a randomised, crossover study on an electronic vapour product, a nicotine inhalator and a conventional cigarette. Part B: Safety and subjective effects

Introduction:
This text is a summary of a clinical study on the safety and subjective effects of an electronic vapour product (EVP) compared to a nicotine inhalator and conventional cigarettes. The study was designed as a randomized, controlled, crossover trial with outcomes including adverse events (aEs), vital signs, exhaled carbon monoxide (CO), clinical laboratory parameters, smoking urges, and withdrawal symptoms.

Key Points:

* The study consisted of two parts, with 12 subjects each.
* Part 1 compared the EVP with unflavored and flavored e-liquid at 2.0% nicotine to a conventional cigarette and a licensed nicotine inhalator.
* 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%).
* Only mild non-serious aEs were reported in both study parts.
* 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 pro file to Nicorette® and relieved smoking urges and nicotine withdrawal symptoms to a similar extent as Nicorette® and CC.

Main Message:
The study suggests that the EVP may offer an alternative for those finding it dif ficult to quit the behavioral and sensorial aspects of smoking as it had a similar short-term safety profile to an MhRa approved NRT product and relieved smoking urges and nicotine withdrawal symptoms to a similar extent as Nicorette® and CC. however, further work should be carried out on the use of the EVP in real-life settings to ensure it meets the standards of efficacy, safety and quality set by relevant regulatory authorities such as the MhRa.

Walele, Tanvir, Girish Sharma, Rebecca Savioz, Claire Martin, and Josie Williams. “a Randomised, Crossover Study on an Electronic Vapour Product, a Nicotine Inhalator and a Conventional Cigarette. Part B: Safety and Subjective Effects.” Regulatory Toxicology and Pharmacology 74 (February 2016): 193–99. https://doi.org/10.1016/j.yrtph.2015.12.004.