Vascular EffectS of regUlar Cigarettes Versus electronIc Cigarette USe

Study Overview
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Brief Summary
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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 Switch to electronic cigarettes containing nicotine plus flavor 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
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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.

Official Title
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Vascular Effects of Regular Cigarettes Versus electronIc Cigarette Use

Conditions
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Vascular Diseases

Intervention / Treatment
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* Device: electronic cigarette + 16mg nicotine & flavor
* Other: electronic cigarette + 0mg nicotine & flavor
* Other: Tobacco cigarette


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tobacco cigarette<br>Intervention: tobacco cigarettes min 15/day | Other: Tobacco cigarette<br>* Participant to remain on traditional cigarettes for 28 days<br>* Other names: Traditional cigarette, any brand;|
| Active Comparator: e.cigarettes + 16mg nicotine & flavor<br>Intervention: One flavoured electronic cigarette 16mg nicotine/day | Device: electronic cigarette + 16mg nicotine & flavor<br>* comparison of different strengths of nicotine<br>* Other names: e.cigarette;|
| Active Comparator: e.cigarettes + 0mg nicotine & flavour<br>Intervention: One electronic cigarette with flavour +0mg nicotine/day | Other: electronic cigarette + 0mg nicotine & flavor<br>* comparison of different strengths of nicotine<br>* Other names: e.cigarette;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Flow mediated Dilation (FMD) between the TC group and the EC-nicotine and EC-nicotine free groups |  | Baseline and 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FMD between EC-nicotine and EC-nicotine free groups |  | Baseline and 1 month | 
| Change in FMD between TC and EC groups combined |  | Baseline and 1 month | 
| Change in oxidised LDL between the TC, EC-nicotine free and EC-nicotine groups |  | Baseline and 1 month | 
| Change in PAI-1 between the TC, EC-nicotine free and EC-nicotine groups |  | Baseline and 1 month | 
| Change in hs-CRP between the TC, EC-nicotine free and EC-nicotine groups |  | Baseline and 1 month | 
| Change in Pulse Wave Velocity between the TC group and the EC-nicotine free groups. |  | Baseline and 1 month | 
| Change in tPA between the TC, EC-nicotine free and EC-nicotine groups |  | Baseline and 1 month | 
| Change in Augmentation Index@75bpm between the TC group,EC-nicotine and the EC-nicotine free groups |  | Baseline and 1 month |