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EASY EFFECTIVE SMOKELESS With NICORETTE®

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01323491
Enrollment
184
Registered
2011-03-25
Start date
2011-04-30
Completion date
2012-10-31
Last updated
2013-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stereotyped Behavior, Tobacco Smoking Behavior

Keywords

smoking cessation, nicotine replacement therapy, routine smokers

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.

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

Sponsors

Anfomed GmbH
CollaboratorINDUSTRY
Johnson & Johnson GmbH
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Further knowledge of smoking cessation in would-be non-smokersBaseline (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)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026