NCT05199480.

Study name	Understanding the impact of cartridge‐based electronic cigarettes and generated aerosols on cardiopulmonary health
Methods	RCT Virginia Commonwealth University, USA
Participants	Estimated enrolment: 57 Inclusion criteria: E‐cigarette group: ≥ 21 yrs; used EC (≥ 3 times/week for ≥ 3 months) Non‐e‐cigarette group: ≥ 21 yrs Exclusion criteria: 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; 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; pregnancy/breastfeeding
Interventions	EC: commercially available cartridge‐based EC device Arm 1: E‐cigarette liquid type 1  A commercially available cartridge‐based device with tobacco flavoured liquid. Participants will be instructed to use at least one study product daily in place of their own e‐cigarettes during the intervention period. Arm 2: E‐cigarettes liquid type 2 A commercially available cartridge‐based device with tobacco flavoured liquid. Participants will be instructed to use at least one study product daily in place of their own e‐cigarettes during the intervention period. Arm 3: No e‐cigarettes. No e‐cigarette use
Outcomes	Baseline, 2 weeks Change in peak oxygen consumption (VO2 peak)  Change in expiratory volume Change in skeletal muscle O2 utilization  Change in maximal microvascular dilation
Starting date	Study start date: January 10 2022. Estimated completion date: May 2023
Contact information	Paula Rodriguez Miguelez, PhD804‐396‐4498, prodriguezmig@vcu.edu
Notes	New to 2022 update