Effects of varenicline and cognitive bias modification on neural response to smoking-related cues: study protocol for a randomized controlled study.

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2014-10-07

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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.

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10.1186/1745-6215-15-391

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Attwood, Angela S, Tim Williams, Sally Adams, Francis J McClernon and Marcus R Munafò (2014). Effects of varenicline and cognitive bias modification on neural response to smoking-related cues: study protocol for a randomized controlled study. Trials, 15. p. 391. 10.1186/1745-6215-15-391 Retrieved from https://hdl.handle.net/10161/14612.

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Scholars@Duke

McClernon

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 been critical to building a culture of evaluation and continuous improvement, in strengthening the institute’s partnership with North Carolina Central University and other regional partners, and in planning strategy and development for the institute. 

 Dr. McClernon earned a Ph.D. in clinical psychology in 2001 from Southern Illinois University-Carbondale and completed a postdoctoral fellowship at Duke in 2002. He served as Director of the Addiction Division in Psychiatry and Behavioral Sciences from 2012-2020. His research is focused on increasing our understanding of tobacco use, developing new and more effective interventions to nicotine dependence, and informing the FDA’s regulation of tobacco products. He has served as a site-PI and Co-I for more than ten years in the Center for the Evaluation of Nicotine in Cigarettes (CENIC)— a national consortium that has provided the bulk of evidence to the FDA for informing national policies that will reduce nicotine in cigarettes to non-addictive levels, thus saving millions of lives. Dr. McClernon is now leading efforts to transition CENIC’s focus to public health interventions that ensure the new policy will be implemented in ways that enable equitable outcomes for marginalized groups. Other regulatory science research has evaluated the effects of nicotine in cigarettes on a model of cigarette experimentation, the impact of flavors in cigarettes and e-cigarettes, and the influence of product characteristics and policy on multiple tobacco product use. He has led other groundbreaking research on the influence of drug-associated environments on drug use, relapse, and treatment; tobacco use disparities among individuals with comorbid psychiatric (e.g., ADHD, serious mental illness) and health (e.g., HIV; chronic pain) problems.

Dr. McClernon has actively mentored early career individuals from high school students through early career faculty. His former postdoctoral fellows are faculty or staff scientists at academic medical centers, government agencies, and research institutes. He has been continuously NIH-, FDA-, and foundation- funded since 2002. He has authored/co-authored more than 170 peer-reviewed publications, has two patents, has served as chair of NIH grant review panels, and is the recipient of numerous awards including the Society for Research on Nicotine and Tobacco Jarvik-Russell New Investigator Award.


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