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NCT Number: NCT07419425

My Path to Quit Tobacco

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Arizona State University, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotine patch

Drug

Patch dosing will be consistent with the package insert

Other names: NicoDerm CQ

Quitline Counseling Phone Calls

Other

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 Sessions

Other

Participants will have the option of choosing 8, 30-minute counseling phone calls or 8, 60-minute video group counseling sessions

Pathways to Freedom

Other

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 Incentive

Other

up to $50 for completing counseling sessions ($5 for completing sessions 1-6 and $10 for completing sessions 7 and 8)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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])

  2. Treatment Satisfaction

    Time frame: 8 weeks post-TQD

    Scored from 1 to 7 where higher scores indicate increased satisfaction with treatment.

  3. Cigarettes per day

    Time frame: baseline, 8 and 26 weeks post-TQD

    Cigarettes per day based on the past 7 days.

  4. 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.

  5. Money spent on cigarettes per week

    Time frame: baseline, 8 and 26 weeks post-TQD

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Megan Piper, PhD

CONTACT

[email protected]

608-265-5472

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Comparing Three Multicomponent Interventions to Help Adults Quit Smoking

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 19, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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