NCT02794220

A Study of Blood Levels of Nicotine Following an Electronic Cigarette

A Randomised, 4-way Crossover, Relative Bioavailability Study of Nicotine Delivered by an Electronic Cigarette, Nicorette® Inhalator and Cigarette Smoking

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Simbec Research · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the amount of nicotine that is absorbed into the blood stream following the use of a new Electronic Cigarette device called the CN electronic cigarette. The amount of nicotine delivered via the CN electronic cigarette will be compared to the amount of nicotine delivered from smoking a regular cigarette and from using the Nicorette® Inhalator. Electronic cigarettes aim to mimic the experience of cigarette smoking, by delivering nicotine rapidly. Unlike cigarettes however, they do not contain all of the many harmful combustion products contained in tobacco smoke. Electronic cigarettes are readily available in many markets, and may contain significant quantities of nicotine. However, they are not regulated as medicines, and their manufacturers can make no medicinal claims about them. Such products are unregulated, having not been subjected to regulatory review by either the Medicines and Healthcare Products Regulatory Agency (MHRA) or any Notified Body. It is the intention of CN Creative (makers of the CN electronic cigarette) to submit an application to the MHRA for the CN Electronic Cigarette, in order to make a high quality, regulated product available. Males aged 18-65, who smoke and who have no intention of stopping smoking during the trial are eligible to take part in this study. The study consist of a screening visit, a treatment period with 5 overnight stays with nicotine treatment on days 1, 2, 3 and 4 with a post study visit on day 5.

Conditions

• Nicotine Replacement Therapy

Interventions

Type	Name	Description
DEVICE	CN electronic cigarette 10 mg	Inhalation
DEVICE	CN electronic cigarette 15 mg	Inhalation
DEVICE	Nicorette Inhalator 15 mg	Inhalation
OTHER	Cigarette	Inhalation

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2016-06-09
• Last updated: 2016-06-09