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Not Yet Recruiting
NCT07693660
VergeRx for Smokers Not Ready to Quit
Conditions: Tobacco Use Cessation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 592
Sponsor: University of Virginia
Location: University of Virginia Charlottesville 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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07693660). StuddyBuddy aggregates publicly available trial information.