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

Not Applicable

Active, not recruiting

• Conditions: Smoking, Tobacco; Smoking; Smoking, Cigarette

• Registration Number: NCT04279483
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-2-14
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

<br><br> - Be between the ages of 21-65<br><br> - Smoke at least 5 cigarettes a day for the past 6 months<br><br> - Own an iPhone or Android smartphone that can be used on a daily basis<br><br> - Plan to be in PA, DE, or NJ (for the remote cohort) or the Philadelphia metropolitan<br> area (for the fMRI cohort) for the next 3 months, with the exception of short<br> periods of absence (no longer than 3 consecutive days and no more than 10 days in<br> total)<br><br> - Read and speak English fluently<br><br> - Fully vaccinated against COVID-19<br><br>Smoking exclusion criteria:<br><br> - Current enrollment or plans to enroll in a smoking cessation program in the next 3<br> months<br><br> - Plan to use nicotine substitutes or smoking cessation treatments in the next 3<br> months<br><br> - Urine cotinine test at Session 1 indicates a non-smoker level of cotinine<br><br>General exclusion criteria:<br><br> - Pregnancy<br><br> - Inability or refusal to install Google Maps or LifeData applications on mobile phone<br><br> - Inability or refusal to upload Google Timeline data after receiving instructions and<br> guidance from a researcher<br><br> - Inability to provide informed consent or complete any of the study tasks as<br> determined by the Principal Investigator and/or Study Physician.<br><br> - Any physical or visual impairment that may prevent the individual from using a<br> computer keyboard or completing any study tasks.<br><br> - During the first two weeks of the study, failure to complete the study tasks (e.g.,<br> response to at least 75% of the brief EMA survey questions).<br><br> - The phones of potential participants will be assessed by trained recruiters either<br> during in-person recruiting or during a phone call used to invite eligible<br> participants who filled out the online screening survey for the first appointment.<br> Specifically, recruiters will assess whether phones' functionality allows easy<br> reception and sending of text messages, the use of the geolocation tracking and<br> LifeData applications, whether potential participants have an existing Google<br> account (created prior to Jan 2024), and whether phones have an adequate battery<br> life to allow participants to fulfill study requirements.<br><br> - Any medical condition or concomitant medication that could compromise participant<br> safety or treatment, as determined by the Principal Investigator and/or Study<br> Physician.<br><br>Drug & fMRI exclusion criteria (fMRI cohort only - 822815 participants and fMRI subset of<br>850796 participants):<br><br> - Currently or recently (within the last 5 years) receiving treatment for substance<br> abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants). Treatment of<br> substance use disorders that occurred greater than 5 years prior to study<br> participation is acceptable if participants are in stable condition<br><br> - Report consuming any of the following drugs within the past two weeks or indicate<br> plans to do so within the coming 6 weeks during the initial recruitment call:<br> Benzodiazepines, Amphetamines, Methamphetamines, Cocaine, MDMA, Methadone,<br> Barbiturates, PCP, Heroin, Oxycodone, Opiates (e.g., morphine, heroin),<br> Buprenorphine.<br><br> - Test positive for any of the above drugs at Appointment 1 (822815) or at the scan<br> appointment (850796)<br><br> - Schizophrenia or psychosis, regardless of treatment status<br><br> - History of stroke or other neurological disorder likely to affect cognition<br><br> - For 850796, history of seizures, brain tumor, penetrative head trauma that cracks<br> the skull<br><br> - Psychiatric hospitalization within the past year<br><br>MRI exclusion criteria:<br><br> - For 850796, history of problems in previous MRI that are likely to occur again<br><br> - For 822815, left-handedness<br><br> - Propensity to experience claustrophobia<br><br> - Ferromagnetic metal in the body, including anything that might set off a metal<br> detector. Examples include bullet shrapnel, metal shavings (e.g., from welding<br> without protection), or any implant that may be attracted to or damaged by magnets.<br> Dental fillings are generally acceptable.<br><br> - Metal in the body of an unverifiable origin<br><br> - Non-removable piercings<br><br> - Non-removable retainers or other dental work not compatible with fMRI.<br><br> - Any orthopedic implant above the neck<br><br> - Due to constraints of the fMRI scanner, participants whose weight exceeds 350 pounds<br> also will be excluded<br><br> - For 850796, scan must be scheduled within 6 months after completing the third Online<br> Session

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-reported cigarette craving during the experimental manipulation period;Self-reported number of cigarettes smoked per day during the experimental manipulation period;Neural cue reactivity region definition (822815 participants and fMRI subset of 850796 participants);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)