E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Smoking among young people aged 12 – 18 years. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053325 |
E.1.2 | Term | Smoking cessation therapy |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint: smoking cessation 6 months after quitting Co-primary endpoint: smoking cessation 12 months after quitting |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |