Smoking among young people aged 12 – 18 years. MedDRA version: 12.1 Level: LLT Classification code 10053325 Term: Smoking cessation therapy
Conditions
Interventions
Trade Name: Nicotinell Patches
Product Name: Nicotinell
Pharmaceutical Form: Transdermal patch
CAS Number: 54115
Other descriptive name: NICOTINE
Concentration unit: mg/h milligram(s)/hour
Concentrati
Sponsors
ZonMw
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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. | — |
Countries
Netherlands
Outcome results
None listed