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…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
(stoppen met) roken
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main primary endpoint is abstinence at 6 months after quitting, and a
co-primary endpoint of abstinence at 12 months after quitting.
Secondary outcome
A first secondary endpoint includes mediating effects of changes in nicotine
dependence symptoms such as 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). Finally, the acceptability
and possible side effects of NRT are secondary endpoint.
Background summary
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.
Study 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 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. Also the acceptability and possible
side effects of NRT will be measured.
Study design
A double blind, randomized, placebo-controlled trial will be conducted testing
the effectiveness of nicotine patch therapy in comparison to a placebo
condition.
Intervention
Participants will be recruited and randomly assigned (after stratification for
gender and for intensity of smoking) to one of two conditions: (1) an active
nicotine patch condition, and (2) a placebo patch condition (the control
condition). The period of treatment will be about 6 to 9 weeks, depending on
the number of cigarettes they smoke. Every day they will use a new patch
(nicotine or placebo) with declining doses.
Study burden and risks
First, all participants will receive a behavioral intervention and will receive
instructions for the use of NRT, which will last about 2 hours. During the
treatment they have to fill-out 6 online questionnaires, which will each last
about 15 minutes. Questionnaires can be filled-out at home. Also two more
online questionnaires will take place at 6 and 12 months after quitting.
Finally, to validate self-reported measures of abstinence, both at the 6 and
the 12 month follow up measurement, a random selection of about 1/3 of the
participants who reported to be abstinent for at least 7-days will receive a
saliva-based cotinine test. For this test the participants have to give a
saliva sample. The burden associated with particpation is limited, because
participants only have to fill-out some online questionnaires, which they can
do at home. Besides, we will visit them at their home for the cotinine test.
The only risk for the participants is possible side-effects of the nicotine
patches. However these are small and easy to prevent or diminish. Clearly,
smoking cessation will be the main benefit for participants.
Heidelberglaan 2
3584 CS Utrecht
NL
Heidelberglaan 2
3584 CS Utrecht
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-017862-22-NL |
| CCMO | NL30912.041.10 |