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 Thirty-six volunteers entered the study, and 2 were withdrawn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.
