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
|Condition or disease||Intervention/treatment||Phase|
|Smoking, Tobacco Smoking Smoking, Cigarette||Behavioral: 7-11 Behavioral: CVS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|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 Description:||Investigator will not know the condition assignment of individual participants unless reassessment is triggered by the stopping rule.|
|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|
Experimental: 7-11 Group
Participants visit 7-11 every weekday during the 4-week (20 store visits total) intervention period
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
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
- 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).
- 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?".
- 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.
- 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.
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
|Contact: Research Coordinatorfirstname.lastname@example.org|
|Contact: Lab Manageremail@example.com|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Research Coordinator 267-296-4072 firstname.lastname@example.org|
|Principal Investigator:||Emily Falk, PhD||University of Pennsylvania|