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Behavioral Intervention
Machine Learning for Smoking Cessation
N/A
Recruiting
Led By Emily Hebert, DrPH
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-weeks after quit day
Awards & highlights
Summary
This trial will test how well a machine learning-based intervention can help people quit smoking.
Who is the study for?
This trial is for individuals who want to quit smoking and are currently smoking more than 5 cigarettes a day. They should have no issues with using nicotine patches, be able to read at a basic level (REALM-SF score ≥4), and own an Android phone (version 5.2+) on which they can install the InsightTM mHealth app.Check my eligibility
What is being tested?
The study tests a personalized intervention that uses machine learning to predict when someone might lapse in their attempt to quit smoking. It includes interviewing-based counseling, nicotine patches, and monitoring through an Android Wear smartwatch.See study design
What are the potential side effects?
Potential side effects may include skin irritation from the nicotine patch and typical withdrawal symptoms from quitting smoking such as irritability, cravings, or difficulty concentrating.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4-weeks after quit day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-weeks after quit day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients who quit smoking as confirmed by absence of salivary cotinine
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Adaptive Treatment plus usual careExperimental Treatment4 Interventions
Group II: Usual careActive Control3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine
FDA approved
Find a Location
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,503 Previous Clinical Trials
2,625,523 Total Patients Enrolled
The University of Texas Health Science Center, HoustonLead Sponsor
919 Previous Clinical Trials
324,981 Total Patients Enrolled
Emily Hebert, DrPHPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to safely use nicotine replacement therapy (NRT).You smoke fewer than 5 cigarettes a day.You must be willing to stop smoking two weeks after the first visit.You agree to stop smoking within 14 days after the first visit.Participants must have an Android smartphone with a screen size of 5.2 inches or larger, and be willing to install the InsightTM mHealth app on their phone.You are not unable to use nicotine replacement therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Adaptive Treatment plus usual care
- Group 2: Usual care
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Smoking Cessation Patient Testimony for trial: Trial Name: NCT04839198 — N/A
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