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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-28

Study Completion Date

2023-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease Chronic Bronchitis Emphysema Asthma-COPD Overlap Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Combustible Cigarette

Participants in this arm will smoke their usual brand of combustible cigarettes for two weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

E-Cigarette

Intervention Type OTHER

Altering the availability of e-cigarettes

Financial Incentives

Intervention Type BEHAVIORAL

Altering the availability of financial incentives for abstaining from combustible cigarettes

Interventions

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E-Cigarette

Altering the availability of e-cigarettes

Intervention Type OTHER

Financial Incentives

Altering the availability of financial incentives for abstaining from combustible cigarettes

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No