Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RG_09-156
Study information
Scientific title
A randomised controlled trial of attentional bias retraining in cigarette smokers attempting smoking cessation
Acronym
ARTS
Study hypothesis
Smokers often attend differentially to objects in their environment by exhibiting an 'attentional bias' or readiness to process cues related to smoking over other types of cues. There is evidence that attentional bias can alter processes like craving, which may increase the risk of relapse in smokers who are trying to quit. A translational study is proposed here to examine the effectiveness of computerised attentional bias retraining to change the way smokers respond to smoking-related cues. The trial will examine the strength of association between attentional bias and urges to smoke, whether attentional bias is associated with an increased probability of relapse and the effects of attentional bias retraining in cigarette smokers attempting cessation.
The trial will randomise smokers to either an intervention group who will receive attentional retraining or a control group who will receive a placebo procedure completed in a clinic on a laptop computer, while standard smoking cessation medication and NHS behavioural support is provided.
Ethics approval
South Staffordshire Research Ethics Committee (REC) – approval pending as of 25/02/2010
Study design
Single-centre feasibility double-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Smoking cessation
Intervention
Participants attending a seven-session weekly NHS stop smoking clinic will be randomised to either an intervention group receiving a modified visual probe task consisting of attentional retraining (AR) or a control group who receive a modified visual probe task of placebo training (PT). Both groups will undergo 6 weekly sessions of either AR or PT, starting one week prior to quit day and then be given on quit day and at weeks 1, 2, 3 and 4. Attentional bias will be assessed during test trials of the visual probe task, two weeks and one week prior to quit day, on quit day and at weeks 1, 2, 3, 4 and again at follow-up at 8 weeks, 3 months and 6 months post-quit. The procedure that assesses attentional bias and trains smokers runs off a computer and will take between 20 - 30 minutes to complete.
Participants in both the intervention group and control group will use 21 mg/24 hour transdermal nicotine patches, starting one week prior to quit day and lasting 8 - 12 weeks following quit day. Nicotine patch dose will be adjusted accordingly for light smokers, based on exhaled carbon monoxide and nicotine dependence measured using the Fagerstrom Test of Nicotine Dependence (FTND). Behavioural support starts 2 weeks before quit day and lasts 4 weeks following quit day, which follows the typical 7-session UK withdrawal orientated therapy programme.
Both groups will be given a cue exposure procedure to test subjective craving immediately after completion of the visual probe tasks at 4 weeks and follow-up sessions at 8 weeks, 3 months and 6 months. They will be instructed to handle an unlit cigarette and provide ratings of urges to smoke.
Participants will also be trained to use a hand-held electronic diary to capture withdrawal and behaviour as it happens on a day-by-day basis. Participants will use the diaries from two weeks prior to their designated quit date to 6 weeks post-quit.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Assessment of attentional bias during test trials of the visual probe task, as measured by reaction time data. This will be assessed in abstinent smokers at 4 weeks post-quit.
2. Strength of urge to smoke and withdrawal symptoms measured using the Mood and Physical Symptoms Scale (MPSS) measured prior to and at the end of the cue-exposure task at 4 weeks, 8 weeks, 3 months and 6 months in abstinent smokers and using the electronic diaries from baseline to 6 weeks post-quit
Secondary outcome measures
Prolonged abstinence measured and biochemically validated at 4 weeks, 8 weeks, 3 months and 6 months post-quit, using the Russell standard (allows a two week grace period from quit day for slips). Abstinence will be assessed by means of expired carbon monoxide reading, with a cut-off point of less than 10 ppm.
Overall trial start date
01/07/2010
Overall trial end date
31/03/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 years or over, either sex
2. Smokes at least 10 cigarettes per day or blows greater than or equal to 10 on carbon monoxide (CO) monitor
3. Have normal or corrected-to-normal vision
4. Be able and willing to complete all study procedures
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
Participants will be excluded if they present with any of the following:
1. A medical condition that prevents them seeing the computerised images properly, attending to the task, or pressing the keyboard buttons on the computer accurately, or completing any other study procedures
2. Are currently using other nicotene replacement therapy (NRT), bupropion, nortriptyline, mecamylamine, reserpine, or varenicline, or undergoing any treatment for tobacco dependence (e.g. acupuncture)
3. Unstable angina pectoris, myocardial infarction, or cerebrovascular accident during the last 3 weeks
4. Severe cardiac arrhythmia
5. Currently uncontrolled hyperthyroidism
6. Active phaeocromocytoma
7. Suspected alcohol or drug abuse
8. Are taking part in other medicinal trials during study participation
9. Have previously had severe skin reactions to nicotine patches or severe eczema or other skin diseases that make patch use hazardous or undesirable
10. Severe acute or chronic medical or psychiatric condition or previously diagnosed clinically important renal or hepatic disease, which may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study
Recruitment start date
01/07/2010
Recruitment end date
31/03/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UK Centre for Tobacco Control Studies
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
c/o Brendan Laverty
Research and Enterprise Services
Edgbaston
Birmingham
B15 2TT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Doctoral Research Fellowship (DRF) (ref: DRF-2009-02-15)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24330656
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25697911
Publication citations
-
Protocol
Begh R, Munafò MR, Shiffman S, Ferguson SG, Nichols L, Mohammed MA, Holder RL, Sutton S, Aveyard P, Attentional bias retraining in cigarette smokers attempting smoking cessation (ARTS): study protocol for a double blind randomised controlled trial., BMC Public Health, 2013, 13, 1176, doi: 10.1186/1471-2458-13-1176.
-
Results
Begh R, Munafò MR, Shiffman S, Ferguson SG, Nichols L, Mohammed MA, Holder RL, Sutton S, Aveyard P, Lack of attentional retraining effects in cigarette smokers attempting cessation: A proof of concept double-blind randomised controlled trial, Drug Alcohol Depend, 2015 , doi: 10.1016/j.drugalcdep.2015.01.041.