Bronchoscopy in Determining the Effect of E-Cigarette Smoking on Biomarkers in the Lungs
NCT ID: NCT03691350
Last Updated: 2023-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
EARLY_PHASE1
239 participants
INTERVENTIONAL
2018-09-17
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Impact of E-cigarette Use on the Body
NCT04972513
Switching to a Vaping Device: Evaluating Risk Reduction Among Quitline Treatment Failures
NCT03502200
Pulmonary and Cardiac Effects of E-Cigarette Use in Pulmonary Patients Who Smoke Cigarettes
NCT05610514
E-Cigarette Effects on Markers of Cardiovascular and Pulmonary Disease
NCT03863509
Examining Heavy Metal Exposure and Respiratory Health in Young Adult Electronic Cigarette Users
NCT07215065
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To assess inflammatory changes over 10 weeks for lung and urine biomarkers in smokers who undergo serial bronchoscopy. The randomized trial includes four conditions: continued use (n=32), complete switching to the nicotine standardized research electronic cigarettes (e-cig) (SREC) (n=32), complete switching to the placebo (nicotine free) SREC (n=32), and complete switching to nicotine replacement therapy (NRT)(n=32).
OUTLINE: Participants are randomized to 1 of 4 groups.
GROUP I: Participants undergo bronchoscopy over 30-60 minutes at baseline. Participants continue to smoke their usual brand of cigarettes. Participants undergo a second bronchoscopy on day 71.
GROUP II: Participants undergo bronchoscopy over 30-60 minutes at baseline. After the baseline bronchoscopy, participants learn to use the SREC with nicotine for 2 weeks and switch completely to the SREC with nicotine for 2 weeks and switch completely to the SREC with nicotine starting day 15 for 8 weeks. Participants undergo a second bronchoscopy on day 71.
GROUP III: Participants undergo bronchoscopy over 30-60 minutes at baseline. After the baseline bronchoscopy, participants learn to use the SREC without nicotine for 2 weeks and switch completely to the SREC without nicotine starting day 15 for 8 weeks. Participants will be offered varenicline to aid cessation. Participants undergo a second bronchoscopy on day 71.
GROUP IV: Participants undergo bronchoscopy over 30-60 minutes at baseline. Beginning 1 week before the day 15 quit date, participants stop smoking using NRT comprising either patch, gum, or lozenge for 8 weeks. Participants undergo a second bronchoscopy on day 71.
After completion of study, participants are followed up at 3 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group I (usual cigarette brand)
Participants undergo bronchoscopy over 30-60 minutes at baseline. Participants continue to smoke their usual brand of cigarettes. Participants undergo a second bronchoscopy on day 71.
Bronchoscopy with Bronchoalveolar Lavage
Undergo bronchoscopy with bronchoalveolar lavage
Cigarette
Smoke usual brand
Laboratory Biomarker Analysis
Correlative studies
Questionnaire Administration
Ancillary studies
Group II (SREC with nicotine)
Participants undergo bronchoscopy over 30-60 minutes at baseline. After the baseline bronchoscopy, participants learn to use the SREC with nicotine for 2 weeks and switch completely to the SREC with nicotine starting day 15 for 8 weeks. Participants undergo a second bronchoscopy on day 71.
Bronchoscopy with Bronchoalveolar Lavage
Undergo bronchoscopy with bronchoalveolar lavage
Electronic Cigarette
Smoke SREC with nicotine
Laboratory Biomarker Analysis
Correlative studies
Questionnaire Administration
Ancillary studies
Group III (SREC without nicotine)
Participants undergo bronchoscopy over 30-60 minutes at baseline. Beginning 1 week after bronchoscopy, participants learn to use the SREC without nicotine for 2 weeks and switch completely to the SREC without nicotine starting day 15 for 8 weeks. Participants will be offered varenicline to aid cessation. Participants undergo a second bronchoscopy on day 71.
Bronchoscopy with Bronchoalveolar Lavage
Undergo bronchoscopy with bronchoalveolar lavage
Electronic Cigarette
Smoke SREC without nictoine
Laboratory Biomarker Analysis
Correlative studies
Questionnaire Administration
Ancillary studies
Group IV (Nicotine Replacement Therapy [NRT])
Participants undergo bronchoscopy over 30-60 minutes at baseline. One week before the day 15 quit date, participants stop smoking using NRT comprising either patch, gum, or lozenge for 8 weeks. Participants undergo a second bronchoscopy on day 71.
Bronchoscopy with Bronchoalveolar Lavage
Undergo bronchoscopy with bronchoalveolar lavage
Laboratory Biomarker Analysis
Correlative studies
Nicotine Replacement
Receive NRT comprising patch, gum, or lozenge
Questionnaire Administration
Ancillary studies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bronchoscopy with Bronchoalveolar Lavage
Undergo bronchoscopy with bronchoalveolar lavage
Cigarette
Smoke usual brand
Electronic Cigarette
Smoke SREC with nicotine
Electronic Cigarette
Smoke SREC without nictoine
Laboratory Biomarker Analysis
Correlative studies
Nicotine Replacement
Receive NRT comprising patch, gum, or lozenge
Questionnaire Administration
Ancillary studies
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* No unstable or significant medical conditions as determined by medical history to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures
* Able to read adequately to complete the survey and related study documents or give consent
* Subject has provided written informed consent to participate in the study
Exclusion Criteria
* Immune system disorders requiring medication
* Prior diagnosis of chronic pulmonary disease (e.g., asthma with regular use of medications, chronic obstructive pulmonary disease \[COPD\], chronic bronchitis, and restrictive lung disease)
* Acute bronchitis or pneumonia within 1 year
* Reported history of diagnosed kidney or liver disease
* Any medical disorder that will increase the risk from bronchoscopy, affect biomarker data, or increase risk of an adverse effect from e-cig use
* General anesthesia within 1 year
* Regular use of inhalant medications in the last 2 months
* Use of antibiotics in prior 30 days
* Use of steroids, including corticosteroids, in prior 30 days
* Allergies to study medications, such as, lidocaine, Versed, fentanyl or Cetacaine
* Allergies to propylene glycol/glycerin or flavors
* History of hypersensitivity to varenicline
* Bronchoscopy or any other lung procedure for any reason within the previous 6 months
* Current or recent (within three months) alcohol or drug abuse problems
* Regularly smoked marijuana within the prior 3 months
* Use of an e-cigarette or other combustible tobacco products in the prior 3 months
* Currently using nicotine replacement or other tobacco cessation products (to minimize confounding effects of another product) or intention to quit in next three months
* Adverse reaction to previous e-cig use
* Body mass index (BMI) \> 40 (risk of unstable airway)
* Pregnant or breastfeeding - if the subject is female, a urine pregnancy test at no cost to the subject will be done on the day of bronchoscopy
* Unable to read for comprehension or completion of study documents
21 Years
52 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Drug Abuse (NIDA)
NIH
Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Peter Shields
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Peter Shields, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Related Links
Access external resources that provide additional context or updates about the study.
The Jamesline
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2018-00283
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-18044
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.