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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04279483
• Other study ID #: 822815, 850796
• Secondary ID: 1R01CA229305-01A
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2019
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Research Coordinator
• Phone: 267-225-0399
• Email: geo[@]falklab.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking
• Smoking, Cigarette
• Smoking, Tobacco

Intervention

Behavioral:
• 7-11
Assigned to make a small (~$3.00) purchase from any 7-11 store(s) using a study-provided debit card during each retail environment visit
• CVS
Assigned to make a small (~$3.00) purchase from any CVS store(s) using a study-provided debit card during each retail environment visit.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	National Cancer Institute (NCI), New York University, Stanford University

Country where clinical trial is conducted

United States, 

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported cigarette craving during the experimental manipulation period	Participants will report cigarette craving throughout the day, using a 100-point scale that asks "Right now, how much do you want to smoke a cigarette?"(From "0 - Not at all" to "100 = Extremely).	4-week experimental manipulation period
Primary	Self-reported number of cigarettes smoked per day during the 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?".	4-week experimental manipulation period
Primary	Neural cue reactivity region definition (822815 participants and fMRI subset of 850796 participants)	We will functionally define a set of regions responsive to smoking cues 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.	For 822815, fMRI scan day 1 (at least 2 weeks after initial enrollment); for 850796, fMRI scan 1 (at least 6 weeks after initial enrollment)]
Primary	Brain activity (measured by functional magnetic resonance imaging), in a priori regions of interest, in response to smoking vs nonsmoking cues (all 822815 participants and fMRI subset of 850796 participants)	In key neural cue reactivity regions (see Outcome #3 titled "Neural cue reactivity region definition (822815 participants and fMRI subset of 850796 participants)"), we will extract estimates of neural activity during exposure to smoking vs nonsmoking cues, including retail photographs.	For 822815, fMRI scan day 2 (at least 6 weeks after initial enrollment); for 850796, fMRI scan 1 (at least 6 weeks after initial enrollment)