Geo Smoking Study and Neural and Geospatial Examination of Smokers' Exposure to Retail Environments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 343
- 试验地点
- 1
- 主要终点
- Self-reported Cigarette Craving During the Experimental Manipulation Period
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
Investigator will not know the condition assignment of individual participants unless reassessment is triggered by the stopping rule.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be between the ages of 21-65
- •Smoke at least 5 cigarettes a day for the past 6 months
- •Own an iPhone or Android smartphone that can be used on a daily basis
- •Plan to be in PA, DE, or NJ (for the remote cohort) or the Philadelphia metropolitan area (for the fMRI cohort) for the next 3 months, with the exception of short periods of absence (no longer than 3 consecutive days and no more than 10 days in total)
- •Read and speak English fluently
- •Fully vaccinated against COVID-19
排除标准
- •Current enrollment or plans to enroll in a smoking cessation program in the next 3 months
- •Plan to use nicotine substitutes or smoking cessation treatments in the next 3 months
- •Urine cotinine test at Session 1 indicates a non-smoker level of cotinine
- •General exclusion criteria:
- •Pregnancy
- •Inability or refusal to install Google Maps or LifeData applications on mobile phone
- •Inability or refusal to upload Google Timeline data after receiving instructions and guidance from a researcher
- •Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.
- •Any physical or visual impairment that may prevent the individual from using a computer keyboard or completing any study tasks.
- •During the first two weeks of the study, failure to complete the study tasks (e.g., response to at least 75% of the brief EMA survey questions).
- •The phones of potential participants will be assessed by trained recruiters either during in-person recruiting or during a phone call used to invite eligible participants who filled out the online screening survey for the first appointment. Specifically, recruiters will assess whether phones' functionality allows easy reception and sending of text messages, the use of the geolocation tracking and LifeData applications, whether potential participants have an existing Google account (created prior to Jan 2024), and whether phones have an adequate battery life to allow participants to fulfill study requirements.
- •Any medical condition or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
- •Drug & fMRI exclusion criteria (fMRI cohort only - 822815 participants and fMRI subset of 850796 participants):
- •Currently or recently (within the last 5 years) receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants). Treatment of substance use disorders that occurred greater than 5 years prior to study participation is acceptable if participants are in stable condition
- •Report consuming any of the following drugs within the past two weeks or indicate plans to do so within the coming 6 weeks during the initial recruitment call: Benzodiazepines, Amphetamines, Methamphetamines, Cocaine, MDMA, Methadone, Barbiturates, PCP, Heroin, Oxycodone, Opiates (e.g., morphine, heroin), Buprenorphine.
- •Test positive for any of the above drugs at Appointment 1 (822815) or at the scan appointment (850796)
- •Schizophrenia or psychosis, regardless of treatment status
- •History of stroke or other neurological disorder likely to affect cognition
- •For 850796, history of seizures, brain tumor, penetrative head trauma that cracks the skull
- •Psychiatric hospitalization within the past year
- •MRI exclusion criteria:
- •For 850796, history of problems in previous MRI that are likely to occur again
- •For 822815, left-handedness
- •Propensity to experience claustrophobia
- •Ferromagnetic metal in the body, including anything that might set off a metal detector. Examples include bullet shrapnel, metal shavings (e.g., from welding without protection), or any implant that may be attracted to or damaged by magnets. Dental fillings are generally acceptable.
- •Metal in the body of an unverifiable origin
- •Non-removable piercings
- •Non-removable retainers or other dental work not compatible with fMRI.
- •Any orthopedic implant above the neck
- •Due to constraints of the fMRI scanner, participants whose weight exceeds 350 pounds also will be excluded
- •For 850796, scan must be scheduled within 6 months after completing the third Online Session
研究组 & 干预措施
Tobacco Retailer Group
Participants visit a tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period
干预措施: Tobacco retailer (Behavioral)
Non-tobacco Retailer Group
Participants visit a non-tobacco retailer 5 times per week during the 4-week (20 store visits total) intervention period
干预措施: Non-tobacco retailer (Behavioral)
Control
Participants are not asked to alter their behavior during the 4-week (0 store visits) intervention period
结局指标
主要结局
Self-reported Cigarette Craving During the Experimental Manipulation Period
时间窗: 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.
Self-reported Number of Cigarettes Smoked Per Day During the Experimental Manipulation Period
时间窗: 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.
Brain Activity (Measured by Functional Magnetic Resonance Imaging) in a Priori Regions of Interest, in Response to Standardized Smoking vs Nonsmoking Cues.
时间窗: [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.
Brain Activity (Measured by fMRI), in a Priori Regions of Interest, in Response to Retail Smoking vs Nonsmoking Cues
时间窗: [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.
Self-reported Cigarette Craving During the Experimental Manipulation Period
时间窗: 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.
Self-reported Number of Cigarettes Smoked Per Day During the Experimental Manipulation Period
时间窗: 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.
Brain Activity (Measured by Functional Magnetic Resonance Imaging) in a Priori Regions of Interest, in Response to Standardized Smoking vs Nonsmoking Cues.
时间窗: [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.
Brain Activity (Measured by fMRI), in a Priori Regions of Interest, in Response to Retail Smoking vs Nonsmoking Cues
时间窗: [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.
次要结局
未报告次要终点