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

March 3, 2023 updated by: M.D. Anderson Cancer Center

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Up to 8 weeks post-training
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
Time Frame: Up to 8 weeks post-training
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)
Time Frame: Up to 8 weeks post-training
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)
Time Frame: Up to 8 weeks post-training
Mean expired carbon monoxide, in ppm (parts per million), at each time point.
Up to 8 weeks post-training
Urinary Cotinine
Time Frame: Up to 8 weeks post-training
Mean urinary cotinine, measured in ng/mL, at each time point.
Up to 8 weeks post-training
Fagerström Test for Nicotine Dependence (FTND)
Time Frame: Up to 8 weeks post-training
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
Time Frame: Up to 8 weeks post-training
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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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