Personalized Tobacco Treatment in Primary Care (MOTIVATE)

NCT05846841 | Recruiting

• 3 other identifiers: 2022050901R01DA0560505U19CA203654
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 1

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

Keywords

genetics; primary care physicians; tobacco treatment

Outcome Measures

Primary Outcomes (3)

• Patient receipt of tobacco treatment medication for smoking cessation

  This will be quantified by the proportion of enrolled patients who receive cessation medication.

  6 months post-intervention

• Patient use of cessation medication

  This will be quantified by the proportion of patients taking any cessation medication from time of enrollment through 6 months post-intervention.

  6 months post-intervention

• Patient smoking abstinence

  This will be quantified by the proportion of smokers with bioverified point-prevalent abstinence at 6 months.

  6 months post-intervention

Secondary Outcomes (6)

• Patient receipt of recommended tobacco treatment

  6 months post-intervention

• Patient medication adherence

  6 months post-intervention

• Patient smoking abstinence among treated

  6 months post-intervention

• Abstinence Outcomes Across Multiple Time Points

  From intervention through 12 months post-intervention

• Smoking quantity across multiple time points

  From intervention through 12 months post-intervention

Other Outcomes (8)

• Perceived benefits (Clinician)

  Exit interview [after last patient is enrolled per clinician at the time of the last intervention (approximately 3 years)]

• Outcome expectancies (Clinician)

  Exit interview [after last patient is enrolled per clinician at the time of the last intervention (approximately 3 years)]

• Self-efficacy regarding patient-clinician interaction (Clinician)

  Exit interview [after last patient is enrolled per clinician at the time of the last intervention (approximately 3 years)]

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Usual Care

PrecisionTx

EXPERIMENTAL

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.

Behavioral: Precision Treatment

Interventions

Precision Treatment BEHAVIORAL

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.

PrecisionTx

Usual Care BEHAVIORAL

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

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Smoking Cessation; Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Li-Shiun Chen, ScD, MD, MPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li-Shiun Chen, ScD, MD, MPH

CONTACT

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

Alex Ramsey, PhD

CONTACT

314-362-5370; aramsey@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinicians will be randomized on a 1:1 basis to usual care or precision treatment. Patients will be assigned to the same arm as their clinician.

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 6, 2023
• Study Start: September 29, 2023
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 12 months after trial completion

Locations

US (1)