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| ID | Type | Description | Link |
|---|---|---|---|
| U54DA036114-07 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to compare the effects of e-cigarettes and continued smoking on pulmonary and cardiac outcomes in a population with established pulmonary disease.
E-cigarettes with nicotine can affect important cardiopulmonary outcomes and likely pose less risk than cigarettes, but they are not harmless. Given the existing literature, there is a need for controlled trials of e-cigarette use in populations with cardiopulmonary disease to fill the gaps between these existing examinations. Clarifying how the pulmonary and cardiac effects of e-cigarettes compare to use of conventional cigarettes in those with cardiopulmonary disease beyond single acute exposures will provide important new health information that can help inform policy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combustible Cigarette | No Intervention | Participants in this arm will smoke their usual brand of combustible cigarettes for two weeks. | |
| E-Cigarette | Experimental | Participants in this arm will smoke electronic cigarettes for two weeks. E-cigarettes (either JUUL or Vuse Alto) and pods (JUUL: Virginia tobacco flavor at 3% or 5% nicotine concentration; Vuse Alto: golden tobacco flavor at 1.8%, 2.4%, or 5% nicotine concentration) will be provided. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-Cigarette | Other | Altering the availability of e-cigarettes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline FEV1/FVC Ratio | Ratio of the amount of air forced from the lungs in one second (Forced Expiratory Volume in the First Second; FEV1) to the amount of air forced from the lungs throughout an entire measurement (Forced Vital Capacity; FVC), as assessed via spirometry | Intake assessment |
| Change from Baseline FEV1/FVC Ratio each day | Ratio of the amount of air forced from the lungs in one second (Forced Expiratory Volume in the First Second; FEV1) to the amount of air forced from the lungs throughout an entire measurement (Forced Vital Capacity; FVC), as assessed via spirometry | Daily through study completion, an average of 4 weeks |
| Change from Baseline FEV1/FVC Ratio at 2 weeks | Ratio of the amount of air forced from the lungs in one second (Forced Expiratory Volume in the First Second; FEV1) to the amount of air forced from the lungs throughout an entire measurement (Forced Vital Capacity; FVC), as assessed via spirometry | Assessment completed 2 weeks after intake assessment |
| Change from Baseline FEV1/FVC Ratio at 4 weeks | Ratio of the amount of air forced from the lungs in one second (Forced Expiratory Volume in the First Second; FEV1) to the amount of air forced from the lungs throughout an entire measurement (Forced Vital Capacity; FVC), as assessed via spirometry | Assessment completed 4 weeks after intake assessment |
| Baseline Lung Reactance at 5Hz (X5) | Measurement of the ability of the lung to store energy, as measured by oscillometry | Intake assessment |
| Change from Baseline Lung Reactance at 5Hz (X5) at 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Blood Pressure | Force exerted by blood against the walls of the arteries | Intake assessment |
| Change from Baseline Blood Pressure each day | Force exerted by blood against the walls of the arteries |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Carbon Monoxide (CO) | Amount of carbon monoxide in the breath | Intake assessment |
| Change from Baseline Carbon Monoxide (CO) each day | Amount of carbon monoxide in the breath |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diann E Gaalema, PhD | University of Vermont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vermont Center on Behavior and Health | Burlington | Vermont | 05401 | United States |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D029481 | Bronchitis, Chronic |
| D004646 | Emphysema |
| D000080445 | Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D066300 | Electronic Nicotine Delivery Systems |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| Financial Incentives |
| Behavioral |
Altering the availability of financial incentives for abstaining from combustible cigarettes |
|
Measurement of the ability of the lung to store energy, as measured by oscillometry |
| Assessment completed 2 weeks after intake assessment |
| Change from Baseline Lung Reactance at 5Hz (X5) at 4 weeks | Measurement of the ability of the lung to store energy, as measured by oscillometry | Assessment completed 4 weeks after intake assessment |
| Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) | Airway impedence in the lungs as measured by oscillometry | Intake assessment |
| Change from Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) at 2 weeks | Airway impedence in the lungs as measured by oscillometry | Assessment completed 2 weeks after intake assessment |
| Change from Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) at 4 weeks | Airway impedence in the lungs as measured by oscillometry | Assessment completed 4 weeks after intake assessment |
| Baseline Oxygen Saturation (SpO2) | Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry | Intake assessment |
| Change from Baseline Oxygen Saturation (SpO2) each day | Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry | Daily through study completion, an average of 4 weeks |
| Change from Baseline Oxygen Saturation (SpO2) at 2 weeks | Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry | Assessment completed 2 weeks after intake assessment |
| Change from Baseline Oxygen Saturation (SpO2) at 4 weeks | Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry | Assessment completed 4 weeks after intake assessment |
| Baseline Fractional Exhaled Nitric Oxide (FeNO) | Amount of nitric oxide in the breath | Intake assessment |
| Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 2 weeks | Amount of nitric oxide in the breath | Assessment completed 2 weeks after intake assessment |
| Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 4 weeks | Amount of nitric oxide in the breath | Assessment completed 4 weeks after intake assessment |
| Baseline COPD Assessment Test Score | Score measuring the impact of COPD on an individual's life; scale of 0-40; higher score indicates worse outcome | Intake assessment |
| Change from Baseline COPD Assessment Test Score at 2 weeks | Score measuring the impact of COPD on an individual's life; scale of 0-40; higher score indicates worse outcome | Assessment completed 2 weeks after intake assessment |
| Change from Baseline COPD Assessment Test Score at 4 weeks | Score measuring the impact of COPD on an individual's life; scale of 0-40; higher score indicates worse outcome | Assessment completed 4 weeks after intake assessment |
| Baseline St. George's Respiratory Questionnaire for COPD Patients Score | Score measuring the impact of COPD on overall health, daily life, and perceived well-being; scale of 0-100; higher scores indicate more limitations on overall health | Intake assessment |
| Change from Baseline St. George's Respiratory Questionnaire for COPD Patients Score at 2 weeks | Score measuring the impact of COPD on overall health, daily life, and perceived well-being; scale of 0-100; higher scores indicate more limitations on overall health | Assessment completed 2 weeks after intake assessment |
| Change from Baseline St. George's Respiratory Questionnaire for COPD Patients Score at 4 weeks | Score measuring the impact of COPD on overall health, daily life, and perceived well-being; scale of 0-100; higher scores indicate more limitations on overall health | Assessment completed 4 weeks after intake assessment |
| Daily through study completion, an average of 4 weeks |
| Change from Baseline Blood Pressure at 2 weeks | Force exerted by blood against the walls of the arteries | Assessment completed 2 weeks after intake assessment |
| Change from Baseline Blood Pressure at 4 weeks | Force exerted by blood against the walls of the arteries | Assessment completed 4 weeks after intake assessment |
| Baseline Heart Rate | Number of time the heart beats per minute | Intake assessment |
| Change from Baseline Heart Rate each day | Number of time the heart beats per minute | Daily through study completion, an average of 4 weeks |
| Change From Baseline Heart Rate at 2 weeks | Number of time the heart beats per minute | Assessment completed 2 weeks after intake assessment |
| Change From Baseline Heart Rate at 4 weeks | Number of time the heart beats per minute | Assessment completed 4 weeks after intake assessment |
| Daily through study completion, an average of 4 weeks |
| Change from Baseline Carbon Monoxide (CO) at 2 weeks | Amount of carbon monoxide in the breath | Assessment completed 2 weeks after intake assessment |
| Change from Baseline Carbon Monoxide (CO) at 4 weeks | Amount of carbon monoxide in the breath | Assessment completed 4 weeks after intake assessment |
| Baseline Tobacco Use Questionnaire | Assess tobacco use history | Intake assessment |
| Baseline Fagerstrom Test of Nicotine Dependence (FTND) | Survey assessing addiction to nicotine | Intake assessment |
| Baseline Wisconsin Inventory of Smoking Dependence Motives - Brief (WISDM-Brief) | Survey assessing smoking dependence | Intake assessment |
| Baseline Minnesota Tobacco Withdrawal Scale (MNWS) | Evaluates effects of smoking cessation; scale of 0-60; higher scores are a worse outcome | Intake assessment |
| Change from Baseline Minnesota Tobacco Withdrawal Scale (MNWS) at 2 weeks | Evaluates effects of smoking cessation; scale of 0-60; higher scores are a worse outcome | Assessment completed 2 weeks after intake assessment |
| Change from Baseline Minnesota Tobacco Withdrawal Scale (MNWS) at 4 weeks | Evaluates effects of smoking cessation; scale of 0-60; higher scores are a worse outcome | Assessment completed 4 weeks after intake assessment |
| Baseline Questionnaire on Smoking Urges-Brief (QSU-Brief) | Assesses smoking urges; scale of 10-70; higher scores indicate greater urge to smoke | Intake assessment |
| Change from Baseline Questionnaire on Smoking Urges-Brief (QSU-Brief) at 2 weeks | Assesses smoking urges; scale of 10-70; higher scores indicate greater urge to smoke | Assessment completed 2 weeks after intake assessment |
| Change from Baseline Questionnaire on Smoking Urges-Brief (QSU-Brief) at 4 weeks | Assesses smoking urges; scale of 10-70; higher scores indicate greater urge to smoke | Assessment completed 4 weeks after intake assessment |
| Daily Tobacco Use Questionnaire | Measure tobacco use (cigarettes, e-cigarettes, smokeless tobacco) on a daily basis; | Daily during each two-week arm of the study |
| Health Changes Questionnaire at 2 week assessment | Assesses how health has changed since previous visit; 4 yes/no questions about whether there have been any changes in physical/mental health, changes in medications, access to medical care, or changes in normal routine in the last 24 hours; 1 question rating overall health on a scale of 1 to 10 with 10 being the best | Assessment completed 2 weeks after intake assessment |
| Health Changes Questionnaire at 4 week assessment | Assesses how health has changed since previous visit; 4 yes/no questions about whether there have been any changes in physical/mental health, changes in medications, access to medical care, or changes in normal routine in the last 24 hours; 1 question rating overall health on a scale of 1 to 10 with 10 being the best | Assessment completed 4 weeks after intake assessment |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D001249 | Asthma |
| D012130 | Respiratory Hypersensitivity |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012907 | Smoking |
| D001519 | Behavior |