Attentional bias retraining in cigarette smokers attempting smoking cessatio

Completed

• Conditions: Smoking cessation; Mental and Behavioural Disorders; Mental and behavioural disorders due to use of tobacco

• Registration Number: ISRCTN54375405
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-15
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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

Name	Time	Method
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.