My Path to Quit Tobacco

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: Not yet recruiting
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: Nicotine patch; Other: Counseling Sessions; Other: Pathways to Freedom; Other: Monetary Incentive; Other: Quitline Counseling Phone Calls

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: Interventional
• Enrollment (Estimated): 1550
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Megan Piper, PhD; Phone Number: 608-265-5472; Email: mep@ctri.wisc.edu

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Arizona State University
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center Research Institute, Inc
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53233
      • UW School of Medicine and Public Health

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	26 weeks post-TQD

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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])	26 weeks post-TQD
Treatment Satisfaction	Scored from 1 to 7 where higher scores indicate increased satisfaction with treatment.	8 weeks post-TQD
Cigarettes per day	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)	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		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.	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.	baseline, 8 and 26 weeks post-TQD

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Megan Piper, PhD, UW School of Medicine and Public Health

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Health Behavior; Smoking Cessation; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Alkaloids; Solanaceous Alkaloids; Nicotine; Tobacco Use Cessation Devices
• Other Study ID 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