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

NCT02224391 | Completed Results FDA Drug

• 2 other identifiers: 2013-0999NCI-2015-00609
• Study Type: interventional
• Target: 311
• Locations: 1 country
• Sites: 1

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.

Conditions

Current Every Day Smoker

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 8 weeks post-training

• Smoking Stroop Task

  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.

  Up to 8 weeks post-training

Secondary Outcomes (5)

• Cigarette Per Day (CPD)

  Up to 8 weeks post-training

• Expired Carbon Monoxide (CO)

  Up to 8 weeks post-training

• Urinary Cotinine

  Up to 8 weeks post-training

• Fagerström Test for Nicotine Dependence (FTND)

  Up to 8 weeks post-training

• Wisconsin Smoking Withdrawal Scale (WSWS) - Craving

  Up to 8 weeks post-training

Study Arms (2)

Arm I (ABM training)

EXPERIMENTAL

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

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

Arm II (sham training)

SHAM COMPARATOR

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

Other: Laboratory Biomarker Analysis; Drug: Nicotine Patch; Other: Questionnaire Administration; Other: Sham Intervention

Interventions

Computer-Assisted Smoking Cessation Intervention BEHAVIORAL

Receive ABM training via a smartphone

Arm I (ABM training)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (ABM training); Arm II (sham training)

Nicotine Patch DRUG

Given via transdermal patch

Also known as: NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal Patch

Arm I (ABM training); Arm II (sham training)

Questionnaire Administration OTHER

Ancillary studies

Arm I (ABM training); Arm II (sham training)

Sham Intervention OTHER

Undergo sham training

Arm II (sham training)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Robinson JD, Cui Y, Engelmann JM, Kypriotakis G, Cinciripini PM. Using eye tracking to evaluate the impact of smartphone-delivered attentional bias modification training for smokers. Exp Clin Psychopharmacol. 2024 Dec;32(6):728-736. doi: 10.1037/pha0000729. Epub 2024 Jun 27.

  PMID: 38934914 DERIVED

• 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.

  PMID: 35025555 DERIVED

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Tobacco Use Cessation Devices; Nicotine

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Jason Robinson, PHD- Associate Professor, Behavioral Science
• Organization: UT MD Anderson Cancer Center

jdrobinson@mdanderson.org

(713) 792-0919

Study Officials

• Jason Robinson, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 25, 2014
• Study Start: January 20, 2016
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: March 7, 2023
• Results First Posted: September 28, 2022

Record last verified: 2023-03

Locations

US (1)