NCT02878421

Vascular EffectS of regUlar Cigarettes Versus electronIc Cigarette USe

Vascular Effects of Regular Cigarettes Versus electronIc Cigarette Use

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: University of Dundee · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Electronic cigarettes (EC) are gaining popularity as an alternative to Traditional Cigarettes (TC). Despite not containing all the harmful substances seen in TC, EC are known to contain impurities that may have a detrimental impact on human health. The effects of ECs compared with TC on vascular function, inflammation and oxidative stress are unknown. It is increasingly recognised that nicotine itself has significant atherothrombotic effects. Therefore, clinicians are unable to confidently recommend ECs as a less risky alternative to TC. Hypothesis: Endothelial function will be improved on EC compared to TC when measured by flow mediated dilatation (FMD). Potential benefit: This study will provide further information on the potential use these devices and the risks and/or benefits associated with them, specifically in relation to vascular health.

Conditions

• Vascular Diseases

Interventions

Type	Name	Description
DEVICE	electronic cigarette + 16mg nicotine & flavor	comparison of different strengths of nicotine
OTHER	electronic cigarette + 0mg nicotine & flavor	comparison of different strengths of nicotine
OTHER	Tobacco cigarette	Participant to remain on traditional cigarettes for 28 days

Timeline

• Start date: 2016-08-18
• Primary completion: 2018-07-31
• Completion: 2018-07-31
• First posted: 2016-08-25
• Last updated: 2019-02-06

Locations

1 site across 1 country: United Kingdom