"EASY EFFECTIVE SMOKELESS" With NICORETTE®

NCT01323491 | Completed

• 1 other identifier: EER Nicorette - 01
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Stereotyped Behavior; Tobacco Smoking Behavior

Keywords

smoking cessation; nicotine replacement therapy; routine smokers

Outcome Measures

Primary Outcomes (1)

• Further knowledge of smoking cessation in would-be non-smokers

  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)

Study Arms (1)

routine smokers

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

Drug: Nicotine replacement therapy

Interventions

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

routine smokers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

general practitioners

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johnson & Johnson GmbH: lead
• Anfomed GmbH: collaborator

Study Sites (1)

Johnson & Johnson GmbH

Neuss, D-41470, Germany

Location

MeSH Terms

Conditions

Stereotyped Behavior; Smoking; Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2011
• First Posted: March 25, 2011
• Study Start: April 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 16, 2013

Record last verified: 2013-05

Locations

DE (1)