NCT00749463

Evaluation of the Safety Profile, Quit and Reduction Rate After Nicorette® Gum and Patch Treatment

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: McNeil AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety, smoking cessation and reduction rate during 3 months of active nicotine replacement therapy (NRT) and a follow-up period of 3 months in smoking hospital physicians and staff who are motivated to quit

Detailed description

Using Nicorette® gum 2 mg, 4 mg and Nicorette® patch 5 mg/16 h, 10 mg/16 h, 15 mg/16 h to alleviate nicotine cravings and withdrawal symptoms and assist smoking cessation in smoking hospital physicians and staff who are motivated to quit. During the study, brief telephone consultation and SMS are provided as behavioral supports.

Conditions

• Tobacco Dependence

Interventions

Type	Name	Description
DRUG	Nicotine Gum	2 mg or 4 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks
DRUG	Nicotine Patch	Each will use 15 mg/16 h patch for the first 8 weeks, 10 mg/16 h for the following 2 weeks and 5 mg/16 h for the last 2 weeks. Then followed by 12 week off-treatment follow-up.

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2008-09-09
• Last updated: 2012-07-13
• Results posted: 2010-10-01

Locations

6 sites across 1 country: China