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

NCT04279483 | Completed Results

• 2 other identifiers: 822815, 8507961R01CA229305-01A1
• Study Type: interventional
• Target: 343
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to learn more about the relationships between the brain, behavior, and natural daily exposure to particular environments, including the places where smokers regularly spend time and specific retail outlets.

Conditions

Smoking, Tobacco; Smoking; Smoking, Cigarette

Keywords

smoking; smoker; tobacco; cigarette; cigarettes; Philadelphia; healthy

Outcome Measures

Primary Outcomes (4)

• 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.

  [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)]]

Study Arms (3)

Tobacco Retailer Group

EXPERIMENTAL

Participants visit a tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period

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

Behavioral: Non-tobacco retailer

Control

NO INTERVENTION

Participants are not asked to alter their behavior during the 4-week (0 store visits) intervention period

Interventions

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

Tobacco Retailer Group

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.

Non-tobacco Retailer Group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator
• New York University: collaborator
• Stanford University: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (99)

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MeSH Terms

Conditions

Tobacco Smoking; Smoking; Cigarette Smoking

Condition Hierarchy (Ancestors)

Behavior; Tobacco Use

Limitations and Caveats

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.

Results Point of Contact

• Title: Emily Falk
• Organization: University of Pennsylvania

emilybfalk@falklab.org

215-573-9901

Study Officials

• Emily Falk, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator will not know the condition assignment of individual participants unless reassessment is triggered by the stopping rule.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 21, 2020
• Study Start: December 17, 2019
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: August 14, 2025
• Results First Posted: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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.
• 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).

Locations

US (1)