Effects of varenicline and cognitive bias modification on neural response to smoking-related cues: study protocol for a randomized controlled study.
Abstract
BACKGROUND: Smoking-related cues can trigger drug-seeking behaviors, and computer-based
interventions that reduce cognitive biases towards such cues may be efficacious and
cost-effective cessation aids. In order to optimize such interventions, there needs
to be better understanding of the mechanisms underlying the effects of cognitive bias
modification (CBM). Here we present a protocol for an investigation of the neural
effects of CBM and varenicline in non-quitting daily smokers. METHODS/DESIGN: We will
recruit 72 daily smokers who report smoking at least 10 manufactured cigarettes or
15 roll-ups per day and who smoke within one hour of waking. Participants will attend
two sessions approximately one week apart. At the first session participants will
be screened for eligibility and randomized to receive either varenicline or a placebo
over a seven-day period. On the final drug-taking day (day seven) participants will
attend a second session and be further randomized to one of three CBM conditions (training
towards smoking cues, training away from smoking cues, or control training). Participants
will then undergo a functional magnetic resonance imaging scan during which they will
view smoking-related pictorial cues. Primary outcome measures are changes in cognitive
bias as measured by the visual dot-probe task, and neural responses to smoking-related
cues. Secondary outcome measures will be cognitive bias as measured by a transfer
task (modified Stroop test of smoking-related cognitive bias) and subjective mood
and cigarette craving. DISCUSSION: This study will add to the relatively small literature
examining the effects of CBM in addictions. It will address novel questions regarding
the neural effects of CBM. It will also investigate whether varenicline treatment
alters neural response to smoking-related cues. These findings will inform future
research that can develop behavioral treatments that target relapse prevention. TRIAL
REGISTRATION: Registered with Current Controlled Trials: ISRCTN65690030. Registered
on 30 January 2014.
Type
Journal articleSubject
AffectBenzazepines
Clinical Protocols
Cognitive Therapy
Combined Modality Therapy
Craving
Cues
England
Humans
Magnetic Resonance Imaging
Nicotinic Agonists
Quinoxalines
Research Design
Smoking
Smoking Cessation
Stroop Test
Surveys and Questionnaires
Time Factors
Tobacco Use Disorder
Treatment Outcome
Varenicline
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https://hdl.handle.net/10161/14612Published Version (Please cite this version)
10.1186/1745-6215-15-391Publication Info
Attwood, Angela S; Williams, Tim; Adams, Sally; McClernon, Francis J; & Munafò, Marcus
R (2014). Effects of varenicline and cognitive bias modification on neural response to smoking-related
cues: study protocol for a randomized controlled study. Trials, 15. pp. 391. 10.1186/1745-6215-15-391. Retrieved from https://hdl.handle.net/10161/14612.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Show full item recordScholars@Duke
F Joseph McClernon
Professor in Psychiatry and Behavioral Sciences
Joseph McClernon, Ph.D., is a professor in the Department of Psychiatry and Behavioral
Sciences and founder/director of the Center for Addiction Science and Technology (CfAST).
In his four years with the Duke Clinical and Translational Science Institute (CTSI)
he has served as director of the Evaluation and Strategic Planning core, interim co-director
of the Team Science core, and director of the Integration and Strategic Partnerships
pillar. During his tenure with CTSI, his leadership has be

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