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VergeRx for Smokers Not Ready to Quit
Sponsor: University of Virginia
Summary
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
592
Start Date
2027-12-01
Completion Date
2032-11-01
Last Updated
2026-07-09
Healthy Volunteers
Yes
Conditions
Interventions
VergeRx
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
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)
Nicotine lozenge provided in addition to the NRT patch (combination NRT vs. patch monotherapy).
Extended NRT Patch (16 weeks)
Nicotine patch provided for 16 weeks.
Standard NRT Patch (8 weeks)
Nicotine patch provided for 8 weeks (all participants receive at least 8 weeks of patch beginning Week 1).
Locations (1)
University of Virginia
Charlottesville, Virginia, United States