"EASY EFFECTIVE SMOKELESS" With NICORETTE®

This study has been completed.
Sponsor:
Collaborator:
Anfomed GmbH, Germany
Information provided by (Responsible Party):
Johnson & Johnson GmbH
ClinicalTrials.gov Identifier:
NCT01323491
First received: March 21, 2011
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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 Intervention
Stereotyped Behavior
Tobacco Smoking Behavior
Drug: Nicotine replacement therapy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson GmbH:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 184
Study Start Date: April 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

general practitioners

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01323491

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

Additional Information:
No publications provided

Responsible Party: Johnson & Johnson GmbH
ClinicalTrials.gov Identifier: NCT01323491     History of Changes
Other Study ID Numbers: EER Nicorette - 01
Study First Received: March 21, 2011
Last Updated: May 15, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014