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

NCT02480283 | Recruiting DMC

• 2 other identifiers: 14-1957UL1TR001082
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cannabis Smoking; Oxidative Stress

Outcome Measures

Primary Outcomes (3)

• Change in alveolar macrophage phagocytosis related to the use of cannabis

  Alveolar macrophage phagocytosis, secretion of pro-inflammatory cytokines, and cellular apoptosis, both at baseline, and after stimulation with pathogen-associated molecular patterns.

  Baseline and at 18 hours

• Evaluation of intrapulmonary oxidative stress indices in bronchalveolar lavage (BAL)

  Intrapulmonary oxidative stress indices will be measured in both isolated alveolar macrophages (AM) and acellular epithelial lining fluid derived from bronchoalveolar lavage (BAL).

  Baseline

• Assessment of Lung Function

  Spirometry/Pulmonary function testing

  Baseline

Study Arms (2)

Control

Subjects aged 18 to 55 who have never used cannabis by self report (validated via urine drug screen), who have never used tobacco/cigarettes and have the capacity to give informed consent.

Procedure: Bronchoscopy; Radiation: Chest X-ray; Procedure: Venipuncture; Procedure: Intravenous Catheter

Cannabis Smokers

The exposed cohort will have daily or near daily cannabis smoking histories equivalent to a minimum of 20 joint years (number of joints smoked per day multiplied by years of cannabis smoking), will not have a significant tobacco/cigarette smoking history and will be able to provide informed consent.

Procedure: Bronchoscopy; Radiation: Chest X-ray; Procedure: Venipuncture; Procedure: Intravenous Catheter

Interventions

Bronchoscopy 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.

Cannabis Smokers; Control

Chest X-ray RADIATION

To identify any previously undiagnosed lung disease that will either increase the risk of bronchoscopy or confound results of the study.

Also known as: CXR

Cannabis Smokers; Control

Venipuncture PROCEDURE

To collect blood cells and serum for analyses.

Also known as: Blood Test

Cannabis Smokers; Control

Intravenous Catheter PROCEDURE

To administer the appropriate medications for the bronchoscopy procedure.

Also known as: IV

Cannabis Smokers; Control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 to 55 who have been exposed to chronic cannabis smoking (without a history of tobacco smoking) and health, non-smoking controls.

You 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
• 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 may not qualify 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Colorado, Denver

Aurora, Colorado, 80045, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. Urine 2. Exhaled Breath Condensate 3. Blood/Plasma 4. Bronchial brushings 5. Bronchoalveolar Lavage 6. Oral rinse

MeSH Terms

Conditions

Marijuana Smoking

Interventions

Bronchoscopy; X-Rays; Phlebotomy; Hematologic Tests

Condition Hierarchy (Ancestors)

Marijuana Use; Behavior; Smoking, Non-Tobacco Products; Smoking

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Punctures; Therapeutics; Investigative Techniques

Study Officials

• Ellen L Burnham, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey D McKeehan, MSN

CONTACT

303-724-6080; jeffrey.mckeehan@ucdenver.edu

Ellen L Burnham, MD

CONTACT

303-724-6078; ellen.burnham@ucdenver.edu

Study Design

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

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 24, 2015
• Study Start: November 11, 2015
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 10, 2024

Record last verified: 2024-10

Locations

US (1)