NCT07419425

My Path to Quit Tobacco

Comparing Three Multicomponent Interventions to Help Adults Quit Smoking

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,550 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Nicotine patch	Patch dosing will be consistent with the package insert
OTHER	Quitline Counseling Phone Calls	4, 15 to 20-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.
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)

Timeline

• Start date: 2026-06-01
• Primary completion: 2030-01-01
• Completion: 2030-01-01
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study