Quit and nicorette : A comparison of nicotine pharmacokinetics in cigarette smokers

Abstract

Nicotine medications make it easier to abstain from tobacco by partially replacing the nicotine formerly obtained from tobacco. They are referred to as "replacement medications". Considering the many shortcomings of known nicotine delivery systems, a product called Quit® was developed. The aim was to provide an effective, user-friendly and affordable replacement product in support of tobacco withdrawal programmes. Objectives Primary • To compare the relative bioavailability of nicotine and its major metabolite, cotinine, in cigarette smokers after application of nicotine by means of, chewing nicotine resin chew pieces (Nicorette ®), and buccal application from a novel metered-dose applicator (Quit~ • To compare descriptively the pharmacokinetics of nicotine and its major metabolite, cotinine, in cigarette smokers after application of nicotine by means of cigarette smoking, chewing nicotine resin chew pieces (Nicorette~, and buccal application from a novel metered-dose applicator (Quit®). Secondary • Comparison of Nicorette® and Quit® with regard to suppressIOn of cigarette cravlllg. • Comparison ofNicorette® and Quit® with regard to the occurrence and severity of adverse events. Study design This was an open, laboratory-blind, multiple-dose, randomised, 2-way cross-over design. Healthy male and female volunteers, aged 18 to 54 years, and who had smoked cigarettes for at least one year participated. Thirty-six volunteers entered the study, and 2 were withdrawn due to intercurrent illness which required treatment.