The Cardiovascular Impacts of Electronic Cigarettes in Comparison to the Use of Nicotine Replacement Patches
Condition: Smoking, Tobacco
Study type: Interventional

Summary: 
      In Scotland tobacco-related illnesses account for in excess of 56,000 hospital admissions and
      a quarter of deaths each year. The resultant financial impact on NHS Scotland is over £300
      million per annum. To minimise the clinical and financial burden of tobacco on national
      healthcare systems, Scotland's tobacco control strategy aims to create a "tobacco-free"
      generation by 2034, with the prevalence of smoking in the adult population reduced to ≤5 %.
      The multifaceted approach focuses upon tobacco prevention, protection and cessation.

      In relation to smoking cessation, the use of EC has exponentially increased since 2011, and
      EC are presently the most popular nicotine replacement product used in England. The Public
      Health England (PHE) Report published in August 2015 advocates the use of EC when other
      smoking cessation aids have failed.
    

Detailed description: 
      Tobacco smoking (TS) remains a major health challenge for people in Scotland. EC are
      presently the most popular nicotine replacement product used in England. Recently NHS Greater
      Glasgow and Clyde (NHSGGC) have, like other Health Boards and Trusts in the UK, lifted the
      ban on ECs on hospital grounds. This decision has been based on recent evidence that ECs
      appear to be less harmful when compared to TS but it is acknowledged that the short- and
      long-term sequelae of ECs remain unknown. Systematic research focusing on the effectiveness
      of ECs on cardiovascular and pulmonary phenotypes is urgently needed.

      The VAPOUR pilot study is a randomised control trial (RCT) investigating the short-term
      cardiorespiratory effects of EC in comparison to nicotine replacement patches (NRP) in
      smokers following 12 weeks of smoking cessation support with NHSGG&C Smokefree Community
      Services. We hypothesise that both EC and NRP users will experience improvements in
      cardiovascular and pulmonary function; but the effects may be less pronounced in EC users.

      The data generated from the pilot study will be invaluable for sample size and power
      estimation towards the development of a larger scale study. If the data generated from such a
      trial demonstrate that EC have short-term cardiovascular and pulmonary health effects, this
      may reduce tobacco associated morbidity and mortality, improve patient care and minimise NHS
      healthcare costs, and lead to the development of long term studies.
    

Intervention name(s): Electron Cigarette; Nicotine Replacement Patch
Intervention type(s): Device; Device
Intervention description(s): Blended Tobacco flavour, 18mg/ml; NiQuitin 21mg
Other intervention name(s): Smokemax Power e-cigarette; NiQuitin
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: E-cigarette versus nicotine replacement patches
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: electronic cigarettes; cardiovascular; nicotine replacement patches