Early Effects of a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge

2014-08-27 03:15:37 | BioPortfolio


A comparison of two products for oral nicotine replacement with respect to relief of urges to smoke after single doses of nicotine.


This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 2 mg and 4 mg, respectively, after 5 hours of witnessed nicotine abstinence with respect to urges to smoke during the first 5 minutes after start of treatment. Single doses of each treatment are given during separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 200 healthy smokers between 19-55 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion, and who smoke within 30 minutes of waking up. Subjects, study personnel and monitor will be aware of what type of product is administered at a given visit, but not of the administered dose of the lozenge.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Smoking Cessation


Nicotine, NiQuitin™ lozenge (Nicotine Lozenge) 2 mg, NiQuitin™ lozenge (Nicotine Lozenge) 4 mg


Clinical Pharmacology
222 20




Johnson & Johnson Consumer & Personal Products Worldwide

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:15:37-0400

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Medical and Biotech [MESH] Definitions

Nicotine is highly toxic alkaloid. It is the prototypical agonist at nicotinic cholinergic receptors where it dramatically stimulates neurons and ultimately blocks synaptic transmission. Nicotine is also important medically because of its presence in tobacco smoke.

A plant genus of the family FABACEAE that is a source of aromatic resinous balsams (Balsam of Tolu and Balsam of Peru) used in perfumery and as a constituent in cough syrups and lozenge.

A plant genus of the family SOLANACEAE. Members contain NICOTINE and other biologically active chemicals; its dried leaves are used for SMOKING.

The N-glucuronide conjugate of cotinine is a major urinary metabolite of NICOTINE. It thus serves as a biomarker of exposure to tobacco SMOKING. It has CNS stimulating properties.

An alkaloid that has actions similar to NICOTINE on nicotinic cholinergic receptors but is less potent. It has been proposed for a variety of therapeutic uses including in respiratory disorders, peripheral vascular disorders, insomnia, and smoking cessation.

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