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

University of Vermont

Status and phase: Completed; Phase 2

Conditions: Asthma-COPD Overlap Syndrome; Chronic Bronchitis; Chronic Obstructive Pulmonary Disease; Emphysema

Treatments: Other: E-Cigarette; Behavioral: Financial Incentives

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05610514

STUDY00000511

U54DA036114-07 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Combustible Cigarette

No Intervention group

Description:

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

E-Cigarette

Experimental group

Description:

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.

Treatment:

Behavioral: Financial Incentives

Other: E-Cigarette