Recruiting

Standard vs. Intensive vs. Intensive Incentivized

Sponsor:

University of Wisconsin, Madison

Code:

NCT07419425

Conditions

Smoking Cessation

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Nicotine patch

Quitline Counseling Phone Calls

Counseling Sessions

Pathways to Freedom

Monetary Incentive

Study Details

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.

Conditions

Smoking Cessation

Study ID

NCT07419425

Start date

Jul 6, 2026

Status verified date

May, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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 Design

Enrollment

1550 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Intervention

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

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.

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)

Interventions

Nicotine patch

Patch dosing will be consistent with the package insert

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.

Counseling Sessions

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

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.

Monetary Incentive

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

Primary outcome measure

  • Biochemically confirmed abstinence from combusted tobacco at 26-weeks post-target quit day [ Time Frame: 26 weeks post-TQD ]

Central Contacts and Locations

Central contacts

Megan Piper, PhD

608-265-5472mep@ctri.wisc.edu

Locations

UW School of Medicine and Public Health

Recruiting

Milwaukee, Wisconsin, United States, 53233

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Jul 23, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-07-23.