sing nicotine patches to support smoking cessation among adolescents.

Phase 4

Completed

Conditions: (stoppen met) roken
smoking

Registration Number: NL-OMON34738

Lead Sponsor: niversiteit Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 360

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, and 6) aged from 12 upto and including 18 years.

Exclusion Criteria

Pregnancy, lactation, chronic skin conditions, current use of NRT or other smoking cessation medication (e.g. bupropion and Chantix).
Taking narcotics, antidepressants, anxiolytic drugs, xanthine-derived bronchodilators, sympathomimetic agents, alpha-adrenergic blocking agents, St John's Wort, kava-kava or caffeine containing products prior to the start of the study.
Hypersensitivity to any ingredients in the patches.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main primary endpoint is abstinence at 6 months after quitting, and a<br /><br>co-primary endpoint of abstinence at 12 months after quitting. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>A first secondary endpoint includes mediating effects of changes in nicotine<br /><br>dependence symptoms such as craving, withdrawal symptoms, negative affect,<br /><br>hunger, and perceived self-efficacy. Also, we will check for possible<br /><br>moderating effects of demographic characteristics (e.g. age, gender,<br /><br>educational level, and ethnicity) and smoking characteristics (e.g. severity of<br /><br>nicotine dependence, number of cigarettes a day). Finally, the acceptability<br /><br>and possible side effects of NRT are secondary endpoint.</p><br>