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OpenTrials
Completed

NCT Number: NCT01323491

"EASY EFFECTIVE SMOKELESS" With NICORETTE®

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.

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Key information

Conditions

Stereotyped Behavior Behavior Health Behavior Smoking Smoking Cessation Tobacco Smoking Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johnson & Johnson GmbH

Neuss, D-41470, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotine Replacement Therapy

Drug

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

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)

Sponsors and collaborators

Lead sponsor

Johnson & Johnson GmbH

Industry

Collaborators

  • Anfomed GmbH

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 25, 2011
Registry last updated
May 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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