NCT07419425

Brief 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 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,550

participants targeted

Target at P75+ for phase_4

Timeline
44mo left

Started Jun 2026

Longer than P75 for phase_4

Geographic Reach
1 country

5 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Jun 2026Jan 2030

First Submitted

Initial submission to the registry

February 11, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

3.6 years

First QC Date

February 11, 2026

Last Update Submit

May 4, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Biochemically confirmed abstinence from any nicotine product at 26-weeks post-target quit day

    26 weeks post-TQD

  • Treatment Satisfaction

    8 weeks post-TQD

  • Cigarettes per day

    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)

    baseline, 8 and 26 weeks post-TQD

  • Money spent on cigarettes per week

    baseline, 8 and 26 weeks post-TQD

  • +2 more secondary outcomes

Study Arms (3)

Standard Intervention

ACTIVE COMPARATOR

The Standard Intervention will include 2 weeks of nicotine patches + 4 quitline-style counseling phone calls.

Drug: Nicotine patchOther: 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.

Drug: Nicotine patchOther: Counseling SessionsOther: 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)

Drug: Nicotine patchOther: Counseling SessionsOther: Pathways to FreedomOther: Monetary Incentive

Interventions

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.

Intensive Incentivized InterventionIntensive Intervention

Patch dosing will be consistent with the package insert

Also known as: NicoDerm CQ
Intensive Incentivized InterventionIntensive InterventionStandard Intervention

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.

Standard Intervention

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

Intensive Incentivized InterventionIntensive Intervention

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

Intensive Incentivized Intervention

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • currently taking bupropion for non-smoking cessation reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center Research Institute, Inc

Kansas City, Kansas, 66160, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

UW School of Medicine and Public Health

Milwaukee, Wisconsin, 53233, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Tobacco Use Cessation DevicesNicotine

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

TherapeuticsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Megan Piper, PhD

    UW School of Medicine and Public Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Piper, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 19, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations