Terapia con psilocibina para el dolor lumbar crónico (POP)
Un ensayo aleatorio doble ciego que examina la eficacia preliminar de la terapia con psilocibina para personas con dolor lumbar crónico
This study evaluates whether psilocybin therapy helps patients cope with chronic low back pain more effectively. Patients may be recruited at Stanford and University of California San Francisco (UCSF), study procedures will occur at UCSF. Each participant will receive a dose of psilocybin with possibly one or more other drugs. Participants will undergo two preparation sessions, a dosing session, three integration sessions to discuss their psilocybin experience, and several follow up sessions.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Chronic pain is associated with higher levels of pain-related distress, depression, emotional dysfunction, helplessness, hopelessness, and suicidality. Psilocybin is a psychoactive drug that may be well-suited to easing the psychological and emotional symptoms of distress associated with chronic pain. Previous studies testing psilocybin therapy have shown improvements on multiple behavioral and psychiatric outcomes, but it is unknown whether psilocybin therapy similarly enables patients to cope with chronic pain more effectively. The investigators will determine whether psilocybin therapy improves patients' ability to cope with chronic low back pain. If psilocybin therapy is an effective treatment in this population, its use could be incorporated into interventions for chronic low back pain and other psychological conditions.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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San Francisco, California, Estados Unidos, 94107
- University of California San Francisco
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age 25 to 70 years old
- Comfortable speaking and writing in English
- Diagnosed with chronic low back pain
- Able to attend all in-person visits at UCSF as well as virtual visits
- Has tried at least two previous medications/ procedures and physical therapy trials for low back pain
Exclusion Criteria:
- Chronic low back pain that is attributed to malignancy, subacute or acute fracture or infection
- Low back pain with radiation below the knee
- Low back pain with neurologic signs present
- Regular use of medications that may have problematic interactions with psilocybin, including but not limited to dopamine agonists, MAO inhibitors, antipsychotics, and stimulants
- A health condition that makes study unsafe or unfeasible, determined by study physicians
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Psilocybin in combination with Zolpidem and Modafinil
Single dose of Psilocybin (1mg-30mg) in combination with zolpidem and modafinil |
1-30 mg (oral administration), Modafinil (oral administration), and Zolpidem (oral administration)
Otros nombres:
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Experimental: Psilocybin in combination with Zolpidem
Single dose of Psilocybin (1mg-30mg) in combination with zolpidem |
1-30 mg (oral administration), Zolpidem (oral administration), and placebo (oral administration)
Otros nombres:
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Experimental: Psilocybin in combination with Modafinil
Single dose of Psilocybin (1mg-30mg) in combination with modafinil |
1-30 mg (oral administration), Modafinil (oral administration), and placebo (oral administration)
Otros nombres:
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Experimental: Psilocybin in combination with Placebo
Single dose of Psilocybin (1mg-30mg) in combination with placebo |
1-30 mg (oral administration), and placebo (oral administration)
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in pain interference
Periodo de tiempo: Baseline, 1-month after psilocybin session
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The Brief Pain Inventory-Interference subscale (BPI) will be used to assess how pain interferes with a variety of daily activities (e.g., walking, lifting, mood, sleep, relationships). Seven items are rated on a scale from 0 (does not interfere) to 10 (completely interferes) for a total possible score ranging from 0 to 70. Higher scores represent greater interference from pain. |
Baseline, 1-month after psilocybin session
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in pain interference
Periodo de tiempo: Baseline, 1-week, and 3-months
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The Brief Pain Inventory-Interference subscale (BPI) will be used to assess how pain interferes with a variety of daily activities (e.g., walking, lifting, mood, sleep, relationships). Seven items are rated on a scale from 0 (does not interfere) to 10 (completely interferes) for a total possible score ranging from 0 to 70. Higher scores represent greater interference from pain. |
Baseline, 1-week, and 3-months
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Change in average pain intensity
Periodo de tiempo: Baseline, 1-week, 1-month, and 3-months after psilocybin session
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The Brief Pain Inventory with the Michigan Body Map will be used to assess pain location and worst, least, average, and present pain on a numerical rating scale from 0 (no pain) to 10 (pain as bad as you can imagine) over the past 24 hours, where higher scores represent greater pain intensity. |
Baseline, 1-week, 1-month, and 3-months after psilocybin session
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Change in clinical depressive symptom severity
Periodo de tiempo: Baseline, 1-week, 1-month, and 3-months after psilocybin session
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The 17-item clinician administered Hamilton Rating Scale for Depression will be used to assess changes in the severity of depressive symptoms. Each item is scored by a clinician on a 3- or 5-point scale from 0 (Not present) to 4 (severe) and summed for a total score between 0 and 52. A higher total score represents greater depressive symptom severity. |
Baseline, 1-week, 1-month, and 3-months after psilocybin session
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Change in depressive symptom severity
Periodo de tiempo: Baseline, pre-dosing session, 5-days, 11-days, and 77-days after psilocybin session
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The 7-item PROMIS-Depression self-report scale will be used as an additional indicator for changes in depression symptom severity. Items are endorsed on a 5-point scale ranging from 1 (Never) to 5 (Always). A higher total score represents greater depressive symptom severity. |
Baseline, pre-dosing session, 5-days, 11-days, and 77-days after psilocybin session
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Joshua Woolley, University of California, San Francisco
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor crónico
- Químicos orgánicos
- Piridina
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Hidrocarburos
- Hidrocarburos, cíclico
- Hidrocarburos, aromáticos
- Derivados de benceno
- Compuestos de benzhydryl
- Zolpidem
- Modafinilo
Otros números de identificación del estudio
- 20-21441
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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