GeoScan and Remote Geo Smoking Study: Neural and Behavioral Correlates of Smokers' Exposure to Retail Environments
NCT ID: NCT04279483
Last Updated: 2025-08-14
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
343 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-12-17
Study Completion Date
2024-06-10
Brief Summary
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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.
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Detailed Description
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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
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Smoking, Tobacco
Smoking
Smoking, Cigarette
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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
Primary Study Purpose
OTHER
Blinding Strategy
SINGLE
Investigators
Investigator will not know the condition assignment of individual participants unless reassessment is triggered by the stopping rule.
Study Groups
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Tobacco Retailer Group
Participants visit a tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period
Group Type
EXPERIMENTAL
Tobacco retailer
Intervention Type
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
Non-tobacco Retailer Group
Participants visit a non-tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period
Group Type
EXPERIMENTAL
Non-tobacco retailer
Intervention Type
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.
Control
Participants are not asked to alter their behavior during the 4-week (0 store visits) intervention period
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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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
Intervention Type
BEHAVIORAL
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.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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
* 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
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
* 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.
* 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
* 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
* 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
* 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.
* 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
* 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
Minimum Eligible Age
21 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Sponsor Role
collaborator
New York University
OTHER
Sponsor Role
collaborator
Stanford University
OTHER
Sponsor Role
collaborator
Abramson Cancer Center at Penn Medicine
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Emily Falk, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Site Status
Countries
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United States
References
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form: fMRIconsent
Document Type: Informed Consent Form: ScreeningConsent
Document Type: Informed Consent Form: MainConsent
Document Type: Informed Consent Form: fMRIScreenConsent
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
822815, 850796
Identifier Type: -
Identifier Source: org_study_id
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