SmokingNCT01974063
Alternate Nicotine Delivery Systems and Airway Epithelial Biology
An observational study of Smoking and Smoking Cessation, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
Cigarette smoking evokes major changes in the biology of the airway epithelium, the cell population that takes the brunt of the stress of cigarette smoke and the cell population central to the pathogenesis of chronic obstructive pulmonary disease (COPD) and lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking Cessation
- How many people
- 96 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2013to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: New York Metropolitan area residents
Who may be able to join
- Group A - Nonsmokers
- All study subjects should be healthy according to the Weill Cornell IRB protocol #1204012331 and be willing and able to provide informed consent for the follow up study with repeated bronchoscopies.
- Subjects will be male and female ≥18 yr of age.
- Nonsmoker is defined as someone who has smoked <100 cigarettes or <10 shisha pipes per lifetime and whose urine nicotine <2 ng/ml and/or urine cotinine <5 ng/ml, at entry into the study.
- Group B - Current cigarette smokers
- All study subjects should be healthy according to the Weill Cornell IRB protocol #1204012331 and willing and able to provide informed consent for the follow up study with repeated bronchoscopies.
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- Subjects will be male and female ≥18 years of age.
- Active smoker is defined by self-report and urine nicotine >30 ng/ml and/or urine cotinine >50 ng/ml.
- Group C - Current shisha smokers
- All study subjects should be healthy according to the Weill Cornell IRB protocol #1204012331 and willing and able to provide informed consent for the follow up study with repeated bronchoscopies.
- Subjects will be male and female ≥18 yr of age.
- Shisha smoker is defined by self-report of smoking >4 pipes/wk and carboxyhemoglobin >2.5.
- Group D - Current smokers who stop smoking
- All study subjects should be healthy according to the Weill Cornell IRB protocol #1204012331 and willing and able to provide informed consent for the follow up study with repeated bronchoscopies.
- Subjects will be male and female ≥18 years of age.
- Current smoker is defined by self-report and urine nicotine >30 ng/ml and/or urine cotinine >50 ng/ml.
- Subjects must be a current smoker willing to stop smoking with no contra indications to taking varenicline.
- Group E - Current smokers who switch to electronic cigarettes
- All study subjects should be healthy according to the Weill Cornell IRB protocol #1204012331 and willing and able to provide informed consent for the follow up study with repeated bronchoscopies.
- Subjects will be male and female ≥18 years of age. Current smoker is defined by self-report and urine nicotine >30 ng/mL and/or urine cotinine >50 ng/ml.
- Subjects must be willing to switch from tobacco cigarettes to electronic cigarettes.
Who cannot join
- All exclusion criteria apply from the "Airway" (IRB#1204012331) protocol. Additional exclusion criteria specific to this protocol are as follows:
- Groups A-E
- No Weill Cornell (including GMS) students will be included, but students from other institutions may be included. A potential pool of Weill Cornell employees may enter this study provided that they are not under the oversight of the study PI or co-investigators.
- Groups D and E - Current smokers who stop smoking
- Subjects who are not, in the opinion of the responsible investigator, eligible to take smoking cessation medication due to major depressive and/or other significant psychiatric disorder.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rockefeller University Hospital
New York, New York, 10065
Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine
New York, New York, 10065
About this study
Cigarette smoking evokes major changes in the biology of the airway epithelium, the cell population that takes the brunt of the stress of cigarette smoke and the cell population central to the pathogenesis of chronic obstructive pulmonary disease (COPD) and lung cancer. The focus of this study is to identify the differences that two popular alternative nicotine delivery strategies, shisha and electronic cigarettes, have on the airway epithelium compared to cigarette smoking. We hypothesize that both alternative nicotine delivery strategies disorder airway epithelial biology, but in different ways than does cigarette smoking.
Read the detailed description
Hypothesis and Research Questions We hypothesize that shisha smoking and electronic cigarettes both disorder airway biology, but this disordered biology differs from that resulting from cigarette smoking, suggesting that these alternative nicotine delivery methods will cause lung disease, but perhaps with phenotypes different from that of cigarette smoking.
Aim 1: To assess the hypothesis that shisha smoking disorders the biology of the airway epithelium, but that these changes are distinct from that of cigarette smokers.
Aim 2: To evaluate the hypothesis that when the smoker switches from smoking cigarettes to smoking electronic cigarettes, there is a partial normalization of the disordered airway epithelial biology, but that this partial normalization is different from that associated from complete cessation of cigarette smoking.
Standard and Experimental Procedures
All of the study populations and assessments to be carried out in this protocol are already covered under the IRB approved protocol, "Collection of Airway, Blood and/or Urine Specimens from Subjects for Research Studies" (IRB #1204012331); the only purpose of this protocol is to formalize the timing of assessments so that the underlying hypothesis can be assessed.
The above protocol is designed to assess gene expression in lung cells of nonsmokers, smokers and ex-smokers. The purpose of the present study is to asses if shisha smoking and electronic cigarettes both disorder airway biology, and see if this disordered biology differs from that resulting from cigarette smoking, suggesting that these alternative nicotine delivery methods will cause lung disease, but perhaps with phenotypes different from that of cigarette smoking.
This new protocol will use our existing IRB approved protocol, "Collection of Airway, Blood and/or Urine Specimens from Subjects for Research Studies ("Airway")" (IRB #1204012331), for all of the assessments and procedures of this study. This protocol is designed to formalize the time points at which we carry out the various test parameters (see Table II for a timeline of the study parameters). Recruitment for this protocol will be from the cohort of individuals who are recruited for the "Airway" study. Research subjects recruited into this protocol, will sign both the "Airway" informed consent form and also the consent form for this protocol.
The standard clinical care of our pulmonary physicians is to encourage all smokers to stop smoking; hence, all research participants who smoke will be encouraged to stop smoking. If they decide to do so, they will receive standard of care smoking cessation aids including counseling and medications.
Subjects enrolled in Group E of the study will receive an alternative nicotine delivery method such as electronic cigarettes.
- Conditions
- Smoking, Smoking Cessation
- Keywords
- Smoking, Smoking Cessation, Healthy Smoker, Shisha Smoker, Non-smoker
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A. Nonsmokers | Subjects have smoked <100 cigarettes or <10 shisha pipes per lifetime and whose urine nicotine <2 ng/mL and/or urine cotinine <5 ng/mL, at entry into the study. | |
| B.Current cigarette smokers | Defined by self-report and urine nicotine >30 ng/mL and/or urine cotinine >50 ng/ml. | |
| C. Current shisha smokers | Defined by self-report of smoking >4 pipes/wk and carboxyhemoglobin >2.5. | |
| D. smokers willing to quit | Defined by self-report and urine nicotine >30 ng/ml and/or urine cotinine >50 ng/ml. Subjects must be a current smoker willing to stop smoking. Subjects will stop smoking after the baseline bronchoscopy, and switch to taking a smoking cessation medication called varenicline. We will provide subjects with the smoking cessation medication as part of this study. They will also receive phone calls to help with smoking cessation counseling. | |
| E. Smokers switching to E-cigarettes | Defined by self-report and urine nicotine >30 ng/ml and/or urine cotinine >50 ng/ml. Must be willing to switch from tobacco cigarettes to electronic cigarettes. The switch will occur after the baseline bronchoscopy. The nicotine dose that will be given to each subject will be determined by the study physician based on the urine smoking metabolite test. It will be adjusted depending on whether the subject is a light smoker or heavy smoker (Light smoker defined as having either a urine nicotine value from 2ng/ml-1000ng/ml or a urine cotinine value from 5ng/ml-1000ng/ml. Heavy smoker is defined as having either a urine nicotine or cotinine value of over 1000ng/ml.) We will provide the subjects with the electronic cigarettes to use as part of this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with gene expression changes in the small airway epithelium (SAE)
We will measure the effect that shisha smoking has on the small airway epithelium (SAE) by measuring parameters such as the SAE gene expression, DNA methylation, telomere length and cilia length in "pure shisha smokers" (i.e., non-cigarette smokers.) We will compare these parameters to the same parameters measured in non-smokers and cigarette smokers.
Measured: Study individuals will be enrolled in the study for three months.
Secondary outcomes (1)
Number of participants with gene expression changes in the airway epithelium
We will measure the small airway epithelium (SAE) of cigarette smokers who switch to smoking electronic cigarettes by measuring parameters such as the SAE gene expression, DNA methylation, telomere length and cilia length. We will compare these parameters to the same parameters measured in cigarette smokers who stop smoking completely.
Measured: Study individuals will be enrolled in the study for three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2017
- Study completionMay 2017
Why it stopped: Grant Ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Ronald G Crystal, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974063
- Sponsor's protocol ID
- 1208012965
- Other IDs
- R01HL107882-02S1
- Status last verified
- Apr 2018
- First submitted
- 20 Dec 2012
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternate Nicotine Delivery Systems and Airway Epithelial Biology
- ClinicalTrials.gov ID
- NCT01974063
- Acronym / sponsor ID
- 1208012965
- Conditions
- Smoking, Smoking Cessation
- Keywords
- Smoking, Smoking Cessation, Healthy Smoker, Shisha Smoker, Non-smoker
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Grant Ended
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2013 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 1 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cigarette smoking evokes major changes in the biology of the airway epithelium, the cell population that takes the brunt of the stress of cigarette smoke and the cell population central to the pathogenesis of chronic obstructive pulmonary disease (COPD) and lung cancer. The focus of this study is to identify the differences that two popular alternative nicotine delivery strategies, shisha and electronic cigarettes, have on the airway epithelium compared to cigarette smoking. We hypothesize that both alternative nicotine delivery strategies disorder airway epithelial biology, but in different ways than does cigarette smoking.
Detailed description
Hypothesis and Research Questions We hypothesize that shisha smoking and electronic cigarettes both disorder airway biology, but this disordered biology differs from that resulting from cigarette smoking, suggesting that these alternative nicotine delivery methods will cause lung disease, but perhaps with phenotypes different from that of cigarette smoking.
Aim 1: To assess the hypothesis that shisha smoking disorders the biology of the airway epithelium, but that these changes are distinct from that of cigarette smokers.
Aim 2: To evaluate the hypothesis that when the smoker switches from smoking cigarettes to smoking electronic cigarettes, there is a partial normalization of the disordered airway epithelial biology, but that this partial normalization is different from that associated from complete cessation of cigarette smoking.
Standard and Experimental Procedures
All of the study populations and assessments to be carried out in this protocol are already covered under the IRB approved protocol, "Collection of Airway, Blood and/or Urine Specimens from Subjects for Research Studies" (IRB #1204012331); the only purpose of this protocol is to formalize the timing of assessments so that the underlying hypothesis can be assessed.
The above protocol is designed to assess gene expression in lung cells of nonsmokers, smokers and ex-smokers. The purpose of the present study is to asses if shisha smoking and electronic cigarettes both disorder airway biology, and see if this disordered biology differs from that resulting from cigarette smoking, suggesting that these alternative nicotine delivery methods will cause lung disease, but perhaps with phenotypes different from that of cigarette smoking.
This new protocol will use our existing IRB approved protocol, "Collection of Airway, Blood and/or Urine Specimens from Subjects for Research Studies ("Airway")" (IRB #1204012331), for all of the assessments and procedures of this study. This protocol is designed to formalize the time points at which we carry out the various test parameters (see Table II for a timeline of the study parameters). Recruitment for this protocol will be from the cohort of individuals who are recruited for the "Airway" study. Research subjects recruited into this protocol, will sign both the "Airway" informed consent form and also the consent form for this protocol.
The standard clinical care of our pulmonary physicians is to encourage all smokers to stop smoking; hence, all research participants who smoke will be encouraged to stop smoking. If they decide to do so, they will receive standard of care smoking cessation aids including counseling and medications.
Subjects enrolled in Group E of the study will receive an alternative nicotine delivery method such as electronic cigarettes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A. Nonsmokers | – | –Subjects have smoked <100 cigarettes or <10 shisha pipes per lifetime and whose urine nicotine <2 ng/mL and/or urine cotinine <5 ng/mL, at entry into the study. |
| B.Current cigarette smokers | – | –Defined by self-report and urine nicotine >30 ng/mL and/or urine cotinine >50 ng/ml. |
| C. Current shisha smokers | – | –Defined by self-report of smoking >4 pipes/wk and carboxyhemoglobin >2.5. |
| D. smokers willing to quit | – | –Defined by self-report and urine nicotine >30 ng/ml and/or urine cotinine >50 ng/ml. Subjects must be a current smoker willing to stop smoking. Subjects will stop smoking after the baseline bronchoscopy, and switch to taking a smoking cessation medication called varenicline. We will provide subjects with the smoking cessation medication as part of this study. They will also receive phone calls to help with smoking cessation counseling. |
| E. Smokers switching to E-cigarettes | – | –Defined by self-report and urine nicotine >30 ng/ml and/or urine cotinine >50 ng/ml. Must be willing to switch from tobacco cigarettes to electronic cigarettes. The switch will occur after the baseline bronchoscopy. The nicotine dose that will be given to each subject will be determined by the study physician based on the urine smoking metabolite test. It will be adjusted depending on whether the subject is a light smoker or heavy smoker (Light smoker defined as having either a urine nicotine value from 2ng/ml-1000ng/ml or a urine cotinine value from 5ng/ml-1000ng/ml. Heavy smoker is defined as having either a urine nicotine or cotinine value of over 1000ng/ml.) We will provide the subjects with the electronic cigarettes to use as part of this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- New York Metropolitan area residents
Key inclusion criteria (21 listed)
- Group A - Nonsmokers
- All study subjects should be healthy according to the Weill Cornell IRB protocol #1204012331 and be willing and able to provide informed consent for the follow up study with repeated bronchoscopies.
- Subjects will be male and female ≥18 yr of age.
- Nonsmoker is defined as someone who has smoked <100 cigarettes or <10 shisha pipes per lifetime and whose urine nicotine <2 ng/ml and/or urine cotinine <5 ng/ml, at entry into the study.
- Group B - Current cigarette smokers
Key exclusion criteria (5 listed)
- All exclusion criteria apply from the "Airway" (IRB#1204012331) protocol. Additional exclusion criteria specific to this protocol are as follows:
- Groups A-E
- No Weill Cornell (including GMS) students will be included, but students from other institutions may be included. A potential pool of Weill Cornell employees may enter this study provided that they are not under the oversight of the study PI or co-investigators.
- Groups D and E - Current smokers who stop smoking
- Subjects who are not, in the opinion of the responsible investigator, eligible to take smoking cessation medication due to major depressive and/or other significant psychiatric disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with gene expression changes in the small airway epithelium (SAE)
Time frame: Study individuals will be enrolled in the study for three months.
We will measure the effect that shisha smoking has on the small airway epithelium (SAE) by measuring parameters such as the SAE gene expression, DNA methylation, telomere length and cilia length in "pure shisha smokers" (i.e., non-cigarette smokers.) We will compare these parameters to the same parameters measured in non-smokers and cigarette smokers.
1 secondary outcome
Number of participants with gene expression changes in the airway epithelium
Time frame: Study individuals will be enrolled in the study for three months.
Results and safety
The study was stopped early (reason given: Grant Ended). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald G Crystal, MD principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking and Smoking Cessation, run by Weill Medical College of Cornell University at 2 sites 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 21 inclusion and 5 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: stopped early, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early (reason given: Grant Ended). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with gene expression changes in the small airway epithelium (SAE) (time frame: Study individuals will be enrolled in the study for three months.). 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 3 May 2018.