Using nicotine patches to support smoking cessation among adolescents.|
|- candidate number||10262|
|- NTR Number||NTR3031|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-aug-2011|
|- Secondary IDs||200110005 / 10-045; ZonMw / MEC University Medical Center Utrecht |
|- Public Title||Using nicotine patches to support smoking cessation among adolescents.|
|- Scientific Title||The effectiveness of Nicotine Replacement Therapy for young people aged 12 to 18 years.|
|- hypothesis||Rationale: |
There is increasing evidence that Nicotine Replacement Therapy (NRT) may help adolescents to successfully quit smoking. However data on the effectiveness and safety of NRT among adolescents are limited and a large clinical trial of nicotine replacement therapy is warranted to be more conclusive about the effects of NRT among adolescents. The present study will be conducted in response to this need.
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 up to and including 18 years. Other aims of this study are to investigate the mediating and moderating processes through which NRT has an effect on smoking cessation.
|- Healt Condition(s) or Problem(s) studied||Smoking, Adolescents|
|- Inclusion criteria||1. Not having a major physical health problem;|
2. Smoking at least 7 cigarettes a day;
3. Having parents who are aware of their smoking behavior;
4. Motivated to quit smoking;
5. Aged from 12 up to and including 18 years.
|- Exclusion criteria||1. Pregnancy, lactation;|
2. Chronic skin conditions;
3. Current use of NRT or other smoking cessation medication (e.g. bupropion and Chantix);
4. Hypersensitivity to any ingredients in the patches.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||31-jan-2011|
|- planned closingdate||31-mei-2012|
|- Target number of participants||360|
|- Interventions||One week before starting the treatment period participants will attend a meeting where they will receive information about this study, a short behavioural intervention aiming at quitting smoking and instructions for the use of NRT. At the end of this meeting, participants will receive a package of nicotine or placebo patches sufficient for the whole treatment period. Every morning a new patch is put on a clean, dry area of the skin. The nicotine doses and treatment duration will be determined according to the instructions of the producer on basis of the participantís intensity of smoking (number of cigarettes a day). This means that adolescents in the treatment condition who smoke more than 20 cigarettes a day will receive a higher nicotine patch dose and will continue use for 9 weeks (3 weeks TTS21, 3 weeks TTS14 and 3 weeks TTS7), whereas adolescents in the treatment condition who smoke less than 20 cigarettes a day will use a lower dose for a period of 6 weeks (3 weeks TTS14 and 3 weeks TTS7). The instruction for placebo patches is exactly the same. |
The treatment period starts on monday the week after the meeting. Participants have to fill-out six online questionnaires, namely during the first quit day, and next during the 3rd day, the 5th day, the 7th day, the 14th day, and for the last time the first day after finishing treatment.
|- Primary outcome||The main primary endpoint will be prolonged abstinence 6 months after the quit date. In addition, the co-primary endpoint is abstinence 12 months after the quit date.|
|- Secondary outcome||A first secondary endpoint includes mediating effects of changes in nicotine dependence symptoms, craving, withdrawal symptoms, negative affect, hunger, and perceived self-efficacy. Also, we will 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). |
|- Timepoints||First, pretreatment measurements will take place during the meeting, in which we will measure nicotine dependence (using a scale derived from the mFTQ and the HONC), number of cigarettes adolescents smoke, general craving (Dijkstra & Borland, 2003), current craving (Heishman et al., 2003), latency to craving (DiFranza et al., in press), cue-induced craving (DiFranza et al., in press), number and duration of quit attempts, positive emotions about cessation, self-efficacy (Kremers et al. 2001), support of friends and family, perceived pro's and cons of smoking, motivation to quit smoking, depressive symptoms (Kandel & Davies, 1982), impulsivity (EATQR, Capaldi & Rothbart, 1992), physical activity, and alcohol and drug use.|
Second, questionnaires during the treatment period and the two follow-up questionnaires consist of most of the previous mentioned measurements, namely current craving, positive emotions about cessation, self-efficacy, support of friends and family, motivation to quit smoking, depressive symptoms, physical activity, and alcohol and drug use. In addition, withdrawal (WSWS, Welsh et al., 1999), compliance, relapse, weightloss/increase in weight and side effects were also measured.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| Charlotte Scherphof|
|- CONTACT for SCIENTIFIC QUERIES|| Regina Eijnden, van den|
|- Sponsor/Initiator ||Utrecht University (UU)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||22-aug-2011 - 18-okt-2011|
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