Clinical trial NCT02224391: Smartphone-Delivered Attentional Bias Modification Training in Helping Patients Quit Smoking
Official title: Smartphone-Delivered Attentional Bias Modification Training for Quitting Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Current Every Day Smoker
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-08-25
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Dot-probe Task
timeFrame: Up to 8 weeks post-training
measure: Smoking Stroop Task
timeFrame: Up to 8 weeks post-training
Secondary outcomes:
measure: Cigarette Per Day (CPD)
timeFrame: Up to 8 weeks post-training
measure: Expired Carbon Monoxide (CO)
timeFrame: Up to 8 weeks post-training
measure: Urinary Cotinine
timeFrame: Up to 8 weeks post-training
measure: Fagerström Test for Nicotine Dependence (FTND)
timeFrame: Up to 8 weeks post-training
measure: Wisconsin Smoking Withdrawal Scale (WSWS) - Craving
timeFrame: Up to 8 weeks post-training
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jason Robinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Robinson JD, Cui Y, Linares Abrego P, Engelmann JM, Prokhorov AV, Vidrine DJ, Shete S, Cinciripini PM. Sustained reduction of attentional bias to smoking cues by smartphone-delivered attentional bias modification training for smokers. Psychol Addict Behav. 2022 Nov;36(7):906-919. doi: 10.1037/adb0000805. Epub 2022 Jan 13.