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

Not Applicable

Completed

• Conditions: Smoking, Tobacco; Smoking; Smoking, Cigarette
• Interventions: Behavioral: 7-11; Behavioral: CVS

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

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.

Detailed 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.

Study Timeline

• Study Start: 2019-12-17
• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-21
• Primary Completion: 2024-06-10
• Study Completion: 2024-06-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
7-11 Group	7-11	Participants visit 7-11 5 times per week during the 4-week (20 store visits total) intervention period
CVS Group	CVS	Participants visit CVS 5 times per week during the 4-week (20 store visits total) intervention period

Primary Outcome Measures

Name	Time	Method
Self-reported number of cigarettes smoked per day during the experimental manipulation period	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?".
Neural cue reactivity region definition (822815 participants and fMRI subset of 850796 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)]	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.
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)	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)	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.
Self-reported cigarette craving during the experimental manipulation period	4-week 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).

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States