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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00609 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2013-0999 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Arm II (sham training) | Sham Comparator | Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computer-Assisted Smoking Cessation Intervention | Behavioral | Receive ABM training via a smartphone |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Robinson, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38934914 | Derived | 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. | |
| 35025555 | 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. |
| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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246 participants were randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I: Attention Bias Modification (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. |
| FG001 | Arm II: Sham Training |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 3, 2022 |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Nicotine Patch | Drug | Given via transdermal patch |
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| Questionnaire Administration | Other | Ancillary studies |
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| Sham Intervention | Other | Undergo sham training |
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| 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 |
Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I: Attention Bias Modification (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. |
| BG001 | Arm II: Sham Training | Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Years of education | Mean | Standard Deviation | years |
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| Number of Participants Employed | Count of Participants | Participants |
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| Fagerström Test for Nicotine Dependence (FTND) total score | The Fagerström Test for Nicotine Dependence (FTND), 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 | Standard Deviation | score on a scale |
| ||||||||||||||
| Cigarettes per day | Mean | Standard Deviation | cigarettes per day |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Least Squares Mean | Standard Error | milliseconds | Up to 8 weeks post-training |
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| Primary | 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. | Posted | Least Squares Mean | Standard Error | milisecond | Up to 8 weeks post-training |
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| Secondary | Cigarette Per Day (CPD) | Mean number of cigarettes per day smoked for the seven days preceding each time point. | Posted | Least Squares Mean | Standard Error | number of cigerettes | Up to 8 weeks post-training |
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| Secondary | Expired Carbon Monoxide (CO) | Mean expired carbon monoxide, in ppm (parts per million), at each time point. | Posted | Least Squares Mean | Standard Error | Parts Per Million | Up to 8 weeks post-training |
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| Secondary | Urinary Cotinine | Mean urinary cotinine, measured in ng/mL, at each time point. | Posted | Least Squares Mean | Standard Error | ng/mL | Up to 8 weeks post-training |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Up to 8 weeks post-training |
|
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Up to 8 weeks post-training |
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12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I: Attention Bias Modification (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. | 0 | 124 | 4 | 124 | 60 | 124 |
| EG001 | Arm II: Sham Training | Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks. | 0 | 122 | 2 | 122 | 67 | 122 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Chest pain - cardiac | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
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| Colonic obstruction | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal dreams | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Concentration impairment | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
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| Irritability | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
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| Mucosal infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Palpitations | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Stomach pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jason Robinson, PHD- Associate Professor, Behavioral Science | UT MD Anderson Cancer Center | (713) 792-0919 | jdrobinson@mdanderson.org |
| Jun 13, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 8-weeks post-training |
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