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

July 29, 2025 updated by: Abramson Cancer Center at Penn Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

343

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Participants are not asked to alter their behavior during the 4-week (0 store visits) intervention period
Experimental: Tobacco Retailer Group
Participants visit a tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period
Behavioral: 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
Experimental: Non-tobacco Retailer Group
Participants visit a non-tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4-week experimental manipulation period
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.
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.
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.
[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
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.
[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)]]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Collaborators

National Cancer Institute (NCI)
New York University
Stanford University

Investigators

  • Principal Investigator: Emily Falk, PhD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2019

Primary Completion (Actual)

June 10, 2024

Study Completion (Actual)

June 10, 2024

Study Registration Dates

First Submitted

February 14, 2020

First Submitted That Met QC Criteria

February 19, 2020

First Posted (Actual)

February 21, 2020

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

July 29, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 822815, 850796
  • 1R01CA229305-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

  • 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.

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

  • Data will be made available to scientists who are approved by the study team for collaborative research with members of the study team.
  • Qualified investigators who wish to access the study materials will be able to complete a form on the main project website on GitHub (https://github.com/cnlab), which describes the proposed study and delineates the data specifics of data use. The requests will be reviewed and approved by the investigators. The requested research data files will be accompanied by a description of variables and how they were collected. We will also share protocols relevant to data collection procedures, as useful and in consultation with other interested researchers.
  • Study tasks and code to reproduce analyses will be made available on the Falk lab GitHub account (https://github.com/cnlab)
  • Statistical Analysis Plans will be available in the form of pre-registrations on the Open Science Framework site (https://osf.io).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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