SmokingPhase 4DEDUCENCT07089901
Project DEDUCE: Digital Envirotyping to Develop Understanding of Cigarette Smoking and the Environment
A Phase 4 study testing transdermal nicotine replacement therapy in people with Smoking, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- transdermal nicotine replacement therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2026to 31 Mar 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27706
Laura E Van Althuis, MHA, 9196684312
About this study
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.
- Conditions
- Smoking
- Being tested
- transdermal nicotine replacement therapy
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transdermal nicotine replacement therapyDrug
Also called NRT, nicotine patch
All participants will receive transdermal nicotine replacement therapy (21 mg. patches)
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | All participants will receive transdermal nicotine replacement therapy. Receives: Drug: transdermal nicotine replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From quit date to 6-month follow-up (about 6.5 months)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 6-month follow-up (around 6.5 months after beginning treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start6 May 2026
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Francis J. McClernon, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089901
- Sponsor's protocol ID
- Pro00117480
- Other IDs
- 1R01DA062639
- Acronym
- DEDUCE
- Status last verified
- May 2026
- First submitted
- 22 Jul 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project DEDUCE: Digital Envirotyping to Develop Understanding of Cigarette Smoking and the Environment
- ClinicalTrials.gov ID
- NCT07089901
- Acronym / sponsor ID
- DEDUCE / Pro00117480
- Conditions
- Smoking
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 6 May 2026 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: transdermal nicotine replacement therapyAll participants will receive transdermal nicotine replacement therapy. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transdermal nicotine replacement therapyAlso: NRT, nicotine patchAll participants will receive transdermal nicotine replacement therapy (21 mg. patches) | Drug | study group |
Primary outcome
Average number of days to smoking relapse
Time frame: 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.
3 secondary outcomes
Number of participants who self-report 7-day point prevalence abstinence
Time frame: 1-month follow-up (around 1.5 months after beginning treatment)
Number of participants who self-report 7-day point prevalence abstinence
Time frame: 3-month follow-up (around 3.5 months after beginning treatment)
Number of participants who self-report 7-day point prevalence abstinence
Time frame: 6-month follow-up (around 6.5 months after beginning treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francis J. McClernon, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing transdermal nicotine replacement therapy in people with Smoking, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Van Althuis, MHA (919-668-4312, deduce@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average number of days to smoking relapse (time frame: From quit date to 6-month follow-up (about 6.5 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.