Pulmonary and Cardiac Effects of E-Cigarette Use in Pulmonary Patients Who Smoke Cigarettes

• ClinicalTrials.gov Identifier: NCT05610514
• Recruitment Status: Recruiting
• First Posted: November 9, 2022
• Last Update Posted: November 9, 2022
• Sponsor: University of Vermont
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Diann Gaalema, University of Vermont

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Chronic Obstructive Pulmonary Disease; Chronic Bronchitis; Emphysema; Asthma-COPD Overlap Syndrome	Other: E-Cigarette; Behavioral: Financial Incentives	Phase 2

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Pulmonary and Cardiac Effects of E-Cigarette Use in Pulmonary Patients Who Smoke Cigarettes
• Actual Study Start Date: April 28, 2022
• Estimated Primary Completion Date: April 2023
• Estimated Study Completion Date: April 2023

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Combustible Cigarette; Participants in this arm will smoke their usual brand of combustible cigarettes for two weeks.
Experimental: E-Cigarette; 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.	Other: E-Cigarette; Altering the availability of e-cigarettes; Behavioral: Financial Incentives; Altering the availability of financial incentives for abstaining from combustible cigarettes

Outcome Measures

Primary Outcome Measures :

1. Baseline FEV1/FVC Ratio [ Time Frame: Intake assessment ]
   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
2. Change from Baseline FEV1/FVC Ratio each day [ Time Frame: Daily through study completion, an average of 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
3. Change from Baseline FEV1/FVC Ratio at 2 weeks [ Time Frame: Assessment completed 2 weeks after intake assessment ]
   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
4. Change from Baseline FEV1/FVC Ratio at 4 weeks [ Time Frame: Assessment completed 4 weeks after intake assessment ]
   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
5. Baseline Lung Reactance at 5Hz (X5) [ Time Frame: Intake assessment ]
   Measurement of the ability of the lung to store energy, as measured by oscillometry
6. Change from Baseline Lung Reactance at 5Hz (X5) at 2 weeks [ Time Frame: Assessment completed 2 weeks after intake assessment ]
   Measurement of the ability of the lung to store energy, as measured by oscillometry
7. Change from Baseline Lung Reactance at 5Hz (X5) at 4 weeks [ Time Frame: Assessment completed 4 weeks after intake assessment ]
   Measurement of the ability of the lung to store energy, as measured by oscillometry
8. Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) [ Time Frame: Intake assessment ]
   Airway impedence in the lungs as measured by oscillometry
9. Change from Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) at 2 weeks [ Time Frame: Assessment completed 2 weeks after intake assessment ]
   Airway impedence in the lungs as measured by oscillometry
10. Change from Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) at 4 weeks [ Time Frame: Assessment completed 4 weeks after intake assessment ]
    Airway impedence in the lungs as measured by oscillometry
11. Baseline Oxygen Saturation (SpO2) [ Time Frame: Intake assessment ]
    Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry
12. Change from Baseline Oxygen Saturation (SpO2) each day [ Time Frame: Daily through study completion, an average of 4 weeks ]
    Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry
13. Change from Baseline Oxygen Saturation (SpO2) at 2 weeks [ Time Frame: Assessment completed 2 weeks after intake assessment ]
    Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry
14. Change from Baseline Oxygen Saturation (SpO2) at 4 weeks [ Time Frame: Assessment completed 4 weeks after intake assessment ]
    Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry
15. Baseline Fractional Exhaled Nitric Oxide (FeNO) [ Time Frame: Intake assessment ]
    Amount of nitric oxide in the breath
16. Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 2 weeks [ Time Frame: Assessment completed 2 weeks after intake assessment ]
    Amount of nitric oxide in the breath
17. Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 4 weeks [ Time Frame: Assessment completed 4 weeks after intake assessment ]
    Amount of nitric oxide in the breath
18. Baseline COPD Assessment Test Score [ Time Frame: Intake assessment ]
    Score measuring the impact of COPD on an individual's life; scale of 0-40; higher score indicates worse outcome
19. Change from Baseline COPD Assessment Test Score at 2 weeks [ Time Frame: Assessment completed 2 weeks after intake assessment ]
    Score measuring the impact of COPD on an individual's life; scale of 0-40; higher score indicates worse outcome
20. Change from Baseline COPD Assessment Test Score at 4 weeks [ Time Frame: Assessment completed 4 weeks after intake assessment ]
    Score measuring the impact of COPD on an individual's life; scale of 0-40; higher score indicates worse outcome
21. Baseline St. George's Respiratory Questionnaire for COPD Patients Score [ Time Frame: Intake assessment ]
    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
22. Change from Baseline St. George's Respiratory Questionnaire for COPD Patients Score at 2 weeks [ Time Frame: Assessment completed 2 weeks after intake assessment ]
    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
23. Change from Baseline St. George's Respiratory Questionnaire for COPD Patients Score at 4 weeks [ Time Frame: Assessment completed 4 weeks after intake assessment ]
    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

Secondary Outcome Measures :

1. Baseline Blood Pressure [ Time Frame: Intake assessment ]
   Force exerted by blood against the walls of the arteries
2. Change from Baseline Blood Pressure each day [ Time Frame: Daily through study completion, an average of 4 weeks ]
   Force exerted by blood against the walls of the arteries
3. Change from Baseline Blood Pressure at 2 weeks [ Time Frame: Assessment completed 2 weeks after intake assessment ]
   Force exerted by blood against the walls of the arteries
4. Change from Baseline Blood Pressure at 4 weeks [ Time Frame: Assessment completed 4 weeks after intake assessment ]
   Force exerted by blood against the walls of the arteries
5. Baseline Heart Rate [ Time Frame: Intake assessment ]
   Number of time the heart beats per minute
6. Change from Baseline Heart Rate each day [ Time Frame: Daily through study completion, an average of 4 weeks ]
   Number of time the heart beats per minute
7. Change From Baseline Heart Rate at 2 weeks [ Time Frame: Assessment completed 2 weeks after intake assessment ]
   Number of time the heart beats per minute
8. Change From Baseline Heart Rate at 4 weeks [ Time Frame: Assessment completed 4 weeks after intake assessment ]
   Number of time the heart beats per minute

Other Outcome Measures:

1. Baseline Carbon Monoxide (CO) [ Time Frame: Intake assessment ]
   Amount of carbon monoxide in the breath
2. Change from Baseline Carbon Monoxide (CO) each day [ Time Frame: Daily through study completion, an average of 4 weeks ]
   Amount of carbon monoxide in the breath
3. Change from Baseline Carbon Monoxide (CO) at 2 weeks [ Time Frame: Assessment completed 2 weeks after intake assessment ]
   Amount of carbon monoxide in the breath
4. Change from Baseline Carbon Monoxide (CO) at 4 weeks [ Time Frame: Assessment completed 4 weeks after intake assessment ]
   Amount of carbon monoxide in the breath
5. Baseline Tobacco Use Questionnaire [ Time Frame: Intake assessment ]
   Assess tobacco use history
6. Baseline Fagerstrom Test of Nicotine Dependence (FTND) [ Time Frame: Intake assessment ]
   Survey assessing addiction to nicotine
7. Baseline Wisconsin Inventory of Smoking Dependence Motives - Brief (WISDM-Brief) [ Time Frame: Intake assessment ]
   Survey assessing smoking dependence
8. Baseline Minnesota Tobacco Withdrawal Scale (MNWS) [ Time Frame: Intake assessment ]
   Evaluates effects of smoking cessation; scale of 0-60; higher scores are a worse outcome
9. Change from Baseline Minnesota Tobacco Withdrawal Scale (MNWS) at 2 weeks [ Time Frame: Assessment completed 2 weeks after intake assessment ]
   Evaluates effects of smoking cessation; scale of 0-60; higher scores are a worse outcome
10. Change from Baseline Minnesota Tobacco Withdrawal Scale (MNWS) at 4 weeks [ Time Frame: Assessment completed 4 weeks after intake assessment ]
    Evaluates effects of smoking cessation; scale of 0-60; higher scores are a worse outcome
11. Baseline Questionnaire on Smoking Urges-Brief (QSU-Brief) [ Time Frame: Intake assessment ]
    Assesses smoking urges; scale of 10-70; higher scores indicate greater urge to smoke
12. Change from Baseline Questionnaire on Smoking Urges-Brief (QSU-Brief) at 2 weeks [ Time Frame: Assessment completed 2 weeks after intake assessment ]
    Assesses smoking urges; scale of 10-70; higher scores indicate greater urge to smoke
13. Change from Baseline Questionnaire on Smoking Urges-Brief (QSU-Brief) at 4 weeks [ Time Frame: Assessment completed 4 weeks after intake assessment ]
    Assesses smoking urges; scale of 10-70; higher scores indicate greater urge to smoke
14. Daily Tobacco Use Questionnaire [ Time Frame: Daily during each two-week arm of the study ]
    Measure tobacco use (cigarettes, e-cigarettes, smokeless tobacco) on a daily basis;
15. Health Changes Questionnaire at 2 week assessment [ Time Frame: Assessment completed 2 weeks after intake 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
16. Health Changes Questionnaire at 4 week assessment [ Time Frame: Assessment completed 4 weeks after intake 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

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Men and women 40 years of age or older
• Current, every day smoker (5 or more cigarettes per day for one year or longer) confirmed with intake CO of 8ppm or greater
• Established pulmonary disease (chronic obstructive pulmonary disease [COPD], chronic bronchitis, emphysema, or asthma-COPD overlap syndrome) confirmed by physician diagnosis and/or current prescription of medication for treatment (i.e., LABA, LAMA, +/- ICS, or combination)
• Lives and plans to remain in the greater Burlington, VT area for the next month
• No intention to quit smoking within the next month
• Speaks English

Exclusion Criteria:

• Patients who are medically unstable (unstable symptoms, changes in medications or hospitalizations within last 3 months)
• Inability to conduct in-home measurements.

Contacts and Locations

Contacts

Contact: Brian R Katz, PhD; 8025511798; Brian.Katz@uvm.edu

Contact: Shannon O'connor; 8025511798; shannon.oconnor@uvm.edu

Locations

United States, Vermont

Vermont Center on Behavior and Health; Recruiting

Burlington, Vermont, United States, 05401

Contact: Brian R Katz, PhD 802-551-1798 brian.katz@uvm.edu

Contact: Shannon O'connor 8025511798 shannon.oconnor@uvm.edu

Principal Investigator: Diann E Gaalema, PhD

Sponsors and Collaborators

University of Vermont

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Diann E Gaalema, PhD; University of Vermont

More Information

• Responsible Party: Diann Gaalema, Associate Professor, Department of Psychiatry, University of Vermont
• ClinicalTrials.gov Identifier: NCT05610514
• Other Study ID Numbers: STUDY00000511; U54DA036114-07 ( U.S. NIH Grant/Contract )
• First Posted: November 9, 2022
• Last Update Posted: November 9, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Diann Gaalema, University of Vermont:

chronic obstructive pulmonary disease; pulmonary; cardiac; cigarettes; e-cigarettes; smokers

Additional relevant MeSH terms:

Bronchitis; Bronchitis, Chronic; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome; Emphysema; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Respiratory Tract Infections; Infections; Bronchial Diseases; Asthma; Respiratory Hypersensitivity; Hypersensitivity; Immune System Diseases