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

Not Applicable

Completed

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

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Arm II (sham training)	Sham Intervention	Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
Arm I (ABM training)	Computer-Assisted Smoking Cessation Intervention	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 I (ABM training)	Laboratory Biomarker Analysis	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 I (ABM training)	Questionnaire Administration	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 (sham training)	Laboratory Biomarker Analysis	Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
Arm II (sham training)	Nicotine Patch	Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
Arm I (ABM training)	Nicotine Patch	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 (sham training)	Questionnaire Administration	Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.

Primary Outcome Measures

Name	Time	Method
Smoking Stroop Task	Up to 8 weeks post-training	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.
Modified Dot-probe Task	Up to 8 weeks post-training	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.

Secondary Outcome Measures

Name	Time	Method
Fagerström Test for Nicotine Dependence (FTND)	Up to 8 weeks post-training	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.
Cigarette Per Day (CPD)	Up to 8 weeks post-training	Mean number of cigarettes per day smoked for the seven days preceding each time point.
Wisconsin Smoking Withdrawal Scale (WSWS) - Craving	Up to 8 weeks post-training	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.
Urinary Cotinine	Up to 8 weeks post-training	Mean urinary cotinine, measured in ng/mL, at each time point.
Expired Carbon Monoxide (CO)	Up to 8 weeks post-training	Mean expired carbon monoxide, in ppm (parts per million), at each time point.