title: A randomised, crossover study on an electronic vapour product, a nicotine inhalator and a conventional cigarette. Part B: Safety and subjective effects.
abstract: 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(®), 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(®). 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(®) and relieved smoking urges and nicotine withdrawal symptoms to a similar extent as Nicorette(®) 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.
authors.affiliation: Fontem Ventures, Barbara Strozzilaan 101, 1083 HN Amsterdam, Netherlands. Electronic address: tanvir.walele@fontemventures.com.
authors.forename: Tanvir
authors.initials: T
authors.lastname: Walele
authors.affiliation: Simbec Research, Merthyr Tydfil, CF48 4DR, UK.
authors.forename: Girish
authors.initials: G
authors.lastname: Sharma
authors.affiliation: Clinopsis S.A., Jardins 6, Concise 1426, Switzerland.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Savioz
authors.affiliation: Clinopsis S.A., Jardins 6, Concise 1426, Switzerland.
authors.forename: Claire
authors.initials: C
authors.lastname: Martin
authors.affiliation: Imperial Tobacco, Product Science, 121 Winterstoke Road, Bristol, UK.
authors.forename: Josie
authors.initials: J
authors.lastname: Williams
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000368:Aged; D001944:Breath Tests; D002248:Carbon Monoxide / Q000378:metabolism; D003257:Consumer Product Safety; D018592:Cross-Over Studies; D066300:Electronic Nicotine Delivery Systems / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D009538:Nicotine / Q000008:administration & dosage* / Q000009:adverse effects; D018722:Nicotinic Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D018570:Risk Assessment; D012907:Smoking / Q000378:metabolism / Q000523:psychology; D016540:Smoking Cessation / Q000379:methods*; D000074606:Smoking Prevention; D013375:Substance Withdrawal Syndrome / Q000378:metabolism / Q000517:prevention & control* / Q000523:psychology; D011795:Surveys and Questionnaires; D013997:Time Factors; D014029:Tobacco Use Disorder / Q000378:metabolism / Q000517:prevention & control* / Q000523:psychology; D014835:Volatilization; D014852:Wales; D055815:Young Adult
chemical_list: D018722:Nicotinic Agonists; D009538:Nicotine; D002248:Carbon Monoxide
keywords: Adverse events; Cigarette; Clinical study; Electronic cigarette; Electronic vapour product; Nicotine inhalator; Smoking urges; Withdrawal symptoms