- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06442566
ACCIÓN: Ensayo de agregar buprenorfina, TCC y TMS para mejorar los resultados de la terapia con opioides a largo plazo para el dolor crónico (ACTION)
Ensayo secuencial de adición de buprenorfina, tratamiento cognitivo conductual y estimulación magnética transcraneal para mejorar los resultados de la terapia con opioides a largo plazo para el dolor crónico (ACTION)
This study will sequentially evaluate three novel and scalable interventions for at-risk individuals on long term opioid therapy for chronic pain: (1) low-dose transdermal buprenorphine initiation without a period of opioid withdrawal; (2) a brief Cognitive Behavioral Intervention for pain (CBI); and (3) "accelerated" rTMS over the left dorsolateral prefrontal cortex, by examining standardized repeated measures of clinical outcomes at baseline, during treatment, and at 4-, 12-, 24- and 52-week follow-up.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
With little evidence available to guide the provision of clinical care for patients on long-term opioid therapy (LTOT) in whom the risks outweigh the benefits, major questions remain about optimizing the risk/benefit profile of LTOT, including: how to best engage patients voluntarily in this process; the safety, tolerability and effectiveness of newer treatment approaches; and optimal treatment selection. The primary objective of the proposed study is to begin to systematically address gaps in this important area to improve pain, reduce risk, and improve quality of life for individuals on LTOT.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Kelly Barth
- Número de teléfono: 843-792-0686
- Correo electrónico: stephen@musc.edu
Copia de seguridad de contactos de estudio
- Nombre: Rafael Mendoza
- Correo electrónico: mendozra@musc.edu
Ubicaciones de estudio
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29407
- Reclutamiento
- Medical University of South Carolina
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Contacto:
- Rafael Mendoza
- Correo electrónico: mendozra@musc.edu
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Contacto:
- Kelly Barth
- Correo electrónico: stephen@musc.edu
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Investigador principal:
- Kelly Barth
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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 >/= 18 years
English-speaking
On LTOT, defined as taking prescription opioid therapy for 90 days or more
Past week average morphine equivalent dose (MED) >/= 20mg
Willing and able to complete written informed consent
Willing and able to use a mobile/cell phone
Have at least one additional risk for opioid toxicity or overdose from the following list:
Opioid Toxicity or Overdose Risks:
- Taking benzodiazepines with opioids
- Substance Use Disorder diagnosis [non-tobacco; Opioid Risk Tool]
2) Having ever experienced an overdose 4) Current major medical problem [e.g. mod-severe liver disease, pancreatitis, chronic pulmonary disease, untreated sleep apnea, hospitalized for an acute medical issue in the past 6 months]a,b 5) Response to BPI Item 8 <30%, suggesting less than moderately clinically meaningful response to pain treatmentc 6) Co-morbid psychiatric diagnosis [Opioid Risk Tool] 7) Signs of opioid misuse [any score >0 on the following COMM Items: 3,4,5,9,10,11,14,15,16] 8)Opioid Risk Tool >3 or Current Opioid Misuse Measure ≥ 9 9) Struggling with any of the following side effects from opioids [self-report]
- Dizziness and/or falls
- Difficult-to-manage stomach pain, nausea, constipation or GI issues
- Fatigue or low energy
- Sleepiness or sedation
- Trouble with memory or thinking clearly [COMM Item 1>0]
- Other troublesome side effect [open answer]
Exclusion criteria:
Known allergy to buprenorphine
Active moderate or severe substance use disorder with the exception of those listed below:
- . Those with nicotine use disorder.
- . Those meeting criteria for prescription opioid use disorder using only prescribed opioids will be considered on a case-by-case basis.
Cognitive disorder limiting ability to consent or fully participate in the brief cognitive intervention
Receiving methadone or buprenorphine treatment for OUD or pain
Taking naltrexone
Pregnancy
Currently incarcerated
Taking medications that prolong QTc interval, as determined by study investigators
Personal/immediate family history of Long QT Syndrome.
Significant or unstable condition/s or treatments that may impact safe participation in the study (as determined by the study investigators) such as significant cardiac condition (e.g. poorly-controlled heart failure, current or past cardiac arrhythmia, sustained systolic blood pressure >180), significant metabolic disorder (e.g. labile diabetes, significant electrolyte abnormality), cancer (e.g. brain cancer, chemotherapy-induced cognitive impairment), major psychiatric disorder (e.g. active bipolar disorder, schizophrenia spectrum or other psychotic disorder, suicidal/homicidal intent within the past month, or any suicide attempts within the past year or current active suicidal ideation, as determined by medical clinician), developmental disorder (e.g. autism spectrum disorder, intellectual disability), or other neurologic disease (e.g. movement disorder, multiple sclerosis, moderate to severe brain injury).
Enrolled in a clinical trial or has received an investigational medication or device in the last 30 days.
TMS contraindications (e.g., ferromagnetic implants, conditions or treatments that lower seizure threshold, taking contraindicated medications, no identifiable motor threshold, as determined by study investigators).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: etiqueta abierta BUP
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Buprenorphine patch dosing will be individualized based on each participant's current morphine-equivalent dose (per package insert/recommendations; between 5mcg and 20mcg per hour). Dosage based on baseline MEQ (<30 MEQ = 5mcg/hr patch, 30-80 MEQ =10-15mcg/hour patch; >80 MEQ = 20mcg/hour patch), which will remain on for 7 days (Phase Ia Days 1-7), as tolerated |
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Comparador activo: Real vs Placebo BUP
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Buprenorphine patch dosing will be individualized based on each participant's current morphine-equivalent dose (per package insert/recommendations; between 5mcg and 20mcg per hour). Dosage based on baseline MEQ (<30 MEQ = 5mcg/hr patch, 30-80 MEQ =10-15mcg/hour patch; >80 MEQ = 20mcg/hour patch), which will remain on for 7 days (Phase Ia Days 1-7), as tolerated double-blinded randomization to placebo or transdermal buprenorphine |
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Comparador activo: TMS real versus falso
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double-blinded randomization to REAL intermittent theta burst (iTBS) rTMS double-blinded randomization to SHAM intermittent theta burst (iTBS) rTMS |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Intervention Tolerability
Periodo de tiempo: up to Day-13
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(a) Tolerability of open-label transdermal buprenorphine, defined as the proportion of eligible patients who do not discontinue buprenorphine due to adverse effects, preference, or intolerance. (b) Tolerability of TMS/sham, defined as tolerating 10 sessions of accelerated rTMS |
up to Day-13
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Pain Severity
Periodo de tiempo: up to Day-20
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Pain severity is measured by the Brief Pain Inventory (BPI) Severity Scale and is typically scored as the mean of the four severity items ("average," "worst," "least," "now," range 0-10) with a higher score being worse. This outcome will be measured after both the buprenorphine vs. placebo trial and the TMS vs. sham trial. |
up to Day-20
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Buprenorphine Transition Rate
Periodo de tiempo: Day-20
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Buprenorphine transition rate defined as the proportion of participants who spontaneously elect to continue buprenorphine after Phase I. |
Day-20
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Quality of Life
Periodo de tiempo: up to Day-20
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Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference (PROPr) score summarizes multiple domains into a single score anchored at 0 (as bad as dead) and 1 (perfect or ideal health). This score quantifies the value that individuals place on different states of health. PROPr is calculated from the scores for the 7 PROMIS domains: Cognition, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Ability to Participate in Social Roles and Activities. This outcome will be measured after both the buprenorphine vs. placebo trial and the TMS vs. sham trial. |
up to Day-20
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Pain Interference
Periodo de tiempo: up to Day-20
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BPI Interference Scale (lowest score 0, highest 40; higher worse) |
up to Day-20
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Pain Catastrophizing
Periodo de tiempo: up to Day-20
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Pain Catastrophizing Scale SF 6 (lowest score 0, highest score 24; higher worse) |
up to Day-20
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Patient Global Impression of Change
Periodo de tiempo: up to Day-20
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range 1-7, higher worse |
up to Day-20
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Opioid misuse risk
Periodo de tiempo: up to Day-20
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Current opioid Misuse Measure (COMM |
up to Day-20
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kelly Barth, Medical University of South Carolina
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Otros números de identificación del estudio
- Pro00130123
- 1R01DA058620 (Subvención/contrato del NIH de EE. UU.)
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.
producto fabricado y exportado desde los EE. UU.
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