Smartphone-Delivered Attentional Bias Modification Training in Helping Patients Quit Smoking

Study Overview
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Brief Summary
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This randomized clinical trial studies how well a smartphone-delivered attentional bias modification training works in helping patients quit smoking. Smartphone-delivered attentional bias modification training may help patients quit smoking by reducing the attentional bias (the tendency of one's perception to be affected by their recurring thoughts) towards smoking cues that developed over time as a result of conditioning processes through which smoking cues become important.

Detailed Description
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PRIMARY OBJECTIVES: I. To determine the feasibility of smartphone-delivered, in-home attentional bias modification (ABM) to reduce attentional bias (AB) to smoking cues and to reduce smoking behavior in the short- and long-term. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks. ARM II: Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks. After completion of study treatment, patients are followed up on days 15, 29, 43, 57, and 72.

Official Title
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Smartphone-Delivered Attentional Bias Modification Training for Quitting Smokers

Conditions
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Current Every Day Smoker

Intervention / Treatment
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* Behavioral: Computer-Assisted Smoking Cessation Intervention
* Other: Laboratory Biomarker Analysis
* Drug: Nicotine Patch
* Other: Questionnaire Administration
* Other: Sham Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smoke an average of 5 or more cigarettes or little cigars per day (CPD) prior to telephone screen Produce an expired carbon monoxide (CO) level greater than or equal to 6 parts per million (ppm) or a NicAlert reading of > 2 Have a working telephone Interested in quitting smoking in the next 30 days Fluency in spoken and written English Must sign the picture consent form Exclusion Criteria: Taking psychotropic, anticonvulsive, or narcotic medication Meet criteria for a current major depressive episode or suicidality Have a history of neurological illness or closed head injury Report uncorrected vision problems Involved in current smoking cessation activity Testing positive on a urine drug screen for drugs of abuse/potential abuse Women who are pregnant or breastfeeding Considered by the investigator to be an unsuitable or unstable candidate (e.g., due to cognitive impairment) Shares the same address as a currently enrolled participant Unwilling to alter or remove hairstyle, hair extensions, or wig during the clinic visits to allow for correct electroencephalography (EEG) sensor placement Reports diagnosis of seizure disorder Unwilling to use nicotine replacement therapy (NRT) patches

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (ABM training)<br>Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks. | Behavioral: Computer-Assisted Smoking Cessation Intervention<br>* Receive ABM training via a smartphone<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Drug: Nicotine Patch<br>* Given via transdermal patch<br>* Other names: Nicotine Transdermal Patch;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Sham Comparator: Arm II (sham training)<br>Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks. | Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Drug: Nicotine Patch<br>* Given via transdermal patch<br>* Other names: Nicotine Transdermal Patch;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Sham Intervention<br>* Undergo sham training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Dot-probe Task | Modified dot-probe task evaluated by using 2 (group: ABM vs. sham) X 3 (session: baseline, 1-day post-training, and 8-weeks post-training) linear mixed model using RT difference scores (neutral-cigarette) as the dependent measures and subject as the random effect. | Up to 8 weeks post-training | 
| Smoking Stroop Task | The Stroop task will consist of three blocks, with a 5-s rest period between blocks: (a) practice (40 trials), (b) neutral words (80 trials), and (c) smoking words (80 trials). The score will be calculated by taking the mean RT difference between the smoking and neutral words on trials with correct responses within the response window. | Up to 8 weeks post-training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cigarette Per Day (CPD) | Mean number of cigarettes per day smoked for the seven days preceding each time point. | Up to 8 weeks post-training | 
| Expired Carbon Monoxide (CO) | Mean expired carbon monoxide, in ppm (parts per million), at each time point. | Up to 8 weeks post-training | 
| Urinary Cotinine | Mean urinary cotinine, measured in ng/mL, at each time point. | Up to 8 weeks post-training | 
| Fagerström Test for Nicotine Dependence (FTND) | The Fagerström Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine. Mean Fagerström Test for Nicotine Dependence (FTND) questionnaire score at each time point. | Up to 8 weeks post-training | 
| Wisconsin Smoking Withdrawal Scale (WSWS) - Craving | Mean Wisconsin Smoking Withdrawal Scale (WSWS) - Craving subscale score at each time point. Participants rate each item on a scale of 0-4 (0=Strongly disagree, 1=Disagree, 2=Feel neutral, 3=Agree, 4=Strongly agree). The subscale to each item is determined on how high they agree on the scale. Mean Wisconsin Smoking Withdrawal Scale (WSWS) - Craving subscale score at each time point. For some items, the subscale is determined on how low they agreed. Each score is determined by the mean of each item that applies. Higher means indicate greater withdrawal. | Up to 8 weeks post-training |