Smoking, Smoking, Cigarette, Smoking, Tobacco
Conditions
Keywords
smoking, smoker, tobacco, cigarette, cigarettes, Philadelphia, healthy
Brief summary
The purpose of the study is to learn more about the relationships between the brain, behavior, and natural daily exposure to particular environments, including the places where smokers regularly spend time and specific retail outlets.
Detailed description
Individual participation in this study will take place over a period of approximately 2 months. During (approximately) 6 weeks of the active study period, the participant will be asked to share their geolocation information, complete either (a) 3 online sessions (for all participants in 850796) and an optional fMRI scan (for a subset of protocol 850796) or (b) 3 in-person visits (2 of which involve getting fMRI brain scans, for protocol 822815), and complete short surveys and repeated tasks (e.g., responding to Ecological Momentary Assessment \[EMA\], using study-provided funds to make small purchases from a specified retail environment) in the weeks between visits.
Interventions
BEHAVIORALTobacco retailer
Assigned to make a small (\ $3.00) purchase from a tobacco retail store(s) using a study-provided debit card during each retail environment visit
BEHAVIORALNon-tobacco retailer
Assigned to make a small (\ $3.00) purchase from a store that does not sell tobacco (non-tobacco retailer) using a study-provided debit card during each retail environment visit.
Sponsors
National Cancer Institute (NCI)
New York University
Stanford University
Abramson Cancer Center at Penn Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Masking description
Investigator will not know the condition assignment of individual participants unless reassessment is triggered by the stopping rule.
Intervention model description
Random assignment of retail environment (tobacco retailer, non-tobacco retailer, control \[no store\]) to visit 5 times per week during the 4-week intervention period
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Be between the ages of 21-65 * Smoke at least 5 cigarettes a day for the past 6 months * Own an iPhone or Android smartphone that can be used on a daily basis * Plan to be in PA, DE, or NJ (for the remote cohort) or the Philadelphia metropolitan area (for the fMRI cohort) for the next 3 months, with the exception of short periods of absence (no longer than 3 consecutive days and no more than 10 days in total) * Read and speak English fluently * Fully vaccinated against COVID-19 Smoking
Exclusion criteria
* Current enrollment or plans to enroll in a smoking cessation program in the next 3 months * Plan to use nicotine substitutes or smoking cessation treatments in the next 3 months * Urine cotinine test at Session 1 indicates a non-smoker level of cotinine General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Cigarette Craving During the Experimental Manipulation Period | 4-week experimental manipulation period | Participants were asked 4 times per day, for the 28 days of the intervention period, to rate their level of craving for a cigarette. They responded to the question Right now, how much do you want to smoke a cigarette? using a 100-point scale from 0 (not at all) to 100 (extremely). Craving ratings were first averaged within each day, for each participant; then were averaged across the intervention period days for each participant; and finally averaged across participants in each group. |
| Self-reported Number of Cigarettes Smoked Per Day During the Experimental Manipulation Period | 4-week experimental manipulation period | Participants were asked 2 times per day, for the 28 days of the intervention period, to respond to the question, Within \[timeframe\], how many cigarettes did you smoke?. We calculated a daily sum for each individual, imputing missing counts from the average of that individual's prior reports (missing values for the first daily survey were imputed from the average of that participant's first daily survey answers; and vice versa for the second survey). We averaged the daily counts for each participant, and then averaged across participants. |
| Brain Activity (Measured by Functional Magnetic Resonance Imaging) in a Priori Regions of Interest, in Response to Standardized Smoking vs Nonsmoking Cues. | [Time Frame: For 822815, fMRI scan 1 (at least 2 weeks after initial enrollment); for 850796, fMRI scan 1 (at least 6 weeks after initial enrollment)]] | In key neural cue reactivity regions (based on prior work), we extracted estimates of neural activity during exposure to standardized smoking cues (e.g., photographs of a cigarette pack) and during exposure to standardized nonsmoking cues (approximately compositionally matched, e.g., a pack of pencils). We used SPM12 to create first-level (within-subject) linear regression models to estimate BOLD (blood oxygenation level dependent) activity at each voxel across all repetitions of each task condition, within each subject; and to create contrast estimates comparing task conditions. We used nilearn tools to average task condition contrast estimates across voxels within the regions of interest for each participant. The data values below reflect this contrast estimate - the difference in neural activity as percent change in BOLD signal between the standardized smoking cues condition and the standardized nonsmoking cues condition. |
| Brain Activity (Measured by fMRI), in a Priori Regions of Interest, in Response to Retail Smoking vs Nonsmoking Cues | [Time Frame: For 822815, fMRI scan 1 (at least 2 weeks after initial enrollment); for 850796, fMRI scan 1 (at least 6 weeks after initial enrollment)]] | In key neural cue reactivity regions (based on prior work), we will extract estimates of neural activity during exposure to images showing the cash register area at a convenience store which sells tobacco products, and has tobacco products and tobacco marketing on display behind the register (the power wall; tobacco retail images), and during exposure to nonsmoking cues. We used SPM12 to create first-level (within-subject) linear regression models to estimate BOLD (blood oxygenation level dependent) activity at each voxel across all repetitions of each task condition, within each subject; and to create contrast estimates comparing task conditions. We used nilearn tools to average task condition contrast estimates across voxels within the regions of interest for each participant. The data values below reflect this contrast estimate - the difference in neural activity as percent change in BOLD signal between the retail smoking cues condition and the nonsmoking cues condition. |
Countries
United States
Participant flow
Recruitment details
Adults who smoked cigarettes daily were recruited across PA, DE, and NJ to complete a multi-part, remote study. Recruitment materials for this study were primarily distributed by a clinical trials recruitment company, which utilized study advertisements to engage participants on digital platforms such as Facebook, Google, and WebMD. All recruitment materials included links directing potential participants to the initial screening survey.
Pre-assignment details
Participants completed several screening steps to confirm eligibility and interest in the study. If eligible, they completed the first online survey session, and then began the baseline period, during which they answered questions about their cigarette craving and smoking multiple times daily and recorded their geolocation through the Google Maps smartphone application. Participants who completed the baseline period and began the intervention period were assigned to an experimental condition.
Participants by arm
| Arm | Count |
|---|---|
| Tobacco Retailer Group Participants visit a tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period
Tobacco retailer: Assigned to make a small (\
$3.00) purchase from a tobacco retail store(s) using a study-provided debit card during each retail environment visit | 109 |
| Non-tobacco Retailer Group Participants visit a non-tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period
Non-tobacco retailer: Assigned to make a small (\
$3.00) purchase from a store that does not sell tobacco (non-tobacco retailer) using a study-provided debit card during each retail environment visit. | 109 |
| Control Participants are not asked to alter their behavior during the 4-week (0 store visits) intervention period | 76 |
| Unassigned Participants who enrolled in the study, but did not complete the baseline period and were therefore not assigned to an experimental condition | 49 |
| Total | 343 |
Baseline characteristics
| Characteristic | Tobacco Retailer Group | Non-tobacco Retailer Group | Control | Unassigned | Total |
|---|---|---|---|---|---|
| Age, Continuous | 44 years STANDARD_DEVIATION 11 | 42 years STANDARD_DEVIATION 11 | 42 years STANDARD_DEVIATION 10 | 43 years STANDARD_DEVIATION 11 | 43 years STANDARD_DEVIATION 11 |
| Daily cigarette count | 13.29 cigarettes STANDARD_DEVIATION 6.35 | 14.17 cigarettes STANDARD_DEVIATION 19.18 | 14.05 cigarettes STANDARD_DEVIATION 9.84 | 14.17 cigarettes STANDARD_DEVIATION 9.18 | 13.71 cigarettes STANDARD_DEVIATION 8.71 |
| Daily cigarette craving | 47.89 units on a scale STANDARD_DEVIATION 20.7 | 49.17 units on a scale STANDARD_DEVIATION 19.61 | 48.03 units on a scale STANDARD_DEVIATION 20.81 | 59.86 units on a scale STANDARD_DEVIATION 19.42 | 49.40 units on a scale STANDARD_DEVIATION 20.43 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 7 Participants | 3 Participants | 3 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 99 Participants | 102 Participants | 71 Participants | 42 Participants | 314 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 2 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 24 Participants | 17 Participants | 25 Participants | 93 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 9 Participants | 4 Participants | 0 Participants | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants | 4 Participants | 5 Participants | 17 Participants |
| Race (NIH/OMB) White | 75 Participants | 69 Participants | 47 Participants | 17 Participants | 208 Participants |
| Region of Enrollment United States | 109 Participants | 109 Participants | 76 Participants | 49 Participants | 343 Participants |
| Sex/Gender, Customized Sex/gender Female | 59 Participants | 60 Participants | 42 Participants | 20 Participants | 181 Participants |
| Sex/Gender, Customized Sex/gender Male | 46 Participants | 44 Participants | 32 Participants | 25 Participants | 147 Participants |
| Sex/Gender, Customized Sex/gender Other | 3 Participants | 5 Participants | 1 Participants | 0 Participants | 9 Participants |
| Sex/Gender, Customized Sex/gender Unknown | 1 Participants | 0 Participants | 1 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 109 | 0 / 109 | 0 / 76 | 0 / 49 |
| other Total, other adverse events | 0 / 109 | 0 / 109 | 0 / 76 | 0 / 49 |
| serious Total, serious adverse events | 2 / 109 | 5 / 109 | 0 / 76 | 0 / 49 |
Outcome results
Primary
Brain Activity (Measured by fMRI), in a Priori Regions of Interest, in Response to Retail Smoking vs Nonsmoking Cues
In key neural cue reactivity regions (based on prior work), we will extract estimates of neural activity during exposure to images showing the cash register area at a convenience store which sells tobacco products, and has tobacco products and tobacco marketing on display behind the register (the power wall; tobacco retail images), and during exposure to nonsmoking cues. We used SPM12 to create first-level (within-subject) linear regression models to estimate BOLD (blood oxygenation level dependent) activity at each voxel across all repetitions of each task condition, within each subject; and to create contrast estimates comparing task conditions. We used nilearn tools to average task condition contrast estimates across voxels within the regions of interest for each participant. The data values below reflect this contrast estimate - the difference in neural activity as percent change in BOLD signal between the retail smoking cues condition and the nonsmoking cues condition.
Time frame: [Time Frame: For 822815, fMRI scan 1 (at least 2 weeks after initial enrollment); for 850796, fMRI scan 1 (at least 6 weeks after initial enrollment)]]
Population: Participants who completed at least one scan and whose data passed quality thresholds for in-scanner movement and response rate. Due to COVID-19 pandemic restrictions during data collection, we changed the protocol to make the fMRI scan optional, which means that we do not have adequate statistical power to test experimental group differences. No participants in the unassigned group were scanned, since they did not begin the intervention period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tobacco Retailer Group | Brain Activity (Measured by fMRI), in a Priori Regions of Interest, in Response to Retail Smoking vs Nonsmoking Cues | 0.062 percent change in BOLD signal | Standard Deviation 0.118 |
| Non-tobacco Retailer Group | Brain Activity (Measured by fMRI), in a Priori Regions of Interest, in Response to Retail Smoking vs Nonsmoking Cues | 0.012 percent change in BOLD signal | Standard Deviation 0.092 |
| Control | Brain Activity (Measured by fMRI), in a Priori Regions of Interest, in Response to Retail Smoking vs Nonsmoking Cues | 0.018 percent change in BOLD signal | Standard Deviation 0.108 |
Primary
Brain Activity (Measured by Functional Magnetic Resonance Imaging) in a Priori Regions of Interest, in Response to Standardized Smoking vs Nonsmoking Cues.
In key neural cue reactivity regions (based on prior work), we extracted estimates of neural activity during exposure to standardized smoking cues (e.g., photographs of a cigarette pack) and during exposure to standardized nonsmoking cues (approximately compositionally matched, e.g., a pack of pencils). We used SPM12 to create first-level (within-subject) linear regression models to estimate BOLD (blood oxygenation level dependent) activity at each voxel across all repetitions of each task condition, within each subject; and to create contrast estimates comparing task conditions. We used nilearn tools to average task condition contrast estimates across voxels within the regions of interest for each participant. The data values below reflect this contrast estimate - the difference in neural activity as percent change in BOLD signal between the standardized smoking cues condition and the standardized nonsmoking cues condition.
Time frame: [Time Frame: For 822815, fMRI scan 1 (at least 2 weeks after initial enrollment); for 850796, fMRI scan 1 (at least 6 weeks after initial enrollment)]]
Population: Participants who completed at least one scan and whose data passed quality thresholds for in-scanner movement and response rate. Due to COVID-19 pandemic restrictions during data collection, we changed the protocol to make the fMRI scan optional, which means that we do not have adequate statistical power to test experimental group differences. No participants in the unassigned group were scanned, since they did not begin the intervention period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tobacco Retailer Group | Brain Activity (Measured by Functional Magnetic Resonance Imaging) in a Priori Regions of Interest, in Response to Standardized Smoking vs Nonsmoking Cues. | 0.021 percent change in BOLD signal | Standard Deviation 0.089 |
| Non-tobacco Retailer Group | Brain Activity (Measured by Functional Magnetic Resonance Imaging) in a Priori Regions of Interest, in Response to Standardized Smoking vs Nonsmoking Cues. | -0.025 percent change in BOLD signal | Standard Deviation 0.08 |
| Control | Brain Activity (Measured by Functional Magnetic Resonance Imaging) in a Priori Regions of Interest, in Response to Standardized Smoking vs Nonsmoking Cues. | 0.035 percent change in BOLD signal | Standard Deviation 0.12 |
Primary
Self-reported Cigarette Craving During the Experimental Manipulation Period
Participants were asked 4 times per day, for the 28 days of the intervention period, to rate their level of craving for a cigarette. They responded to the question Right now, how much do you want to smoke a cigarette? using a 100-point scale from 0 (not at all) to 100 (extremely). Craving ratings were first averaged within each day, for each participant; then were averaged across the intervention period days for each participant; and finally averaged across participants in each group.
Time frame: 4-week experimental manipulation period
Population: All participants who responded to any craving rating questions during the intervention period are included in this average. Participants in the unassigned group did not begin the intervention period and therefore are have no outcome data to report.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tobacco Retailer Group | Self-reported Cigarette Craving During the Experimental Manipulation Period | 48.33 units on a scale | Standard Deviation 25.3 |
| Non-tobacco Retailer Group | Self-reported Cigarette Craving During the Experimental Manipulation Period | 49.14 units on a scale | Standard Deviation 22.96 |
| Control | Self-reported Cigarette Craving During the Experimental Manipulation Period | 47.17 units on a scale | Standard Deviation 24.24 |
Comparison: Our hypothesis was that craving would be higher for those in the Tobacco retailer group, relative to the Nontobacco retailer group, during the intervention phase but not the baseline phase. We tested the interaction between study phase and experimental condition, in a model where the baseline was the reference study phase and Tobacco group was the reference experimental condition.p-value: 0.74Mixed Models Analysis
Comparison: Our hypothesis was that craving would be higher for those in the Tobacco retailer group, relative to the control group, during the intervention phase but not the baseline phase. We tested the interaction between study phase and experimental condition, in a model where the baseline was the reference study phase and Tobacco group was the reference experimental condition.p-value: 0.69Mixed Models Analysis
Primary
Self-reported Number of Cigarettes Smoked Per Day During the Experimental Manipulation Period
Participants were asked 2 times per day, for the 28 days of the intervention period, to respond to the question, Within \[timeframe\], how many cigarettes did you smoke?. We calculated a daily sum for each individual, imputing missing counts from the average of that individual's prior reports (missing values for the first daily survey were imputed from the average of that participant's first daily survey answers; and vice versa for the second survey). We averaged the daily counts for each participant, and then averaged across participants.
Time frame: 4-week experimental manipulation period
Population: All participants who responded to any cigarette consumption questions during the intervention period are included in this average. Participants in the unassigned group did not begin the intervention period and therefore are have no outcome data to report.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tobacco Retailer Group | Self-reported Number of Cigarettes Smoked Per Day During the Experimental Manipulation Period | 12.72 cigarettes | Standard Deviation 6.26 |
| Non-tobacco Retailer Group | Self-reported Number of Cigarettes Smoked Per Day During the Experimental Manipulation Period | 12.88 cigarettes | Standard Deviation 8.27 |
| Control | Self-reported Number of Cigarettes Smoked Per Day During the Experimental Manipulation Period | 13.64 cigarettes | Standard Deviation 7.55 |
Comparison: Our hypothesis was that cigarettes smoked would be higher for those in the Tobacco retailer group, relative to the Nontobacco retailer group, during the intervention phase but not the baseline phase. We tested the interaction between study phase and experimental condition, in a model where the baseline was the reference study phase and Tobacco group was the reference experimental condition.p-value: 0.49Mixed Models Analysis
Comparison: Our hypothesis was that craving would be higher for those in the Tobacco retailer group, relative to the control group, during the intervention phase but not the baseline phase. We tested the interaction between study phase and experimental condition, in a model where the baseline was the reference study phase and Tobacco group was the reference experimental condition.p-value: 0.72Mixed Models Analysis