Extract

Background and study aims Many smokers find quitting smoking extremely difficult and failure rates are high. It has been shown that cues associated with smoking (e.g., cigarette packets, smell of smoke) can lead to cigarette cravings. Also, smokers may find that their attention is drawn to smoking cues significantly more than other objects or cues in the environment. This capturing of attention by smoking-related cues is an example of what is known as a 'cognitive bias'. Cognitive biases for smoking cues may lead to increased craving for cigarettes and interfere with attempts to stop smoking. Given this link between cognitive bias and smoking, programmes aimed at reducing cognitive bias are considered promising targets for quitting smoking. Recent research indicates that it is possible to 'train' attention away from drug cues using a computer-based programme known as cognitive bias modification (CBM). Therefore in this study we propose to find out the impact of a CBM procedure on the brain's responses to smoking-related cues. Additionally, a licenced smoking cessation drug, varenicline, has also been proposed to change responses to smoking-related cues. Varenicline may therefore increase the effects of CBM on responses to smoking cues. Who can participate? The study will enrol regular daily smokers (at least 10 cigarettes or 15 roll-ups per day), who smoke within one hour of waking in the morning. What does the study involve? The participants will be randomly allocated to either a training group or a drug group. Participants in the drug group will be randomly allocated to receive either varenicline or a placebo (dummy) tablet. Participants in the training group will be randomly allocated to receive either CBM to induce cognitive bias away from smoking-related cues, CBM to induce cognitive bias towards smoking-related cues, or a treatment designed to induce no change in cognitive bias. They will undergo a brain scan to find out the responses to smoking-related cues and cognitive bias towards smoking-related cues. Cigarette craving and nicotine withdrawal will also be analysed. What are the potential benefits and risks of participation? Information we get from this study may help us to understand and treat cigarette smokers who have difficulty stopping in the future. The study medication (varenicline) is a licensed smoking cessation aid. It has been associated with some side effects. The more common side effects are fatigue, sleeplessness/abnormal dreams and vomiting, which may cause discomfort but are not considered dangerous or life-threatening. Where will the study be run from? The study will be run from Clinical Research and Imaging Centre (CRICBristol), University of Bristol, Bristol, UK. When is the study starting and how long will it be expected to run for? The study ran from August 2012 to February 2013. Who is funding the study? The study funded by Pfizer Inc. (UK). Who is the main contact? Dr Sally Adams [email protected]

Inclusion criteria

• SMOKING CESSATION

Links

• isrctn
• ictrp