Condition category
Mental and Behavioural Disorders
Date applied
09/07/2012
Date assigned
30/01/2014
Last edited
29/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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
sally.adams@bristol.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marcus Munafò

ORCID ID

Contact details

University of Bristol
School of Experimental Psychology
12A Priory Road
Bristol
BS8 1TU
United Kingdom
+44 (0)117 954 6841
marcus.munafo@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UoB:1407

Study information

Scientific title

Effects of varenicline and cognitive bias modification on neural response to smoking-related cues

Acronym

Study hypothesis

1. We hypothesise that experimental procedures designed to induce cognitive bias towards smoking-relates cues will lead to an increase in neural response to smoking-related cues, in brain regions previously implicated in cue reactivity in cigarette smokers.
2. We hypothesise that experimental procedures designed to induce cognitive bias away from smoking-relates cues will lead to a decrease in neural response to smoking-related cues, in brain regions previously implicated in cue reactivity in cigarette smokers.
3. We hypothesise that experimental procedures designed to induce cognitive bias away from smoking-relates cues will lead to a decrease in cognitive bias from pre-training to post-training.
4. We hypothesise that experimental procedures designed to induce cognitive bias towards smoking-relates cues will lead to an increase in cognitive bias from pre-training to post-training
5. We hypothesise that changes in the neural response to smoking-related cues relative to neutral cues, and changes in attentional bias, will be greatest in those trained to attend away from smoking-related cues and treated with varenicline.

Ethics approval

NRES Committee Brent, London, 07/02/2012, ref: 11/LO/1726

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Patient information can be found at: http://www.bris.ac.uk/expsych/research/brain/targ/participants/cbmsally.html

Condition

Smoking cessation

Intervention

Participants are randomised to the training group or the drug group

Drug group:
Participants would receive either varenicline or placebo in tablet form. Varenicline would be taken as 0.5 mg once daily for days 1-3, and 0.5 mg twice daily for days 4-6, and 0.5 mg once daily for day 7, consistent with standard dosing regimen for smoking cessation. All outcome measures would be assessed on day 7.

Training group:
Participants are randomised to three groups:
1. An experimental condition designed to induce cognitive bias away from smoking-related cues
2. An experimental condition designed to induce cognitive bias towards smoking-related cues
3. A control condition designed to induce no change in cognitive bias

Intervention type

Drug

Phase

Not Applicable

Drug names

Varenicline

Primary outcome measures

1. Neural responses to smoking-related cues
2. Cognitive bias

Secondary outcome measures

1. Questionnaire of Smoking Urges
2. Minnesota Nicotine Withdrawal Scale (MNWS)

Overall trial start date

23/07/2012

Overall trial end date

28/02/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Smokes > 10 manufactured cigarettes or > 15 roll up cigarettes per day
2. Smokes within one hour of waking
3. Aged between 18 and 40 years
4. Able to attend all of the study session
5. English as first language or equivalent level of fluency

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

72

Participant exclusion criteria

1. Female volunteers who are pregnant or breast feeding
2. Female volunteers not using adequate contraception
3. Volunteers who do not currently have a GP
4. Current or previous substance or alcohol misuse or dependence [other than nicotine]
5. Alcohol use in excess of 35 Units/week if female or 50 Units/week if male
6. Caffeine use ≥ 8 cups per day
7. Significant current or past psychiatric illness (Axis 1 or 2 psychiatric diagnoses) as diagnosed by a psychiatrist
8. Clinically significant abnormality including cardiology risk factors and history of arrhythmia (as assessed by self-report)
9. Ongoing use of medication (i.e. intake of any medication within 8 weeks of study, with exception of local treatment and occasional paracetamol or non-steroidal anti-inflammatory drugs, e.g., aspirin or ibuprofen)
10. Smokers actively trying to give up smoking during the study period
11. Uncorrected visual impairment (including colour-blindness)
12. Uncorrected auditory impairment
13. Condition that makes MRI scanning unsafe (e.g. metallic implants; history of metal-working)
14. Unable to tolerate scanning environment (as established during a short anatomical MRI scan on day 0)
15. Hypersensitivity to Champix

Recruitment start date

23/07/2012

Recruitment end date

28/02/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bristol
Bristol
BS8 1TU
United Kingdom

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

Research and Enterprise Development
3rd Floor
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom
+44 (0)117 928 8676
Red-Office@bristol.ac.uk

Sponsor type

Not defined

Website

http://www.bris.ac.uk/red/

Funders

Funder type

Industry

Funder name

Pfizer Inc. (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Bristol (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

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

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25294104

Publication citations

Additional files

Editorial Notes