A Phase 4 interventional study of transdermal nicotine replacement therapy in Smoking, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Duke University · Phase 4, Interventional, and Other
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Among 30 studies in Smoking by Duke University — 1 open to participants now, 1 under way, none of them phase 3. Smoking · Duke University.
Among the 30 studies in Smoking by Duke University, this one has the largest planned enrollment of the 27 interventional ones that give a count, is the only one that started in 2026, is one of 4 in phase 4, and was the 30th registered.
1,511 studies on the registry are indexed under Smoking; 194 are open to participants now.
Browse Smoking studies →1 of the 30 studies in Smoking by Duke University is open now, in 1 country.
By country, each count listing its studies:
Of the 140 Smoking studies recruiting now, 74 (53%) set no upper age limit and 48 (34%) stop at 75 or younger; 3 take children under 18; 65 take healthy volunteers.
This study: 21 Years and older · all sexes · no healthy volunteers.
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30 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 600 is above the median of 115 across 1,165 interventional studies indexed under Smoking.
Median enrollment 41 across the 27 interventional studies, 122 across the 3 observational. Of the 26 that completed or were terminated, 7 (27%) have results posted.
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Duke University is the lead sponsor of 2,063 studies on the registry; 272 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 30 studies in Smoking by Duke University, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will receive transdermal nicotine replacement therapy.
Drug: transdermal nicotine replacement therapy
All participants will receive transdermal nicotine replacement therapy (21 mg. patches)
Also known as: NRT, nicotine patch
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.
Time frame: From quit date to 6-month follow-up (about 6.5 months)
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.
Time frame: 1-month follow-up (around 1.5 months after beginning treatment)
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.
Time frame: 3-month follow-up (around 3.5 months after beginning treatment)
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.
Time frame: 6-month follow-up (around 6.5 months after beginning treatment)
Plan to share: Yes — We anticipate depositing the research data with the digital repository of the Inter-university Consortium for Political and Social Research (ICPSR), which supports NIDA-funded data sharing and restricted data access. Data will include photos, ecological momentary assessment data, breath CO readings, and survey data. Each data set will be made available along with the corresponding study protocol and codebook. The codebook will include a basic description of the variable, how and when it was collected, and relevant references or scoring information.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be made available one year after study completion, and will continue as long as the study is open for data analysis.
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Mar 2030, 46 months after the start.
Of 29 non-industry phase 4 interventional studies under Smoking, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 46 months is above that.
Counting every sponsor, half of 29 studies reached it within 35 months; a quarter within 18 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
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