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

M.D. Anderson Cancer Center

Status: Completed

Conditions: Current Every Day Smoker

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02224391

NCI-2015-00609 (Registry Identifier)

2013-0999 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 311 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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311 participants in 2 patient groups

Arm I (ABM training)

Experimental group

Description:

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

Treatment:

Behavioral: Computer-Assisted Smoking Cessation Intervention

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration

Drug: Nicotine Patch

Arm II (sham training)

Sham Comparator group

Description:

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

Treatment:

Other: Sham Intervention

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration

Drug: Nicotine Patch