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

Attwood AS, Williams T, Adams S, McClernon FJ, Munafò MR - Trials (2014)

Bottom Line: Here we present a protocol for an investigation of the neural effects of CBM and varenicline in non-quitting daily smokers.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.

View Article: PubMed Central - PubMed

Affiliation: Medical Research Council Integrative Epidemiology Unit, University of Bristol, 12a Priory Road, Bristol BS8 1TU, UK. angela.attwood@bristol.ac.uk.

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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Related in: MedlinePlus

CONSORT flow diagram. CBM, cognitive bias modification.
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Fig1: CONSORT flow diagram. CBM, cognitive bias modification.

Mentions: Current smokers (n =72; 50% male) will be recruited from the staff and students at the University of Bristol (United Kingdom) and the general population. A CONSORT diagram of participant recruitment is shown in Figure 1. Participants will be recruited through existing email lists and poster and flyer advertisements, and by word of mouth. Participants who are interested in taking part will be sent the study information sheets and a telephone screening will be arranged to assess basic eligibility. Those who meet the study inclusion criteria will be booked in for two sessions approximately one week apart. Participants will receive £70 compensation for their time for participation. Full written informed consent will be obtained from each participant at the start of the study session. Participants will be given a copy of the information and consent form to keep.Figure 1


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

Attwood AS, Williams T, Adams S, McClernon FJ, Munafò MR - Trials (2014)

CONSORT flow diagram. CBM, cognitive bias modification.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4197256&req=5

Fig1: CONSORT flow diagram. CBM, cognitive bias modification.
Mentions: Current smokers (n =72; 50% male) will be recruited from the staff and students at the University of Bristol (United Kingdom) and the general population. A CONSORT diagram of participant recruitment is shown in Figure 1. Participants will be recruited through existing email lists and poster and flyer advertisements, and by word of mouth. Participants who are interested in taking part will be sent the study information sheets and a telephone screening will be arranged to assess basic eligibility. Those who meet the study inclusion criteria will be booked in for two sessions approximately one week apart. Participants will receive £70 compensation for their time for participation. Full written informed consent will be obtained from each participant at the start of the study session. Participants will be given a copy of the information and consent form to keep.Figure 1

Bottom Line: Here we present a protocol for an investigation of the neural effects of CBM and varenicline in non-quitting daily smokers.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.

View Article: PubMed Central - PubMed

Affiliation: Medical Research Council Integrative Epidemiology Unit, University of Bristol, 12a Priory Road, Bristol BS8 1TU, UK. angela.attwood@bristol.ac.uk.

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.

Show MeSH
Related in: MedlinePlus