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Trial record 1 of 1 for:    NCT02878421
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Vascular EffectS of regUlar Cigarettes Versus electronIc Cigarette USe (VESUVIUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02878421
Recruitment Status : Completed
First Posted : August 25, 2016
Last Update Posted : February 6, 2019
Sponsor:
Collaborators:
NHS Tayside
British Heart Foundation
Information provided by (Responsible Party):
Professor. Jacob George, University of Dundee

Brief 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

Condition or disease Intervention/treatment Phase
Vascular Diseases Device: electronic cigarette + 16mg nicotine & flavor Other: electronic cigarette + 0mg nicotine & flavor Other: Tobacco cigarette Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Vascular Effects of Regular Cigarettes Versus electronIc Cigarette Use
Actual Study Start Date : August 18, 2016
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Active Comparator: tobacco cigarette
Intervention: tobacco cigarettes min 15/day
Other: Tobacco cigarette
Participant to remain on traditional cigarettes for 28 days
Other Name: Traditional cigarette, any brand

Active Comparator: e.cigarettes + 16mg nicotine & flavor
Intervention: One flavoured electronic cigarette 16mg nicotine/day
Device: electronic cigarette + 16mg nicotine & flavor
comparison of different strengths of nicotine
Other Names:
  • vapourlites
  • e.cigarette

Active Comparator: e.cigarettes + 0mg nicotine & flavour
Intervention: One electronic cigarette with flavour +0mg nicotine/day
Other: electronic cigarette + 0mg nicotine & flavor
comparison of different strengths of nicotine
Other Names:
  • vapourlites
  • e.cigarette




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02878421


Locations
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United Kingdom
University of Dundee
Dundee, Tayside, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
NHS Tayside
British Heart Foundation
Investigators
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Principal Investigator: Jacob George University of Dundee
  Study Documents (Full-Text)

Documents provided by Professor. Jacob George, University of Dundee:
Study Protocol  [PDF] May 8, 2018
Statistical Analysis Plan  [PDF] September 24, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor. Jacob George, Professor, University of Dundee
ClinicalTrials.gov Identifier: NCT02878421    
Other Study ID Numbers: 2014CV10
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action