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Cannabis SmokingNCT02480283

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

An observational study of Cannabis Smoking and Oxidative Stress, run by University of Colorado, Denver at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Cannabis Smoking, Oxidative Stress
What is being tested?
Bronchoscopy, Chest X-ray and Venipuncture
How many people
100 participants
Where
1 siteUnited States
Study dates
11 Nov 2015to Jul 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • INCLUSION CRITERIA for CANNABIS USING patient: Subjects will be eligible if they meet ALL of the following criteria:
  • 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.

Who cannot join

  • EXCLUSION CRITERIA for CANNABIS USING patient: Subjects will be ineligible if they meet ANY of the following criteria:
  • 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
Show all 40Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jeffrey D McKeehan, MSN contact

303-724-6080

jeffrey.mckeehan@ucdenver.edu

Ellen L Burnham, MD contact

303-724-6078

ellen.burnham@ucdenver.edu

United States1 site, 1 recruiting
  • University of Colorado, Denver

    Aurora, Colorado, 80045

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description
  1. Hypotheses and Specific Aims:

With changing legislation, the landscape of cannabis use is shifting; data demonstrates that public perception of marijuana's "safety" has contributed to increasing usage most commonly via the inhaled route (smoking). The effects of habitual cannabis smoking on lung health, however, remains unclear. Spirometric data has been inconclusive regarding risk of airflow limitation and development of chronic obstructive pulmonary disease, a finding that may be attributable to inaccurate reporting due to its former illegal nature. It seems clear, however, that these patients suffer from an increased incidence of bronchitis symptoms from an uncertain pathophysiologic mechanism. Animal data from the 1990s demonstrates that cannabinoid exposure (of which Tetrahydrocannabinol (THC) is an example) results in increased intra-pulmonary oxidative stress indices and immunomodulatory effects resulting in abnormal macrophage function; a finding that may be related the aforementioned symptoms. However, this data is likely now outmoded given the markedly increased (THC) content of today's cannabis for sale (12 percent Tetrahydrocannabinol (THC) compared to 3 percent in the 1990s). Furthermore, most of these findings have not been validated in human subjects. Thus, the investigators hypothesize that habitually smoked cannabis increases intrapulmonary oxidative stress resulting in impaired alveolar macrophage (AM) phagocytosis, elicits an attenuated AM response to pathogen-associated molecular patterns (PAMPs) and promotes AM apoptosis thereby increasing risk of upper and lower airway infections.

II. Background and Significance:

Cannabis use in the United States is rising since legalization for medical and, more recently, recreational purposes. The United Nations Office on Drugs and Crime estimates that in 2012, when cannabis was legal for medical purposes in 17 states, but illegal for recreational consumption nationally, cannabis use among the American population increased from 11.5% to 12.1%. Over the past 2 years, an additional seven states have legalized medical cannabis, and Colorado and Washington have recently legalized its sale for recreational use. Since January 2014, publicly available Colorado data indicate increasing tax revenue from cannabis sales (both medical and recreational), suggesting a rise in state-wide consumption in a relatively short period of time.

Effects of modern inhaled cannabis on lung health are not established. Published epidemiologic data collected prior to the widespread legalization of cannabis and commercialization of the cannabis industry demonstrate consistent associations between "regular" (e.g. near daily) and "heavy" (e.g. for multiple years) cannabis use with poorer lung health. Clinically, regular inhaled cannabis users complain of increased chronic bronchitis symptoms (eg. wheeze, chronic cough) compared to non-smokers; an increased use of medical services for respiratory infections due to immunosuppressive effects of the drug has also been reported. However, characterization of cannabis use in these investigations varies widely, ranging from 7 joint-years (1 joint per day for 1 year) 12 to 117 joint-years in cohorts examined. These studies were also potentially confounded by under-reporting of cannabis use due to the drug's illegal status, and concomitant use of inhaled tobacco in some study populations. Moreover, the quantity of THC in modern cannabis products has been increasing over the past two decades. Therefore, it remains unclear what use patterns of modern inhaled cannabis are harmful to lung health, although more cannabis is being consumed now than ever before, both for medical and recreational purposes. Today, due to the decriminalization of cannabis sale and purchase, the accuracy of self-reported cannabis use is likely much greater than in prior investigations, providing a novel opportunity to more accurately establish patterns of use associated with ill effects on health. Importantly, no study to date has utilized time series analyses, such as the time line follow-back (TLFB), to quantitate the effects of regular cannabis consumption in association with lung health. TLFB techniques are used extensively to quantitate substance use among chronic users of alcohol, tobacco, and more recently, cannabis. TLFB are calendar-assisted, structured interviews that cue memory to enhance accurate recall, and have been determined to be both reliable and valid in quantitating current substance use in detail. TLFB interviews to characterize past 30 day cannabis use have been routinely conducted in research subjects by Dr. Corsi's (co-mentor to Dr. Biehl) research group since 2010, and longer term joint-year data has been collected as well.

Inhaled cannabis use adversely affects function of alveolar macrophages (AMs), critical pulmonary innate immune effectors. AMs express cannabinoid (CB) receptors, primarily CB2, on their surface, whose ligand is THC15 (a cannabinoid). AMs represent the first line of defense against invading pathogens in the lower airways, and function to keep the lungs sterile. Published investigations using AMs isolated via bronchoalveolar lavage (BAL) from small numbers (n<20) of habitual inhaled cannabis users have reported an inappropriately diminished response to S. aureus, an important lung pathogen. When AMs were exposed to S. aureus, they exhibited decreased bacterial phagocytosis and killing; hampered production of the pro-inflammatory cytokines tumor necrosis factor-α, IL-6, and granulocyte monocyte colony stimulating factor; and decreased production of nitric oxide. Preclinical data has suggested that AM viability and apoptosis may also be adversely influenced by THC in a dose- and time-dependent manner through the CB2 receptor, further impairing the AM's ability to respond to pathogens. As mentioned, cannabis use is increasing on a per capita basis, and continues to be used via an inhaled route, while its THC quantity is increasing. Collectively, this suggests the possibility that individuals who regularly use small doses of inhaled cannabis, or have used cannabis for a shorter length of time, may still be at risk for AM dysfunction, clinically manifested by increased respiratory symptoms and an increased risk for pulmonary infections, particularly since pre-clinical data has consistently reported adverse effects of cannabis exposure on infectious disease resistance.

Cannabis exposure in vitro leads to oxidative stress that in turn affects pulmonary cellular viability. Murine lung epithelial cells exposed to cannabis smoke extract in vitro demonstrate a dose-related increase in oxidative stress, while human lung BEAS-2B cells exposed to cannabis smoke extract in vitro display an increase in reactive oxygen species production. Enhanced oxidative stress in each investigation was further associated with evidence of cytotoxicity, characterized by cellular apoptosis and DNA damage. It seems possible, then, that enhanced oxidative stress due to habitual inhaled cannabis may additionally influence the viability and function of AMs in the lower airways. However, the effect of inhaled cannabis on oxidative stress and its relationship to AMs has never been specifically explored with primary cells from human subjects.

In summary, our collaboration will utilize validated methods to characterize regular and chronic cannabis use patterns among exclusive medical and/or recreational cannabis users, in order to examine their impact on cells critical to the maintenance of lung health. Information the investigators derive may be used to counsel active and contemplating cannabis users, and inform medical providers and researchers.

Being tested
Bronchoscopy, Chest X-ray, Venipuncture, Intravenous Catheter
Medical subject headings
Marijuana Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BronchoscopyProcedure or 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-rayRadiation

    Also called CXR

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

  • VenipunctureProcedure or surgery

    Also called Blood Test

    To collect blood cells and serum for analyses.

  • Intravenous CatheterProcedure or surgery

    Also called IV

    To administer the appropriate medications for the bronchoscopy procedure.

Study groups in NCT02480283
Study groupRoleWhat they receive
ControlSubjects 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.
Receives: Procedure: Bronchoscopy; Radiation: Chest X-ray; Procedure: Venipuncture; Procedure: Intravenous Catheter
Cannabis SmokersThe 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.
Receives: Procedure: Bronchoscopy; Radiation: Chest X-ray; Procedure: Venipuncture; Procedure: Intravenous Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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).

    Measured: Baseline

  3. Assessment of Lung Function

    Spirometry/Pulmonary function testing

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2015 (estimated)
  2. Study start11 Nov 2015
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02480283
Sponsor's protocol ID
14-1957
Other IDs
UL1TR001082
Status last verified
Oct 2024
First submitted
27 May 2015
Last updated
10 Oct 2024
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Cannabis Smoking and Oxidative Stress, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jeffrey D McKeehan, MSN (303-724-6080, jeffrey.mckeehan@ucdenver.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in alveolar macrophage phagocytosis related to the use of cannabis (time frame: Baseline and at 18 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.

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