title: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Registered with Current Controlled Trials: ISRCTN65690030. Registered on 30 January 2014.
authors.affiliation: Medical Research Council Integrative Epidemiology Unit, University of Bristol, 12a Priory Road, Bristol BS8 1TU, UK. angela.attwood@bristol.ac.uk.
authors.forename: Angela S
authors.initials: AS
authors.lastname: Attwood
authors.forename: Tim
authors.initials: T
authors.lastname: Williams
authors.forename: Sally
authors.initials: S
authors.lastname: Adams
authors.forename: Francis J
authors.initials: FJ
authors.lastname: McClernon
authors.forename: Marcus R
authors.initials: MR
authors.lastname: Munafò
mesh_terms: D000339:Affect; D001552:Benzazepines / Q000627:therapeutic use*; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D066249:Craving; D003463:Cues; D004739:England; D006801:Humans; D008279:Magnetic Resonance Imaging; D018722:Nicotinic Agonists / Q000627:therapeutic use*; D011810:Quinoxalines / Q000627:therapeutic use*; D012107:Research Design; D012907:Smoking / Q000523:psychology; D016540:Smoking Cessation / Q000379:methods*; D000074606:Smoking Prevention; D057190:Stroop Test; D011795:Surveys and Questionnaires; D013997:Time Factors; D014029:Tobacco Use Disorder / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D016896:Treatment Outcome; D000068580:Varenicline
chemical_list: D001552:Benzazepines; D018722:Nicotinic Agonists; D011810:Quinoxalines; D000068580:Varenicline