NCT07089901 Project DEDUCE: Digital Envirotyping to Develop Understanding of Cigarette Smoking and the Environment
| NCT ID | NCT07089901 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Duke University |
| Condition | Smoking |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2026-05-06 |
| Primary Completion | 2030-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 600 participants in total. It began in 2026-05-06 with a primary completion date of 2030-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. 21 years of age or older; 2. Smoke ≥ 10 cigarettes/day of a brand delivering 0.5 mg nicotine (FTC method); 3. Smoking daily for ≥ 2 years, with a stable smoking pattern for the past 6 months; 4. Intention to quit smoking and set a target quit date in the next 1 month; 5. Have an iPhone or Android smartphone capable of running the photoEMA and iCO software Exclusion Criteria: 1. Pregnant, breastfeeding, or planning to become pregnant during the course of the study; 2. Currently in smoking cessation treatment or current use of smoking cessation products; 3. Regular use (i.e. \>9 days/month) of non-cigarette nicotine-containing products (e.g. cigarillos, e-cigarettes); 4. Anticipating major life changes (e.g. new job, birth of a child) during the course of the study; 5. Unstable medical conditions; 6. Contraindication for nicotine replacement therapy.
Contact & Investigator
Francis J. McClernon, PhD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT07089901 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Smoking. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07089901 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07089901 currently recruiting?
Yes, NCT07089901 is actively recruiting participants. Contact the research team at laura.vanalthuis@duke.edu for enrollment information.
Where is the NCT07089901 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT07089901 clinical trial?
NCT07089901 is sponsored by Duke University. The principal investigator is Francis J. McClernon, PhD at Duke University. The trial plans to enroll 600 participants.