Smoking CessationNCT04839198
Using Machine Learning to Develop Just-in-Time Adaptive Interventions for Smoking Cessation
A study testing Android Wear smartwatch, Adaptive Treatment and Nicotine Patch in people with Smoking Cessation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the feasibility and preliminary effectiveness of delivering a personalized, just-in-time adaptive intervention driven by machine learning prediction of smoking lapse risk in real time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Android Wear smartwatch, Adaptive Treatment and Nicotine Patch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2024to 22 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a score greater than or equal to 4 on the Rapid Estimate of Adult Literacy in Medicine Short Form (REALM-SF),12
- willingness to quit smoking 14 days after the baseline visit
- no contraindications to using Nicotine replacement therapy (NRT).
- If participants would like to use their own phone to complete the EMAs, they must additionally have an Android smartphone (Android 5.2 or higher), and be willing to install the InsightTM mHealth app on their phone.
Who cannot join
- currently smoking less than 5 cigarettes per day
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to evaluate the feasibility and preliminary effectiveness of delivering a personalized, just-in-time adaptive intervention driven by machine learning prediction of smoking lapse risk in real time.
- Conditions
- Smoking Cessation
- Being tested
- Android Wear smartwatch, Adaptive Treatment, Nicotine Patch, interviewing-based counseling
- Keywords
- Nicotine patch
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Android Wear smartwatchBehavioural
All participants will wear an Android Wear smartwatch, and will complete ecological momentary assessments (EMA).
Adaptive TreatmentBehavioural
Participants will have access to a "Dashboard" button in the InsightTM app that displays personalized statistics based on their progress and patterns in the study.The dashboard will update as more data is collected about the participant's smoking habits, starting in the pre-quit period and continuing through the post-quit period. Second, in the post-quit period, participants will receive treatment messages when the machine learning algorithm determines that they are at high risk for lapse.At the follow-up visit, participants will complete a survey to evaluate what they liked and disliked about the intervention, how accurate they thought the app was in predicting their risk, and how useful they found the dashboard.
Nicotine PatchDrug
At Visit 2, participants will be asked to begin their attempt to quit smoking and will receive a 12-week supply of nicotine replacement therapy (i.e., nicotine patches and gum)
interviewing-based counselingBehavioural
At Visit 2, participants will be asked to begin their attempt to quit smoking and meet with a Tobacco Treatment Specialist, who will provide motivational interviewing-based counseling, help the participants develop a quit plan, and discuss relapse prevention. During the 6-weeks of the study, participants will have the option of attending up to 6 counseling sessions with the Tobacco Treatment Specialist, either in-person or via phone or web.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Treatment plus usual care | Experimental | Not described Receives: Behavioral: Android Wear smartwatch; Behavioral: Adaptive Treatment; Drug: Nicotine Patch; Behavioral: interviewing-based counseling |
| Usual care | Active comparator | Not described Receives: Behavioral: Android Wear smartwatch; Drug: Nicotine Patch; Behavioral: interviewing-based counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who quit smoking as confirmed by absence of salivary cotinine
Measured: 4-weeks after quit day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start6 Feb 2024
- Primary completion22 Nov 2024
- Study completion22 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Emily Hebert, The University of Texas Health Science Center, Houston
- Investigators
- Emily Hebert, DrPH, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839198
- Sponsor's protocol ID
- HSC-SPH-20-1159
- Other IDs
- R00DA046564
- Status last verified
- Sep 2024
- First submitted
- 7 Apr 2021
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Machine Learning to Develop Just-in-Time Adaptive Interventions for Smoking Cessation
- ClinicalTrials.gov ID
- NCT04839198
- Acronym / sponsor ID
- HSC-SPH-20-1159
- Conditions
- Smoking Cessation
- Keywords
- Nicotine patch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 9 Apr 2021 (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.
The purpose of this study is to evaluate the feasibility and preliminary effectiveness of delivering a personalized, just-in-time adaptive intervention driven by machine learning prediction of smoking lapse risk in real time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptive Treatment plus usual care | Experimental | Behavioral: Android Wear smartwatch, Behavioral: Adaptive Treatment, Drug: Nicotine Patch, Behavioral: interviewing-based counseling |
| Usual care | Active comparator | Behavioral: Android Wear smartwatch, Drug: Nicotine Patch, Behavioral: interviewing-based counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a score greater than or equal to 4 on the Rapid Estimate of Adult Literacy in Medicine Short Form (REALM-SF),12
- willingness to quit smoking 14 days after the baseline visit
- no contraindications to using Nicotine replacement therapy (NRT).
- If participants would like to use their own phone to complete the EMAs, they must additionally have an Android smartphone (Android 5.2 or higher), and be willing to install the InsightTM mHealth app on their phone.
Key exclusion criteria (1 listed)
- currently smoking less than 5 cigarettes per day
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 |
|---|---|---|
| Android Wear smartwatchAll participants will wear an Android Wear smartwatch, and will complete ecological momentary assessments (EMA). | Behavioural | Adaptive Treatment plus usual care, Usual care |
| Adaptive TreatmentParticipants will have access to a "Dashboard" button in the InsightTM app that displays personalized statistics based on their progress and patterns in the study.The dashboard will update as more data is collected about the participant's smoking habits, starting in the pre-quit period and continuing through the post-quit period. Second, in the post-quit period, participants will receive treatment messages when the machine learning algorithm determines that they are at high risk for lapse.At the follow-up visit, participants will complete a survey to evaluate what they liked and disliked about the intervention, how accurate they thought the app was in predicting their risk, and how useful they found the dashboard. | Behavioural | Adaptive Treatment plus usual care |
| Nicotine PatchAt Visit 2, participants will be asked to begin their attempt to quit smoking and will receive a 12-week supply of nicotine replacement therapy (i.e., nicotine patches and gum) | Drug | Adaptive Treatment plus usual care, Usual care |
| interviewing-based counselingAt Visit 2, participants will be asked to begin their attempt to quit smoking and meet with a Tobacco Treatment Specialist, who will provide motivational interviewing-based counseling, help the participants develop a quit plan, and discuss relapse prevention. During the 6-weeks of the study, participants will have the option of attending up to 6 counseling sessions with the Tobacco Treatment Specialist, either in-person or via phone or web. | Behavioural | Adaptive Treatment plus usual care, Usual care |
Primary outcome
Number of patients who quit smoking as confirmed by absence of salivary cotinine
Time frame: 4-weeks after quit day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Emily Hebert, DrPH principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Android Wear smartwatch, Adaptive Treatment and Nicotine Patch in people with Smoking Cessation, run by The University of Texas Health Science Center, Houston 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 28 Mar 2025. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who quit smoking as confirmed by absence of salivary cotinine (time frame: 4-weeks after quit day). 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 28 Mar 2025.