Conditions: Tobacco Dependence
Keywords: Smoking Cessation, Nicotine pharmacokinetics
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 40
Healthy volunteers: no

Brief summary:
A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after multiple-doses of nicotine.

Detailed description:
This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to steady-state nicotine pharmacokinetics, during 12 hours after start of the first administration. Multiple doses of each treatment are given once hourly during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 40 healthy smokers between 18-50 years, who have been smoking at least 20 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.

Arms:
arm 1: 2 Self-administrations of Experimental Nicotine once every hour arm 2: 2 administrations of Experimental Nicotine by study personnel once every hour arm 3: 2 administrations of Experimental Nicotine by study personnel once every 30 minutes arm 4: 1 NiQuitin™ lozenge, administered by study personnel once every hour arm 5: 1 piece Nicorette® gum, chewed for 30 minutes once every hour

Interventions: intervention 1: Oral Nicotine intervention 2: Nicotine Lozenge intervention 3: Nicotine gum
Intervention descriptions: intervention 1: Oral Nicotine either self-administered or provided by study personnel within 12 hours intervention 2: Nicotine lozenge marketed as NiQuitin™ 4 mg hourly within 12 hours intervention 3: Nicotine gum marketed as Nicorette® 4 mg hourly within 12 hours

Protocol document: