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Outcomes Registry After Ketamine Infusions for Chronic Pain: A Longitudinal Evaluation (ORACLE)

11 de septiembre de 2026 actualizado por: Theresa Lii, Stanford University

Nationwide Observational Registry of Patient Outcomes Following Ketamine Infusion Therapy for Chronic Pain

Ketamine is an anesthetic drug that is sometimes used to relieve chronic pain. The goal of this observational study is to learn about how patients respond to ketamine infusions for chronic pain.

Note: This study does not provide ketamine - instead, this study uses surveys to follow patients who are already scheduled to receive ketamine infusions as part of their regular medical care.

We will also follow a second group of patients who were recommended ketamine infusions by their doctor but were denied insurance coverage for this treatment. These participants will complete the same surveys for up to 16 weeks, starting from when their treatment was originally scheduled. Comparing this group to patients who received ketamine will help researchers better understand ketamine's effects and how insurance denials affect chronic pain patients.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Some key questions this study would like to answer:

  1. How do patients respond to ketamine over time? This study will use surveys to track pain, sleep, mood, function, and other experiences for up to 16 weeks after a ketamine infusion.
  2. Does the dose matter? This study aims to find out whether patients who get higher doses of ketamine have longer-lasting pain relief, and whether there is a point of diminishing returns.
  3. What makes some patients respond better than others? For example, there are some early data suggesting that patients who worry more about their pain might have more trouble reducing their opioids after ketamine treatment even if they had pain relief.
  4. Are ketamine infusions addictive when used for pain treatment? This study will track cravings and drug liking for up to 16 weeks after a ketamine infusion. Addiction risk is expected to be low, but this study will document this risk systematically.
  5. What happens to patients who were recommended ketamine but denied insurance coverage? This study will compare their outcomes to patients who received ketamine, to better understand the impact of insurance denials and the real-world effects of ketamine treatment.

STUDY PROCEDURES SUMMARY

Upon consenting to the study, eligible participants will be asked to share their contact information, some background health information, details about their scheduled infusion, prior ketamine experience, and baseline symptoms. All personal information will be kept private and secure. Participants will be assigned a unique study number, and their name and contact details will not be shared with anyone outside the core study team.

Afterwards, participants will:

  • Complete an online survey a few days before their infusion; then one survey each week for up to 16 weeks after their infusion. These surveys will track pain, mood, sleep, medication use, and other symptoms over time.
  • Optionally allow the study team to review medical records related to their ketamine treatment (such as the ketamine dose, side effects, and diagnoses linked with treatment).
  • Patients who were recommended ketamine but denied insurance coverage will have to opportunity to complete the same surveys

Tipo de estudio

De observación

Inscripción (Estimado)

800

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.

Estudio Contacto

  • Nombre: Protocol Director
  • Número de teléfono: 650-264-9442
  • Correo electrónico: tlii@stanford.edu

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Stanford, California, Estados Unidos, 94305
        • Stanford Health Care
        • Contacto:
          • Protocol Director
          • Número de teléfono: 650-264-9442
          • Correo electrónico: tlii@stanford.edu

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

Método de muestreo

Muestra no probabilística

Población de estudio

Adults who have had a treating physician order ketamine infusion therapy for the treatment of chronic pain

Descripción

Inclusion Criteria:

  • Planning to receive an intravenous ketamine infusion for the treatment of chronic pain

Exclusion Criteria:

  • Unable to read or understand English questionnaires

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Ketamine Treated Cohort
Observational cohort of patients who received ketamine infusion therapy for the treatment of chronic pain
Droga: Ketamine (Ketalar)
Intravenous ketamine infusion delivered as part of routine clinical care
Otros nombres:
  • Ketamine Infusion
  • Intravenous Ketamine
Denied Treatment Cohort
Observational cohort of patients who were recommended ketamine infusion therapy but did not receive this treatment due to lack of insurance coverage

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Change in PROMIS Pain Interference Score From Baseline
Periodo de tiempo: 8, 10, and 12 weeks after the ketamine infusion
8, 10, and 12 weeks after the ketamine infusion

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Change in Opioid Use From Baseline, Patient-Rated Global Assessment
Periodo de tiempo: From enrollment to 12 weeks after the ketamine infusion
From enrollment to 12 weeks after the ketamine infusion

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Pain Intensity From Baseline, 0-10 Numeric Rating Scale
Periodo de tiempo: From enrollment to 16 weeks after the ketamine infusion
From enrollment to 16 weeks after the ketamine infusion
Change in PROMIS Physical Function Score From Baseline
Periodo de tiempo: From enrollment to 16 weeks after the ketamine infusion
From enrollment to 16 weeks after the ketamine infusion
Change in PROMIS Sleep Disturbance Score From Baseline
Periodo de tiempo: From enrollment to 16 weeks after the ketamine infusion
From enrollment to 16 weeks after the ketamine infusion
Change in PROMIS Anxiety Score From Baseline
Periodo de tiempo: From enrollment to 16 weeks after the ketamine infusion
From enrollment to 16 weeks after the ketamine infusion
Change in PROMIS Depression Score From Baseline
Periodo de tiempo: From enrollment to 16 weeks after the ketamine infusion
From enrollment to 16 weeks after the ketamine infusion
Change in PROMIS Social Isolation Score From Baseline
Periodo de tiempo: From enrollment to 16 weeks after the ketamine infusion
From enrollment to 16 weeks after the ketamine infusion
Change in Pain Catastrophizing Scale Score From Baseline
Periodo de tiempo: From enrollment to 16 weeks after the ketamine infusion
From enrollment to 16 weeks after the ketamine infusion
Change in Pain Self-Efficacy Questionnaire Score From Baseline
Periodo de tiempo: From enrollment to 16 weeks after the ketamine infusion
From enrollment to 16 weeks after the ketamine infusion
Baseline Pain Medication Beliefs
Periodo de tiempo: Pre-Treatment Baseline
From the medication subscale of the Survey of Pain Attitudes (SOPA-Med) Scale
Pre-Treatment Baseline
Average Drug Liking and Craving Score
Periodo de tiempo: From 1 to 16 weeks after the ketamine infusion
Drug Liking and Craving Questionnaire items modified for ketamine
From 1 to 16 weeks after the ketamine infusion

Colaboradores e Investigadores

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

Patrocinador

Stanford University

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 (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

1 de diciembre de 2034

Finalización del estudio (Estimado)

1 de diciembre de 2034

Fechas de registro del estudio

Enviado por primera vez

9 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

12 de junio de 2026

Publicado por primera vez (Actual)

15 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de septiembre de 2026

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

11 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 87368

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Marco de tiempo para compartir IPD

Upon publication of study results with no end date

Criterios de acceso compartido de IPD

A proposal that describes planned analyses must be approved and a data sharing agreement must be signed before accessing IPD from the study team

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • CÓDIGO_ANALÍTICO

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

producto fabricado y exportado desde los 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. .

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