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OpenTrials
Completed

NCT Number: NCT02878421

Vascular EffectS of regUlar Cigarettes Versus electronIc Cigarette USe

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Dundee

Dundee, Tayside, DD1 9SY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years and over
  • Currently smoking ≥15 full strength tobacco cigarettes per day for at least 2 years, or roll-up tobacco equivalent (cigar or pipe smokers not included).
  • Willing to stop tobacco cigarettes for period of study if required
  • Willing not to use electronic cigarettes if required
  • Able to give informed consent

Exclusion criteria

  • Pregnant or lactating.
  • Women of childbearing potential who do not abstain from sex or use effective contraception.
  • On current prescribed medication for cardiovascular disease.
  • History of cardiovascular disease (excluding hypertension), diabetes, active malignance or chronic renal disease.
  • Nut allergy
  • Participation in another clinical trial (other than observational trials and registries) with an investigational product and/or intervention within 30 days before visit 1.

Treatment and study plan

electronic cigarette + 16mg nicotine & flavor

Device

comparison of different strengths of nicotine

Other names: vapourlites, e.cigarette

electronic cigarette + 0mg nicotine & flavor

Other

comparison of different strengths of nicotine

Other names: vapourlites, e.cigarette

Tobacco Cigarette

Other

Participant to remain on traditional cigarettes for 28 days

Other names: Traditional cigarette, any brand

Primary outcomes

  1. Change in Flow mediated Dilation (FMD) between the TC group and the EC-nicotine and EC-nicotine free groups

    Time frame: Baseline and 1 month

Secondary outcomes

  1. Change in FMD between EC-nicotine and EC-nicotine free groups

    Time frame: Baseline and 1 month

  2. Change in FMD between TC and EC groups combined

    Time frame: Baseline and 1 month

  3. Change in oxidised LDL between the TC, EC-nicotine free and EC-nicotine groups

    Time frame: Baseline and 1 month

  4. Change in PAI-1 between the TC, EC-nicotine free and EC-nicotine groups

    Time frame: Baseline and 1 month

  5. Change in hs-CRP between the TC, EC-nicotine free and EC-nicotine groups

    Time frame: Baseline and 1 month

  6. Change in Pulse Wave Velocity between the TC group and the EC-nicotine free groups.

    Time frame: Baseline and 1 month

  7. Change in tPA between the TC, EC-nicotine free and EC-nicotine groups

    Time frame: Baseline and 1 month

  8. Change in Augmentation Index@75bpm between the TC group,EC-nicotine and the EC-nicotine free groups

    Time frame: Baseline and 1 month

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Collaborators

  • British Heart Foundation
  • NHS Tayside

Registry information

Acronym: VESUVIUS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 25, 2016
Registry last updated
Feb 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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