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ReclutandoNCT07419425Registro de ClinicalTrials.gov

My Path to Quit Tobacco

Smoking Cessation

LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio
De intervención
Fase
Fase 4
Rango de edad
21 años - No especificado
Sexo admitido
Todos los sexos
Voluntarios sanos
Aceptados
Participantes
1550 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

Leer la descripción completa

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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
Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
Asignación al azar
Enmascaramiento
Enmascaramiento simple
Standard Intervention

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

Drug: Nicotine patch · Other: Quitline Counseling Phone Calls

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.

Drug: Nicotine patch · Other: Counseling Sessions · Other: Pathways to Freedom

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)

Drug: Nicotine patch · Other: Counseling Sessions · Other: Pathways to Freedom · Other: Monetary Incentive

Nicotine patch DRUG

Patch dosing will be consistent with the package insert

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)

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Biochemically confirmed abstinence from combusted tobacco at 26-weeks post-target quit day

Plazo: 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

Medidas secundarias

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

Plazo: 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 \[NRT\])

Treatment Satisfaction

Plazo: 8 weeks post-TQD

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

Cigarettes per day

Plazo: baseline, 8 and 26 weeks post-TQD

Cigarettes per day based on the past 7 days.

Quality of Life measured by the Medical Outcomes Study's 12-item Short Form Survey Instrument (SF-12)

Plazo: baseline, 8 and 26 weeks post-TQD

Scores range from 0 to 100 where higher scores indicate better quality of life.

Money spent on cigarettes per week

Plazo: baseline, 8 and 26 weeks post-TQD

No informado en este registro.

Smoking Cessation Self-efficacy using a single 10-point Likert scale

Plazo: baseline, 8 and 26 weeks post-TQD

Scores range from 1 to 10 where higher scores mean higher cessation self-efficacy.

Psychological Distress measured by the 6-item Kessler screener (K6)

Plazo: baseline, 8 and 26 weeks post-TQD

Total range of scores is from 0-24 where higher scores mean decreased psychological distress.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (5)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

5 centros

Arizona State UniversityPhoenix, Arizona, United StatesAún no recluta
Indiana UniversityIndianapolis, Indiana, United StatesAún no recluta
University of Kansas Medical Center Research Institute, IncKansas City, Kansas, United StatesAún no recluta
Virginia Commonwealth UniversityRichmond, Virginia, United StatesAún no recluta
UW School of Medicine and Public HealthMilwaukee, Wisconsin, United StatesReclutando

Equipo y fechas

Patrocinador principal
University of Wisconsin, Madison
Inicio del estudio
6 jul 2026 Real
Finalización primaria
2030-01 Estimado
Finalización del estudio
2030-01 Estimado
Primera publicación
19 feb 2026 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

Megan Piper, PhDCONTACTmep@ctri.wisc.edu608-265-5472
Título oficial del estudio

Comparing Three Multicomponent Interventions to Help Adults Quit Smoking

EL PRÓXIMO PASO, CON APOYO HUMANO

Consulta a Wellness Clinical Research

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026