Recruiting

Personalized Tobacco Treatment

Sponsor:

Washington University School of Medicine

Code:

NCT05846841

Conditions

Physician's Role

Smoking Cessation

Smoking

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Precision Treatment

Usual Care

Study Details

Brief summary:

This study examines the application of precision treatment intervention for smoking cessation from both the clinician perspective and patient perspective, and compares it to usual care on tobacco treatment in the primary care setting. The precision treatment intervention includes personalized tobacco treatment recommendations using the patient's clinical, genetic, and biomarker information. This approach may increase effectiveness and adherence for the patient, and increase the clinician's likelihood of prescribing.

Conditions

Physician's Role

Smoking Cessation

Smoking

Study ID

NCT05846841

Start date

Sep 29, 2023

Status verified date

Jul, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Eligibility Criteria for Primary and Specialty Care Clinicians

  • Clinician from participating clinic
  • At least 18 years of age
  • Can speak and understand English

Eligibility Criteria for Primary Care and Specialty Patients

Inclusion:

  • Patient at participating clinic
  • Age 18 years or older, inclusive
  • Current smoking (cigarettes per day >=5)
  • Can speak and understand English
  • Willing to consider medication to help reduce craving or smoking such as nicotine patch, lozenge, or varenicline

Exclusion:

  • Active use of smoking cessation medication (within the past 30 days)
  • Receipt of smoking cessation medication or prescription for smoking cessation medication (within the past 30 days)
  • Having a contraindication for cNRT or varenicline (allergic reactions, current cardiac problems, pregnancy)

Study Design

Enrollment

850 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Usual Care

The arm will represent usual care in the primary care clinics. Physicians will receive a report designed to recommend guideline-based tobacco treatment. Patients will receive a report on guideline-based advice about smoking cessation and a brief discussion with a behavior interventionist.

experimental: PrecisionTx

Physicians will receive PrecisionTx, an intervention designed to recommend precision tobacco treatment. Patients will receive PrecisionTx, an intervention designed to recommend precision tobacco treatment, and a brief discussion with a behavior interventionist.

Interventions

Precision Treatment

Precision treatment will be informed by practice guidelines (standard of care, brief advice, and guideline awareness), plus patient-specific risk feedback and personalized tobacco treatment recommendations using patients' clinical, genetic, and biomarker information.

Usual Care

Usual care will be informed by practice guidelines (standard of care, brief advice, and guideline awareness).

Primary outcome measure

  • Patient receipt of tobacco treatment medication for smoking cessation [ Time Frame: 6 months post-intervention ]
  • Patient use of cessation medication [ Time Frame: 6 months post-intervention ]
  • Patient smoking abstinence [ Time Frame: 6 months post-intervention ]

Central Contacts and Locations

Central contacts

Li-Shiun Chen, ScD, MD, MPH

314-362-3932li-shiun@wustl.edu

Alex Ramsey, PhD

314-362-5370aramsey@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Li-Shiun Chen, ScD, MD, MPH

314-362-3932li-shiun@wustl.edu

Alex Ramsey, PhD

314-362-5370aramsey@wustl.edu

Principal Investigator:

Li-Shiun Chen, ScD, MD, MPH

More Information

Sponsor

Washington University School of Medicine

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • genetics
  • primary care physicians
  • tobacco treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-08-03.