Understanding the Impact of Cartridge-Based Electronic Cigarettes and Generated Aerosols on Cardiopulmonary Health

Virginia Commonwealth University (VCU)

Status and phase: Completed; Early Phase 1

Conditions: E-Cig Use

Treatments: Drug: Tobacco flavored liquid type 1; Drug: Tobacco flavored liquid type 2

Study type: Interventional

Funder types: Other

Identifiers

NCT05199480

HM20022776

Details and patient eligibility

About

Over the last decade, e-cigarettes have become increasingly popular, due to their promotion as a healthy alternative to traditional tobacco cigarettes. However, there are large discrepancies of knowledge in understanding how these e-cigarettes affect the user's health. The overall goal of this study is to evaluate the impact of e-cigarettes usage on user's cardiopulmonary health

Enrollment: 4 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

E-Cigarette group:

• 21 years of age or older
• Used e-cigarettes (≥3 times/week for ≥3 months)

Non e-cigarette group

● 21 years of age or older

Exclusion criteria

• 20 years old and younger
• Use of cigarettes for 15 days or more in the past 60 days
• Use of other tobacco products (cigars, hookah, smokeless) weekly or more frequently in the past 60 days
• Use of marijuana or any illicit or prescription drugs for non-medical use weekly or more frequently in the past 60 days
• Known allergy to propylene glycol or vegetable glycerin
• Evidence of cardiovascular, pulmonary, renal, hepatic, metabolic, or cerebral diseases
• Disorder or use of medication that affects cardiopulmonary health
• Evidence of pregnancy or current nursing

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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4 participants in 3 patient groups

E-cigarette liquid type 1

Experimental group

Description:

Participants will be instructed to use at least one study product daily in place of their own e-cigarettes during the intervention period.

Treatment:

Drug: Tobacco flavored liquid type 1

E-cigarettes liquid type 2

Active Comparator group

Description:

Participants will be instructed to use at least one study product daily in place of their own e-cigarettes during the intervention period.

Treatment:

Drug: Tobacco flavored liquid type 2

No e-cigarettes

No Intervention group

Description:

No e-cigarette use