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临床试验/NCT07089901
NCT07089901招募中4 期

Project DEDUCE: Digital Envirotyping to Develop Understanding of Cigarette Smoking and the Environment

Duke University1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2026年5月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
600
试验地点
1
主要终点
Average number of days to smoking relapse

研究概览

简要总结

Tobacco use is a chronic relapsing condition. That is, even with state-of-the-art treatment, >70% of smoking cessation attempts end in a return to regular smoking. Research demonstrates that everyday environments associated with smoking trigger craving for cigarettes, provoke smoking, and lead to relapse. However, despite this knowledge, understanding of environmental correlates of smoking has been limited by a reliance on self-report, leading to imprecise information about the physical environments in which people live. To overcome this challenge, the research team has pioneered the development of digital envirotyping, which uses digital tools (e.g., sensors, cameras, artificial intelligence) to efficiently and accurately characterize and categorize environments with the goal of identifying environmental markers of behavior and health. Foundational to the digital envirotyping research is computer vision (CV), a type of artificial intelligence (AI) that enables computer systems to recognize objects and scenes in digital images, mimicking how humans perceive and understand visual information. With CV researchers can extract detailed and accurate information (i.e., objects and location types) about the everyday environments of people who smoke (PWS) and relate that information to smoking behavior. After validating the use of CV, the researchers used CV to develop enviromarkers of relapse risk. Importantly, they identified a novel enviromarker in which people at greater risk for relapse when they quit are exposed to a more consistent level of environment-related smoking risk as they move between their smoking and nonsmoking environments.

Research is now needed to advance digital envirotyping and enviromarker development in the field of tobacco addiction. The study will recruit a diverse, national sample of n=500 adults who are interested in quitting smoking. For two weeks prior to quitting, they will undergo photoEMA in which they will take two pictures of their current environment when they smoke, and randomly 10 times per day resulting in >300,000 images total. Cessation will be supported by nicotine replacement therapy (i.e., nicotine patch). The primary clinical outcome will be days to relapse. Specific aims are to (1) further develop, refine, and validate methods for efficient digital envirotyping at scale, (2) leverage CV and AI approaches to develop enviromarkers of smoking relapse, and (3) conduct analyses to increase understanding of environmental smoking risk in women and individuals with low socioeconomic status.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •21 years of age or older;
  • •Smoke ≥ 10 cigarettes/day
  • •Smoking daily for ≥ 2 years, with a stable smoking pattern for the past 6 months;
  • •Intention to quit smoking and set a target quit date in the next 1 month;
  • •Have an iPhone or Android smartphone capable of running the photoEMA and iCO software
  • •Positive Urine Cotinine Test

排除标准

  • •Pregnant, breastfeeding, or planning to become pregnant during the course of the study;
  • •Currently in smoking cessation treatment or current use of smoking cessation products;
  • •Regular use (i.e. >9 days/month) of non-cigarette nicotine-containing products (e.g. cigarillos, e-cigarettes);
  • •Anticipating major life changes (e.g. new job, birth of a child) during the course of the study;
  • •Unstable medical conditions;
  • •Contraindication for nicotine replacement therapy.

研究组 & 干预措施

study group

Experimental

All participants will receive transdermal nicotine replacement therapy.

干预措施: transdermal nicotine replacement therapy (Drug)

结局指标

主要结局

Average number of days to smoking relapse

时间窗: From quit date to 6-month follow-up (about 6.5 months)

Participants will self-report smoking from quit date to the 6-month follow-up visit. Days to relapse will be defined as the first of seven consecutive days of smoking.

Average number of days to smoking relapse

时间窗: From quit date to 6-month follow-up (about 6.5 months)

Participants will self-report smoking from quit date to the 6-month follow-up visit. Days to relapse will be defined as the first of seven consecutive days of smoking.

次要结局

  • Number of participants who self-report 7-day point prevalence abstinence(1-month follow-up (around 1.5 months after beginning treatment))
  • Number of participants who self-report 7-day point prevalence abstinence(3-month follow-up (around 3.5 months after beginning treatment))
  • Number of participants who self-report 7-day point prevalence abstinence(6-month follow-up (around 6.5 months after beginning treatment))

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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