An interventional study of Precision Treatment and Usual Care in Physician's Role, Smoking Cessation and Smoking, sponsored by Washington University School of Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
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.
The overarching goal of this study is to test the impact of a multilevel precision treatment intervention aiming to address gaps in clinician and patient uptake of tobacco treatment and overall treatment effectiveness. This study builds on evidence that (1) genetic and metabolic factors may inform precision tobacco treatment and (2) increasingly high demand for precision treatment, in particular, may signal its potential to activate behavior change. The multilevel precision treatment intervention to be tested--PrecisionTx-- provides the opportunity to present personalized risk, benefit, and treatment recommendation to increase clinician ordering, patient uptake, and overall effectiveness of tobacco treatment. This study aims to understand the relative benefit of precision treatment over usual care and associated mechanistic and implementation outcomes. Therefore, the investigators propose a 2-arm cluster randomized controlled trial of 50 clinicians and 800 screen-eligible patients (\~16 per clinician) from diverse primary care settings. Clinicians and patients will be randomized with 1:1 allocation to usual care (UC) vs. precision treatment (PT) to evaluate the effect of precision treatment on smoking cessation success. In Aim 1, the investigators will test the effect of PT on clinician prescribing (or patient receipt of medication when prescription is not needed) and patient use of medication for smoking cessation. The investigators hypothesize that patient receipt of tobacco treatment medication for smoking cessation at 6 months post-intervention will be higher in PT vs UC. The investigators also hypothesize that patient use of cessation medication at 6 months post-intervention will be higher in PT vs. UC. In Aim 2, the investigators will test the effect of PT on patient smoking abstinence. The investigators hypothesize that patient bioverified smoking abstinence at 6 months will be higher in PT vs. UC. In Aim 3, the investigators will examine mechanisms of behavior change and implementation outcomes. The investigators will evaluate putative mechanisms for PT (e.g., outcome expectancy and withdrawal suppression). The investigators will conduct assessments at baseline, intervention, and 1-month, 3-month, 6-month, and 12-month post-intervention follow-ups.
Primary outcomes include patient receipt of tobacco treatment, patient use of tobacco treatment, and patient smoking abstinence. Secondary outcomes include patient receipt of recommended medication, patient medication adherence, and additional patient smoking cessation outcomes. Mechanistic outcomes include clinician level (perceived benefit, outcome expectancy), clinician-patient interaction (self-efficacy), patient-level (perceived risk, outcome expectancy, withdrawal suppression, adverse events). Implementation outcomes will be evaluated based on the RE-AIM framework. The study is an innovative paradigm shift from a traditional treatment model to precision treatment that includes both metabolic and genetic markers to motivate and guide tobacco treatment for both clinicians and patients, integrated within primary care.
Smoking is a leading cause of premature death, causing more than half of all cancer deaths. However, tobacco treatment is often not provided and is not highly effective in primary care. New evidence suggests that a precision treatment approach to motivate and guide treatment based on personal genetic and metabolic markers could improve treatment uptake and quit success. This study will test the impact of a multilevel precision treatment intervention on improving tobacco treatment and health outcomes in primary care.
1,581 studies on the registry are indexed under Smoking Cessation; 198 are open to participants now.
This study's planned enrollment of 850 is above the median of 164 across 1,423 interventional studies indexed under Smoking Cessation.
Browse Smoking Cessation studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Eligibility Criteria for Primary and Specialty Care Clinicians
Eligibility Criteria for Primary Care and Specialty Patients
Inclusion:
Exclusion:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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 will be informed by practice guidelines (standard of care, brief advice, and guideline awareness).
Patient receipt of tobacco treatment medication for smoking cessation
This will be quantified by the proportion of enrolled patients who receive cessation medication.
Time frame: 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.
Time frame: 6 months post-intervention
Patient smoking abstinence
This will be quantified by the proportion of smokers with bioverified point-prevalent abstinence at 6 months.
Time frame: 6 months post-intervention
Patient receipt of recommended tobacco treatment
This will be quantified by the proportion of enrolled patients who received recommended cessation medication.
Time frame: 6 months post-intervention
Patient medication adherence
This will be quantified by the proportion of medication taken among medication prescribed.
Time frame: 6 months post-intervention
Patient smoking abstinence among treated
This will be quantified by the proportion of smokers with bioverified point-prevalence abstinence among those receiving cessation medication.
Time frame: 6 months post-intervention
Abstinence Outcomes Across Multiple Time Points
The outcome measures abstinence (self-reported no smoking (not even a puff of a cigarette) for at least 7 days prior to the assessment) over these time points.
Time frame: From intervention through 12 months post-intervention
Smoking quantity across multiple time points
The outcome measures smoking quantity (self-reported average cigarettes smoked per day for the past 30 days prior to the assessment) over these time points.
Time frame: From intervention through 12 months post-intervention
Quit attempts
This outcome measures the number of quit attempts in the past 30 days prior to the assessment over these time points.
Time frame: 6 and 12 months post-intervention
Perceived benefits (Clinician)
Clinicians' perceived importance and benefits of patients receiving smoking cessation medications will be assessed using a modified version of the Beliefs and Attitudes About Bupropion Scale.
Time frame: Exit interview [after clinician has been enrolled in the trial for approximately 6 months]
Outcome expectancies (Clinician)
Clinicians' outcome expectancies regarding tobacco treatment will be assessed using a modified version of the Stanford Expectation of Treatment Scale.
Time frame: Exit interview [after clinician has been enrolled in the trial for approximately 6 months]
Self-efficacy regarding patient-clinician interaction (Clinician)
Clinicians' perceived self-efficacy regarding patient-clinician communication will be assessed using a modified version of the Communication Perceived Self-Efficacy Scale.
Time frame: Exit interview [after clinician has been enrolled in the trial for approximately 6 months]
Self-efficacy regarding patient-clinician interaction (Patient)
Patients' perceived self-efficacy regarding patient-clinician communication will be assessed using a modified version of the Communication Perceived Self-Efficacy Scale.
Time frame: From intervention through 12 months post-intervention
Perceived risk (Patient)
Patients' perceived smoking-related disease risks will be assessed using a modified version of the Perceived Susceptibility and Severity Scale.
Time frame: From baseline through 12 months post-intervention
Outcome expectancies (Patient)
Patients' outcome expectancies regarding tobacco treatment will be assessed using a modified version of the Stanford Expectation of Treatment Scale.
Time frame: From baseline through 12 months post-intervention
Withdrawal
Withdrawal severity is assessed by Wisconsin Smoking Withdrawal Scale (WSWS).
Time frame: From baseline through 12 months post-intervention
Side Effects
All reported side effects will be summarized and presented for the study. In addition, the investigators will further identify a pre-specified set of key side effects as being related to drug agonist effects (e.g., nausea, vomiting, racing heart, headache, and sleep disturbance). These will be analyzed as the rate of occurrence during the period of cessation medication use, if applicable.
Time frame: From baseline through 12 months post-intervention
Plan to share: Yes — The University will share anonymized human genomic data and relevant associated data from approximately 800 research participants by depositing these data in a NIH-designated data repository or other repositories that meet the appropriate data security measures, confidentiality, privacy, and data use measures. The genotype data will be made available 12 months after trial completion in a NIH-designated data repository after data cleaning and quality control completion, which we anticipate to be in year 5, without restrictions on publication or other dissemination. In addition, information necessary to interpret the submitted data will be included, such as study protocols, data instruments and survey tools.
Supporting information: Study protocol, Statistical analysis plan
Time frame: 12 months after trial completion
Started Sep 2023 (actual). Primary completion is estimated for Mar 2028, 54 months after the start.
Of 546 non-industry interventional studies with no phase under Smoking Cessation, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 54 months is above that.
Counting every sponsor, half of 563 studies reached it within 24 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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