Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-00283 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| U01DA045530 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
This trial studies biomarkers obtained by bronchoscopy (bronchoalveolar lavage and lung brushings) to determine the effect of smoking e-cigarettes on the lungs. Studying samples of lung cells from participants who smoke e-cigarettes may help doctors learn more about changes that occur in deoxyribonucleic acid and identify biomarkers related to cancer.
PRIMARY OBJECTIVES:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (usual cigarette brand) | Active Comparator | 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 (SREC with nicotine) | Experimental | 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. |
|
| Group III (SREC without nicotine) | Experimental | 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. |
|
| Group IV (Nicotine Replacement Therapy [NRT]) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronchoscopy with Bronchoalveolar Lavage | Procedure | Undergo bronchoscopy with bronchoalveolar lavage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Cytokines | Obtained via bronchoscopy with saline bronchoalveolar lavage (BAL) and bronchial brushings. Descriptive statistics and clustering (e.g., principal components analysis [PCA]), will be performed for all biomarker data measured at the different visits. Baseline data (1st bronchoscopy) will then be compared between the four groups (3 conditions and control) using a one-way analysis of variance (ANOVA). The non-parametric Kruskal-Wallis test (continuous or ordinal variables) or the chi-square test (categorical variables) will be applied when the normality assumption of the data is not met. Controls will be compared to complete substitution with the standardized research electronic cigarettes (SREC) (with and without nicotine) or nicotine replacement therapy (NRT. Generalized linear models (GLM) will be employed with measurement (cell count, gene expression, etc.) as the dependent variable, a covariable for baseline measure, and a main effect of arm. | Baseline to day 71 |
| Changes in Cell Counts | Obtained via bronchoscopy with saline bronchoalveolar lavage (BAL) and bronchial brushings. Descriptive statistics and clustering (e.g., principal components analysis [PCA]), will be performed for all biomarker data measured at the different visits. Baseline data (1st bronchoscopy) will then be compared between the four groups (3 conditions and control) using a one-way analysis of variance (ANOVA). The non-parametric Kruskal-Wallis test (continuous or ordinal variables) or the chi-square test (categorical variables) will be applied when the normality assumption of the data is not met. Controls will be compared to complete substitution with the standardized research electronic cigarettes (SREC) (with and without nicotine) or nicotine replacement therapy (NRT. Generalized linear models (GLM) will be employed with measurement (cell count, gene expression, etc.) as the dependent variable, a covariable for baseline measure, and a main effect of arm. | Baseline to day 71 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Fractional Exhaled Nitric Oxide (FeNO) Levels | FeNO will be measured with the NIOX VERO. Descriptive statistics and clustering (e.g. PCA), will be performed for all biomarker data measured at the different visits. Baseline data (1st bronchoscopy) will then be compared between the four groups (3 conditions and control) using a one-way ANOVA. The non-parametric Kruskal-Wallis test (continuous or ordinal variables) or the chi-square test (categorical variables) will be applied when the normality assumption of the data is not met. Controls will be compared to complete substitution with the SREC (with and without nicotine) or NRT. GLM will be employed with measurement (cell count, gene expression, etc.) as the dependent variable, a covariable for baseline measure, and a main effect of arm. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter Shields, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
Not provided
| Label | URL |
|---|---|
| The Jamesline | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Subjects were withdrawn from the study post-consent if they did not meet eligibility criteria or chose not to participate.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 19, 2022 | Feb 11, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
|
|
| Cigarette | Drug | Smoke usual brand |
|
| Electronic Cigarette | Other | Smoke SREC with nicotine |
|
|
| Electronic Cigarette | Other | Smoke SREC without nictoine |
|
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Nicotine Replacement | Drug | Receive NRT comprising patch, gum, or lozenge |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Baseline up to day 71 |
| Changes in Messenger (m) Ribonucleic Acid (RNA) and microRNA (miRNA) Gene Expression Analyzed Using Sequencing | Total RNA containing small RNAs will be extracted from bronchial brushing specimens using commercially available kits and used for both gene expression using the Affymetrix GeneChip Human Transcriptome Array and for miRNA expression using the Affymetrix GeneChip miRNA Array. Expression will separately be assessed through RNA sequencing. Total RNA will be extracted from lavage cells and saliva for comprehensive profiling of microbiome using commercially available kits. The ?omics? (miRNA, mRNA, and metabolomics) analysis and visualization of the data will be performed in the R statistical language. Data will be log2-transformed and normalized using either quantile normalization for gene expression (miRNA and mRNA) or normalization for metabolomics. Unsupervised clustering analysis, including PCA and hierarchical clustering will be performed to visualize natural clusters in the dataset and evaluate data quality. | Baseline up to day 71 |
| Changes in Deoxyribonucleic Acid (DNA) Gene Methylation | Total DNA will be extracted using commercially available kits and used for genome-wide DNA methylation profiling. Total DNA including mitochondrial DNA (mtDNA) will be extracted using commercially available kits and used for mtDNA mutation using Hiseq Next Generation Sequencing (NGS) and for mtDNA contents using quantitative polymerase chain reaction (qPCR). For preliminary identification of patterns in DNA methylation, unsupervised hierarchical clustering among the groups of samples will be performed. The Euclidian distance among the groups of samples will be calculated by the average linkage. In order to assess variance among samples, PCA will be done. | Baseline up to day 71 |
| Changes in the Microbiome in BAL Cells and Saliva | Obtained via bronchoscopy with saline BAL and bronchial brushings. Samples will be analyzed to determine their bacterial composition. | Baseline up to day 71 |
| Changes in Untargeted Metabolomics Using Mass Spectrometry | Obtained via bronchoscopy with saline BAL and bronchial brushings. The omics (miRNA, mRNA, and metabolomics) analysis and visualization of the data will be performed in the R statistical language. Data will be log2-transformed and normalized using either quantile normalization for gene expression (miRNA and mRNA) or normalization for metabolomics. Unsupervised clustering analysis, including PCA and hierarchical clustering will be performed to visualize natural clusters in the dataset and evaluate data quality. | Baseline up to day 71 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
Due to several issues (e.g., product concerns, COVID-19, etc.) outside of the study team's control, this project shifted to a feasibility pilot. Planned analyses were unable to be completed due to small sample size.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Cytokines | Obtained via bronchoscopy with saline bronchoalveolar lavage (BAL) and bronchial brushings. Descriptive statistics and clustering (e.g., principal components analysis [PCA]), will be performed for all biomarker data measured at the different visits. Baseline data (1st bronchoscopy) will then be compared between the four groups (3 conditions and control) using a one-way analysis of variance (ANOVA). The non-parametric Kruskal-Wallis test (continuous or ordinal variables) or the chi-square test (categorical variables) will be applied when the normality assumption of the data is not met. Controls will be compared to complete substitution with the standardized research electronic cigarettes (SREC) (with and without nicotine) or nicotine replacement therapy (NRT. Generalized linear models (GLM) will be employed with measurement (cell count, gene expression, etc.) as the dependent variable, a covariable for baseline measure, and a main effect of arm. | Descriptive analysis - mean of within subject change | Posted | Mean | Standard Deviation | pg/ml | Baseline to day 71 | Samples | Samples |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Changes in Fractional Exhaled Nitric Oxide (FeNO) Levels | FeNO will be measured with the NIOX VERO. Descriptive statistics and clustering (e.g. PCA), will be performed for all biomarker data measured at the different visits. Baseline data (1st bronchoscopy) will then be compared between the four groups (3 conditions and control) using a one-way ANOVA. The non-parametric Kruskal-Wallis test (continuous or ordinal variables) or the chi-square test (categorical variables) will be applied when the normality assumption of the data is not met. Controls will be compared to complete substitution with the SREC (with and without nicotine) or NRT. GLM will be employed with measurement (cell count, gene expression, etc.) as the dependent variable, a covariable for baseline measure, and a main effect of arm. | Subjects completing two bronchoscopy procedures | Posted | Mean | Standard Deviation | PPM | Baseline up to day 71 | Exhaled breath | Exhaled breath |
| ||||||||||||||||||||||||||||||||||
| Secondary | Changes in Messenger (m) Ribonucleic Acid (RNA) and microRNA (miRNA) Gene Expression Analyzed Using Sequencing | Total RNA containing small RNAs will be extracted from bronchial brushing specimens using commercially available kits and used for both gene expression using the Affymetrix GeneChip Human Transcriptome Array and for miRNA expression using the Affymetrix GeneChip miRNA Array. Expression will separately be assessed through RNA sequencing. Total RNA will be extracted from lavage cells and saliva for comprehensive profiling of microbiome using commercially available kits. The ?omics? (miRNA, mRNA, and metabolomics) analysis and visualization of the data will be performed in the R statistical language. Data will be log2-transformed and normalized using either quantile normalization for gene expression (miRNA and mRNA) or normalization for metabolomics. Unsupervised clustering analysis, including PCA and hierarchical clustering will be performed to visualize natural clusters in the dataset and evaluate data quality. | Only a fraction of the anticipated number of samples were collected, preventing completion of testing and analysis. Recruitment was adversely affected by several challenges, including COVID-19 and manufacturer-related product delays. As a result, the target sample size was not achieved, and no further analysis is planned at this time. | Posted | Number | Samples | Baseline up to day 71 | Samples | Samples |
| |||||||||||||||||||||||||||||||||||
| Secondary | Changes in Deoxyribonucleic Acid (DNA) Gene Methylation | Total DNA will be extracted using commercially available kits and used for genome-wide DNA methylation profiling. Total DNA including mitochondrial DNA (mtDNA) will be extracted using commercially available kits and used for mtDNA mutation using Hiseq Next Generation Sequencing (NGS) and for mtDNA contents using quantitative polymerase chain reaction (qPCR). For preliminary identification of patterns in DNA methylation, unsupervised hierarchical clustering among the groups of samples will be performed. The Euclidian distance among the groups of samples will be calculated by the average linkage. In order to assess variance among samples, PCA will be done. | Only a fraction of the anticipated number of samples were collected, preventing completion of testing and analysis. Recruitment was adversely affected by several challenges, including COVID-19 and manufacturer-related product delays. As a result, the target sample size was not achieved, and no further analysis is planned at this time. | Posted | Count of Units | Samples | Baseline up to day 71 | Samples | Samples |
| |||||||||||||||||||||||||||||||||||
| Secondary | Changes in the Microbiome in BAL Cells and Saliva | Obtained via bronchoscopy with saline BAL and bronchial brushings. Samples will be analyzed to determine their bacterial composition. | Only a fraction of the anticipated number of samples were collected, preventing completion of testing and analysis. Recruitment was adversely affected by several challenges, including COVID-19 and manufacturer-related product delays. As a result, the target sample size was not achieved, and no further analysis is planned at this time. | Posted | Count of Units | Samples | Baseline up to day 71 | Samples | Samples |
| |||||||||||||||||||||||||||||||||||
| Secondary | Changes in Untargeted Metabolomics Using Mass Spectrometry | Obtained via bronchoscopy with saline BAL and bronchial brushings. The omics (miRNA, mRNA, and metabolomics) analysis and visualization of the data will be performed in the R statistical language. Data will be log2-transformed and normalized using either quantile normalization for gene expression (miRNA and mRNA) or normalization for metabolomics. Unsupervised clustering analysis, including PCA and hierarchical clustering will be performed to visualize natural clusters in the dataset and evaluate data quality. | Only a fraction of the anticipated number of samples were collected, preventing completion of testing and analysis. Recruitment was adversely affected by several challenges, including COVID-19 and manufacturer-related product delays. As a result, the target sample size was not achieved, and no further analysis is planned at this time. | Posted | Count of Units | Samples | Baseline up to day 71 | Samples | Samples |
| |||||||||||||||||||||||||||||||||||
| Primary | Changes in Cell Counts | Obtained via bronchoscopy with saline bronchoalveolar lavage (BAL) and bronchial brushings. Descriptive statistics and clustering (e.g., principal components analysis [PCA]), will be performed for all biomarker data measured at the different visits. Baseline data (1st bronchoscopy) will then be compared between the four groups (3 conditions and control) using a one-way analysis of variance (ANOVA). The non-parametric Kruskal-Wallis test (continuous or ordinal variables) or the chi-square test (categorical variables) will be applied when the normality assumption of the data is not met. Controls will be compared to complete substitution with the standardized research electronic cigarettes (SREC) (with and without nicotine) or nicotine replacement therapy (NRT. Generalized linear models (GLM) will be employed with measurement (cell count, gene expression, etc.) as the dependent variable, a covariable for baseline measure, and a main effect of arm. | Descriptive analysis - mean of within subject change | Posted | Mean | Standard Deviation | cells/ml | Baseline to day 71 | Samples | Samples |
|
Reported AE's were collected from the first bronchoscopy through the follow-up period (6 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 11 | 0 | 11 | 7 | 11 |
| EG001 | 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 | 0 | 9 | 0 | 9 | 9 | 9 |
| EG002 | 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 | 0 | 10 | 0 | 10 | 6 | 10 |
| EG003 | 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 | 0 | 5 | 0 | 5 | 5 | 5 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild phlegm without cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Mild sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Mild dry cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Mild hoarseness of voice | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Mild headache (non-migraine) | Nervous system disorders | Systematic Assessment |
| ||
| Mild throat irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Mild productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Mild irritability (mood) | Nervous system disorders | Systematic Assessment |
| ||
| Mild dry mouth | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Unfortunately, the study encountered several challenges that impacted recruitment (e.g., COVID-19 and product delays from the manufacturer). The target sample size was not met. Therefore, samples were not analyzed, and we were unable to report analyze data for several outcomes (i.e., changes in mRNA and miRNA gene expression, DNA methylation, microbiome in BAL cells and saliva, and untargeted metabolomics). No future analyses are planned at this time.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter G. Shields | Ohio State University Comprehensive Cancer Center | 614-688-6563 | peter.shields@osumc.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 19, 2022 | Jul 3, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 5, 2018 | Jul 22, 2024 | ICF_002.pdf |
| ID | Term |
|---|---|
| D018893 | Bronchoalveolar Lavage |
| D001992 | Bronchoalveolar Lavage Fluid |
| D062789 | Tobacco Products |
| D066300 | Electronic Nicotine Delivery Systems |
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D007507 | Therapeutic Irrigation |
| D008919 | Investigative Techniques |
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Samples |
|
| IL.10..pg.ml. |
|
| IL.12p70..pg.ml. |
|
| IL.13..pg.ml. |
|
| IL.1B..pg.ml. |
|
| IL.2..pg.ml. |
|
| IL.4..pg.ml. |
|
| IL.6..pg.ml. |
|
| IL.8..pg.ml. |
|
| TNF.a..pg.ml. |
|
| OG002 | 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 |
| OG003 | 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 |
|
|
| OG001 | 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 |
| OG002 | 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 |
| OG003 | 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 |
|
| 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 |
| OG002 | 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 |
| OG003 | 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 |
|
|
| OG002 | 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 |
| OG003 | 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 |
|
|
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
| OG002 | 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 |
| OG003 | 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 |
|
|
| 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 |
| OG002 | 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 |
| OG003 | 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 |
|
|