My Path to Quit Tobacco

July 22, 2026 updated by: University of Wisconsin, Madison

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1550

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Not yet recruiting
        • Arizona State University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Not yet recruiting
        • Indiana University
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Not yet recruiting
        • University of Kansas Medical Center Research Institute, Inc
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Not yet recruiting
        • Virginia Commonwealth University
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • Recruiting
        • UW School of Medicine and Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • currently taking bupropion for non-smoking cessation reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard Intervention
The Standard Intervention will include 2 weeks of nicotine patches + 4 quitline-style counseling phone calls.
Drug: Nicotine patch
Patch dosing will be consistent with the package insert
Other Names:
  • NicoDerm CQ
Other: Quitline Counseling Phone Calls
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.
Experimental: Intensive Intervention
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.
Drug: Nicotine patch
Patch dosing will be consistent with the package insert
Other Names:
  • NicoDerm CQ
Other: Counseling Sessions
Participants will have the option of choosing 8, 30-minute counseling phone calls or 8, 60-minute video group counseling sessions
Other: Pathways to Freedom
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.
Experimental: Intensive Incentivized Intervention
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)
Drug: Nicotine patch
Patch dosing will be consistent with the package insert
Other Names:
  • NicoDerm CQ
Other: Counseling Sessions
Participants will have the option of choosing 8, 30-minute counseling phone calls or 8, 60-minute video group counseling sessions
Other: Pathways to Freedom
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.
Other: Monetary Incentive
up to $50 for completing counseling sessions ($5 for completing sessions 1-6 and $10 for completing sessions 7 and 8)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
26 weeks post-TQD

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Biochemically confirmed abstinence from any nicotine product at 26-weeks post-target quit day
Time Frame: 26 weeks post-TQD
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])
26 weeks post-TQD
Treatment Satisfaction
Time Frame: 8 weeks post-TQD
Scored from 1 to 7 where higher scores indicate increased satisfaction with treatment.
8 weeks post-TQD
Cigarettes per day
Time Frame: baseline, 8 and 26 weeks post-TQD
Cigarettes per day based on the past 7 days.
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
Scores range from 0 to 100 where higher scores indicate better quality of life.
baseline, 8 and 26 weeks post-TQD
Money spent on cigarettes per week
Time Frame: baseline, 8 and 26 weeks post-TQD
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
Scores range from 1 to 10 where higher scores mean higher cessation self-efficacy.
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
Total range of scores is from 0-24 where higher scores mean decreased psychological distress.
baseline, 8 and 26 weeks post-TQD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Megan Piper, PhD, UW School of Medicine and Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 6, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-1697
  • SMPH / CTRI (Other Identifier: UW Madison)
  • BPS-2024C1-36762 (Other Grant/Funding Number: PCORI)
  • Protocol Version 4/6/26 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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