VergeRx for Smokers Not Ready to Quit

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.

Conditions

• Tobacco Use Cessation

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

DRUG

NRT Lozenge (Combination)

Nicotine lozenge provided in addition to the NRT patch (combination NRT vs. patch monotherapy).

DRUG

Extended NRT Patch (16 weeks)

Nicotine patch provided for 16 weeks.

DRUG

Standard NRT Patch (8 weeks)

Nicotine patch provided for 8 weeks (all participants receive at least 8 weeks of patch beginning Week 1).

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Virginia

  lead OTHER

Principal Investigators

• Melissa Little, PhD, MPH · University of Virginia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2027-12-01

Primary Completion

2031-12-01

Completion

2032-11-01

Countries

• United States

Study Locations