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OpenTrials
Completed

NCT Number: NCT04839198

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

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Android Wear smartwatch

Behavioral

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

Adaptive Treatment

Behavioral

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 patch

Drug

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 counseling

Behavioral

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.

Primary outcomes

  1. Number of patients who quit smoking as confirmed by absence of salivary cotinine

    Time frame: 4-weeks after quit day

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 9, 2021
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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