Early Effects of a New Oral Nicotine Replacement Product and NiQuitinâ„¢ Lozenge
Summary
A comparison of two products for oral nicotine replacement with respect to relief of urges to smoke after single doses of nicotine.
Description
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
Conditions
Smoking Cessation
Intervention
Nicotine, NiQuitin™ lozenge (Nicotine Lozenge) 2 mg, NiQuitin™ lozenge (Nicotine Lozenge) 4 mg
Location
Clinical Pharmacology
Lund
Sweden
222 20
Status
Completed
Source
Johnson & Johnson Consumer & Personal Products Worldwide
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01075659
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Nicotine
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.
Myroxylon
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.
Tobacco
A plant genus of the family SOLANACEAE. Members contain NICOTINE and other biologically active chemicals; its dried leaves are used for SMOKING.
Cotinine
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.
Lobeline
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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