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

Smartphone-Delivered Attentional Bias Modification Training for Quitting Smokers

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.

Study Overview

• Status: Completed
• Conditions: Current Every Day Smoker
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Behavioral: Computer-Assisted Smoking Cessation Intervention; Drug: Nicotine Patch; Other: Sham Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 311
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Questionnaire Administration; Ancillary studies; Behavioral: Computer-Assisted Smoking Cessation Intervention; Receive ABM training via a smartphone; Drug: Nicotine Patch; Given via transdermal patch; Other Names: NicoDerm CQ; Nicotine Skin Patch; Nicotine Transdermal Patch
Sham Comparator: Arm II (sham training); Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Questionnaire Administration; Ancillary studies; Drug: Nicotine Patch; Given via transdermal patch; Other Names: NicoDerm CQ; Nicotine Skin Patch; Nicotine Transdermal Patch; Other: Sham Intervention; Undergo sham training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cigarette Per Day (CPD)	Mean number of cigarettes per day smoked for the seven days preceding each time point.	Up to 8 weeks post-training
Expired Carbon Monoxide (CO)	Mean expired carbon monoxide, in ppm (parts per million), at each time point.	Up to 8 weeks post-training
Urinary Cotinine	Mean urinary cotinine, measured in ng/mL, at each time point.	Up to 8 weeks post-training
Fagerström Test for Nicotine Dependence (FTND)	The Fagerström Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine. Mean Fagerström Test for Nicotine Dependence (FTND) questionnaire score at each time point.	Up to 8 weeks post-training
Wisconsin Smoking Withdrawal Scale (WSWS) - Craving	Mean Wisconsin Smoking Withdrawal Scale (WSWS) - Craving subscale score at each time point. Participants rate each item on a scale of 0-4 (0=Strongly disagree, 1=Disagree, 2=Feel neutral, 3=Agree, 4=Strongly agree). The subscale to each item is determined on how high they agree on the scale. Mean Wisconsin Smoking Withdrawal Scale (WSWS) - Craving subscale score at each time point. For some items, the subscale is determined on how low they agreed. Each score is determined by the mean of each item that applies. Higher means indicate greater withdrawal.	Up to 8 weeks post-training

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jason Robinson, MD, M.D. Anderson Cancer Center

Publications and helpful links

General Publications

• 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.

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2016
• Primary Completion (Actual): March 15, 2021
• Study Completion (Actual): March 15, 2021

Study Registration Dates

• First Submitted: August 21, 2014
• First Submitted That Met QC Criteria: August 22, 2014
• First Posted (Estimate): August 25, 2014

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2013-0999 (Other Identifier: M D Anderson Cancer Center); NCI-2015-00609 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No