Health TrialsbyHealthPanel

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

ConditionsCannabis SmokingOxidative Stress
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-55
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Bronchoscopy

    Procedure/Surgery

    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

    Radiation

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

  • Venipuncture

    Procedure/Surgery

    To collect blood cells and serum for analyses.

  • Intravenous Catheter

    Procedure/Surgery

    To administer the appropriate medications for the bronchoscopy procedure.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Control4 interventions
Group B: Cannabis Smokers4 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and at 18 hours
2

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).

Time frame
Baseline
3

Assessment of Lung Function

Spirometry/Pulmonary function testing

Time frame
Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Source ClinicalTrials.gov
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