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Using Machine Learning to Develop Just-in-Time Adaptive Interventions for Smoking Cessation

Using Machine Learning to Develop Just-in-Time Adaptive Interventions for Smoking Cessation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04839198
Enrollment
60
Registered
2021-04-09
Start date
2024-02-06
Completion date
2024-11-22
Last updated
2025-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

Nicotine patch

Brief 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.

Interventions

BEHAVIORALAndroid Wear smartwatch

All participants will wear an Android Wear smartwatch, and will complete ecological momentary assessments (EMA).

BEHAVIORALAdaptive Treatment

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.

DRUGNicotine Patch

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)

BEHAVIORALinterviewing-based counseling

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.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* currently smoking less than 5 cigarettes per day

Design outcomes

Primary

MeasureTime frame
Number of patients who quit smoking as confirmed by absence of salivary cotinine4-weeks after quit day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026