Smoking, TobaccoNCT04279483

GeoScan and Remote Geo Smoking Study: Neural and Behavioral Correlates of Smokers' Exposure to Retail Environments

A study testing Tobacco retailer and Non-tobacco retailer in people with Smoking, Tobacco and Smoking, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Smoking, Tobacco, Smoking, Smoking, Cigarette
What is being tested?: Tobacco retailer and Non-tobacco retailer
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 343 participants
Where: 1 siteUnited States
Study dates: 17 Dec 2019to 10 Jun 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Show all 38Show fewer

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 exclusion criteria:
Pregnancy
Inability or refusal to install Google Maps or LifeData applications on mobile phone
Inability or refusal to upload Google Timeline data after receiving instructions and guidance from a researcher
Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.
Any physical or visual impairment that may prevent the individual from using a computer keyboard or completing any study tasks.
During the first two weeks of the study, failure to complete the study tasks (e.g., response to at least 75% of the brief EMA survey questions).
The phones of potential participants will be assessed by trained recruiters either during in-person recruiting or during a phone call used to invite eligible participants who filled out the online screening survey for the first appointment. Specifically, recruiters will assess whether phones' functionality allows easy reception and sending of text messages, the use of the geolocation tracking and LifeData applications, whether potential participants have an existing Google account (created prior to Jan 2024), and whether phones have an adequate battery life to allow participants to fulfill study requirements.
Any medical condition or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
Drug \& fMRI exclusion criteria (fMRI cohort only - 822815 participants and fMRI subset of 850796 participants):
Currently or recently (within the last 5 years) receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants). Treatment of substance use disorders that occurred greater than 5 years prior to study participation is acceptable if participants are in stable condition
Report consuming any of the following drugs within the past two weeks or indicate plans to do so within the coming 6 weeks during the initial recruitment call: Benzodiazepines, Amphetamines, Methamphetamines, Cocaine, MDMA, Methadone, Barbiturates, PCP, Heroin, Oxycodone, Opiates (e.g., morphine, heroin), Buprenorphine.
Test positive for any of the above drugs at Appointment 1 (822815) or at the scan appointment (850796)
Schizophrenia or psychosis, regardless of treatment status
History of stroke or other neurological disorder likely to affect cognition
For 850796, history of seizures, brain tumor, penetrative head trauma that cracks the skull
Psychiatric hospitalization within the past year
MRI exclusion criteria:
For 850796, history of problems in previous MRI that are likely to occur again
For 822815, left-handedness
Propensity to experience claustrophobia
Ferromagnetic metal in the body, including anything that might set off a metal detector. Examples include bullet shrapnel, metal shavings (e.g., from welding without protection), or any implant that may be attracted to or damaged by magnets. Dental fillings are generally acceptable.
Metal in the body of an unverifiable origin
Non-removable piercings
Non-removable retainers or other dental work not compatible with fMRI.
Any orthopedic implant above the neck
Due to constraints of the fMRI scanner, participants whose weight exceeds 350 pounds also will be excluded
For 850796, scan must be scheduled within 6 months after completing the third Online Session

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Geo Smoking Study and Neural and Geospatial Examination of Smokers' Exposure to Retail Environments

Read the 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.

Conditions: Smoking, Tobacco, Smoking, Smoking, Cigarette
Being tested: Tobacco retailer, Non-tobacco retailer
Keywords: smoking, smoker, tobacco, cigarette, cigarettes, Philadelphia, healthy
Medical subject headings: Tobacco Smoking, Smoking, Cigarette Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tobacco retailerBehavioural
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
Non-tobacco retailerBehavioural
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.

Study groups in NCT04279483
Study group	Role	What they receive
Tobacco Retailer Group	Experimental	Participants visit a tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period Receives: Behavioral: Tobacco retailer
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 Receives: Behavioral: Non-tobacco retailer
Control	No intervention	Participants are not asked to alter their behavior during the 4-week (0 store visits) intervention period

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: [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.
Measured: [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)]]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Dec 201910 Jun 2024

First posted21 Feb 2020
Study start17 Dec 2019
Primary completion10 Jun 2024
Study completion10 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (100)Papers the sponsor has linked to this study.
Other trials for Smoking, TobaccoStudies of the same condition, open and under way.
More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
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
Masking: Single blind
Who is masked: Investigator
Enrolment: 343 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04279483
Sponsor's protocol ID: 822815, 850796
Other IDs: 1R01CA229305-01A1
Status last verified: Jul 2025
First submitted: 14 Feb 2020
Last updated: 14 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: * The final data set will include data from 310 subjects in PA, NJ, or DE. Data (collected via questionnaires, urine cotinine assessments, and smartphone applications) will include measures concerned with health behaviors, individuals' geospatial distance from nearby tobacco retail outlets, and personality and individual differences. 822815 and the fMRI subset of 850796 will include data from the brain imaging scan(s). 822815 will also include saliva cotinine assessments conducted during 2 of the 3 in-person sessions. * Final research data, with all identity-related information deleted and in consultation with the relevant IRBs, will be made available to scientists who are approved by the study team for collaborative research with members of the study team. Data will be shared in spreadsheet format for all non-imaging data and in NIFTI format for fMRI data. Unthresholded statistical maps for the fMRI data will be made available to researchers through a secure file-sharing interface.

Publications

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.
PubMed 12036782
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.
PubMed 22345238
Henriksen L, Ribisl KM, Rogers T, Moreland-Russell S, Barker DM, Sarris Esquivel N, Loomis B, Crew E, Combs T. Standardized Tobacco Assessment for Retail Settings (STARS): dissemination and implementation research. Tob Control. 2016 Oct;25(Suppl 1):i67-i74. doi: 10.1136/tobaccocontrol-2016-053076.
PubMed 27697950
Feld AL, Johnson TO, Byerly KW, Ribisl KM. How to Conduct Store Observations of Tobacco Marketing and Products. Prev Chronic Dis. 2016 Feb 18;13:E25. doi: 10.5888/pcd13.150504.
PubMed 26890408
Li L, Borland R, Fong GT, Thrasher JF, Hammond D, Cummings KM. Impact of point-of-sale tobacco display bans: findings from the International Tobacco Control Four Country Survey. Health Educ Res. 2013 Oct;28(5):898-910. doi: 10.1093/her/cyt058. Epub 2013 May 2.
PubMed 23640986
Kirchner TR, Cantrell J, Anesetti-Rothermel A, Ganz O, Vallone DM, Abrams DB. Geospatial exposure to point-of-sale tobacco: real-time craving and smoking-cessation outcomes. Am J Prev Med. 2013 Oct;45(4):379-85. doi: 10.1016/j.amepre.2013.05.016.
PubMed 24050412
Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.
PubMed 18509902
Engelmann JM, Versace F, Robinson JD, Minnix JA, Lam CY, Cui Y, Brown VL, Cinciripini PM. Neural substrates of smoking cue reactivity: a meta-analysis of fMRI studies. Neuroimage. 2012 Mar;60(1):252-62. doi: 10.1016/j.neuroimage.2011.12.024. Epub 2011 Dec 21.
PubMed 22206965
McClernon FJ, Hiott FB, Huettel SA, Rose JE. Abstinence-induced changes in self-report craving correlate with event-related FMRI responses to smoking cues. Neuropsychopharmacology. 2005 Oct;30(10):1940-7. doi: 10.1038/sj.npp.1300780.
PubMed 15920499
McClernon FJ, Conklin CA, Kozink RV, Adcock RA, Sweitzer MM, Addicott MA, Chou YH, Chen NK, Hallyburton MB, DeVito AM. Hippocampal and Insular Response to Smoking-Related Environments: Neuroimaging Evidence for Drug-Context Effects in Nicotine Dependence. Neuropsychopharmacology. 2016 Feb;41(3):877-85. doi: 10.1038/npp.2015.214. Epub 2015 Jul 16.
PubMed 26179147
Henriksen L, Schleicher NC, Feighery EC, Fortmann SP. A longitudinal study of exposure to retail cigarette advertising and smoking initiation. Pediatrics. 2010 Aug;126(2):232-8. doi: 10.1542/peds.2009-3021. Epub 2010 Jul 19.
PubMed 20643725
Robertson L, McGee R, Marsh L, Hoek J. A systematic review on the impact of point-of-sale tobacco promotion on smoking. Nicotine Tob Res. 2015 Jan;17(1):2-17. doi: 10.1093/ntr/ntu168. Epub 2014 Aug 30.
PubMed 25173775
Burton S, Clark L, Jackson K. The association between seeing retail displays of tobacco and tobacco smoking and purchase: findings from a diary-style survey. Addiction. 2012 Jan;107(1):169-75. doi: 10.1111/j.1360-0443.2011.03584.x. Epub 2011 Oct 7.
PubMed 21777322
Carter OB, Phan T, Mills BW. Impact of a point-of-sale tobacco display ban on smokers' spontaneous purchases: comparisons from postpurchase interviews before and after the ban in Western Australia. Tob Control. 2015 Mar;24(e1):e81-6. doi: 10.1136/tobaccocontrol-2013-050991. Epub 2013 Dec 23.
PubMed 24365702
Carter OB, Mills BW, Donovan RJ. The effect of retail cigarette pack displays on unplanned purchases: results from immediate postpurchase interviews. Tob Control. 2009 Jun;18(3):218-21. doi: 10.1136/tc.2008.027870. Epub 2009 Mar 4.
PubMed 19264731

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation

All Smoking, Tobacco trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Geo Smoking Study and Neural and Geospatial Examination of Smokers' Exposure to Retail Environments
ClinicalTrials.gov ID: NCT04279483
Acronym / sponsor ID: 822815, 850796
Conditions: Smoking, Tobacco, Smoking, Smoking, Cigarette
Keywords: smoking, smoker, tobacco, cigarette, cigarettes, Philadelphia, healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 343 participants (actual)
Lead sponsor: Abramson Cancer Center at Penn MedicineUniversity, hospital or other
Collaborators: National Cancer Institute (NCI), New York University, Stanford University
Study start: 17 Dec 2019 (actual)
Primary completion: 10 Jun 2024 (actual)
Study completion: 10 Jun 2024 (actual)
First posted: 21 Feb 2020 (actual)
Results: Posted 14 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3
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

Arm	Type	Receives
Tobacco Retailer Group	Experimental	Behavioral: Tobacco retailerParticipants visit a tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period
Non-tobacco Retailer Group	Experimental	Behavioral: Non-tobacco retailerParticipants 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

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (38 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tobacco retailerAssigned to make a small (~$3.00) purchase from a tobacco retail store(s) using a study-provided debit card during each retail environment visit	Behavioural	Tobacco Retailer Group
Non-tobacco retailerAssigned 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.	Behavioural	Non-tobacco Retailer Group

Primary outcome

Self-reported Cigarette Craving During the Experimental Manipulation Period
Time frame: 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
Time frame: 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: [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: [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.

Results and safety

Results posted to the registry on 14 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tobacco Retailer Group	109	109
Non-tobacco Retailer Group	109	109
Control	76	76
Unassigned	49	10

Primary outcome: Self-reported Cigarette Craving During the Experimental Manipulation Period

Time frame: 4-week experimental manipulation period. Mean (Standard Deviation). Unit: units on a scale

Measure	Tobacco Retailer Group n = 101	Non-tobacco Retailer Group n = 104	Control n = 75
Value	48.33 (25.30)	49.14 (22.96)	47.17 (24.24)

Tobacco Retailer Group vs Non-tobacco Retailer Group: Slope: -0.64, p = 0.74, Mixed Models Analysis
Tobacco Retailer Group vs Control: Slope: -0.84, p = 0.69, Mixed Models Analysis

Population analysed: 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.

Primary outcome: Self-reported Number of Cigarettes Smoked Per Day During the Experimental Manipulation Period

Time frame: 4-week experimental manipulation period. Mean (Standard Deviation). Unit: cigarettes

Measure	Tobacco Retailer Group n = 101	Non-tobacco Retailer Group n = 104	Control n = 75
Value	12.72 (6.26)	12.88 (8.27)	13.64 (7.55)

Tobacco Retailer Group vs Non-tobacco Retailer Group: Slope: -0.37, p = 0.49, Mixed Models Analysis
Tobacco Retailer Group vs Control: Slope: 0.21, p = 0.72, Mixed Models Analysis

Population analysed: 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.

Primary outcome: Brain Activity (Measured by Functional Magnetic Resonance Imaging) in a Priori Regions of Interest, in Response to Standardized Smoking vs Nonsmoking Cues.

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)]]. Mean (Standard Deviation). Unit: percent change in BOLD signal

Measure	Tobacco Retailer Group n = 7	Non-tobacco Retailer Group n = 10	Control n = 11
Value	0.021 (0.089)	-0.025 (0.080)	0.035 (0.120)

Population analysed: 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.

Primary outcome: Brain Activity (Measured by fMRI), in a Priori Regions of Interest, in Response to Retail Smoking vs Nonsmoking Cues

Measure	Tobacco Retailer Group n = 7	Non-tobacco Retailer Group n = 10	Control n = 11
Value	0.062 (0.118)	0.012 (0.092)	0.018 (0.108)

Adverse events

Time frame: Period of enrollment for each participant (approximately 6 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tobacco Retailer Group	2 of 109 (1.8%)	0 of 109 (0%)	0 of 109
Non-tobacco Retailer Group	5 of 109 (4.6%)	0 of 109 (0%)	0 of 109
Control	0 of 76 (0%)	0 of 76 (0%)	0 of 76
Unassigned	0 of 49 (0%)	0 of 49 (0%)	0 of 49

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12036782Wakefield 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.
Background: PubMed 22345238Henriksen L. Comprehensive tobacco marketing restrictions: promotion, packaging, price and place. Tob Control. 2012 Mar;21(2):147-53. doi: 10.1136/tobaccocontrol-2011-050416.
Background: PubMed 27697950Henriksen L, Ribisl KM, Rogers T, Moreland-Russell S, Barker DM, Sarris Esquivel N, Loomis B, Crew E, Combs T. Standardized Tobacco Assessment for Retail Settings (STARS): dissemination and implementation research. Tob Control. 2016 Oct;25(Suppl 1):i67-i74. doi: 10.1136/tobaccocontrol-2016-053076.
Background: PubMed 26890408Feld AL, Johnson TO, Byerly KW, Ribisl KM. How to Conduct Store Observations of Tobacco Marketing and Products. Prev Chronic Dis. 2016 Feb 18;13:E25. doi: 10.5888/pcd13.150504.
Background: PubMed 23640986Li L, Borland R, Fong GT, Thrasher JF, Hammond D, Cummings KM. Impact of point-of-sale tobacco display bans: findings from the International Tobacco Control Four Country Survey. Health Educ Res. 2013 Oct;28(5):898-910. doi: 10.1093/her/cyt058. Epub 2013 May 2.
Background: PubMed 24050412Kirchner TR, Cantrell J, Anesetti-Rothermel A, Ganz O, Vallone DM, Abrams DB. Geospatial exposure to point-of-sale tobacco: real-time craving and smoking-cessation outcomes. Am J Prev Med. 2013 Oct;45(4):379-85. doi: 10.1016/j.amepre.2013.05.016.
Background: PubMed 18509902Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.
Background: PubMed 22206965Engelmann JM, Versace F, Robinson JD, Minnix JA, Lam CY, Cui Y, Brown VL, Cinciripini PM. Neural substrates of smoking cue reactivity: a meta-analysis of fMRI studies. Neuroimage. 2012 Mar;60(1):252-62. doi: 10.1016/j.neuroimage.2011.12.024. Epub 2011 Dec 21.
Background: PubMed 15920499McClernon FJ, Hiott FB, Huettel SA, Rose JE. Abstinence-induced changes in self-report craving correlate with event-related FMRI responses to smoking cues. Neuropsychopharmacology. 2005 Oct;30(10):1940-7. doi: 10.1038/sj.npp.1300780.
Background: PubMed 26179147McClernon FJ, Conklin CA, Kozink RV, Adcock RA, Sweitzer MM, Addicott MA, Chou YH, Chen NK, Hallyburton MB, DeVito AM. Hippocampal and Insular Response to Smoking-Related Environments: Neuroimaging Evidence for Drug-Context Effects in Nicotine Dependence. Neuropsychopharmacology. 2016 Feb;41(3):877-85. doi: 10.1038/npp.2015.214. Epub 2015 Jul 16.
Background: PubMed 20643725Henriksen L, Schleicher NC, Feighery EC, Fortmann SP. A longitudinal study of exposure to retail cigarette advertising and smoking initiation. Pediatrics. 2010 Aug;126(2):232-8. doi: 10.1542/peds.2009-3021. Epub 2010 Jul 19.
Background: PubMed 25173775Robertson L, McGee R, Marsh L, Hoek J. A systematic review on the impact of point-of-sale tobacco promotion on smoking. Nicotine Tob Res. 2015 Jan;17(1):2-17. doi: 10.1093/ntr/ntu168. Epub 2014 Aug 30.
Individual participant dataSharing planned: Yes. * The final data set will include data from 310 subjects in PA, NJ, or DE. Data (collected via questionnaires, urine cotinine assessments, and smartphone applications) will include measures concerned with health behaviors, individuals' geospatial distance from nearby tobacco retail outlets, and personality and individual differences. 822815 and the fMRI subset of 850796 will include data from the brain imaging scan(s). 822815 will also include saliva cotinine assessments conducted during 2 of the 3 in-person sessions. * Final research data, with all identity-related information deleted and in consultation with the relevant IRBs, will be made available to scientists who are approved by the study team for collaborative research with members of the study team. Data will be shared in spreadsheet format for all non-imaging data and in NIFTI format for fMRI data. Unthresholded statistical maps for the fMRI data will be made available to researchers through a secure file-sharing interface.

Related trials for Smoking, Tobacco

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Emily Falk, PhD principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Tobacco retailer and Non-tobacco retailer in people with Smoking, Tobacco and Smoking, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 38 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-reported Cigarette Craving During the Experimental Manipulation Period (time frame: 4-week experimental manipulation period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04279483, which also lists 100 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.