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Completed

NCT Number: NCT04279483

GeoScan and Remote Geo Smoking Study: Neural and Behavioral Correlates 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.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • National Cancer Institute (NCI)
  • New York University
  • Stanford University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2020
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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