Trial Outcomes & Findings for GeoScan and Remote Geo Smoking Study: Neural and Behavioral Correlates of Smokers' Exposure to Retail Environments (NCT NCT04279483)

NCT ID: NCT04279483

Last Updated: 2025-08-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

343 participants

Primary outcome timeframe

4-week experimental manipulation period

Results posted on

2025-08-14

Participant Flow

Adults who smoked cigarettes daily were recruited across PA, DE, and NJ to complete a multi-part, remote study. Recruitment materials for this study were primarily distributed by a clinical trials recruitment company, which utilized study advertisements to engage participants on digital platforms such as Facebook, Google, and WebMD. All recruitment materials included links directing potential participants to the initial screening survey.

Participants completed several screening steps to confirm eligibility and interest in the study. If eligible, they completed the first online survey session, and then began the baseline period, during which they answered questions about their cigarette craving and smoking multiple times daily and recorded their geolocation through the Google Maps smartphone application. Participants who completed the baseline period and began the intervention period were assigned to an experimental condition.

Participant milestones

Participant milestones
Measure
Tobacco Retailer Group
Participants visit a tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period Tobacco retailer: 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
Non-tobacco Retailer Group
Participants visit a non-tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period Non-tobacco retailer: 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.
Control
Participants are not asked to alter their behavior during the 4-week (0 store visits) intervention period
Unassigned
Participants who enrolled in the study but did not complete the baseline period and therefore were not assigned an experimental condition
Baseline Period
STARTED
109
109
76
49
Baseline Period
Began Baseline Period
109
109
76
36
Baseline Period
COMPLETED
109
109
76
10
Baseline Period
NOT COMPLETED
0
0
0
39
Intervention Period
STARTED
109
109
76
0
Intervention Period
Completed All Store Visits
55
46
0
0
Intervention Period
COMPLETED
88
92
74
0
Intervention Period
NOT COMPLETED
21
17
2
0
fMRI Scans
STARTED
10
13
13
1
fMRI Scans
Completed Second Scan
1
3
5
0
fMRI Scans
COMPLETED
10
12
13
0
fMRI Scans
NOT COMPLETED
0
1
0
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Some participants in the Unassigned group did not respond to any daily messages and are not represented in the average.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Tobacco Retailer Group
n=109 Participants
Participants visit a tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period Tobacco retailer: 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
Non-tobacco Retailer Group
n=109 Participants
Participants visit a non-tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period Non-tobacco retailer: 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.
Control
n=76 Participants
Participants are not asked to alter their behavior during the 4-week (0 store visits) intervention period
Unassigned
n=49 Participants
Participants who enrolled in the study, but did not complete the baseline period and were therefore not assigned to an experimental condition
Total
n=343 Participants
Total of all reporting groups
Age, Continuous
44 years
STANDARD_DEVIATION 11 • n=109 Participants
42 years
STANDARD_DEVIATION 11 • n=109 Participants
42 years
STANDARD_DEVIATION 10 • n=76 Participants
43 years
STANDARD_DEVIATION 11 • n=49 Participants
43 years
STANDARD_DEVIATION 11 • n=343 Participants
Sex/Gender, Customized
Sex/gender · Female
59 Participants
n=109 Participants
60 Participants
n=109 Participants
42 Participants
n=76 Participants
20 Participants
n=49 Participants
181 Participants
n=343 Participants
Sex/Gender, Customized
Sex/gender · Male
46 Participants
n=109 Participants
44 Participants
n=109 Participants
32 Participants
n=76 Participants
25 Participants
n=49 Participants
147 Participants
n=343 Participants
Sex/Gender, Customized
Sex/gender · Other
3 Participants
n=109 Participants
5 Participants
n=109 Participants
1 Participants
n=76 Participants
0 Participants
n=49 Participants
9 Participants
n=343 Participants
Sex/Gender, Customized
Sex/gender · Unknown
1 Participants
n=109 Participants
0 Participants
n=109 Participants
1 Participants
n=76 Participants
4 Participants
n=49 Participants
6 Participants
n=343 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
9 Participants
n=109 Participants
7 Participants
n=109 Participants
3 Participants
n=76 Participants
3 Participants
n=49 Participants
22 Participants
n=343 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
99 Participants
n=109 Participants
102 Participants
n=109 Participants
71 Participants
n=76 Participants
42 Participants
n=49 Participants
314 Participants
n=343 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=109 Participants
0 Participants
n=109 Participants
2 Participants
n=76 Participants
4 Participants
n=49 Participants
7 Participants
n=343 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=109 Participants
0 Participants
n=109 Participants
1 Participants
n=76 Participants
0 Participants
n=49 Participants
2 Participants
n=343 Participants
Race (NIH/OMB)
Asian
0 Participants
n=109 Participants
3 Participants
n=109 Participants
3 Participants
n=76 Participants
2 Participants
n=49 Participants
8 Participants
n=343 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=109 Participants
0 Participants
n=109 Participants
0 Participants
n=76 Participants
0 Participants
n=49 Participants
0 Participants
n=343 Participants
Race (NIH/OMB)
Black or African American
27 Participants
n=109 Participants
24 Participants
n=109 Participants
17 Participants
n=76 Participants
25 Participants
n=49 Participants
93 Participants
n=343 Participants
Race (NIH/OMB)
White
75 Participants
n=109 Participants
69 Participants
n=109 Participants
47 Participants
n=76 Participants
17 Participants
n=49 Participants
208 Participants
n=343 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=109 Participants
9 Participants
n=109 Participants
4 Participants
n=76 Participants
0 Participants
n=49 Participants
15 Participants
n=343 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants
n=109 Participants
4 Participants
n=109 Participants
4 Participants
n=76 Participants
5 Participants
n=49 Participants
17 Participants
n=343 Participants
Region of Enrollment
United States
109 Participants
n=109 Participants
109 Participants
n=109 Participants
76 Participants
n=76 Participants
49 Participants
n=49 Participants
343 Participants
n=343 Participants
Daily cigarette craving
47.89 units on a scale
STANDARD_DEVIATION 20.70 • n=109 Participants • Some participants in the Unassigned group did not respond to any daily messages and are not represented in the average.
49.17 units on a scale
STANDARD_DEVIATION 19.61 • n=109 Participants • Some participants in the Unassigned group did not respond to any daily messages and are not represented in the average.
48.03 units on a scale
STANDARD_DEVIATION 20.81 • n=76 Participants • Some participants in the Unassigned group did not respond to any daily messages and are not represented in the average.
59.86 units on a scale
STANDARD_DEVIATION 19.42 • n=28 Participants • Some participants in the Unassigned group did not respond to any daily messages and are not represented in the average.
49.40 units on a scale
STANDARD_DEVIATION 20.43 • n=322 Participants • Some participants in the Unassigned group did not respond to any daily messages and are not represented in the average.
Daily cigarette count
13.29 cigarettes
STANDARD_DEVIATION 6.35 • n=109 Participants • Some participants in the Unassigned group did not respond to any daily messages and are not represented in the average.
14.17 cigarettes
STANDARD_DEVIATION 19.18 • n=109 Participants • Some participants in the Unassigned group did not respond to any daily messages and are not represented in the average.
14.05 cigarettes
STANDARD_DEVIATION 9.84 • n=76 Participants • Some participants in the Unassigned group did not respond to any daily messages and are not represented in the average.
14.17 cigarettes
STANDARD_DEVIATION 9.18 • n=28 Participants • Some participants in the Unassigned group did not respond to any daily messages and are not represented in the average.
13.71 cigarettes
STANDARD_DEVIATION 8.71 • n=322 Participants • Some participants in the Unassigned group did not respond to any daily messages and are not represented in the average.

PRIMARY outcome

Timeframe: 4-week experimental manipulation period

Population: All participants who responded to any craving rating questions during the intervention period are included in this average. Participants in the "unassigned" group did not begin the intervention period and therefore are have no outcome data to report.

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.

Outcome measures

Outcome measures
Measure
Tobacco Retailer Group
n=101 Participants
Participants visit a tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period Tobacco retailer: 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
Non-tobacco Retailer Group
n=104 Participants
Participants visit a non-tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period Non-tobacco retailer: 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.
Control
n=75 Participants
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
48.33 units on a scale
Standard Deviation 25.30
49.14 units on a scale
Standard Deviation 22.96
47.17 units on a scale
Standard Deviation 24.24

PRIMARY outcome

Timeframe: 4-week experimental manipulation period

Population: All participants who responded to any cigarette consumption questions during the intervention period are included in this average. Participants in the "unassigned" group did not begin the intervention period and therefore are have no outcome data to report.

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.

Outcome measures

Outcome measures
Measure
Tobacco Retailer Group
n=101 Participants
Participants visit a tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period Tobacco retailer: 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
Non-tobacco Retailer Group
n=104 Participants
Participants visit a non-tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period Non-tobacco retailer: 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.
Control
n=75 Participants
Participants are not asked to alter their behavior during the 4-week (0 store visits) intervention period
Self-reported Number of Cigarettes Smoked Per Day During the Experimental Manipulation Period
12.72 cigarettes
Standard Deviation 6.26
12.88 cigarettes
Standard Deviation 8.27
13.64 cigarettes
Standard Deviation 7.55

PRIMARY outcome

Timeframe: [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)]]

Population: Participants who completed at least one scan and whose data passed quality thresholds for in-scanner movement and response rate. Due to COVID-19 pandemic restrictions during data collection, we changed the protocol to make the fMRI scan optional, which means that we do not have adequate statistical power to test experimental group differences. No participants in the "unassigned" group were scanned, since they did not begin the intervention period.

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.

Outcome measures

Outcome measures
Measure
Tobacco Retailer Group
n=7 Participants
Participants visit a tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period Tobacco retailer: 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
Non-tobacco Retailer Group
n=10 Participants
Participants visit a non-tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period Non-tobacco retailer: 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.
Control
n=11 Participants
Participants are not asked to alter their behavior during the 4-week (0 store visits) intervention period
Brain Activity (Measured by Functional Magnetic Resonance Imaging) in a Priori Regions of Interest, in Response to Standardized Smoking vs Nonsmoking Cues.
0.021 percent change in BOLD signal
Standard Deviation 0.089
-0.025 percent change in BOLD signal
Standard Deviation 0.080
0.035 percent change in BOLD signal
Standard Deviation 0.120

PRIMARY outcome

Timeframe: [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)]]

Population: Participants who completed at least one scan and whose data passed quality thresholds for in-scanner movement and response rate. Due to COVID-19 pandemic restrictions during data collection, we changed the protocol to make the fMRI scan optional, which means that we do not have adequate statistical power to test experimental group differences. No participants in the "unassigned" group were scanned, since they did not begin the intervention period.

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.

Outcome measures

Outcome measures
Measure
Tobacco Retailer Group
n=7 Participants
Participants visit a tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period Tobacco retailer: 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
Non-tobacco Retailer Group
n=10 Participants
Participants visit a non-tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period Non-tobacco retailer: 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.
Control
n=11 Participants
Participants are not asked to alter their behavior during the 4-week (0 store visits) intervention period
Brain Activity (Measured by fMRI), in a Priori Regions of Interest, in Response to Retail Smoking vs Nonsmoking Cues
0.062 percent change in BOLD signal
Standard Deviation 0.118
0.012 percent change in BOLD signal
Standard Deviation 0.092
0.018 percent change in BOLD signal
Standard Deviation 0.108

Adverse Events

Tobacco Retailer Group

Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths

Non-tobacco Retailer Group

Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Unassigned

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Tobacco Retailer Group
n=109 participants at risk
Participants visit a tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period Tobacco retailer: 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
Non-tobacco Retailer Group
n=109 participants at risk
Participants visit a non-tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period Non-tobacco retailer: 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.
Control
n=76 participants at risk
Participants are not asked to alter their behavior during the 4-week (0 store visits) intervention period
Unassigned
n=49 participants at risk
Participants who began the baseline period, but did not begin the intervention period and therefore were not assigned to an experimental group.
General disorders
Hospitalization
1.8%
2/109 • Period of enrollment for each participant (approximately 6 weeks)
4.6%
5/109 • Period of enrollment for each participant (approximately 6 weeks)
0.00%
0/76 • Period of enrollment for each participant (approximately 6 weeks)
0.00%
0/49 • Period of enrollment for each participant (approximately 6 weeks)

Other adverse events

Adverse event data not reported

Additional Information

Emily Falk

University of Pennsylvania

Phone: 215-573-9901

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place