My Path to Quit Tobacco

Official title

Comparing Three Multicomponent Interventions to Help Adults Quit Smoking

Overview

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.

Interventions

• Drug Nicotine patch
  Patch dosing will be consistent with the package insert
• 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.
• 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)

Primary outcome measures

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

Secondary outcome measures (7)

• Biochemically confirmed abstinence from any nicotine product at 26-weeks post-target quit day [Time frame: 26 weeks post-TQD]
• Treatment Satisfaction [Time frame: 8 weeks post-TQD]
• Cigarettes per day [Time frame: 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) [Time frame: baseline, 8 and 26 weeks post-TQD]
• Money spent on cigarettes per week [Time frame: baseline, 8 and 26 weeks post-TQD]
• Smoking Cessation Self-efficacy using a single 10-point Likert scale [Time frame: baseline, 8 and 26 weeks post-TQD]
• Psychological Distress measured by the 6-item Kessler screener (K6) [Time frame: baseline, 8 and 26 weeks post-TQD]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 5 centers

• Arizona State University — Phoenix
• Indiana University — Indianapolis
• University of Kansas Medical Center Research Institute, Inc — Kansas City
• Virginia Commonwealth University — Richmond
• UW School of Medicine and Public Health — Milwaukee

Identifiers

NCT: NCT07419425 · 2025-1697 · Protocol Version 4/6/26 · SMPH / CTRI · BPS-2024C1-36762

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗