About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Single group
Treatments tested in this trial
transdermal nicotine replacement therapy
DrugAll participants will receive transdermal nicotine replacement therapy (21 mg. patches)
Treatment groups
Trial outcomes
Primary outcomes
Average number of days to smoking relapse
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.
Secondary outcomes
Number of participants who self-report 7-day point prevalence abstinence
7-day point prevalence abstinence is defined as no smoking in the prior 7 days.
Number of participants who self-report 7-day point prevalence abstinence
7-day point prevalence abstinence is defined as no smoking in the prior 7 days.
Number of participants who self-report 7-day point prevalence abstinence
7-day point prevalence abstinence is defined as no smoking in the prior 7 days.
Sponsors and contacts
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Duke University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator