Optimizing Pharmacist-Led Tobacco Treatment for Individuals Who Smoke and Are Not Ready to Make a Quit Attempt in Federally-Qualified Health Centers

Background and rationale. People who smoke but are not ready to quit in the next 30 days (SNRTQ) are underserved by conventional cessation treatments, which typically require a near-term commitment to quit. Substantial questions remain about how best to treat this population, including whether combination NRT outperforms monotherapy for these smokers and how long NRT patch treatment should be provided. This study applies the optimization phase of the Multiphase Optimization Strategy (MOST) to efficiently evaluate multiple candidate components within a single experiment, guided by a Phase-Based Framework for smoking cessation.

Design. The study is a fully-crossed 2×2×2×2 factorial experiment with 16 treatment conditions and a planned enrollment of 592 participants (~37 per condition). Four components are independently randomized:

VergeRx (yes vs. no): Participants receive up to three pre-quit modules with a local pharmacist or pharmacy technician to promote NRT adherence. Readiness to quit is assessed at weekly REDCap check-ins conducted by the research team; participants may also report readiness to their pharmacist during or between sessions. Upon reporting readiness, participants advance to six treatment sessions delivered over four weeks. If readiness is not reported after four weekly check-ins, the VergeRx component ends.

SmokefreeTXT (yes vs. no): Participants receive up to three 7-day pre-quit modules ("Daily Challenges") to prepare for a quit attempt. Upon reporting readiness at a weekly check-in, participants transition to the SmokefreeTXT program, which delivers 3-5 messages per day for seven weeks. If readiness is not reported after four weekly check-ins, the component ends.

Combination NRT Lozenge + NRT Patch (vs. patch alone): Participants assigned to this component receive nicotine lozenge in addition to the NRT patch, testing whether combining delivery mechanisms improves outcomes relative to patch monotherapy in this population.