asthma that is not clinically controlled (have not required systemic corticosteroids in the past month) 10. Prior history of HIV, not controlled or on medication 11. Peripheral white blood cell count of less than 3000 12. 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 13. Use of systemic antibiotics for any reason in the past month (4 weeks) 14. Failure of a subject or the subject's substance abuse counselor to provide assent 15. Nutritional risk index of less than 95 16. 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) 17. Pregnancy 18. Decisionally challenged 19. Prisoners. 1. History of inhaled cannabis exposure EXCEEDING one "joint year" or positive urine toxicology screen (for cannabis) 2. History of inhaled tobacco product exposure EXCEEDING one "pack year" or a positive urine cotinine screen 3. Elevated AUDIT-C score: A 3 item questionnaire to identify subjects with alcohol use disorders. 4. Prior medical history of liver disease: cirrhosis, total bilirubin \> 2.0 mg/dL or albumin \<3 5. Prior medical history of myocardial infarction or congestive heart failure 6. Prior medical history of end-stage renal disease or serum creatinine \>3 mg/dL 7. Prior history of or current use of illicit drug use defined as a positive toxicology screen for opiates or cocaine 8. Prior history of diabetes mellitus 9. Prior history of chronic obstructive pulmonary disease (COPD) or asthma that is not clinically controlled (have not required systemic corticosteroids in the past month) 10. Prior history of HIV, not controlled or on medication 11. Peripheral white blood cell count of less than 3000 12. 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 13. Use of systemic antibiotics in the past month (4 weeks) 14. Failure of a subject or the subject's substance abuse counselor to provide assent 15. Nutritional risk index of less than 95 16. Age \< 21 or \> 55 17. Pregnancy 18. Decisionally challenged 19. Prisoners.

Inclusion Criteria

Exclusion Criteria

1. 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.
2. 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.
3. Capacity to answer screening questions and provide informed consent at time of interview, along with contact information
1. No cannabis use ever by self-report, and validated through urine drug screen.
2. Never users of tobacco/cigarettes
3. Capacity to answer screening questions and provide informed consent at time of interview, along with contact information.

1. 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)
2. Inhaled tobacco product exposure EXCEEDING one "pack year" or a positive urine cotinine screen
3. Elevated AUDIT-C score: A 3 item questionnaire to identify subjects with alcohol use disorders.
4. Prior medical history of liver disease: cirrhosis, total bilirubin \> 2.0 mg/dL or albumin \<3
5. Prior medical history of myocardial infarction or congestive heart failure
6. Prior medical history of end-stage renal disease or serum creatinine \>3 mg/dL
7. Prior history of or current use of illicit drug use defined as a positive toxicology screen for opiates or cocaine
8. Prior history of diabetes mellitus
9. Prior history of chronic obstructive pulmonary disease (COPD) or asthma that is not clinically controlled (have not required systemic corticosteroids in the past month)
10. Prior history of HIV, not controlled or on medication
11. Peripheral white blood cell count of less than 3000
12. 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
13. Use of systemic antibiotics for any reason in the past month (4 weeks)
14. Failure of a subject or the subject's substance abuse counselor to provide assent
15. Nutritional risk index of less than 95
16. 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)
17. Pregnancy
18. Decisionally challenged
19. Prisoners.
1. History of inhaled cannabis exposure EXCEEDING one "joint year" or positive urine toxicology screen (for cannabis)
2. History of inhaled tobacco product exposure EXCEEDING one "pack year" or a positive urine cotinine screen
3. Elevated AUDIT-C score: A 3 item questionnaire to identify subjects with alcohol use disorders.
4. Prior medical history of liver disease: cirrhosis, total bilirubin \> 2.0 mg/dL or albumin \<3
5. Prior medical history of myocardial infarction or congestive heart failure
6. Prior medical history of end-stage renal disease or serum creatinine \>3 mg/dL
7. Prior history of or current use of illicit drug use defined as a positive toxicology screen for opiates or cocaine
8. Prior history of diabetes mellitus
9. Prior history of chronic obstructive pulmonary disease (COPD) or asthma that is not clinically controlled (have not required systemic corticosteroids in the past month)
10. Prior history of HIV, not controlled or on medication
11. Peripheral white blood cell count of less than 3000
12. 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
13. Use of systemic antibiotics in the past month (4 weeks)
14. Failure of a subject or the subject's substance abuse counselor to provide assent
15. Nutritional risk index of less than 95
16. Age \< 21 or \> 55
17. Pregnancy
18. Decisionally challenged
19. Prisoners.

Contacts and Locations

Study Contact

Jeffrey D McKeehan, MSN

CONTACT

303-724-6080

jeffrey.mckeehan@ucdenver.edu

Ellen L Burnham, MD

CONTACT

303-724-6078

ellen.burnham@ucdenver.edu

Principal Investigator

Ellen L Burnham, MD

PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Study Locations (Sites)

University of Colorado, Denver

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Ellen L Burnham, MD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-11-11

Study Completion Date2027-07

Study Record Updates

Study Start Date2015-11-11

Study Completion Date2027-07

Terms related to this study

Additional Relevant MeSH Terms

Cannabis Smoking
Oxidative Stress