Nicotine exposure profile, subjective and behavioral effects of P4M3

• Research type

  Research Study

• Full title

  A single-center, single-sequence, concentration-ranging study to investigate the nicotine exposure profile and subjective and behavioral effects of P4M3 in healthy, adult experienced users of electronic cigarettes

• IRAS ID

  216508

• Sponsor organisation

  Phillip Morris Products S.A

• Duration of Study in the UK

  0 years, 1 months, 28 days

• Research summary

  It is widely recognized that the newer-generations of e-cigarettes have become more efficient in delivering nicotine compared to earlier generation products but still fail to appeal to smokers in terms of the speed of nicotine delivery compared to conventional cigarettes. The goal of this study will be to evaluate plasma nicotine concentrations, subjective and behavioral effects of smoking, and topography parameters (puff volume, number of puffs and puff duration) of an e-cigarette with four liquids of various nicotine levels. The study will be performed in experienced e-cigarette users following a single-use experience with fixed puffing and after ad libitum use of P4M3 (Platform 4 Mesh Heater Version 3) over a 60 minute period.
  To investigate this, 16 healthy male and female subjects aged between 19-65 years who have used e-cigarettes daily for at least 1 month prior to the screening visit will be enrolled into this study which will be conducted at one UK site.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  16/SC/0605

• Date of REC Opinion

  21 Nov 2016

• REC opinion

  Unfavourable Opinion