University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT04279483
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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Notify Me21 year–65 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Smoking exclusion criteria:
General exclusion criteria:
Drug & fMRI exclusion criteria (fMRI cohort only - 822815 participants and fMRI subset of 850796 participants):
MRI exclusion criteria:
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
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.
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.
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.
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.
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.
Abramson Cancer Center at Penn Medicine
Other
Geo Smoking Study and Neural and Geospatial Examination of Smokers' Exposure to Retail Environments
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