NCT01075659

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

Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge: A Study in Healthy Smokers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: McNeil AB · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Nicotine	Two single doses of experimental Nicotine Replacement Therapy (NRT) 2 mg, with five hours between treatments. Seven hours duration of total follow-up period
DRUG	Nicotine	Two single doses of Nicotine Lozenge 2 mg, with five hours between treatments. Seven hours duration of total follow-up period.
DRUG	Nicotine	Two single doses of Nicotine Lozenge 4 mg, with five hours between treatments. Seven hours duration of total follow-up period.

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2010-02-25
• Last updated: 2012-07-10

Locations

1 site across 1 country: Sweden