Current Every Day Smoker
Conditions
Brief summary
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.
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.
Interventions
Receive ABM training via a smartphone
OTHERLaboratory Biomarker Analysis
Correlative studies
DRUGNicotine Patch
Given via transdermal patch
OTHERQuestionnaire Administration
Ancillary studies
OTHERSham Intervention
Undergo sham training
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Dot-probe Task | 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. |
| Smoking Stroop Task | 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
| Measure | Time frame | Description |
|---|---|---|
| Urinary Cotinine | Up to 8 weeks post-training | Mean urinary cotinine, measured in ng/mL, at each time point. |
| Cigarette Per Day (CPD) | Up to 8 weeks post-training | Mean number of cigarettes per day smoked for the seven days preceding each time point. |
| Wisconsin Smoking Withdrawal Scale (WSWS) - Craving | 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. |
| Fagerström Test for Nicotine Dependence (FTND) | 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. |
| Expired Carbon Monoxide (CO) | Up to 8 weeks post-training | Mean expired carbon monoxide, in ppm (parts per million), at each time point. |
Countries
United States
Participant flow
Pre-assignment details
246 participants were randomized
Participants by arm
| Arm | Count |
|---|---|
| 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. | 124 |
| Arm II: Sham Training Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks. | 122 |
| Total | 246 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 26 | 19 |
| Overall Study | Withdrawal by Subject | 6 | 5 |
Baseline characteristics
| Characteristic | Arm I: Attention Bias Modification (ABM) Training | Arm II: Sham Training | Total |
|---|---|---|---|
| Age, Continuous | 47.27 years STANDARD_DEVIATION 10.13 | 45.28 years STANDARD_DEVIATION 11.65 | 46.28 years STANDARD_DEVIATION 10.93 |
| Cigarettes per day | 18.14 cigarettes per day STANDARD_DEVIATION 8.87 | 18.48 cigarettes per day STANDARD_DEVIATION 9.27 | 18.31 cigarettes per day STANDARD_DEVIATION 9.05 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 14 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 108 Participants | 108 Participants | 216 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Fagerström Test for Nicotine Dependence (FTND) total score | 4.82 score on a scale STANDARD_DEVIATION 2.14 | 4.96 score on a scale STANDARD_DEVIATION 2.11 | 4.89 score on a scale STANDARD_DEVIATION 2.12 |
| Number of Participants Employed | 83 Participants | 96 Participants | 179 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants | 22 Participants | 56 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 5 Participants | 11 Participants |
| Race (NIH/OMB) White | 80 Participants | 92 Participants | 172 Participants |
| Region of Enrollment United States | 124 participants | 122 participants | 246 participants |
| Sex: Female, Male Female | 45 Participants | 44 Participants | 89 Participants |
| Sex: Female, Male Male | 79 Participants | 78 Participants | 157 Participants |
| Years of education | 13.35 years STANDARD_DEVIATION 1.86 | 13.72 years STANDARD_DEVIATION 2 | 13.53 years STANDARD_DEVIATION 1.94 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 124 | 0 / 122 |
| other Total, other adverse events | 60 / 124 | 67 / 122 |
| serious Total, serious adverse events | 4 / 124 | 2 / 122 |
Outcome results
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.
Time frame: Up to 8 weeks post-training
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I: Attention Bias Modification (ABM) Training | Modified Dot-probe Task | Baseline | 5.49 milliseconds | Standard Error 0.99 |
| Arm I: Attention Bias Modification (ABM) Training | Modified Dot-probe Task | 1-day post-training | 2.42 milliseconds | Standard Error 1.04 |
| Arm I: Attention Bias Modification (ABM) Training | Modified Dot-probe Task | 8-weeks post-training | 4.94 milliseconds | Standard Error 1.19 |
| Arm II: Sham Training | Modified Dot-probe Task | 1-day post-training | 9.85 milliseconds | Standard Error 1.03 |
| Arm II: Sham Training | Modified Dot-probe Task | Baseline | 7.49 milliseconds | Standard Error 1 |
| Arm II: Sham Training | Modified Dot-probe Task | 8-weeks post-training | 9.48 milliseconds | Standard Error 1.14 |
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.
Time frame: Up to 8 weeks post-training
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I: Attention Bias Modification (ABM) Training | Smoking Stroop Task | Baseline | -6.57 milisecond | Standard Error 4.11 |
| Arm I: Attention Bias Modification (ABM) Training | Smoking Stroop Task | 1-day post-training | -2.38 milisecond | Standard Error 4.31 |
| Arm I: Attention Bias Modification (ABM) Training | Smoking Stroop Task | 8-weeks post-training | -4.59 milisecond | Standard Error 4.94 |
| Arm II: Sham Training | Smoking Stroop Task | Baseline | 4.94 milisecond | Standard Error 4.15 |
| Arm II: Sham Training | Smoking Stroop Task | 1-day post-training | 3.73 milisecond | Standard Error 4.29 |
| Arm II: Sham Training | Smoking Stroop Task | 8-weeks post-training | 10.97 milisecond | Standard Error 4.7 |
Secondary
Cigarette Per Day (CPD)
Mean number of cigarettes per day smoked for the seven days preceding each time point.
Time frame: Up to 8 weeks post-training
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I: Attention Bias Modification (ABM) Training | Cigarette Per Day (CPD) | Baseline | 18.1 number of cigerettes | Standard Error 0.8 |
| Arm I: Attention Bias Modification (ABM) Training | Cigarette Per Day (CPD) | 1-day post-training | 14.94 number of cigerettes | Standard Error 0.82 |
| Arm I: Attention Bias Modification (ABM) Training | Cigarette Per Day (CPD) | 8-weeks post-training | 8.29 number of cigerettes | Standard Error 0.9 |
| Arm II: Sham Training | Cigarette Per Day (CPD) | Baseline | 18.45 number of cigerettes | Standard Error 0.81 |
| Arm II: Sham Training | Cigarette Per Day (CPD) | 1-day post-training | 14.78 number of cigerettes | Standard Error 0.83 |
| Arm II: Sham Training | Cigarette Per Day (CPD) | 8-weeks post-training | 7.52 number of cigerettes | Standard Error 0.87 |
Secondary
Expired Carbon Monoxide (CO)
Mean expired carbon monoxide, in ppm (parts per million), at each time point.
Time frame: Up to 8 weeks post-training
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I: Attention Bias Modification (ABM) Training | Expired Carbon Monoxide (CO) | Baseline | 22.41 Parts Per Million | Standard Error 1.1 |
| Arm I: Attention Bias Modification (ABM) Training | Expired Carbon Monoxide (CO) | 1-day post-training | 22.28 Parts Per Million | Standard Error 1.13 |
| Arm I: Attention Bias Modification (ABM) Training | Expired Carbon Monoxide (CO) | 8-day post-training | 12.54 Parts Per Million | Standard Error 1.24 |
| Arm II: Sham Training | Expired Carbon Monoxide (CO) | 8-day post-training | 12.99 Parts Per Million | Standard Error 1.19 |
| Arm II: Sham Training | Expired Carbon Monoxide (CO) | Baseline | 22.27 Parts Per Million | Standard Error 1.11 |
| Arm II: Sham Training | Expired Carbon Monoxide (CO) | 1-day post-training | 22.95 Parts Per Million | Standard Error 1.13 |
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.
Time frame: Up to 8 weeks post-training
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I: Attention Bias Modification (ABM) Training | Fagerström Test for Nicotine Dependence (FTND) | Baseline | 4.84 score on a scale | Standard Error 0.19 |
| Arm I: Attention Bias Modification (ABM) Training | Fagerström Test for Nicotine Dependence (FTND) | 1-day post-training | 4.34 score on a scale | Standard Error 0.2 |
| Arm I: Attention Bias Modification (ABM) Training | Fagerström Test for Nicotine Dependence (FTND) | 8-weeks post-training | 2.93 score on a scale | Standard Error 0.21 |
| Arm II: Sham Training | Fagerström Test for Nicotine Dependence (FTND) | Baseline | 4.96 score on a scale | Standard Error 0.19 |
| Arm II: Sham Training | Fagerström Test for Nicotine Dependence (FTND) | 1-day post-training | 4.05 score on a scale | Standard Error 0.2 |
| Arm II: Sham Training | Fagerström Test for Nicotine Dependence (FTND) | 8-weeks post-training | 2.65 score on a scale | Standard Error 0.21 |
Secondary
Urinary Cotinine
Mean urinary cotinine, measured in ng/mL, at each time point.
Time frame: Up to 8 weeks post-training
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I: Attention Bias Modification (ABM) Training | Urinary Cotinine | 1-Day post-training | 6.91 ng/mL | Standard Error 0.09 |
| Arm I: Attention Bias Modification (ABM) Training | Urinary Cotinine | Baseline | 7.11 ng/mL | Standard Error 0.99 |
| Arm I: Attention Bias Modification (ABM) Training | Urinary Cotinine | 8-Day post-training | 6.16 ng/mL | Standard Error 0.12 |
| Arm II: Sham Training | Urinary Cotinine | 1-Day post-training | 6.99 ng/mL | Standard Error 0.09 |
| Arm II: Sham Training | Urinary Cotinine | Baseline | 7.12 ng/mL | Standard Error 0.09 |
| Arm II: Sham Training | Urinary Cotinine | 8-Day post-training | 6.61 ng/mL | Standard Error 0.12 |
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.
Time frame: Up to 8 weeks post-training
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I: Attention Bias Modification (ABM) Training | Wisconsin Smoking Withdrawal Scale (WSWS) - Craving | Baseline | 9.9 score on a scale | Standard Error 0.29 |
| Arm I: Attention Bias Modification (ABM) Training | Wisconsin Smoking Withdrawal Scale (WSWS) - Craving | 1-day post-training | 8.36 score on a scale | Standard Error 0.3 |
| Arm I: Attention Bias Modification (ABM) Training | Wisconsin Smoking Withdrawal Scale (WSWS) - Craving | 8-weeks post-training | 6.92 score on a scale | Standard Error 0.34 |
| Arm II: Sham Training | Wisconsin Smoking Withdrawal Scale (WSWS) - Craving | Baseline | 9.76 score on a scale | Standard Error 0.29 |
| Arm II: Sham Training | Wisconsin Smoking Withdrawal Scale (WSWS) - Craving | 1-day post-training | 8.52 score on a scale | Standard Error 0.3 |
| Arm II: Sham Training | Wisconsin Smoking Withdrawal Scale (WSWS) - Craving | 8-weeks post-training | 6.73 score on a scale | Standard Error 0.32 |