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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA229305-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| New York University | OTHER |
| Stanford University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tobacco Retailer Group | Experimental | Participants visit a tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period |
|
| Non-tobacco Retailer Group | Experimental | Participants visit a non-tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period |
|
| Control | No Intervention | Participants are not asked to alter their behavior during the 4-week (0 store visits) intervention period |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobacco retailer | Behavioral | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4-week experimental manipulation period |
| 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. | 4-week experimental manipulation period |
| 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. |
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Inclusion criteria:
Smoking exclusion criteria:
General exclusion criteria:
Drug & fMRI exclusion criteria (fMRI cohort only - 822815 participants and fMRI subset of 850796 participants):
MRI exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily Falk, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12036782 | Background | Wakefield MA, Terry-McElrath YM, Chaloupka FJ, Barker DC, Slater SJ, Clark PI, Giovino GA. Tobacco industry marketing at point of purchase after the 1998 MSA billboard advertising ban. Am J Public Health. 2002 Jun;92(6):937-40. doi: 10.2105/ajph.92.6.937. No abstract available. | |
| 22345238 | Background | Henriksen L. Comprehensive tobacco marketing restrictions: promotion, packaging, price and place. Tob Control. 2012 Mar;21(2):147-53. doi: 10.1136/tobaccocontrol-2011-050416. |
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The data will be available within six months following publication of the study's primary results. Data will remain available for a minimum of three years following the closeout of the grant.
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| FG002 | Control | Participants are not asked to alter their behavior during the 4-week (0 store visits) intervention period |
| FG003 | Unassigned | Participants who enrolled in the study but did not complete the baseline period and therefore were not assigned an experimental condition |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Period |
| ||||||||||||||||
| Intervention Period |
| ||||||||||||||||
| fMRI Scans |
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Baseline population includes each individual who signed the informed consent form.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 4-week experimental manipulation period |
|
Period of enrollment for each participant (approximately 6 weeks)
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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 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Non-systematic Assessment | All hospitalizations were unrelated to participation in the study |
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Due to COVID-19 pandemic-related constraints and delays, we were unable to reach our goal of 60 complete datasets per condition. We prioritized remote participation and made fMRI scans optional. This resulted in few participants completing fMRI scans. Our planned analyses investigating the effects of intervention group assignment on smoking and craving are well-powered with this sample size, but examination of intervention effects on neural responses to tobacco marketing is not possible.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Falk | University of Pennsylvania | 215-573-9901 | emilybfalk@falklab.org |
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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 | Jun 2, 2025 | Jun 10, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: fMRIconsent | Mar 1, 2023 | Jul 1, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: ScreeningConsent | Sep 20, 2023 | Jul 1, 2025 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: MainConsent | Sep 20, 2023 | Jul 1, 2025 | ICF_003.pdf |
| ICF | No | No | Yes | Informed Consent Form: fMRIScreenConsent | Jul 19, 2023 | Jul 1, 2025 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D064424 | Tobacco Use |
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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
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Investigator will not know the condition assignment of individual participants unless reassessment is triggered by the stopping rule.
| Non-tobacco retailer | Behavioral | 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. |
|
| [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)]] |
| 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: For 822815, fMRI scan 1 (at least 2 weeks after initial enrollment); for 850796, fMRI scan 1 (at least 6 weeks after initial enrollment)]] |
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| 21401252 | Background | Berkman ET, Dickenson J, Falk EB, Lieberman MD. Using SMS text messaging to assess moderators of smoking reduction: Validating a new tool for ecological measurement of health behaviors. Health Psychol. 2011 Mar;30(2):186-94. doi: 10.1037/a0022201. |
| 26356504 | Background | Konrath S, Falk E, Fuhrel-Forbis A, Liu M, Swain J, Tolman R, Cunningham R, Walton M. Can Text Messages Increase Empathy and Prosocial Behavior? The Development and Initial Validation of Text to Connect. PLoS One. 2015 Sep 10;10(9):e0137585. doi: 10.1371/journal.pone.0137585. eCollection 2015. |
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| 26400858 | Background | Falk EB, O'Donnell MB, Tompson S, Gonzalez R, Dal Cin S, Strecher V, Cummings KM, An L. Functional brain imaging predicts public health campaign success. Soc Cogn Affect Neurosci. 2016 Feb;11(2):204-14. doi: 10.1093/scan/nsv108. Epub 2015 Sep 23. |
| 28578131 | Background | Pegors TK, Tompson S, O'Donnell MB, Falk EB. Predicting behavior change from persuasive messages using neural representational similarity and social network analyses. Neuroimage. 2017 Aug 15;157:118-128. doi: 10.1016/j.neuroimage.2017.05.063. Epub 2017 May 31. |
| 28240271 | Background | Cooper N, Bassett DS, Falk EB. Coherent activity between brain regions that code for value is linked to the malleability of human behavior. Sci Rep. 2017 Feb 27;7:43250. doi: 10.1038/srep43250. |
| 27019865 | Background | Green AE, Mays D, Falk EB, Vallone D, Gallagher N, Richardson A, Tercyak KP, Abrams DB, Niaura RS. Young Adult Smokers' Neural Response to Graphic Cigarette Warning Labels. Addict Behav Rep. 2016 Jun 1;3:28-32. doi: 10.1016/j.abrep.2016.02.001. |
| 29057013 | Background | Cooper N, Tompson S, O'Donnell MB, Falk EB. Brain Activity in Self- and Value-Related Regions in Response to Online Antismoking Messages Predicts Behavior Change. J Media Psychol. 2015;27:93-109. doi: 10.1027/1864-1105/a000146. Epub 2015 Sep 15. |
| 27521303 | Background | Vezich IS, Katzman PL, Ames DL, Falk EB, Lieberman MD. Modulating the neural bases of persuasion: why/how, gain/loss, and users/non-users. Soc Cogn Affect Neurosci. 2017 Feb 1;12(2):283-297. doi: 10.1093/scan/nsw113. |
| 21261410 | Background | Falk EB, Berkman ET, Whalen D, Lieberman MD. Neural activity during health messaging predicts reductions in smoking above and beyond self-report. Health Psychol. 2011 Mar;30(2):177-85. doi: 10.1037/a0022259. |
| 20573889 | Background | Falk EB, Berkman ET, Mann T, Harrison B, Lieberman MD. Predicting persuasion-induced behavior change from the brain. J Neurosci. 2010 Jun 23;30(25):8421-4. doi: 10.1523/JNEUROSCI.0063-10.2010. |
| 29140500 | Background | Huskey R, Mangus JM, Turner BO, Weber R. The persuasion network is modulated by drug-use risk and predicts anti-drug message effectiveness. Soc Cogn Affect Neurosci. 2017 Dec 1;12(12):1902-1915. doi: 10.1093/scan/nsx126. |
| 25646442 | Background | Falk EB, O'Donnell MB, Cascio CN, Tinney F, Kang Y, Lieberman MD, Taylor SE, An L, Resnicow K, Strecher VJ. Self-affirmation alters the brain's response to health messages and subsequent behavior change. Proc Natl Acad Sci U S A. 2015 Feb 17;112(7):1977-82. doi: 10.1073/pnas.1500247112. Epub 2015 Feb 2. |
| 25100217 | Background | Cascio CN, Carp J, O'Donnell MB, Tinney FJ Jr, Bingham CR, Shope JT, Ouimet MC, Pradhan AK, Simons-Morton BG, Falk EB. Buffering social influence: neural correlates of response inhibition predict driving safety in the presence of a peer. J Cogn Neurosci. 2015 Jan;27(1):83-95. doi: 10.1162/jocn_a_00693. |
| 29718764 | Background | Kelly MP, Kriznik NM, Kinmonth AL, Fletcher PC. The brain, self and society: a social-neuroscience model of predictive processing. Soc Neurosci. 2019 Jun;14(3):266-276. doi: 10.1080/17470919.2018.1471003. Epub 2018 May 10. |
| 24478540 | Background | Berkman ET, Falk EB. Beyond Brain Mapping: Using Neural Measures to Predict Real-World Outcomes. Curr Dir Psychol Sci. 2013 Feb;22(1):45-50. doi: 10.1177/0963721412469394. |
| 21378368 | Background | Berkman ET, Falk EB, Lieberman MD. In the trenches of real-world self-control: neural correlates of breaking the link between craving and smoking. Psychol Sci. 2011 Apr;22(4):498-506. doi: 10.1177/0956797611400918. Epub 2011 Mar 4. |
| 28344683 | Background | Kang Y, O'Donnell MB, Strecher VJ, Falk EB. Dispositional Mindfulness Predicts Adaptive Affective Responses to Health Messages and Increased Exercise Motivation. Mindfulness (N Y). 2017 Apr;8(2):387-397. doi: 10.1007/s12671-016-0608-7. Epub 2016 Sep 13. |
| 23722983 | Background | Falk EB, Morelli SA, Welborn BL, Dambacher K, Lieberman MD. Creating buzz: the neural correlates of effective message propagation. Psychol Sci. 2013 Jul 1;24(7):1234-42. doi: 10.1177/0956797612474670. Epub 2013 May 30. |
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| 24759437 | Background | Falk EB, Cascio CN, O'Donnell MB, Carp J, Tinney FJ Jr, Bingham CR, Shope JT, Ouimet MC, Pradhan AK, Simons-Morton BG. Neural responses to exclusion predict susceptibility to social influence. J Adolesc Health. 2014 May;54(5 Suppl):S22-31. doi: 10.1016/j.jadohealth.2013.12.035. |
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| Completed All Store Visits | Participants could complete the final study session without having completed the full intervention of making 20 visits to their assigned store. |
|
| COMPLETED |
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| NOT COMPLETED |
|
| Completed Second Scan | The original version of the study protocol required 2 fMRI scan sessions, one prior to the intervention period and one after the intervention period. We changed the study protocol during the COVID-19 pandemic to make fMRI scans optional, and to only offer a single scan session after the intervention period. |
|
| COMPLETED |
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| NOT COMPLETED |
|
| 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. |
| BG002 | Control | Participants are not asked to alter their behavior during the 4-week (0 store visits) intervention period |
| BG003 | Unassigned | Participants who enrolled in the study, but did not complete the baseline period and were therefore not assigned to an experimental condition |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Daily cigarette craving | Participants were asked 4 times per day, for the 14 days of the baseline 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 baseline period days for each participant; and finally averaged across participants in each group. | Some participants in the Unassigned group did not respond to any daily messages and are not represented in the average. | Mean | Standard Deviation | units on a scale |
|
| Daily cigarette count | Participants were asked 2 times per day, for each day of the 14 day baseline 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. | Some participants in the Unassigned group did not respond to any daily messages and are not represented in the average. | Mean | Standard Deviation | cigarettes |
|
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 |
| OG001 | 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. |
| OG002 | Control | Participants are not asked to alter their behavior during the 4-week (0 store visits) intervention period |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | cigarettes | 4-week experimental manipulation period |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | percent change in BOLD signal | [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)]] |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | percent change in BOLD signal | [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)]] |
|
|
|
| 0 |
| 109 |
| 2 |
| 109 |
| 0 |
| 109 |
| EG001 | 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. | 0 | 109 | 5 | 109 | 0 | 109 |
| EG002 | Control | Participants are not asked to alter their behavior during the 4-week (0 store visits) intervention period | 0 | 76 | 0 | 76 | 0 | 76 |
| EG003 | Unassigned | Participants who began the baseline period, but did not begin the intervention period and therefore were not assigned to an experimental group. | 0 | 49 | 0 | 49 | 0 | 49 |
|
Not provided
Not provided
| Male |
|
| Other |
|
| Unknown |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Linear mixed effects
| 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. | Mixed Models Analysis | 0.72 | Statistical significance was evaluated at α = 0.05. | Slope | 0.21 | Standard Error of the Mean | 0.59 | 2-Sided | Superiority | Linear mixed effects |