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CompletedNCT01323491Updated May 16, 2013

"EASY EFFECTIVE SMOKELESS" With NICORETTE®

An observational study in Stereotyped Behavior and Tobacco Smoking Behavior, sponsored by Johnson & Johnson GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-16.

Sponsored by Johnson & Johnson GmbH · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
184
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Stereotyped Behavior
  • Tobacco Smoking Behavior

Keywords

  • smoking cessation
  • nicotine replacement therapy
  • routine smokers
03

In context

Lead sponsor

This is the only study on the registry with Johnson & Johnson GmbH as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

general practitioners

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Contraindication according to Summary of Product Characteristics (SPC)
  • Other nicotine replacement therapy during the last month
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
184 participants (actual)

Groups and cohorts

  • routine smokers

    would-be non-smokers, no actual nicotine replacement therapy

    Drug: Nicotine replacement therapy

Interventions

  • DrugNicotine replacement therapy

    Nicorette® TX tape 10mg, 15mg, 25mg Nicorette® microtab 2mg Nicorette® inhaler 10mg Nicorette® chewing gum 2 mg, 4mg freshfruit, freshmint, mint, whitemint

06

What researchers measure

Primary outcomes

  1. Further knowledge of smoking cessation in would-be non-smokers

    Time frame: 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)

07

Study locations

1 site
  • Johnson & Johnson GmbH
    Neuss, D-41470, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01323491
Lead sponsor
Johnson & Johnson GmbH
Collaborators
Anfomed GmbH
Responsible party
Sponsor
First posted
Mar 25, 2011
Start date
Apr 2011
Primary completion
Oct 2012
Completion
Oct 2012
Last update
May 16, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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