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NCT02224391

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

Completed NA Results posted Last updated 7 March 2023
What this trial tests

NA trial testing Computer-Assisted Smoking Cessation Intervention in Current Every Day Smoker in 311 participants. Completed in 15 March 2021.

Timeline
20 January 2016
Primary endpoint
15 March 2021
15 March 2021

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment311
Start date20 January 2016
Primary completion15 March 2021
Estimated completion15 March 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

Adults 18 to 65, any sex, with Current Every Day Smoker. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Modified Dot-probe Task Primary · 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.

Baseline
GroupValue95% CI
Arm I: Attention Bias Modification (ABM) Training5.49± 0.99
Arm II: Sham Training7.49± 1
1-day post-training
GroupValue95% CI
Arm I: Attention Bias Modification (ABM) Training2.42± 1.04
Arm II: Sham Training9.85± 1.03
8-weeks post-training
GroupValue95% CI
Arm I: Attention Bias Modification (ABM) Training4.94± 1.19
Arm II: Sham Training9.48± 1.14
Smoking Stroop Task Primary · 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.

Baseline
GroupValue95% CI
Arm I: Attention Bias Modification (ABM) Training-6.57± 4.11
Arm II: Sham Training4.94± 4.15
1-day post-training
GroupValue95% CI
Arm I: Attention Bias Modification (ABM) Training-2.38± 4.31
Arm II: Sham Training3.73± 4.29
8-weeks post-training
GroupValue95% CI
Arm I: Attention Bias Modification (ABM) Training-4.59± 4.94
Arm II: Sham Training10.97± 4.7
Cigarette Per Day (CPD) Secondary · Up to 8 weeks post-training

Mean number of cigarettes per day smoked for the seven days preceding each time point.

Baseline
GroupValue95% CI
Arm I: Attention Bias Modification (ABM) Training18.1± 0.8
Arm II: Sham Training18.45± 0.81
1-day post-training
GroupValue95% CI
Arm I: Attention Bias Modification (ABM) Training14.94± 0.82
Arm II: Sham Training14.78± 0.83
8-weeks post-training
GroupValue95% CI
Arm I: Attention Bias Modification (ABM) Training8.29± 0.9
Arm II: Sham Training7.52± 0.87
Expired Carbon Monoxide (CO) Secondary · Up to 8 weeks post-training

Mean expired carbon monoxide, in ppm (parts per million), at each time point.

Baseline
GroupValue95% CI
Arm I: Attention Bias Modification (ABM) Training22.41± 1.1
Arm II: Sham Training22.27± 1.11
1-day post-training
GroupValue95% CI
Arm I: Attention Bias Modification (ABM) Training22.28± 1.13
Arm II: Sham Training22.95± 1.13
8-day post-training
GroupValue95% CI
Arm I: Attention Bias Modification (ABM) Training12.54± 1.24
Arm II: Sham Training12.99± 1.19
Urinary Cotinine Secondary · Up to 8 weeks post-training

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

Baseline
GroupValue95% CI
Arm I: Attention Bias Modification (ABM) Training7.11± .99
Arm II: Sham Training7.12± .09
1-Day post-training
GroupValue95% CI
Arm I: Attention Bias Modification (ABM) Training6.91± .09
Arm II: Sham Training6.99± .09
8-Day post-training
GroupValue95% CI
Arm I: Attention Bias Modification (ABM) Training6.16± .12
Arm II: Sham Training6.61± .12
Fagerström Test for Nicotine Dependence (FTND) Secondary · 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.

Baseline
GroupValue95% CI
Arm I: Attention Bias Modification (ABM) Training4.84± 0.19
Arm II: Sham Training4.96± 0.19
1-day post-training
GroupValue95% CI
Arm I: Attention Bias Modification (ABM) Training4.34± 0.2
Arm II: Sham Training4.05± 0.2
8-weeks post-training
GroupValue95% CI
Arm I: Attention Bias Modification (ABM) Training2.93± 0.21
Arm II: Sham Training2.65± 0.21
Wisconsin Smoking Withdrawal Scale (WSWS) - Craving Secondary · 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.

Baseline
GroupValue95% CI
Arm I: Attention Bias Modification (ABM) Training9.9± 0.29
Arm II: Sham Training9.76± 0.29
1-day post-training
GroupValue95% CI
Arm I: Attention Bias Modification (ABM) Training8.36± 0.3
Arm II: Sham Training8.52± 0.3
8-weeks post-training
GroupValue95% CI
Arm I: Attention Bias Modification (ABM) Training6.92± 0.34
Arm II: Sham Training6.73± 0.32

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm I: Attention Bias Modification (ABM) Training
Serious: 4/124 (3%)
Deaths: 0/124
Arm II: Sham Training
Serious: 2/122 (2%)
Deaths: 0/122

Serious adverse events (6 terms)

ReactionSystemArm I: Attention Bias Modi…Arm II: Sham Training
Back painMusculoskeletal and connective tissue disorders
Chest pain - cardiacCardiac disorders
Colonic obstructionGastrointestinal disorders
InsomniaPsychiatric disorders
Pain in extremityMusculoskeletal and connective tissue disorders
Suicide attemptPsychiatric disorders
Other adverse events (22 terms — click to expand)

ReactionSystemArm I: Attention Bias Modi…Arm II: Sham Training
PruritusSkin and subcutaneous tissue disorders
Abnormal dreamsNervous system disorders
InsomniaPsychiatric disorders
NauseaGastrointestinal disorders
DizzinessNervous system disorders
HeadacheNervous system disorders
ArthralgiaMusculoskeletal and connective tissue disorders
Back painMusculoskeletal and connective tissue disorders
ConstipationGastrointestinal disorders
DiarrheaGastrointestinal disorders
Mucosal infectionInfections and infestations
AnxietyPsychiatric disorders
Concentration impairmentNervous system disorders
CoughRespiratory, thoracic and mediastinal disorders
DepressionPsychiatric disorders
Dry mouthGastrointestinal disorders
FatigueGeneral disorders
FlatulenceGastrointestinal disorders
IrritabilityPsychiatric disorders
Pain in extremityMusculoskeletal and connective tissue disorders
PalpitationsCardiac disorders
Stomach painGastrointestinal disorders

Most-reported serious reactions: Back pain, Chest pain - cardiac, Colonic obstruction, Insomnia, Pain in extremity, Suicide attempt.

Data from ClinicalTrials.gov NCT02224391 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Sustained reduction of attentional bias to smoking cues by smartphone-delivered attentional bias modification training for smokers.
    Robinson JD, Cui Y, Linares Abrego P, Engelmann JM, et al · · 2022 · cited 13× · PMID 35025555 · DOI 10.1037/adb0000805
  2. Using eye tracking to evaluate the impact of smartphone-delivered attentional bias modification training for smokers.
    Robinson JD, Cui Y, Engelmann JM, Kypriotakis G, et al · · 2024 · PMID 38934914 · DOI 10.1037/pha0000729

Verify or expand the search:

Other trials of Computer-Assisted Smoking Cessation Intervention

Trials testing the same drug.

Other recruiting trials for Current Every Day Smoker

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02224391.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing