Proof-of-principle that a 3-day intervention protocol, during which smoking memories are being retrieved and desensitised, will lead to a reduced ability of nicotine-associated stimuli to induce cigarette craving.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
tabakverslaving
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1 day before and 1 day after the intervention cue-ïnduced cigarette craving
will be assessed with questionaires. At the 2 week and 3 month follow-up
nicotine-dependence will be assessed with a questionare.
Secondary outcome
Before the first and second exposure-test: the Questionnaire of smoking urges
(QSU)
Background summary
Smoking is the leading risk factor for premature death and disabilities. The
latest global report on addictive behaviour shows that the harm to society from
legal drugs far outweighs the harm from illicit drugs: 240 million people have
an alcohol use disorder and more than 1 billion people smoke tobacco with 6
million annual deaths from smoking, and approximately 600,000 premature deaths
from exposure to second hand cigarette smoke. Tobacco use disorder is a
chronically relapsing condition. During abstinence, memories of smoking,
typically triggered by exposure to smoking-associated stimuli in the
environment, elicit craving and precipitate relapse and are associated with
brain activation/connectivity abnormalities. Therefore, this brain-related
disease can be viewed as the result of maladaptive processes of Pavlovian and
instrumental learning and memory. Manipulating the maladaptive memories may
thus open new venues to reduce the impact of smoking-related cues on craving
and relapse behaviour. Pharmacological and behavioural disruption of
reconsolidation of drug memories has been repeatedly demonstrated in
well-established animal models of addiction and resulted in long-lasting
reductions in cue-reactivity and relapse probability. Now is the time to
translate these promising findings to clinical applications and to cure the
most prevalent brain-related disorder in our society. Based on our own
preclinical data and recent clinical observations it is our goal to establish a
novel behavioural intervention in smokers aimed at reducing smoking-cue
reactivity and the probability to relapse by reframing the nicotine-occupied
mind. To that end, we have developed a modified Eye Movement Desensitization
and Reprocessing (EMDR) protocol in which distractor stimuli will be used to
blur nicotine memories.
Study objective
Proof-of-principle that a 3-day intervention protocol, during which smoking
memories are being retrieved and desensitised, will lead to a reduced ability
of nicotine-associated stimuli to induce cigarette craving.
Study design
Doubleblind placebo controled intervention study with a 2 week and 3 months
follow-up. The primary outcome measures (cue-induced craving) will be collected
on day 1 (baseline), day 5 (after the intervention) and during the follow-up by
a research assistent blind for thee experimental condition. The experimenter
guids the intervention itself and has (of necessity) knowledge of the
experimental condition.
Intervention
Intervention includes 3 sessions of 45 minutes on 3 consecutive days during
which the experimental group (n=40) walks in a virtual surrounding and is
alternately exposed to visual smoking cues and distractor stimuli. The control
group (n=40) receives neutral stimuli in stead of the distractor stimuli.
Study burden and risks
Participants are asked to stop smoking during the 5 day study. The financial
reward is ¤20 per day. This wil be assesed by self-report and daily CO breath
tests. There is a risk that craving induced during the exposure tests and the
intervention will provoke a relapse. Given the fact that these cues are also
present in daily life, the addictional risk is considered small. There is, in
fact, no extra risk as participants will then return to their previous
(smoking) condition. There is a chance that the intervention will reduce the
risk to relapse, which obviously is a positive outcome. The intervention itself
does not cause healthrisks. After the study, participants will be provided with
information from Rookstoppoli Beverwijk on support for smoking cessation.
De Boelelaan 1108
Amsterdam 1081HZ
NL
De Boelelaan 1108
Amsterdam 1081HZ
NL
Listed location countries
Age
Inclusion criteria
1) between 25 and 55
2) history of smoking of >10 year
3) >=10 cigarettes a day
Exclusion criteria
1) neurological disorders 2) lifetime diagnosis or treatment of psychosis or
mania 3) other psychiatric dagnosis or treatment in the past 4 years 4) current
use of psychoactive drugs 5) current drug dependence, except for nicotine 6)
physical impairment 7) inability to understand study procedures
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
In other registers
Register | ID |
---|---|
CCMO | NL63887.029.18 |
OMON | NL-OMON27225 |