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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

311 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-20

Study Completion Date

2021-03-15

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.

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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.

Conditions

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Current Every Day Smoker

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm I (ABM training)

Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.

Group Type EXPERIMENTAL

Computer-Assisted Smoking Cessation Intervention

Intervention Type BEHAVIORAL

Receive ABM training via a smartphone

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Nicotine Patch

Intervention Type DRUG

Given via transdermal patch

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm II (sham training)

Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.

Group Type SHAM_COMPARATOR

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Nicotine Patch

Intervention Type DRUG

Given via transdermal patch

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Sham Intervention

Intervention Type OTHER

Undergo sham training

Interventions

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Computer-Assisted Smoking Cessation Intervention

Receive ABM training via a smartphone

Intervention Type BEHAVIORAL

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Nicotine Patch

Given via transdermal patch

Intervention Type DRUG

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Sham Intervention

Undergo sham training

Intervention Type OTHER

Other Intervention Names

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NicoDerm CQ Nicotine Skin Patch Nicotine Transdermal Patch

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No