Smoking CessationPhase 4NCT07419425
My Path to Quit Tobacco
A Phase 4 study testing Nicotine patch, Quitline Counseling Phone Calls and Counseling Sessions in people with Smoking Cessation, run by University of Wisconsin, Madison at 5 sites in United States.
Trial summary
The overarching goal of this program of research is to reduce smoking-related health disparities by increasing smoking cessation among Black adults. The goal of this research proposal is to determine whether more intensive, culturally specific, evidence-based interventions are more effective at promoting long-term… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Nicotine patch, Quitline Counseling Phone Calls and Counseling Sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,550 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Jul 2026to Jan 2030
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-identify as Black
- smoke cigarettes (greater than or equal to 1 cigarette on greater than or equal to 4 days/week)
- motivated to quit smoking
- willing to discontinue any non-study smoking cessation pharmacotherapy use during study treatment.
Who cannot join
- currently taking bupropion for non-smoking cessation reasons
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Not yet recruiting
Indiana University
Indianapolis, Indiana, 46202
- Not yet recruiting
University of Kansas Medical Center Research Institute, Inc
Kansas City, Kansas, 66160
- Recruiting
UW School of Medicine and Public Health
Milwaukee, Wisconsin, 53233
- Not yet recruiting
Arizona State University
Phoenix, Arizona, 85004
- Not yet recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Comparing Three Multicomponent Interventions to Help Adults Quit Smoking
The overarching goal of this program of research is to reduce smoking-related health disparities by increasing smoking cessation among Black adults. The goal of this research proposal is to determine whether more intensive, culturally specific, evidence-based interventions are more effective at promoting long-term cessation and other key patient-centered outcomes compared to the usual evidence-based standard of care: services provided by a state-run quitline. This study compares the relative effectiveness of three different treatments (Standard, Intensive, and Intensive Incentivized) on long-term smoking cessation (biochemically confirmed abstinence from combusted tobacco at 26-weeks post-target quit day) among Black adults who smoke and want to quit.
Read the detailed description
Primary Objective: Identify the most effective treatment for increasing long-term smoking abstinence among Black adults who smoke.
Secondary Objectives:
- Compare the 3 interventions on key patient-relevant outcomes (e.g., treatment satisfaction, smoke fewer cigarettes per day, quality of life) using validated measures collected at 8 and 26 weeks post-target quit day (TQD)
- Identify subgroups for whom these treatments are especially effective or ineffective with respect to the primary and secondary outcomes.
- Compare indices of treatment engagement (e.g., percentage of counseling sessions attended, percentage of days used nicotine patch) among Black people who smoke and are randomly assigned to the 3 different treatment conditions.
- Conditions
- Smoking Cessation
- Being tested
- Nicotine patch, Quitline Counseling Phone Calls, Counseling Sessions, Pathways to Freedom, Monetary Incentive
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine patchDrug
Also called NicoDerm CQ
Patch dosing will be consistent with the package insert
Quitline Counseling Phone CallsOther
4, 10 to 15-minute counseling sessions (the duration of a typical quitline call) will occur via phone one week prior to the TQD, 1 day after the TQD, and 1 and 2 weeks after the TQD.
Counseling SessionsOther
Participants will have the option of choosing 8, 30-minute counseling phone calls or 8, 60-minute video group counseling sessions
Pathways to FreedomOther
Pathways to Freedom video content, a 60-minute video that addresses key issues such as emotional dependence, nicotine replacement, identifying smoking triggers, developing coping skills, and other behavioral strategies people can use to support a quit attempt.
Monetary IncentiveOther
up to $50 for completing counseling sessions ($5 for completing sessions 1-6 and $10 for completing sessions 7 and 8)
| Study group | Role | What they receive |
|---|---|---|
| Standard Intervention | Active comparator | The Standard Intervention will include 2 weeks of nicotine patches + 4 quitline-style counseling phone calls. Receives: Drug: Nicotine patch; Other: Quitline Counseling Phone Calls |
| Intensive Intervention | Experimental | The Intensive Intervention will include 8 weeks of nicotine patches (if eligible) + 8 counseling sessions (choice of individual phone or virtual group) + the Pathways to Freedom video content on the study website with additional smoking cessation content. Receives: Drug: Nicotine patch; Other: Counseling Sessions; Other: Pathways to Freedom |
| Intensive Incentivized Intervention | Experimental | The Intensive Incentivized Intervention will include all components provided in the Intensive intervention (8 weeks of nicotine patches (if eligible) + 8 counseling sessions (choice of individual phone or virtual group) + the Pathways to Freedom video content on the study website with additional smoking cessation content) and up to $50 for completing counseling sessions ($5 for completing sessions 1-6 and $10 for completing sessions 7 and 8) Receives: Drug: Nicotine patch; Other: Counseling Sessions; Other: Pathways to Freedom; Other: Monetary Incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically confirmed abstinence from combusted tobacco at 26-weeks post-target quit day
The primary outcome for this study will be biochemically confirmed (anabasine less than 2 ng/ml) 7-day point-prevalence smoking abstinence at 26- weeks post-TQD
Measured: 26 weeks post-TQD
Secondary outcomes (7)
Biochemically confirmed abstinence from any nicotine product at 26-weeks post-target quit day
salivary cotinine using a cut-off of less than 10 ng/ml to indicate abstinence from any nicotine product (combusted cigarettes, e-cigarettes, nicotine replacement therapy [NRT])
Measured: 26 weeks post-TQD
Treatment Satisfaction
Scored from 1 to 7 where higher scores indicate increased satisfaction with treatment.
Measured: 8 weeks post-TQD
Cigarettes per day
Cigarettes per day based on the past 7 days.
Measured: baseline, 8 and 26 weeks post-TQD
Quality of Life measured by the Medical Outcomes Study's 12-item Short Form Survey Instrument (SF-12)
Scores range from 0 to 100 where higher scores indicate better quality of life.
Measured: baseline, 8 and 26 weeks post-TQD
Money spent on cigarettes per week
Measured: baseline, 8 and 26 weeks post-TQD
Smoking Cessation Self-efficacy using a single 10-point Likert scale
Scores range from 1 to 10 where higher scores mean higher cessation self-efficacy.
Measured: baseline, 8 and 26 weeks post-TQD
Psychological Distress measured by the 6-item Kessler screener (K6)
Total range of scores is from 0-24 where higher scores mean decreased psychological distress.
Measured: baseline, 8 and 26 weeks post-TQD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start6 Jul 2026
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Megan Piper, PhD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419425
- Sponsor's protocol ID
- 2025-1697
- Other IDs
- Protocol Version 4/6/26, SMPH / CTRI, BPS-2024C1-36762
- Status last verified
- May 2026
- First submitted
- 11 Feb 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Three Multicomponent Interventions to Help Adults Quit Smoking
- ClinicalTrials.gov ID
- NCT07419425
- Acronym / sponsor ID
- 2025-1697
- Conditions
- Smoking Cessation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,550 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 19 Feb 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.
The overarching goal of this program of research is to reduce smoking-related health disparities by increasing smoking cessation among Black adults. The goal of this research proposal is to determine whether more intensive, culturally specific, evidence-based interventions are more effective at promoting long-term cessation and other key patient-centered outcomes compared to the usual evidence-based standard of care: services provided by a state-run quitline. This study compares the relative effectiveness of three different treatments (Standard, Intensive, and Intensive Incentivized) on long-term smoking cessation (biochemically confirmed abstinence from combusted tobacco at 26-weeks post-target quit day) among Black adults who smoke and want to quit.
Detailed description
Primary Objective: Identify the most effective treatment for increasing long-term smoking abstinence among Black adults who smoke.
Secondary Objectives:
- Compare the 3 interventions on key patient-relevant outcomes (e.g., treatment satisfaction, smoke fewer cigarettes per day, quality of life) using validated measures collected at 8 and 26 weeks post-target quit day (TQD)
- Identify subgroups for whom these treatments are especially effective or ineffective with respect to the primary and secondary outcomes.
- Compare indices of treatment engagement (e.g., percentage of counseling sessions attended, percentage of days used nicotine patch) among Black people who smoke and are randomly assigned to the 3 different treatment conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Intervention | Active comparator | Drug: Nicotine patch, Other: Quitline Counseling Phone CallsThe Standard Intervention will include 2 weeks of nicotine patches + 4 quitline-style counseling phone calls. |
| Intensive Intervention | Experimental | Drug: Nicotine patch, Other: Counseling Sessions, Other: Pathways to FreedomThe Intensive Intervention will include 8 weeks of nicotine patches (if eligible) + 8 counseling sessions (choice of individual phone or virtual group) + the Pathways to Freedom video content on the study website with additional smoking cessation content. |
| Intensive Incentivized Intervention | Experimental | Drug: Nicotine patch, Other: Counseling Sessions, Other: Pathways to Freedom, Other: Monetary IncentiveThe Intensive Incentivized Intervention will include all components provided in the Intensive intervention (8 weeks of nicotine patches (if eligible) + 8 counseling sessions (choice of individual phone or virtual group) + the Pathways to Freedom video content on the study website with additional smoking cessation content) and up to $50 for completing counseling sessions ($5 for completing sessions 1-6 and $10 for completing sessions 7 and 8) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- self-identify as Black
- smoke cigarettes (greater than or equal to 1 cigarette on greater than or equal to 4 days/week)
- motivated to quit smoking
- willing to discontinue any non-study smoking cessation pharmacotherapy use during study treatment.
Key exclusion criteria (1 listed)
- currently taking bupropion for non-smoking cessation reasons
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 |
|---|---|---|
| Nicotine patchAlso: NicoDerm CQPatch dosing will be consistent with the package insert | Drug | Intensive Incentivized Intervention, Intensive Intervention, Standard Intervention |
| Quitline Counseling Phone Calls4, 10 to 15-minute counseling sessions (the duration of a typical quitline call) will occur via phone one week prior to the TQD, 1 day after the TQD, and 1 and 2 weeks after the TQD. | Other | Standard Intervention |
| Counseling SessionsParticipants will have the option of choosing 8, 30-minute counseling phone calls or 8, 60-minute video group counseling sessions | Other | Intensive Incentivized Intervention, Intensive Intervention |
| Pathways to FreedomPathways to Freedom video content, a 60-minute video that addresses key issues such as emotional dependence, nicotine replacement, identifying smoking triggers, developing coping skills, and other behavioral strategies people can use to support a quit attempt. | Other | Intensive Incentivized Intervention, Intensive Intervention |
| Monetary Incentiveup to $50 for completing counseling sessions ($5 for completing sessions 1-6 and $10 for completing sessions 7 and 8) | Other | Intensive Incentivized Intervention |
Primary outcome
Biochemically confirmed abstinence from combusted tobacco at 26-weeks post-target quit day
Time frame: 26 weeks post-TQD
The primary outcome for this study will be biochemically confirmed (anabasine less than 2 ng/ml) 7-day point-prevalence smoking abstinence at 26- weeks post-TQD
7 secondary outcomes
Biochemically confirmed abstinence from any nicotine product at 26-weeks post-target quit day
Time frame: 26 weeks post-TQD
Treatment Satisfaction
Time frame: 8 weeks post-TQD
Cigarettes per day
Time frame: baseline, 8 and 26 weeks post-TQD
Quality of Life measured by the Medical Outcomes Study's 12-item Short Form Survey Instrument (SF-12)
Time frame: baseline, 8 and 26 weeks post-TQD
Money spent on cigarettes per week
Time frame: baseline, 8 and 26 weeks post-TQD
Smoking Cessation Self-efficacy using a single 10-point Likert scale
Time frame: baseline, 8 and 26 weeks post-TQD
Psychological Distress measured by the 6-item Kessler screener (K6)
Time frame: baseline, 8 and 26 weeks post-TQD
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 23 Jul 2026.
- Individual participant dataSharing planned: Yes
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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.
Megan Piper, PhD principal investigator
UW School of Medicine and Public Health
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine patch, Quitline Counseling Phone Calls and Counseling Sessions in people with Smoking Cessation, run by University of Wisconsin, Madison at 5 sites 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 4 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: looking for participants now, as of the sponsor's last update on 23 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 5 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Megan Piper, PhD (608-265-5472, mep@ctri.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically confirmed abstinence from combusted tobacco at 26-weeks post-target quit day (time frame: 26 weeks post-TQD). 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 23 Jul 2026.