NCT02878421: VESUVIUS

Vascular EffectS of regUlar Cigarettes Versus electronIc Cigarette USe

Completed NA Last updated 6 February 2019

What this trial tests

NA trial testing electronic cigarette + 16mg nicotine & flavor in Vascular Diseases in 145 participants. Completed in 31 July 2018.

Timeline

18 August 2016

Primary endpoint
31 July 2018

31 July 2018

Quick facts

Lead sponsor	University of Dundee
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	145
Start date	18 August 2016
Primary completion	31 July 2018
Estimated completion	31 July 2018
Sites	1 location across United Kingdom

Drugs / interventions tested

• electronic cigarette + 16mg nicotine & flavor
• electronic cigarette + 0mg nicotine & flavor
• Tobacco cigarette

Conditions studied

• Vascular Diseases — all drugs for Vascular Diseases →

Sponsor

University of Dundee

Who can join

18 and older, any sex, with Vascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to assess the effects of electronic cigarettes-nicotine and electronic cigarette-nicotine free on endothelial function as compared to traditional cigarettes. Due to ethical reasons, we cannot fully randomise all particpants to the three arms.

Participants who wish to quit smoking will be randomized to

1. Switch to electronic cigarettes containing nicotine plus flavor
2. Switch to electronic cigarettes containing flavor alone Those who do not wish to quit smoking will continue on the Tobacco Cigarette arm Treatment period will be 28 days

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cardiovascular Effects of Switching From Tobacco Cigarettes to Electronic Cigarettes.
   George J, Hussain M, Vadiveloo T, Ireland S, et al · · 2019 · cited 153× · PMID 31740017 · DOI 10.1016/j.jacc.2019.09.067