With this study we aim to investigate the occurrence and development of PBS indicative of nicotine dependence in never smokers and novice smokers and the underlying neurobiological mechanisms as a function of the level of ETS exposure. Therefore, we…
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Brief title
Condition
- Other condition
Synonym
Health condition
Rookgerelateerde aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
At each wave and during the three weeks of EMA data collection the primary
outcome variables will be the PBS: feelings of craving, cue-triggered wanting
to smoke, nicotine dependence and behavioral mood and concentration symptoms.
These outcomes will be measured by using well-validated questionnaires to
measure the occurrence and development of PBS.
The primary outcome variable for the EEG study will be the magnitude of the ERP
components. ERPs of smoking cue-reactivity (P3 and LPP), non-drug reward
sensitivity (P3, FRN and LPP) and impulse control (N2 and P3) will be measured.
The primary outcome variable for the fMRI study will be the changes in brain
functioning over time in specific brain regions of interest (ROIs) involved in
smoking cue-reactivity, non-drug reward sensitivity and impulse control in
novice smokers. Brain activity in ROIs of smoking cue-reactivity (NA, amygdala
and ACC), non-drug reward sensitivity (NA and vmPFC) and impulse control (IFG,
ACC and dlPFC) will be measured immediately after the EMA and once again two
years later.
Secondary outcome
Not applicable
Background summary
Research has shown that exposure to environmental tobacco smoke (ETS) leads to
the uptake of nicotine in the body, and a growing number of studies suggest
that this may possibly result in neuro-physiological changes in the brain and
altered psycho-behavioural responses to nicotine in never- and novice-smoking
adolescents. Psycho-behavioural responses or psycho-behavioural symptoms (PBS)
are symptoms that develop in response to nicotine dependence (e.g., tolerance
to aversive effects of nicotine, sensitization to rewarding effect of nicotine,
withdrawal symptoms after the effects of nicotine wear off). Recently it has
been shown that in never-smoking adolescents, a higher number of smokers in the
social environment is associated with self-reported PBS indicative of nicotine
dependence. In addition, exposure to ETS is associated with increased rewarding
sensations in response to the first dose of nicotine in adolescents who
recently initiated smoking. These studies indicate that exposure to ETS may
result in the development of psycho-behavioural symptoms indicative of nicotine
dependence in never-smokers and in an increased vulnerability to develop
nicotine dependence in novice smokers.
Although previous research indicates a relationship between ETS exposure and
PBS indicative of nicotine dependence in both non-smokers and novice smokers,
it has never been investigated whether ETS exposure actually precedes the
occurrence of PBS. Moreover, the potential underlying neurobiological
mechanisms through which ETS might predispose both never smokers and novice
smokers towards addiction are unknown.
Therefore, the proposed project aims to test whether PBS among adolescent
non-smokers and novice smokers are indeed the result of ETS. Furthermore, the
proposed project aims to investigate the underlying neurobiological mechanisms
through which ETS predispose adolescents towards addiction.
Study objective
With this study we aim to investigate the occurrence and development of PBS
indicative of nicotine dependence in never smokers and novice smokers and the
underlying neurobiological mechanisms as a function of the level of ETS
exposure. Therefore, we specified the following main objectives:
1) To test whether ETS exposure precedes the occurrence of psycho-behavioural
symptoms (PBS) indicative of nicotine dependence.
2) To investigate the role of ETS on time period and the process in which
smoking initiation occurs and potentially progresses into more established
levels of smoking and more severe levels of PBS.
3) To investigate the association of ETS exposure with brain activation during
smoking cue-reactivity, non-drug reward sensitivity and impulse control in
never smokers by means of event-related potentials (ERPs) measured with EEG.
4) To investigate the association of ETS exposure with changes in brain
functioning over time in specific brain regions of interest (ROIs) involved in
smoking cue-reactivity, non-drug reward sensitivity and impulse control in
novice smokers using fMRI.
Study design
To determine whether ETS exposure precedes the occurrence of PBS, this study
will use Ecological Momentary Assessments (EMA) for a period of three weeks at
the start of the study. To investigate the role of ETS on the time period and
the process in which smoking initiation occurs and potentially progresses into
more established levels of smoking and PBS, this study will have a three wave
longitudinal design (1 year with six-month intervals). During both the three
waves of the longitudinal study and the EMA study, self-report questionnaires
assessing smoking patterns, dependence symptoms, and ETS exposure will be
filled out. These questionnaires provide more information on adolescents*
exposure to ETS, development of PBS, own smoking behavior, as well as smoking
behavior of their parents, siblings and friends.
To investigate the underlying neurobiological mechanisms through which ETS
predisposes adolescents towards addiction, we will use EEG measurements in
never-smoking adolescents and we will use fMRI measurements in novice smoking
adolescents at two time points, once at the start and once again one year
later. Brain activation during smoking cue-reactivity, non-drug reward
sensitivity and impulse control will be measured by means of event-related
potentials (ERPs) measured with EEG and within specific regions of interest
(ROIs) measured with fMRI. This brain activity will be related to the amount of
exposure to ETS.
Study burden and risks
There is no risk during both the EMA study and the longitudinal study as
participants will only be asked to fill out questionnaires and provide saliva
samples. Furthermore, fMRI and EEG are safe and non-invasive methods for
measuring brain activity. However, the noise and the relative confined space of
the MRI scanner may cause some level of discomfort to some subjects. The study
has no therapeutic goals; there are no benefits for the participants. The
participants in this study will be aged between 12-18 years old to
appropriately follow the initiation of smoking and potentially progresses into
more established levels of smoking and development of PBS. Overall, the
knowledge we gain through this project, as well as the risk-free nature of this
study, justifies the efforts of the participants.
Montessorilaan 3, kamer 06.23
Nijmegen 6525 HR
NL
Montessorilaan 3, kamer 06.23
Nijmegen 6525 HR
NL
Listed location countries
Age
Inclusion criteria
Inclusion Criteria Experimental Smokers:
- Smoked between 5-500 cigarettes
- Smoked in the past 6 months
- Never smoked daily
- Aged between 12 en 18 years old
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
o Head Injury
o Regular use of other addictive substances other than nicotine
o Use of (psychoactive medication)
To take part in the fMRI study the subjects need to be free from metal in or outside the body. Therefore, he or she will be excluded if he or she meets any of the following criteria:
Standard exclusion criteria for MRI scanning
o* Metal objects or fragments in the body that cannot be taken out
o* Active implants in the body
o* Using medical plasters
o* Epilepsy
o* Previous head surgery
o* Pregnancy
o* Claustrophobia
Design
Recruitment
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 |
---|---|
CCMO | NL55542.091.15 |