Optimizing Pharmacist-Led Tobacco Treatment for Individuals Who Smoke and Are Not Ready to Make a Quit Attempt in Federally-Qualified Health Centers
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 Exclusion Criteria: * Currently pregnant, or planning to become pregnant in the next 6 months
Interventions
- BehavioralVergeRx
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.
- BehavioralSmokefreeTXT
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.
- DrugNRT Lozenge (Combination)
Nicotine lozenge provided in addition to the NRT patch (combination NRT vs. patch monotherapy).
- DrugExtended NRT Patch (16 weeks)
Nicotine patch provided for 16 weeks.
- DrugStandard NRT Patch (8 weeks)
Nicotine patch provided for 8 weeks (all participants receive at least 8 weeks of patch beginning Week 1).
Location
- University of VirginiaCharlottesville, Virginia