The effectiveness of Nicotine Replacement Therapy for young people aged 12 to 18 years

• Conditions: Smoking among young people aged 12 – 18 years.; MedDRA version: 12.1Level: LLTClassification code 10053325Term: Smoking cessation therapy

• Registration Number: EUCTR2009-017862-22-NL
• Lead Sponsor: ZonMw

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) not having a major physical or mental health problem
2) smoking > 10 cigarettes a day
3) having parents who are aware of their smoking behaviour
4) a minimal score of 6 on the modified Fagerstrom Tolerance Questionnaire (mFTQ)
5) planning to quit smoking within 1 à 2 months.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy, lactation, chronic skin conditions, current use of NRT or other smoking cessation medication (e.g. bupropion and Chantix) will be reasons for exclusion.
Also restriction of subject if they are taking narcotics, antidepressants or anxiolytic drugs prior to the start of the study; as well as taking xanthine-derived bronchodilators, sympathomimetic agents, alpha-adrenergic blocking agents, St John's Wort, kava-kava or caffeine containing products. Finally, participants will be excluded if they report hypersensitivity to any ingredients in the patches should be an exclusion criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main aim of this study is to determine the effectiveness and safety of nicotine replacement therapy (NRT) in achieving long-term smoking cessation among young smokers aged 12 – 18 years. ;Primary end point(s): Primary endpoint: smoking cessation 6 months after quitting<br>Co-primary endpoint: smoking cessation 12 months after quitting;Secondary Objective: The most important secondary aim of this study is to examine whether the effectiveness of NRT is mediated by changes in nicotine dependence symptoms such as craving, withdrawal symptoms, negative affect, hunger, and perceived self-efficacy. Another aim is to check for possible moderating effects of demographic characteristics (e.g. age, gender, educational level, and ethnicity) and smoking characteristics (e.g. severity of nicotine dependence, number of cigarettes a day). The final aim is to gain more insight into the acceptability and possible side effects of NRT among young smokers aged 12 – 18 years.