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

M.D. Anderson Cancer Center311 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

311

Conditions

Current Every Day Smoker

Interventions

Computer-Assisted Smoking Cessation InterventionBEHAVIORAL

Receive ABM training via a smartphone

Laboratory Biomarker AnalysisOTHER

Correlative studies

Nicotine PatchDRUG

Given via transdermal patch

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

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.