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| ID | Type | Description | Link |
|---|---|---|---|
| P20GM130414 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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Smoking is the main cause of preventable disease and death in the US and impacts respiratory illnesses including COPD and asthma. However, little is known about the effects on smoking and lung health of substituting cigarettes with ENDS in adults with asthma. This project aims to test whether providing ENDS to adults with asthma will lead to substitution of smoking for ENDS, reduced dependence, and improved lung function so such knowledge can inform interventions to reduce the public health burden of tobacco.
This study will use an unequally allocated between-subjects (N=30) randomized, controlled design to investigate the influence of complimentary electronic nicotine delivery system (ENDS) provision on combustible cigarette and ENDS use, cigarette dependence, pulmonary function, clinical indicators and biomarkers, and substitution of smoking for ENDS use over 16 weeks. Participants will be adults from the local community with persistent asthma symptoms who are regular combustible cigarette smokers and do not also regularly use ENDS. The study will recruit 30 non-treatment seeking participants using flyers, advertisements, a website triaging visitors to the Center for Alcohol and Addiction Studies, and through targeted recruitment at community immunology clinic partners at Rhode Island Hospital as facilitated by mentor McQuaid. Participants meeting eligibility criteria will be assessed at baseline and then randomized to one of two study conditions: a complimentary ENDS provision condition or assessment-only control. Participants will return for eight weekly visits to complete follow-up assessments; participants in the experimental condition will be provided with additional e-liquid cartridges for their ENDS devices at all follow-up visits. Tobacco use behaviors (cigarette and ENDS) and lung function will be assessed at each visits, with additional collection of biological samples and assessments of nicotine dependence, self-efficacy for cessation, and mood at week eight. Provision of complimentary ENDS will discontinue eight weeks after enrollment. Participants will complete a remote follow-up assessment sixteen weeks after enrollment. This project, and all projects at the Center for Addiction and Disease Risk Exacerbation (CADRE) are supported by the Clinical Laboratory Core (CLC) which will oversee the collection and storage of data and biological samples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electronic cigarette | Experimental | Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges. |
|
| Smoking As Usual | No Intervention | Participants in this assessment-only condition will continue smoking as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine | Other | Participants will be provided with electronic cigarettes and 5% nicotine e-liquid cartridges for 8 weeks and encouraged at weekly assessments to use the electronic cigarette any time they would normally smoke. Participants will be able to choose commercially available e-liquid flavors (tobacco) at each weekly assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cigarettes Per Day From Baseline to Week 8 and Week 16 | Past week average cigarettes per day assessed using timeline follow-back (TLFB). | Baseline, Week 8, Week 16 |
| Change in Cigarette Dependence From Baseline to Week 8 | Assessed using the Fagerstrom Test for Cigarette Dependence (FTCD). Range: 0-10; higher scores = more dependent. | Baseline, Week 8 |
| Change in Cigarette Dependence Motives From Baseline to Week 8 | Assessed using the Wisconsin Inventory for Smoking Dependence Motives - Brief (Brief-WISDM). The value of this outcome variable is the TOTAL SCORE (possible range: 1-7). The TOTAL SCORE is computed as a MEAN of all subscale scores (possible range: 1-7). Each subscale score is the mean of the relevant item scores (possible range: 1-7). Only the TOTAL SCORE is being investigated as an outcome measure. HIGHER SCORES = STRONGER dependence motive. | Baseline, Week 8 |
| Change in Asthma Symptoms From Baseline to Week 8 | Assessed using the Asthma Symptom Utility Index (ASUI). Range: 0-1 continuous; higher scores = fewer or lighter symptoms (0 = worst possible symptoms, 1 = no symptoms). | Baseline, Week 8 |
| Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Volume [FEV]) | Assessed using spirometry and indexed in liters. | Baseline, Week 8 |
| Change in Pulmonary Functioning From Baseline to Week 8 (Forced Vital Capacity [FVC]) | Assessed using spirometry and indexed in liters. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Alcohol and Addiction Studies | Providence | Rhode Island | 02903 | United States |
Deidentified study data will be made available after the completion of all study activities.
After closing the study IRB protocol and destroying all identifiers. Anticipated 2 years after completion of primary data collection. Data availability will be perpetual. Data dissemination plan is pending.
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| ID | Title | Description |
|---|---|---|
| FG000 | Electronic Cigarette | Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges. Nicotine: Participants will be provided with electronic cigarettes and 5% nicotine e-liquid cartridges for 8 weeks and encouraged at weekly assessments to use the electronic cigarette any time they would normally smoke. Participants will be able to choose commercially available e-liquid flavors (tobacco) at each weekly assessment. |
| FG001 | Smoking As Usual | Participants in this assessment-only condition will continue smoking as usual. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Electronic Cigarette | Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges. Nicotine: Participants will be provided with electronic cigarettes and 5% nicotine e-liquid cartridges for 8 weeks and encouraged at weekly assessments to use the electronic cigarette any time they would normally smoke. Participants will be able to choose commercially available e-liquid flavors (tobacco) at each weekly assessment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Cigarettes Per Day From Baseline to Week 8 and Week 16 | Past week average cigarettes per day assessed using timeline follow-back (TLFB). | 1 participant withdrew from the study between baseline and week 8 | Posted | Mean | Standard Deviation | cigarettes per day | Baseline, Week 8, Week 16 |
|
Entire 8 week experimental and 8 week follow-up period (16 weeks
Adverse changes in medical status were assessed weekly during the experimental period (baseline - wk 8) and again at the final follow-up visit (wk 16)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Electronic Cigarette | Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges. Nicotine: Participants will be provided with electronic cigarettes and 5% nicotine e-liquid cartridges for 8 weeks and encouraged at weekly assessments to use the electronic cigarette any time they would normally smoke. Participants will be able to choose commercially available e-liquid flavors (tobacco) at each weekly assessment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Irritation from e-cigarette vapor | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Irritation, including coughing, from use of an electronic nicotine delivery system |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexander Sokolovsky | Brown University | 401-863-6629 | alexander_sokolovsky@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 26, 2023 | Sep 18, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 17, 2020 | Oct 7, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D001249 | Asthma |
| D000072137 | Vaping |
| D000073865 | Cigarette Smoking |
| D040261 | Harm Reduction |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| D066300 | Electronic Nicotine Delivery Systems |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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2:1 allocation of experimental to assessment only control
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|
|
| Baseline, Week 8 |
| Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Flow 25%-75% [FEF25-75]) | Assessed using spirometry and indexed as liters per section (L/s). | Baseline, Week 8 |
| Change in Pulmonary Functioning From Baseline to Week 8 (Peak Expiratory Flow [PEF]) | Assessed using spirometry and indexed in liters per minute (L/min). | Baseline, Week 8 |
| Change in Fractional Exhaled Nitric Oxide (FENO) From Baseline to Week 8 | Level of exhaled FENO assessed with NIOX breath sensor in parts per billion (PPB). | Baseline, Week 8 |
| BG001 | Smoking As Usual | Participants in this assessment-only condition will continue smoking as usual. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| Smoking As Usual |
Participants in this assessment-only condition will continue smoking as usual. |
|
|
|
| Primary | Change in Cigarette Dependence From Baseline to Week 8 | Assessed using the Fagerstrom Test for Cigarette Dependence (FTCD). Range: 0-10; higher scores = more dependent. | 1 participant withdrew from the study between baseline and week 8 | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 8 |
|
|
|
|
| Primary | Change in Cigarette Dependence Motives From Baseline to Week 8 | Assessed using the Wisconsin Inventory for Smoking Dependence Motives - Brief (Brief-WISDM). The value of this outcome variable is the TOTAL SCORE (possible range: 1-7). The TOTAL SCORE is computed as a MEAN of all subscale scores (possible range: 1-7). Each subscale score is the mean of the relevant item scores (possible range: 1-7). Only the TOTAL SCORE is being investigated as an outcome measure. HIGHER SCORES = STRONGER dependence motive. | 1 participant withdrew from the study between baseline and week 8 | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 8 |
|
|
|
|
| Primary | Change in Asthma Symptoms From Baseline to Week 8 | Assessed using the Asthma Symptom Utility Index (ASUI). Range: 0-1 continuous; higher scores = fewer or lighter symptoms (0 = worst possible symptoms, 1 = no symptoms). | 1 participant withdrew from the study between baseline and week 8 | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 8 |
|
|
|
|
| Primary | Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Volume [FEV]) | Assessed using spirometry and indexed in liters. | 1 participant withdrew from the study between baseline and week 8 | Posted | Mean | Standard Deviation | liters | Baseline, Week 8 |
|
|
|
|
| Primary | Change in Pulmonary Functioning From Baseline to Week 8 (Forced Vital Capacity [FVC]) | Assessed using spirometry and indexed in liters. | 1 participant withdrew from the study between baseline and week 8 | Posted | Mean | Standard Deviation | liters | Baseline, Week 8 |
|
|
|
|
| Primary | Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Flow 25%-75% [FEF25-75]) | Assessed using spirometry and indexed as liters per section (L/s). | 1 participant withdrew from the study between baseline and week 8 | Posted | Mean | Standard Deviation | liters per second (L/s) | Baseline, Week 8 |
|
|
|
|
| Primary | Change in Pulmonary Functioning From Baseline to Week 8 (Peak Expiratory Flow [PEF]) | Assessed using spirometry and indexed in liters per minute (L/min). | 1 participant withdrew from the study between baseline and week 8 | Posted | Mean | Standard Deviation | liters per minute (L/min) | Baseline, Week 8 |
|
|
|
|
| Primary | Change in Fractional Exhaled Nitric Oxide (FENO) From Baseline to Week 8 | Level of exhaled FENO assessed with NIOX breath sensor in parts per billion (PPB). | 1 participant withdrew from the study between baseline and week 8 | Posted | Mean | Standard Deviation | parts per billion (PPB) | Baseline, Week 8 |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Smoking As Usual | Participants in this assessment-only condition will continue smoking as usual. | 0 | 5 | 0 | 5 | 0 | 5 |
|
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| D008171 |
| Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000073869 | Tobacco Smoking |
| D064424 | Tobacco Use |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| Week 8 |
|
|
| t-test, 2 sided |
Paired t-test |
| 1.00 |
| Mean Difference (Final Values) |
| 0 |
| 2-Sided |
| 95 |
| -2.32 |
| 2.32 |
| Superiority |
| GEE | Corstr = AR1; test of condition x time interaction | 0.44 | Slope | -0.66 | 2-Sided | Superiority |
| Week 8 |
|
|
| t-test, 2 sided |
Paired t-test |
| 0.280 |
| Mean Difference (Final Values) |
| 1.23 |
| 2-Sided |
| 95 |
| -1.50 |
| 3.95 |
| Superiority |
| GEE | Corstr = AR1; test of condition x time interaction | 0.38 | Slope | .802 | 2-Sided | Superiority |
| Week 8 |
|
|
| t-test, 2 sided |
Paired t-test |
| 0.624 |
| Mean Difference (Final Values) |
| -0.047 |
| 2-Sided |
| 95 |
| -0.291 |
| 0.198 |
| Superiority |
| GEE | Corstr = AR1; test of condition x time interaction | 0.17 | Slope | -0.15 | 2-Sided | Superiority |
| Week 8 |
|
|
| t-test, 2 sided |
Paired t-test |
| .077 |
| Mean Difference (Final Values) |
| 0.116 |
| 2-Sided |
| 95 |
| -0.020 |
| 0.252 |
| Superiority |
| GEE | Corstr = AR1; test of condition x time interaction | .149 | Slope | 0.193 | 2-Sided | Superiority |
| Week 8 |
|
|
| t-test, 2 sided |
Paired t-test |
| 0.065 |
| Mean Difference (Final Values) |
| 0.37 |
| 2-Sided |
| 95 |
| -0.036 |
| 0.78 |
| Superiority |
| GEE | Corstr = AR1; test of condition x time interaction | .006 | Slope | 0.486 | 2-Sided | Superiority |
| Week 8 |
|
|
| t-test, 2 sided |
Paired t-test |
| .107 |
| Mean Difference (Final Values) |
| -0.302 |
| 2-Sided |
| 95 |
| -0.706 |
| 0.102 |
| Superiority |
| GEE | Corstr = AR1; test of condition x time interaction | 0.19 | Slope | -0.34 | 2-Sided | Superiority |
| Week 8 |
|
|
| t-test, 2 sided |
Paired t-test |
| 0.249 |
| Mean Difference (Final Values) |
| 0.762 |
| 2-Sided |
| 95 |
| -0.81 |
| 2.33 |
| Superiority |
| GEE | Corstr = AR1; test of condition x time interaction | 0.17 | Slope | 0.857 | 2-Sided | Superiority |
| Week 8 |
|
|
Paired t-test |
| 0.522 |
| Mean Difference (Final Values) |
| 3.25 |
| 2-Sided |
| 95 |
| -11.1 |
| 17.6 |
| Superiority |
| GEE | Corstr = AR1; test of condition x time interaction | 0.781 | Slope | 1.41 | 2-Sided | Superiority |