Tobacco Use CessationNCT07693660
VergeRx for Smokers Not Ready to Quit
A study testing VergeRx, SmokefreeTXT and NRT Lozenge (Combination) in people with Tobacco Use Cessation, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- VergeRx, SmokefreeTXT and NRT Lozenge (Combination)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 592 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2027to 1 Nov 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently pregnant, or planning to become pregnant in the next 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Virginia
Charlottesville, Virginia, 22904
Melissa Little, 434-924-1935, mal7uj@virginia.edu
About this study
Official title: Optimizing Pharmacist-Led Tobacco Treatment for Individuals Who Smoke and Are Not Ready to Make a Quit Attempt in Federally-Qualified Health Centers
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.
Read the detailed description
Background and rationale. People who smoke but are not ready to quit in the next 30 days (SNRTQ) are underserved by conventional cessation treatments, which typically require a near-term commitment to quit. Substantial questions remain about how best to treat this population, including whether combination NRT outperforms monotherapy for these smokers and how long NRT patch treatment should be provided. This study applies the optimization phase of the Multiphase Optimization Strategy (MOST) to efficiently evaluate multiple candidate components within a single experiment, guided by a Phase-Based Framework for smoking cessation.
Design. The study is a fully-crossed 2×2×2×2 factorial experiment with 16 treatment conditions and a planned enrollment of 592 participants (~37 per condition). Four components are independently randomized:
VergeRx (yes vs. no): Participants receive up to three pre-quit modules with a local pharmacist or pharmacy technician to promote NRT adherence. Readiness to quit is assessed at weekly REDCap check-ins conducted by the research team; participants may also report readiness to their pharmacist during or between sessions. Upon reporting readiness, participants advance to six treatment sessions delivered over four weeks. If readiness is not reported after four weekly check-ins, the VergeRx component ends.
SmokefreeTXT (yes vs. no): Participants receive up to three 7-day pre-quit modules ("Daily Challenges") to prepare for a quit attempt. Upon reporting readiness at a weekly check-in, participants transition to the SmokefreeTXT program, which delivers 3-5 messages per day for seven weeks. If readiness is not reported after four weekly check-ins, the component ends.
Combination NRT Lozenge + NRT Patch (vs. patch alone): Participants assigned to this component receive nicotine lozenge in addition to the NRT patch, testing whether combining delivery mechanisms improves outcomes relative to patch monotherapy in this population.
16 weeks of NRT patch (vs. standard 8 weeks): This factor tests whether an extended patch duration improves cessation relative to the standard 8-week course.
All participants receive at least 8 weeks of NRT patch beginning in Week 1. Recruitment. Participants are referred by physicians and pharmacists at their local FQHC through an ask-advise-connect model, supplemented by advertisements placed around the FQHC. Eligible participants do not intend to quit in the next 30 days, a motivational cutoff based on prior literature.
Analysis. Consistent with the factorial/MOST approach, the 16 conditions are not compared individually. The main effect of each component is estimated by pooling data across all conditions-for example, the main effect of VergeRx compares abstinence among the ~296 participants who received it against the ~296 who did not. This design uses data from all participants to estimate each component's main effect, providing adequate statistical power with approximately 37 participants per condition. A conceptual model based on the Phase-Based Framework specifies the mediating constructs (proximal outcomes) through which the components are hypothesized to influence cessation, and these mediators are assessed alongside the cessation outcomes.
Outcomes. The primary outcome is biochemically confirmed point-prevalence cigarette abstinence at the 26-week follow-up. A secondary outcome is biochemically confirmed point-prevalence abstinence at the 52-week follow-up.
- Conditions
- Tobacco Use Cessation
- Being tested
- VergeRx, SmokefreeTXT, NRT Lozenge (Combination), Extended NRT Patch (16 weeks), Standard NRT Patch (8 weeks)
- Keywords
- federally qualified health center, rural, urban, appalachia, smoking cessation, readiness to quit, smokers not ready to quit, pharmacists, low income, medicaid
- Medical subject headings
- Tobacco Use Cessation, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VergeRxBehavioural
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.
SmokefreeTXTBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| VergeRx + SmokefreeTXT + 16-wk Patch + Lozenge | Experimental | VergeRx; SmokefreeTXT; Extended NRT Patch (16 wk); NRT Lozenge Receives: Behavioral: VergeRx; Behavioral: SmokefreeTXT; Drug: NRT Lozenge (Combination); Drug: Extended NRT Patch (16 weeks) |
| VergeRx + SmokefreeTXT + 16-wk Patch | Experimental | VergeRx; SmokefreeTXT; Extended NRT Patch (16 wk) Receives: Behavioral: VergeRx; Behavioral: SmokefreeTXT; Drug: Extended NRT Patch (16 weeks) |
| VergeRx + SmokefreeTXT + 8-wk Patch + Lozenge | Experimental | VergeRx; SmokefreeTXT; Standard NRT Patch (8 wk); NRT Lozenge Receives: Behavioral: VergeRx; Behavioral: SmokefreeTXT; Drug: NRT Lozenge (Combination); Drug: Standard NRT Patch (8 weeks) |
| VergeRx + SmokefreeTXT + 8-wk Patch | Experimental | VergeRx; SmokefreeTXT; Standard NRT Patch (8 wk) Receives: Behavioral: VergeRx; Behavioral: SmokefreeTXT; Drug: Standard NRT Patch (8 weeks) |
| VergeRx + 16-wk Patch + Lozenge | Experimental | VergeRx; Extended NRT Patch (16 wk); NRT Lozenge Receives: Behavioral: VergeRx; Drug: NRT Lozenge (Combination); Drug: Extended NRT Patch (16 weeks) |
| VergeRx + 16-wk Patch | Experimental | VergeRx + 16-wk Patch Receives: Behavioral: VergeRx; Drug: Extended NRT Patch (16 weeks) |
| VergeRx + 8-wk Patch + Lozenge | Experimental | VergeRx; Standard NRT Patch (8 wk); NRT Lozenge Receives: Behavioral: VergeRx; Drug: NRT Lozenge (Combination); Drug: Standard NRT Patch (8 weeks) |
| VergeRx + 8-wk Patch | Experimental | VergeRx; Standard NRT Patch (8 wk) Receives: Behavioral: VergeRx; Drug: Standard NRT Patch (8 weeks) |
| SmokefreeTXT + 16-wk Patch + Lozenge | Experimental | SmokefreeTXT; Extended NRT Patch (16 wk); NRT Lozenge Receives: Behavioral: SmokefreeTXT; Drug: NRT Lozenge (Combination); Drug: Extended NRT Patch (16 weeks) |
| SmokefreeTXT + 16-wk Patch | Experimental | SmokefreeTXT; Extended NRT Patch (16 wk) Receives: Behavioral: SmokefreeTXT; Drug: Extended NRT Patch (16 weeks) |
| SmokefreeTXT + 8-wk Patch + Lozenge | Experimental | SmokefreeTXT; Standard NRT Patch (8 wk); NRT Lozenge Receives: Behavioral: SmokefreeTXT; Drug: NRT Lozenge (Combination); Drug: Standard NRT Patch (8 weeks) |
| SmokefreeTXT + 8-wk Patch | Experimental | SmokefreeTXT; Standard NRT Patch (8 wk) Receives: Behavioral: SmokefreeTXT; Drug: Standard NRT Patch (8 weeks) |
| 16-wk Patch + Lozenge | Experimental | Extended NRT Patch (16 wk); NRT Lozenge Receives: Drug: Extended NRT Patch (16 weeks) |
| 16-wk Patch | Experimental | Extended NRT Patch (16 wk) Receives: Drug: Extended NRT Patch (16 weeks) |
| 8-wk Patch + Lozenge | Experimental | Standard NRT Patch (8 wk); NRT Lozenge Receives: Drug: Standard NRT Patch (8 weeks) |
| 8-wk Patch (reference) | Experimental | Standard NRT Patch (8 wk) Receives: Drug: Standard NRT Patch (8 weeks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 52 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Dec 2027 (estimated)
- Primary completion1 Dec 2031 (estimated)
- Study completion1 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This is a 2×2×2×2 fully-crossed factorial optimization experiment conducted within the optimization phase of the Multiphase Optimization Strategy (MOST) framework. Four treatment components are independently randomized: (1) VergeRx (yes/no), (2) SmokefreeTXT (yes/no), (3) combination NRT lozenge added to the NRT patch (vs. patch alone), and (4) 16 weeks of NRT patch (vs. the standard 8 weeks). The crossing of these four two-level factors yields 16 experimental conditions. This is not a 16-arm comparative trial; individual conditions are not compared to one another. Instead, the analysis estimates the main effect of each component by pooling across all conditions-comparing the \~296 participants who receive a component against the \~296 who do not. All participants receive at least 8 weeks of NRT patch beginning in Week 1.
- Masking
- None (open label)
- Enrolment
- 592 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Melissa Little, PhD, MPH, University of Virginia
- Investigators
- Melissa Little, PhD, MPH, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693660
- Sponsor's protocol ID
- HSR303823
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share data at the individual level
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Pharmacist-Led Tobacco Treatment for Individuals Who Smoke and Are Not Ready to Make a Quit Attempt in Federally-Qualified Health Centers
- ClinicalTrials.gov ID
- NCT07693660
- Acronym / sponsor ID
- HSR303823
- Conditions
- Tobacco Use Cessation
- Keywords
- federally qualified health center, rural, urban, appalachia, smoking cessation, readiness to quit, smokers not ready to quit, pharmacists
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 592 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Dec 2027 (estimated)
- Primary completion
- 1 Dec 2031 (estimated)
- Study completion
- 1 Nov 2032 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and rationale. People who smoke but are not ready to quit in the next 30 days (SNRTQ) are underserved by conventional cessation treatments, which typically require a near-term commitment to quit. Substantial questions remain about how best to treat this population, including whether combination NRT outperforms monotherapy for these smokers and how long NRT patch treatment should be provided. This study applies the optimization phase of the Multiphase Optimization Strategy (MOST) to efficiently evaluate multiple candidate components within a single experiment, guided by a Phase-Based Framework for smoking cessation.
Design. The study is a fully-crossed 2×2×2×2 factorial experiment with 16 treatment conditions and a planned enrollment of 592 participants (~37 per condition). Four components are independently randomized:
VergeRx (yes vs. no): Participants receive up to three pre-quit modules with a local pharmacist or pharmacy technician to promote NRT adherence. Readiness to quit is assessed at weekly REDCap check-ins conducted by the research team; participants may also report readiness to their pharmacist during or between sessions. Upon reporting readiness, participants advance to six treatment sessions delivered over four weeks. If readiness is not reported after four weekly check-ins, the VergeRx component ends.
SmokefreeTXT (yes vs. no): Participants receive up to three 7-day pre-quit modules ("Daily Challenges") to prepare for a quit attempt. Upon reporting readiness at a weekly check-in, participants transition to the SmokefreeTXT program, which delivers 3-5 messages per day for seven weeks. If readiness is not reported after four weekly check-ins, the component ends.
Combination NRT Lozenge + NRT Patch (vs. patch alone): Participants assigned to this component receive nicotine lozenge in addition to the NRT patch, testing whether combining delivery mechanisms improves outcomes relative to patch monotherapy in this population.
16 weeks of NRT patch (vs. standard 8 weeks): This factor tests whether an extended patch duration improves cessation relative to the standard 8-week course.
All participants receive at least 8 weeks of NRT patch beginning in Week 1. Recruitment. Participants are referred by physicians and pharmacists at their local FQHC through an ask-advise-connect model, supplemented by advertisements placed around the FQHC. Eligible participants do not intend to quit in the next 30 days, a motivational cutoff based on prior literature.
Analysis. Consistent with the factorial/MOST approach, the 16 conditions are not compared individually. The main effect of each component is estimated by pooling data across all conditions-for example, the main effect of VergeRx compares abstinence among the ~296 participants who received it against the ~296 who did not. This design uses data from all participants to estimate each component's main effect, providing adequate statistical power with approximately 37 participants per condition. A conceptual model based on the Phase-Based Framework specifies the mediating constructs (proximal outcomes) through which the components are hypothesized to influence cessation, and these mediators are assessed alongside the cessation outcomes.
Outcomes. The primary outcome is biochemically confirmed point-prevalence cigarette abstinence at the 26-week follow-up. A secondary outcome is biochemically confirmed point-prevalence abstinence at the 52-week follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 16
- Model description
- This is a 2×2×2×2 fully-crossed factorial optimization experiment conducted within the optimization phase of the Multiphase Optimization Strategy (MOST) framework. Four treatment components are independently randomized: (1) VergeRx (yes/no), (2) SmokefreeTXT (yes/no), (3) combination NRT lozenge added to the NRT patch (vs. patch alone), and (4) 16 weeks of NRT patch (vs. the standard 8 weeks). The crossing of these four two-level factors yields 16 experimental conditions. This is not a 16-arm comparative trial; individual conditions are not compared to one another. Instead, the analysis estimates the main effect of each component by pooling across all conditions-comparing the ~296 participants who receive a component against the ~296 who do not. All participants receive at least 8 weeks of NRT patch beginning in Week 1.
| Arm | Type | Receives |
|---|---|---|
| VergeRx + SmokefreeTXT + 16-wk Patch + Lozenge | Experimental | Behavioral: VergeRx, Behavioral: SmokefreeTXT, Drug: NRT Lozenge (Combination), Drug: Extended NRT Patch (16 weeks)VergeRx; SmokefreeTXT; Extended NRT Patch (16 wk); NRT Lozenge |
| VergeRx + SmokefreeTXT + 16-wk Patch | Experimental | Behavioral: VergeRx, Behavioral: SmokefreeTXT, Drug: Extended NRT Patch (16 weeks)VergeRx; SmokefreeTXT; Extended NRT Patch (16 wk) |
| VergeRx + SmokefreeTXT + 8-wk Patch + Lozenge | Experimental | Behavioral: VergeRx, Behavioral: SmokefreeTXT, Drug: NRT Lozenge (Combination), Drug: Standard NRT Patch (8 weeks)VergeRx; SmokefreeTXT; Standard NRT Patch (8 wk); NRT Lozenge |
| VergeRx + SmokefreeTXT + 8-wk Patch | Experimental | Behavioral: VergeRx, Behavioral: SmokefreeTXT, Drug: Standard NRT Patch (8 weeks)VergeRx; SmokefreeTXT; Standard NRT Patch (8 wk) |
| VergeRx + 16-wk Patch + Lozenge | Experimental | Behavioral: VergeRx, Drug: NRT Lozenge (Combination), Drug: Extended NRT Patch (16 weeks)VergeRx; Extended NRT Patch (16 wk); NRT Lozenge |
| VergeRx + 16-wk Patch | Experimental | Behavioral: VergeRx, Drug: Extended NRT Patch (16 weeks)VergeRx + 16-wk Patch |
| VergeRx + 8-wk Patch + Lozenge | Experimental | Behavioral: VergeRx, Drug: NRT Lozenge (Combination), Drug: Standard NRT Patch (8 weeks)VergeRx; Standard NRT Patch (8 wk); NRT Lozenge |
| VergeRx + 8-wk Patch | Experimental | Behavioral: VergeRx, Drug: Standard NRT Patch (8 weeks)VergeRx; Standard NRT Patch (8 wk) |
| SmokefreeTXT + 16-wk Patch + Lozenge | Experimental | Behavioral: SmokefreeTXT, Drug: NRT Lozenge (Combination), Drug: Extended NRT Patch (16 weeks)SmokefreeTXT; Extended NRT Patch (16 wk); NRT Lozenge |
| SmokefreeTXT + 16-wk Patch | Experimental | Behavioral: SmokefreeTXT, Drug: Extended NRT Patch (16 weeks)SmokefreeTXT; Extended NRT Patch (16 wk) |
| SmokefreeTXT + 8-wk Patch + Lozenge | Experimental | Behavioral: SmokefreeTXT, Drug: NRT Lozenge (Combination), Drug: Standard NRT Patch (8 weeks)SmokefreeTXT; Standard NRT Patch (8 wk); NRT Lozenge |
| SmokefreeTXT + 8-wk Patch | Experimental | Behavioral: SmokefreeTXT, Drug: Standard NRT Patch (8 weeks)SmokefreeTXT; Standard NRT Patch (8 wk) |
| 16-wk Patch + Lozenge | Experimental | Drug: Extended NRT Patch (16 weeks)Extended NRT Patch (16 wk); NRT Lozenge |
| 16-wk Patch | Experimental | Drug: Extended NRT Patch (16 weeks)Extended NRT Patch (16 wk) |
| 8-wk Patch + Lozenge | Experimental | Drug: Standard NRT Patch (8 weeks)Standard NRT Patch (8 wk); NRT Lozenge |
| 8-wk Patch (reference) | Experimental | Drug: Standard NRT Patch (8 weeks)Standard NRT Patch (8 wk) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Currently pregnant, or planning to become pregnant in the next 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VergeRxUp 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. | Behavioural | VergeRx + 16-wk Patch, VergeRx + 16-wk Patch + Lozenge, VergeRx + 8-wk Patch, VergeRx + 8-wk Patch + Lozenge, VergeRx + SmokefreeTXT + 16-wk Patch, VergeRx + SmokefreeTXT + 16-wk Patch + Lozenge, VergeRx + SmokefreeTXT + 8-wk Patch, VergeRx + SmokefreeTXT + 8-wk Patch + Lozenge |
| SmokefreeTXTUp 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. | Behavioural | SmokefreeTXT + 16-wk Patch, SmokefreeTXT + 16-wk Patch + Lozenge, SmokefreeTXT + 8-wk Patch, SmokefreeTXT + 8-wk Patch + Lozenge, VergeRx + SmokefreeTXT + 16-wk Patch, VergeRx + SmokefreeTXT + 16-wk Patch + Lozenge, VergeRx + SmokefreeTXT + 8-wk Patch, VergeRx + SmokefreeTXT + 8-wk Patch + Lozenge |
| NRT Lozenge (Combination)Nicotine lozenge provided in addition to the NRT patch (combination NRT vs. patch monotherapy). | Drug | SmokefreeTXT + 16-wk Patch + Lozenge, SmokefreeTXT + 8-wk Patch + Lozenge, VergeRx + 16-wk Patch + Lozenge, VergeRx + 8-wk Patch + Lozenge, VergeRx + SmokefreeTXT + 16-wk Patch + Lozenge, VergeRx + SmokefreeTXT + 8-wk Patch + Lozenge |
| Extended NRT Patch (16 weeks)Nicotine patch provided for 16 weeks. | Drug | 16-wk Patch, 16-wk Patch + Lozenge, SmokefreeTXT + 16-wk Patch, SmokefreeTXT + 16-wk Patch + Lozenge, VergeRx + 16-wk Patch, VergeRx + 16-wk Patch + Lozenge, VergeRx + SmokefreeTXT + 16-wk Patch, VergeRx + SmokefreeTXT + 16-wk Patch + Lozenge |
| Standard NRT Patch (8 weeks)Nicotine patch provided for 8 weeks (all participants receive at least 8 weeks of patch beginning Week 1). | Drug | 8-wk Patch (reference), 8-wk Patch + Lozenge, SmokefreeTXT + 8-wk Patch, SmokefreeTXT + 8-wk Patch + Lozenge, VergeRx + 8-wk Patch, VergeRx + 8-wk Patch + Lozenge, VergeRx + SmokefreeTXT + 8-wk Patch, VergeRx + SmokefreeTXT + 8-wk Patch + Lozenge |
Primary outcome
Biochemically confirmed 7-day point prevalence cigarette abstinence at 26 weeks
Time frame: 26 weeks after enrollment
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.
1 secondary outcome
Biochemically confirmed 7-day point prevalence cigarette abstinence at 52 weeks
Time frame: 52 weeks after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No. No plans to share data at the individual level
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa Little, PhD, MPH principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VergeRx, SmokefreeTXT and NRT Lozenge (Combination) in people with Tobacco Use Cessation, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa A Little (4349241935, mal7uj@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically confirmed 7-day point prevalence cigarette abstinence at 26 weeks (time frame: 26 weeks after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.