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GeoScan Smoking Study: Neural Correlates of Smokers' Exposure to Retail Environments

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ClinicalTrials.gov Identifier: NCT04279483
Recruitment Status : Recruiting
First Posted : February 21, 2020
Last Update Posted : September 16, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
New York University
Stanford University
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Smoking, Tobacco Smoking Smoking, Cigarette Behavioral: 7-11 Behavioral: CVS Not Applicable

Detailed Description:
Individual participation in this study will take place over a period of up to 5 months. During (approximately) the first 6 weeks, the participant will be asked to share their geolocation information, attend 3 in-person visits (2 of which involve getting fMRI brain scans), and complete short surveys and repeated tasks (e.g., responding to EMA, using study-provided funds to make small purchases from a specified retail environment) in the weeks between visits. Approximately 3-months after the in-person participation in the study is complete, participants will receive a follow-up phone call during which a researcher will ask the participant to verbally answer brief survey questions.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Random assignment of retail environment (7-11, CVS, control [no store]) to visit every weekday during the 4-week intervention period
Masking: Single (Investigator)
Masking Description: Investigator will not know the condition assignment of individual participants unless reassessment is triggered by the stopping rule.
Primary Purpose: Other
Official Title: Neural and Geospatial Examination of Smokers' Exposure to Retail Environments
Actual Study Start Date : December 17, 2019
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: 7-11 Group
Participants visit 7-11 every weekday during the 4-week (20 store visits total) intervention period
Behavioral: 7-11
Assigned to make a small (~$2.00) purchase from a 7-11 using a study-provided gift card during each retail environment visit. Specific store to be chosen by study team in consultation with participant according to convenience (near home/work/etc.).

Experimental: CVS Group
Participants visit CVS every weekday during the 4-week (20 store visits total) intervention period
Behavioral: CVS
Assigned to make a small (~$2.00) purchase from a CVS using a study-provided gift card during each retail environment visit. Specific store to be chosen by study team in consultation with participant according to convenience (near home/work/etc.).

No Intervention: Control
Participants are not asked to alter their behavior during the 4-week (0 store visits) intervention period



Primary Outcome Measures :
  1. Self-reported cigarette craving during the experimental manipulation period [ Time Frame: 4-week experimental manipulation period ]
    Participants will report cigarette craving throughout the day, using a 9-point Likert-type scale that asks "Right now, how much do you want to smoke a cigarette?"(From "0 - Not at all" to "9 = Extremely).

  2. Self-reported number of cigarettes smoked per day during the experimental manipulation period [ Time Frame: 4-week experimental manipulation period ]
    Participants will report the number of cigarettes smoked throughout the day in response to the question, "Within [timeframe], how many cigarettes did you smoke?".

  3. Neural cue reactivity region definition [ Time Frame: fMRI scan day 1 (at least 2 weeks after initial enrollment) ]
    We will functionally define a set of regions responsive to smoking cues at T1 using the standardized cue images. To establish these ROIs, we will perform a t-test in all voxels in the brain to find voxels that show significantly different activation levels for smoking vs nonsmoking standardized images across all participants.

  4. Brain activity (measured by functional magnetic resonance imaging), in a priori regions of interest, in response to smoking vs nonsmoking cues. [ Time Frame: fMRI scan day 2 (at least 6 weeks after initial enrollment) ]
    In key neural cue reactivity regions (see Outcome #3 titled "Neural cue reactivity region definition"), we will extract estimates of neural activity during exposure to smoking vs nonsmoking cues, including retail photographs.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  • Be between the ages of 18-65
  • Smoke at least 10 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 the Philadelphia metropolitan area 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

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
  • Demonstrate carbon monoxide reading of less than 5ppm at intake session

Drug exclusion criteria

  • Currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants)
  • 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.

Medical, medication, and fMRI exclusion criteria

  • Use of any psychotropic medications included in the above list of drugs within 2 weeks prior to T1 or anticipated use of these medications in the 6 weeks following T1
  • Test positive for any of the above drugs at Appointment 1
  • Schizophrenia or psychosis, regardless of treatment status
  • Pregnancy
  • History of stroke or other neurological disorder likely to affect cognition
  • Psychiatric hospitalization within the past year
  • MRI exclusion criteria
  • 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

General exclusion criteria

  • Refusal to install Google Maps or LifeData applications on mobile phone
  • Left handedness
  • Any medical condition or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
  • 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 80% 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 and whether phones have an adequate battery life to allow participants to fulfill study requirements.
  • Refusal to comply with COVID-19 building entry requirements (as applicable)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04279483


Contacts
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Contact: Research Coordinator 267-296-4072 geoscan@falklab.org
Contact: Lab Manager 215-573-9901 lab.manager@falklab.org

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Research Coordinator    267-296-4072    geoscan@falklab.org   
Sponsors and Collaborators
University of Pennsylvania
National Cancer Institute (NCI)
New York University
Stanford University
Investigators
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Principal Investigator: Emily Falk, PhD University of Pennsylvania
Publications:

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04279483    
Other Study ID Numbers: 822815
1R01CA229305-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:
  • The final data set will include data from 180 subjects in the greater Philadelphia, PA area. Data will consist of measures concerned with health behaviors (measured using carbon monoxide monitors, saliva cotinine assessments, blood pressure, and questionnaires), measures of individuals' geospatial distance from nearby tobacco retail outlets (measured using smartphone applications), personality and individual difference measures (questionnaires) and brain imaging data (fMRI scans).
  • 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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).
URL: https://docs.google.com/document/d/1UkubuRug0gY8DEkTiB75fgcJuxdwlBZtmeY4qrUfog4/edit

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pennsylvania:
smoking
smoker
tobacco
cigarette
cigarettes
Philadelphia
healthy