PMID- 26702788
OWN - NLM
STAT- MEDLINE
DCOM- 20161021
LR  - 20171116
IS  - 1096-0295 (Electronic)
IS  - 0273-2300 (Linking)
VI  - 74
DP  - 2016 Feb
TI  - A randomised, crossover study on an electronic vapour product, a nicotine 
      inhalator and a conventional cigarette. Part B: Safety and subjective effects.
PG  - 193-9
LID - S0273-2300(15)30139-2 [pii]
LID - 10.1016/j.yrtph.2015.12.004 [doi]
AB  - An Electronic Vapour Product (EVP) has been evaluated for short-term safety 
      parameters and subjective effects in a 2-part study, in smokers. Part 1 compared 
      the EVP with unflavoured (UF) and flavoured (FL) e-liquid at 2.0% nicotine to a 
      conventional cigarette (CC; JPS Silver King Size, 0.6 mg) and a licensed nicotine 
      inhalator (Nicorette((R)), 15 mg). Part 2 assessed the effect of increasing 
      concentrations of nicotine in the e-liquid used with the EVP (0%, 0.4%, 0.9%, 
      2.0%). The study was designed as a randomised, controlled, crossover trial. 
      Outcomes included adverse events (AEs), vital signs, exhaled carbon monoxide 
      (CO), clinical laboratory parameters, smoking urges and withdrawal symptoms. In 
      both study parts, only mild non-serious AEs were reported. No major differences 
      were observed in AEs between the EVPs and Nicorette((R)). Exhaled CO levels only 
      increased for CC. All products appeared to decrease smoking urges and nicotine 
      withdrawal symptom scores to a similar extent. The EVP had a similar short-term 
      safety profile to Nicorette((R)) and relieved smoking urges and nicotine withdrawal 
      symptoms to a similar extent as Nicorette((R)) and CC. Unlike nicotine replacement 
      therapies, the EVP may offer an alternative for those finding it difficult to 
      quit the behavioural and sensorial aspects of smoking.
CI  - Copyright (c) 2015 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Walele, Tanvir
AU  - Walele T
AD  - Fontem Ventures, Barbara Strozzilaan 101, 1083 HN Amsterdam, Netherlands. 
      Electronic address: tanvir.walele@fontemventures.com.
FAU - Sharma, Girish
AU  - Sharma G
AD  - Simbec Research, Merthyr Tydfil, CF48 4DR, UK.
FAU - Savioz, Rebecca
AU  - Savioz R
AD  - Clinopsis S.A., Jardins 6, Concise 1426, Switzerland.
FAU - Martin, Claire
AU  - Martin C
AD  - Clinopsis S.A., Jardins 6, Concise 1426, Switzerland.
FAU - Williams, Josie
AU  - Williams J
AD  - Imperial Tobacco, Product Science, 121 Winterstoke Road, Bristol, UK.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20151215
PL  - Netherlands
TA  - Regul Toxicol Pharmacol
JT  - Regulatory toxicology and pharmacology : RTP
JID - 8214983
RN  - 0 (Nicotinic Agonists)
RN  - 6M3C89ZY6R (Nicotine)
RN  - 7U1EE4V452 (Carbon Monoxide)
SB  - IM
MH  - Administration, Inhalation
MH  - Adult
MH  - Aged
MH  - Breath Tests
MH  - Carbon Monoxide/metabolism
MH  - Consumer Product Safety
MH  - Cross-Over Studies
MH  - *Electronic Nicotine Delivery Systems/adverse effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Nebulizers and Vaporizers
MH  - Nicotine/*administration & dosage/adverse effects
MH  - Nicotinic Agonists/*administration & dosage/adverse effects
MH  - Risk Assessment
MH  - Smoking/metabolism/psychology
MH  - Smoking Cessation/*methods
MH  - *Smoking Prevention
MH  - Substance Withdrawal Syndrome/metabolism/*prevention & control/psychology
MH  - Surveys and Questionnaires
MH  - Time Factors
MH  - Tobacco Use Disorder/metabolism/*prevention & control/psychology
MH  - Volatilization
MH  - Wales
MH  - Young Adult
OTO - NOTNLM
OT  - Adverse events
OT  - Cigarette
OT  - Clinical study
OT  - Electronic cigarette
OT  - Electronic vapour product
OT  - Nicotine inhalator
OT  - Smoking urges
OT  - Withdrawal symptoms
EDAT- 2015/12/26 06:00
MHDA- 2016/10/22 06:00
CRDT- 2015/12/26 06:00
PHST- 2015/08/17 00:00 [received]
PHST- 2015/12/10 00:00 [revised]
PHST- 2015/12/10 00:00 [accepted]
PHST- 2015/12/26 06:00 [entrez]
PHST- 2015/12/26 06:00 [pubmed]
PHST- 2016/10/22 06:00 [medline]
AID - S0273-2300(15)30139-2 [pii]
AID - 10.1016/j.yrtph.2015.12.004 [doi]
PST - ppublish
SO  - Regul Toxicol Pharmacol. 2016 Feb;74:193-9. doi: 10.1016/j.yrtph.2015.12.004. 
      Epub 2015 Dec 15.