Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Multi-Site Trial of Tirzepatide for Smoking Cessation

15 de julio de 2026 actualizado por: University of Southern California

A Multi-Site Trial of Tirzepatide for Smoking Cessation

This multi-site clinical trial will generate data on the efficacy of tirzepatide for smoking cessation and associated outcomes (e.g., post-cessation weight gain) in treatment-seeking people who smoke (PWS) with overweight or obesity. A sample of 300 treatment-seeking people who smoke with body mass index of 25 kg/m2 or greater will be recruited from four geographic sites (University of Southern California, Yale University, University of Chicago, and University of Colorado Anschutz Medical Campus) to participate in a parallel-arm, dose-escalating, placebo-controlled trial. Participants will attend weekly clinic visits to receive subcutaneous tirzepatide or placebo over 16 weeks (Visit Weeks 1-16), followed by follow-up visits at Week 17 and Week 27. Medication will be prescribed according to the standard dose titration schedule for the first 16 weeks of treatment (initial dose: 2.5mg/week; final dose: 10mg/week). All participants will also receive nicotine patches.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

300

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos, 90033
        • Reclutamiento
        • Keck School of Medicine, University of Southern California
        • Contacto:
        • Investigador principal:
          • Christian Hendershot, Ph.D.
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • Reclutamiento
        • University of Colorado Anschutz Medical Campus
        • Investigador principal:
          • Joseph Schacht, PhD
        • Contacto:
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06510
        • Reclutamiento
        • Yale University School Of Medicine
        • Contacto:
        • Investigador principal:
          • Sherry McKee, PhD
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60637
        • Reclutamiento
        • University of Chicago Pritzker School of Medicine
        • Contacto:
        • Investigador principal:
          • Andrea King, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  1. Age 21-65 years
  2. Body mass index ≥ 25kg/m2 at the baseline screening
  3. Reporting ≥10 cigarettes per day, on average, for the past 6 months and > 2 year duration of smoking
  4. Interest in making a long-term cessation attempt within the next 30-60 days
  5. Willingness to receive study medication and standard-of-care smoking cessation supports (nicotine replacement therapy and a smoking cessation app)
  6. Ability to adhere to weekly visits and study procedures over the study period (i.e., no plans to move or travel for extended periods)
  7. Exhaled CO of >5ppm at baseline
  8. Use of an acceptable birth control method for female participants*
  9. Ability to read and communicate in English

Exclusion Criteria:

  1. BMI < 25 kg/m2 at screening
  2. History of diabetes, diabetes-attributable medical conditions, or HbA1c ≥6.5% at baseline
  3. Recent (past 90 days) active suicidal ideation or lifetime history of suicide attempt
  4. Current treatment for psychotic disorders or mood disorders with psychotic features (e.g., schizophrenia, schizoaffective disorder, depression with psychotic features), current treatment for bipolar disorder (with or without psychotic features), or current secondary psychosis due to substance use or another medical condition
  5. Meeting DSM-5 criteria for a current (past 12 months) substance use disorder other than tobacco use disorder, mild or moderate cannabis use disorder, or mild or moderate alcohol use disorder.
  6. Recent (past 30 day) self-report of illicit drug use (excluding cannabis) or non-prescribed opioids; or positive urine screen for illicit drugs. A positive screen for opioids will be allowed if the participant is prescribed an opioid replacement therapy medication and can provide documentation.
  7. Past 30-day initiation of psychiatric medications (e.g., SSRIs) or changes to medication dose
  8. Treatment with tirzepatide or another GLP-1RA medication in the prior 6 months
  9. Current (past month) treatment with other weight loss, diabetes, or smoking cessation medications (varenicline or bupropion; excluding nicotine replacement products)
  10. Severe GI disease (e.g., gastroparesis, ulcerative colitis).
  11. History of gastric bypass surgery or other surgeries of the stomach
  12. Any health condition or treatment/medication that would preclude the use of tirzepatide or NRT, in the opinion of the study physician, including severe cardiovascular disease
  13. History of chronic pancreatitis or acute pancreatitis in the last 6 months
  14. Currently nursing, pregnant, or anticipating pregnancy
  15. History of diabetic retinopathy, proliferative retinopathy, or maculopathy
  16. Elevated serum lipase, amylase, bilirubin, or ALP, ALT, or AST (>5x upper limit of normal range)
  17. History of malignant neoplasms in the last 5 years, except non-melanoma skin cancer
  18. Inability to attend weekly clinic visits as scheduled (i.e., based on travel or work schedule)
  19. Currently enrolled in another clinical study involving an investigational product
  20. Currently living in the same household as someone taking a GLP-1 medication, or living with a current or former participant in the present trial
  21. Planned surgical procedures requiring anesthesia during the planned study medication period
  22. Personal or family history of medullary thyroid cancer
  23. Personal or family history of multiple endocrine neoplasia syndrome type 2 (MEN 2)
  24. Treatment with other weight loss (e.g., phentermine), or FDA-approved, non-NRT smoking cessation therapies (varenicline, bupropion) or FDA-approved AUD medications (naltrexone, acamprosate, disulfiram) or off-label AUD medications (e.g., topiramate) in the past 90 days
  25. Any health condition or treatment/medication that would preclude use of tirzepatide or NRT, in the opinion of the site physicians including thyroid enlargement.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Placebo
Otro: Placebo
Participants will receive placebo (saline) injections for Weeks 1-16
Experimental: Tirzepatida
Droga: Tirzepatide
Participants will receive tirzepatide (subcutaneous injection) at doses of 2.5mg for Weeks 1-4, 5mg for Weeks 5-8, 7.5mg for Weeks 9-12, and 10mg for Weeks 13-16

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
7-day point prevalence abstinence
Periodo de tiempo: From baseline through 16 weeks of treatment (final assessment at Week 17 visit) and at 6 months after the target quit date (assessed at Week 27 visit)
Biochemically verified abstinence from cigarette smoking
From baseline through 16 weeks of treatment (final assessment at Week 17 visit) and at 6 months after the target quit date (assessed at Week 27 visit)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cigarettes per day
Periodo de tiempo: From baseline through 16 weeks of treatment (final assessment at Week 17 visit)
From baseline through 16 weeks of treatment (final assessment at Week 17 visit)
Weekly cigarette craving
Periodo de tiempo: Baseline through 16 weeks of treatment (final assessment at Week 17 visit)
Cigarette craving in the past week will be measured using the craving scale of the Wisconsin Smoking Withdrawal Scale, containing 4 items, each scored on a scale of 1-4. Items are summed to generate a score.
Baseline through 16 weeks of treatment (final assessment at Week 17 visit)

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Current cigarette craving
Periodo de tiempo: Baseline through 16 weeks of treatment (final assessment at Week 17 visit)
Current cigarette craving will be measured with the Questionnaire on Smoking Urges-Brief, a 10-item scale with items, each scored on a 1-7 scale. Items are summed to generate a total score.
Baseline through 16 weeks of treatment (final assessment at Week 17 visit)
Smoking withdrawal
Periodo de tiempo: Baseline through 16 weeks of treatment (final assessment at Week 17 visit)
Withdrawal symptoms are measured with the Wisconsin Smoking Withdrawal Scale (WSWS). The WSWS includes 28 items, each rated on a scale of 0-4. Items are summed to calculate the scale scores.
Baseline through 16 weeks of treatment (final assessment at Week 17 visit)
Body weight
Periodo de tiempo: Treatment week 1 through treatment week 16 (final assessment at Week 17 visit)
Treatment week 1 through treatment week 16 (final assessment at Week 17 visit)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Southern California

Colaboradores

National Institute on Drug Abuse (NIDA)

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

5 de junio de 2026

Finalización primaria (Estimado)

1 de marzo de 2028

Finalización del estudio (Estimado)

1 de septiembre de 2028

Fechas de registro del estudio

Enviado por primera vez

11 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

18 de mayo de 2026

Publicado por primera vez (Actual)

22 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

15 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HS-25-00642
  • U01DA064384 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Marco de tiempo para compartir IPD

The protocol and SAP will be made available at or before the completion of the study. Requests for IPD will be reviewed following publication of primary study results.

Criterios de acceso compartido de IPD

Data will be made available to researchers whose proposed purpose for accessing the data has been approved, and provided a data sharing agreement is in place.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir