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VergeRx for Smokers Not Ready to Quit

Key facts

Who runs it
University of Virginia
Where
Charlottesville, United StatesSee the site
Trial code
Status
Not yet recruiting
People taking part
592 people, planned
Starts
1 Dec 2027
Expected to end
1 Nov 2032
Type of study
Interventional, 16 groups
Treatments tested
  • VergeRx
  • SmokefreeTXT
  • NRT Lozenge (Combination)
  • Extended NRT Patch (16 weeks)
  • Standard NRT Patch (8 weeks)
Record updated
9 July 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • Not ready to quit smoking in the next 30 days
  • Age ≥ 18 years
  • Able to read, speak, and understand English
  • Report smoking ≥ 5 cigarettes per day for the past 6 months
  • Own a cell phone
  • Willing and able to use nicotine replacement therapy (NRT) in the form of patch and lozenge

Who cannot take part

  • Currently pregnant, or planning to become pregnant in the next 6 months

Where in United States

  • University of VirginiaCharlottesville, United StatesContact: Melissa LittleNot yet recruiting

About the trial

What the trial wants to find out

This study uses a factorial optimization experiment to identify which treatment components help adults who smoke and are not ready to quit in the next 30 days (smokers not ready to quit, or SNRTQ) achieve smoking cessation. Participants are recruited through Federally Qualified Health Centers (FQHCs) in Virginia and West Virginia. All participants receive at least 8 weeks of nicotine replacement therapy (NRT) patch. Using a 2×2×2×2 factorial design, the study independently tests four components: a pharmacist-delivered behavioral program (VergeRx), a text-message support program (SmokefreeTXT), the addition of an NRT lozenge to the patch, and an extended 16-week course of the NRT patch versus the standard 8 weeks. The goal is to estimate the effect of each component on biochemically confirmed smoking abstinence so that an optimized treatment package can be assembled. The primary outcome is abstinence at 26 weeks; a secondary outcome is abstinence at 52 weeks.

The 16 groups in the trial

  • VergeRx + SmokefreeTXT + 16-wk Patch + LozengeTreatment being tested

    VergeRx; SmokefreeTXT; Extended NRT Patch (16 wk); NRT Lozenge

    Treatment: VergeRx, SmokefreeTXT, NRT Lozenge (Combination), and Extended NRT Patch (16 weeks)

  • VergeRx + SmokefreeTXT + 16-wk PatchTreatment being tested

    VergeRx; SmokefreeTXT; Extended NRT Patch (16 wk)

    Treatment: VergeRx, SmokefreeTXT, and Extended NRT Patch (16 weeks)

  • VergeRx + SmokefreeTXT + 8-wk Patch + LozengeTreatment being tested

    VergeRx; SmokefreeTXT; Standard NRT Patch (8 wk); NRT Lozenge

    Treatment: VergeRx, SmokefreeTXT, NRT Lozenge (Combination), and Standard NRT Patch (8 weeks)

  • VergeRx + SmokefreeTXT + 8-wk PatchTreatment being tested

    VergeRx; SmokefreeTXT; Standard NRT Patch (8 wk)

    Treatment: VergeRx, SmokefreeTXT, and Standard NRT Patch (8 weeks)

  • VergeRx + 16-wk Patch + LozengeTreatment being tested

    VergeRx; Extended NRT Patch (16 wk); NRT Lozenge

    Treatment: VergeRx, NRT Lozenge (Combination), and Extended NRT Patch (16 weeks)

  • VergeRx + 16-wk PatchTreatment being tested

    Treatment: VergeRx and Extended NRT Patch (16 weeks)

  • VergeRx + 8-wk Patch + LozengeTreatment being tested

    VergeRx; Standard NRT Patch (8 wk); NRT Lozenge

    Treatment: VergeRx, NRT Lozenge (Combination), and Standard NRT Patch (8 weeks)

  • VergeRx + 8-wk PatchTreatment being tested

    VergeRx; Standard NRT Patch (8 wk)

    Treatment: VergeRx and Standard NRT Patch (8 weeks)

  • SmokefreeTXT + 16-wk Patch + LozengeTreatment being tested

    SmokefreeTXT; Extended NRT Patch (16 wk); NRT Lozenge

    Treatment: SmokefreeTXT, NRT Lozenge (Combination), and Extended NRT Patch (16 weeks)

  • SmokefreeTXT + 16-wk PatchTreatment being tested

    SmokefreeTXT; Extended NRT Patch (16 wk)

    Treatment: SmokefreeTXT and Extended NRT Patch (16 weeks)

  • SmokefreeTXT + 8-wk Patch + LozengeTreatment being tested

    SmokefreeTXT; Standard NRT Patch (8 wk); NRT Lozenge

    Treatment: SmokefreeTXT, NRT Lozenge (Combination), and Standard NRT Patch (8 weeks)

  • SmokefreeTXT + 8-wk PatchTreatment being tested

    SmokefreeTXT; Standard NRT Patch (8 wk)

    Treatment: SmokefreeTXT and Standard NRT Patch (8 weeks)

  • 16-wk Patch + LozengeTreatment being tested

    Extended NRT Patch (16 wk); NRT Lozenge

    Treatment: Extended NRT Patch (16 weeks)

  • 16-wk PatchTreatment being tested

    Extended NRT Patch (16 wk)

    Treatment: Extended NRT Patch (16 weeks)

  • 8-wk Patch + LozengeTreatment being tested

    Standard NRT Patch (8 wk); NRT Lozenge

    Treatment: Standard NRT Patch (8 weeks)

  • 8-wk Patch (reference)Treatment being tested

    Standard NRT Patch (8 wk)

    Treatment: Standard NRT Patch (8 weeks)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Optimizing Pharmacist-Led Tobacco Treatment for Individuals Who Smoke and Are Not Ready to Make a Quit Attempt in Federally-Qualified Health Centers
Record updated
9 July 2026