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VergeRx for Smoking Cessation

MA
Overseen ByMelissa A Little
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Virginia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

ML

Melissa Little, PhD, MPH

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for adults who smoke cigarettes, get care at certain health centers in Virginia or West Virginia, and are not planning to quit smoking in the next 30 days. People with serious medical issues related to nicotine replacement therapy may not be able to join.

Inclusion Criteria

Not ready to quit smoking in the next 30 days
Able to read, speak, and understand English
Report smoking ≥ 5 cigarettes per day for the past 6 months
See 3 more

Exclusion Criteria

Currently pregnant, or planning to become pregnant in the next 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Extended NRT Patch (16 weeks)
  • NRT Lozenge (Combination)
  • SmokefreeTXT
  • Standard NRT Patch (8 weeks)
  • VergeRx

Trial Overview

The study tests different combinations of four treatments: a pharmacist-led counseling program (VergeRx), supportive text messages (SmokefreeTXT), adding nicotine lozenges to patches, and using nicotine patches for either 8 or 16 weeks. All participants receive at least an 8-week patch.

How Is the Trial Designed?

16

Treatment groups

Experimental Treatment

Group I: VergeRx + SmokefreeTXT + 8-wk Patch + LozengeExperimental Treatment4 Interventions
Group II: VergeRx + SmokefreeTXT + 8-wk PatchExperimental Treatment3 Interventions
Group III: VergeRx + SmokefreeTXT + 16-wk Patch + LozengeExperimental Treatment4 Interventions
Group IV: VergeRx + SmokefreeTXT + 16-wk PatchExperimental Treatment3 Interventions
Group V: VergeRx + 8-wk Patch + LozengeExperimental Treatment3 Interventions
Group VI: VergeRx + 8-wk PatchExperimental Treatment2 Interventions
Group VII: VergeRx + 16-wk Patch + LozengeExperimental Treatment3 Interventions
Group VIII: VergeRx + 16-wk PatchExperimental Treatment2 Interventions
Group IX: SmokefreeTXT + 8-wk Patch + LozengeExperimental Treatment3 Interventions
Group X: SmokefreeTXT + 8-wk PatchExperimental Treatment2 Interventions
Group XI: SmokefreeTXT + 16-wk Patch + LozengeExperimental Treatment3 Interventions
Group XII: SmokefreeTXT + 16-wk PatchExperimental Treatment2 Interventions
Group XIII: 8-wk Patch + LozengeExperimental Treatment1 Intervention
Group XIV: 8-wk Patch (reference)Experimental Treatment1 Intervention
Group XV: 16-wk Patch + LozengeExperimental Treatment1 Intervention
Group XVI: 16-wk PatchExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials
802
Recruited
1,342,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

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