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Completed

NCT Number: NCT02224391

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer-Assisted Smoking Cessation Intervention

Behavioral

Receive ABM training via a smartphone

laboratory biomarker analysis

Other

Correlative studies

Nicotine patch

Drug

Given via transdermal patch

Other names: NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal Patch

Questionnaire Administration

Other

Ancillary studies

Sham intervention

Other

Undergo sham training

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Urinary Cotinine

    Time frame: Up to 8 weeks post-training

    Mean urinary cotinine, measured in ng/mL, at each time point.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Smartphone-Delivered Attentional Bias Modification Training for Quitting Smokers

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Aug 25, 2014
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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