VergeRx for Smokers Not Ready to Quit

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT07693660
Status
Not Yet Recruiting

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Conditions

  • Tobacco Use Cessation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • VergeRx — BEHAVIORAL
    Up to three pre-quit modules delivered by a local pharmacist/technician to promote NRT adherence; upon reported readiness to quit (assessed at weekly REDCap check-ins), participants advance to six treatment sessions over four weeks. Component ends if readiness is not reported after four weekly check-ins.
  • SmokefreeTXT — BEHAVIORAL
    Up to three 7-day pre-quit "Daily Challenges" text modules; upon reported readiness to quit, the SmokefreeTXT program delivers 3-5 messages/day for seven weeks. Component ends if readiness is not reported after four weekly check-ins.
  • NRT Lozenge (Combination) — DRUG
    Nicotine lozenge provided in addition to the NRT patch (combination NRT vs. patch monotherapy).
  • Extended NRT Patch (16 weeks) — DRUG
    Nicotine patch provided for 16 weeks.
  • Standard NRT Patch (8 weeks) — DRUG
    Nicotine patch provided for 8 weeks (all participants receive at least 8 weeks of patch beginning Week 1).

Study Details

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.

Key Dates

First listed
Jul 9, 2026
Start date
Dec 1, 2027
Status verified
Jul 2026
Primary completion
Dec 1, 2031
Completion
Nov 1, 2032

Study Design

Enrollment
592 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: VergeRx + SmokefreeTXT + 16-wk Patch + Lozenge
    VergeRx; SmokefreeTXT; Extended NRT Patch (16 wk); NRT Lozenge
  • Experimental: VergeRx + SmokefreeTXT + 16-wk Patch
    VergeRx; SmokefreeTXT; Extended NRT Patch (16 wk)
  • Experimental: VergeRx + SmokefreeTXT + 8-wk Patch + Lozenge
    VergeRx; SmokefreeTXT; Standard NRT Patch (8 wk); NRT Lozenge
  • Experimental: VergeRx + SmokefreeTXT + 8-wk Patch
    VergeRx; SmokefreeTXT; Standard NRT Patch (8 wk)
  • Experimental: VergeRx + 16-wk Patch + Lozenge
    VergeRx; Extended NRT Patch (16 wk); NRT Lozenge
  • Experimental: VergeRx + 16-wk Patch
    VergeRx + 16-wk Patch
  • Experimental: VergeRx + 8-wk Patch + Lozenge
    VergeRx; Standard NRT Patch (8 wk); NRT Lozenge
  • Experimental: VergeRx + 8-wk Patch
    VergeRx; Standard NRT Patch (8 wk)
  • Experimental: SmokefreeTXT + 16-wk Patch + Lozenge
    SmokefreeTXT; Extended NRT Patch (16 wk); NRT Lozenge
  • Experimental: SmokefreeTXT + 16-wk Patch
    SmokefreeTXT; Extended NRT Patch (16 wk)
  • Experimental: SmokefreeTXT + 8-wk Patch + Lozenge
    SmokefreeTXT; Standard NRT Patch (8 wk); NRT Lozenge
  • Experimental: SmokefreeTXT + 8-wk Patch
    SmokefreeTXT; Standard NRT Patch (8 wk)
  • Experimental: 16-wk Patch + Lozenge
    Extended NRT Patch (16 wk); NRT Lozenge
  • Experimental: 16-wk Patch
    Extended NRT Patch (16 wk)
  • Experimental: 8-wk Patch + Lozenge
    Standard NRT Patch (8 wk); NRT Lozenge
  • Experimental: 8-wk Patch (reference)
    Standard NRT Patch (8 wk)

Primary Outcome Measure

Biochemically confirmed 7-day point prevalence cigarette abstinence at 26 weeks [ Time Frame: 26 weeks after enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22904
Melissa Little
[email protected]
434-924-1935

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University of Virginia· Charlottesville, VA

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