About this trial
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
Qualifiers
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
Disqualifiers
Currently pregnant, or planning to become pregnant in the next 6 months
Trial design
Treatments tested in this trial
- VergeRx
- SmokefreeTXT
- NRT Lozenge (Combination)
- Extended NRT Patch (16 weeks)
- Standard NRT Patch (8 weeks)
Treatment groups
16
Treatment groupsSee each treatment group below.
Sponsors and collaborators
University of Virginia
Lead sponsor
National Cancer Institute (NCI)
Collaborator