"EASY EFFECTIVE SMOKELESS" With NICORETTE®

Tobacco Smoking Behavior Clinical Trial

Official title:

Nicht-interventionelle Studie (NIS) Zur Strukturierten Raucherentwöhnung Nach Dem Konzept "EINFACH ERFOLGREICH RAUCHFREI" unterstützt Durch NICROETTE®-Produkte

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323491
• Other study ID #: EER Nicorette - 01
• Status: Completed
• Phase: N/A
• First received: March 21, 2011
• Last updated: May 15, 2013
• Start date: April 2011
• Est. completion date: October 2012

Study information

• Verified date: May 2013
• Source: Johnson & Johnson GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

The actually most accepted method of effective smoking cessation is based on structured consultation and medical care in combination with supportive medical treatment. A group of experts developed the concept "EINFACH ERFOLGREICH RAUCHFREI" ("EASY EFFECTIVE SMOKELESS") for general practitioners providing a structured compendium for negotiation.

Physicians who have implemented this concept will conduct this non-interventional study. The implementation of the scheme will be investigated under general practice conditions and the applicability of the concept has to be assessed by the physicians.

In addition further knowledge of smoking cessation in would-be non-smokers which decided to quit, supported by medical treatment with NICORETTE®-products, will be documented for a large patient collective under real practice conditions.

To answer all above mentioned questions for a sufficient number of patients a multicenter, prospective non-interventional study design was used for this trial as only this instrument detects characteristics of the physicians' treatment without any further input or other influences.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Routine smokers

• Nicotine replacement therapy with Nicorette® according to physicians treatment decision

Exclusion Criteria:

• Pregnancy

• Contraindication according to Summary of Product Characteristics (SPC)

• Other nicotine replacement therapy during the last month

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stereotyped Behavior
• Tobacco Smoking Behavior

Intervention

Drug:
• Nicotine replacement therapy
Nicorette® TX tape 10mg, 15mg, 25mg Nicorette® microtab 2mg Nicorette® inhaler 10mg Nicorette® chewing gum 2 mg, 4mg freshfruit, freshmint, mint, whitemint

Locations

Country	Name	City	State
Germany	Johnson & Johnson GmbH	Neuss

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson GmbH	Anfomed GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Further knowledge of smoking cessation in would-be non-smokers		Baseline (about 2 weeks before date of smoking cessation), Follow-up (about 3, 14 and 28 days after date of smoking cessation), Final examination (about 3 months after date of smoking cessation)	No

External Links

•   description of the concept "EASY EFFECTIVE SMOKELESS"