The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01323491
Recruitment Status : Completed
First Posted : March 25, 2011
Last Update Posted : May 16, 2013
Anfomed GmbH
Information provided by (Responsible Party):
Johnson & Johnson GmbH

Brief 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.

Condition or disease Intervention/treatment
Stereotyped Behavior Tobacco Smoking Behavior Drug: Nicotine replacement therapy

Study Type : Observational
Actual Enrollment : 184 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nicht-interventionelle Studie (NIS) Zur Strukturierten Raucherentwöhnung Nach Dem Konzept "EINFACH ERFOLGREICH RAUCHFREI" unterstützt Durch NICROETTE®-Produkte
Study Start Date : April 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
routine smokers
would-be non-smokers, no actual nicotine replacement therapy
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

Primary Outcome Measures :
  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) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01323491

Johnson & Johnson GmbH
Neuss, Germany, D-41470
Sponsors and Collaborators
Johnson & Johnson GmbH
Anfomed GmbH

Responsible Party: Johnson & Johnson GmbH Identifier: NCT01323491     History of Changes
Other Study ID Numbers: EER Nicorette - 01
First Posted: March 25, 2011    Key Record Dates
Last Update Posted: May 16, 2013
Last Verified: May 2013

Keywords provided by Johnson & Johnson GmbH:
smoking cessation
nicotine replacement therapy
routine smokers

Additional relevant MeSH terms:
Stereotypic Movement Disorder
Neurodevelopmental Disorders
Mental Disorders
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action