Health TrialsbyHealthPanel

VergeRx for Smokers Not Ready to Quit

ConditionTobacco Use Cessation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Virginia

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

This trial accepts healthy volunteers

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

Design model

Factorial

Treatments tested in this trial

  • VergeRx

    Behavioral

    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.

  • SmokefreeTXT

    Behavioral

    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.

  • NRT Lozenge (Combination)

    Drug

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

  • Extended NRT Patch (16 weeks)

    Drug

    Nicotine patch provided for 16 weeks.

  • Standard NRT Patch (8 weeks)

    Drug

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

Treatment groups

592 Participants
are divided into 16 treatment groups

16

Treatment groups

See each treatment group below.

Group A: VergeRx + SmokefreeTXT + 16-wk Patch + LozengeExperimental treatment 4 interventions
Group B: VergeRx + SmokefreeTXT + 16-wk PatchExperimental treatment 3 interventions
Group C: VergeRx + SmokefreeTXT + 8-wk Patch + LozengeExperimental treatment 4 interventions
Group D: VergeRx + SmokefreeTXT + 8-wk PatchExperimental treatment 3 interventions
Group E: VergeRx + 16-wk Patch + LozengeExperimental treatment 3 interventions
Group F: VergeRx + 16-wk PatchExperimental treatment 2 interventions
Group G: VergeRx + 8-wk Patch + LozengeExperimental treatment 3 interventions
Group H: VergeRx + 8-wk PatchExperimental treatment 2 interventions
Group I: SmokefreeTXT + 16-wk Patch + LozengeExperimental treatment 3 interventions
Group J: SmokefreeTXT + 16-wk PatchExperimental treatment 2 interventions
Group K: SmokefreeTXT + 8-wk Patch + LozengeExperimental treatment 3 interventions
Group L: SmokefreeTXT + 8-wk PatchExperimental treatment 2 interventions
Group M: 16-wk Patch + LozengeExperimental treatment 1 intervention
Group N: 16-wk PatchExperimental treatment 1 intervention
Group O: 8-wk Patch + LozengeExperimental treatment 1 intervention
Group P: 8-wk Patch (reference)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Biochemically confirmed 7-day point prevalence cigarette abstinence at 26 weeks

Point prevalence abstinence, defined as no cigarette smoking (not even a puff) within the past 7 days, biochemically confirmed using a CoVita Smokerlyzer carbon monoxide (CO) monitor at the FQHC. Participants unable to travel who report no combustible tobacco use are mailed a cotinine test completed via Zoom. Participants who do not provide outcome data are classified as smoking.

Time frame
26 weeks after enrollment

Secondary outcomes

1

Biochemically confirmed 7-day point prevalence cigarette abstinence at 52 weeks

Same definition and biochemical confirmation procedure as the primary outcome (no smoking within the past 7 days; CO-verified, with mailed cotinine confirmation via Zoom when travel is not possible; missing data classified as smoking), assessed at the 52-week follow-up to evaluate cessation maintenance.

Time frame
52 weeks after enrollment

Other outcomes

1

Motivation to quit

Self-reported motivation/readiness to quit smoking, assessed by questionnaire at each assessment point.

Time frame
Baseline through 52 weeks
2

Cigarettes smoked per day

Self-reported number of cigarettes smoked per day.

Time frame
Baseline through 52 weeks
3

Adherence to NRT

Adherence measured as the percentage of dispensed NRT patch and/or lozenge that was used.

Time frame
Weeks 1 through 52
4

Frequency of urges to smoke

Self-reported frequency of urges to smoke (Strength of Urges to Smoke measure).

Time frame
Baseline through 52 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Virginia

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: