- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03881618
Efficacy of Electro-Acupuncture Therapy for Patients With Methadone Maintenance Treatment
the Efficacy of Electro-acupuncture Therapy for Patients With Methadone Maintenance Treatment : a Randomized Control Trial
The population of drug abuse(heroin) had reached about 200,000 in Taiwan, and the age distribution is mainly in young adults. The social, medical and economic problems of drug addiction are profound and include lost productivity, disrupted relationships, crime and violence, HIV/AIDS and other infectious diseases. Methadone substitution therapy has been the treatment of first choice for opiate dependence, but patient on Methadone substitution therapy report a wide side effects, and relapse rate is up to two third of methadone treatment patients between one to two years.
This research is aim to build a development model. First of all, investigators plan to review some convincing articles and then analyze the efficacy of TCM in drug addiction. According to review articles and experience of professionals, investigators establish a model for TCM included in addiction treatment. Investigators will cooperate with Western medicine together , through common assessment scales to confirm the efficacy of traditional Chinese medicine and compare with current routine treatment.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Drug addiction is a chronic medical illness and an important public health problem worldwide. The population of drug abuse had reached about 200,000 in Taiwan, and the age distribution is mainly in young adults. The social, medical and economic problems of drug addiction are profound and include lost productivity, disrupted relationships, crime and violence, HIV/AIDS and other infectious diseases. Therefore, drug addiction treatment is a hot issue of Ministry of Health and Welfare . Methadone substitution therapy has been the treatment of first choice for opiate dependence, but patient on Methadone substitution therapy report a wide side effects, and relapse rate is up to two third of methadone treatment patients between one to two years. Therefore, adjuvant therapeutic interventions for drug addiction patients are needed. Contrast to conventional Western medicine, traditional Chinese medicine is the most common used therapy of complementary and alternative medicine. However, traditional Chinese medicine (TCM) was excluded from the service for drug addiction treatment. Investigators need to establish a model for TCM as an alternative therapy included in addiction treatment and provide a better care system for drug addiction.
This research is aim to build a development model. First of all, investigators plan to review some convincing articles and then analyze the efficacy of TCM in drug addiction. According to review articles and experience of professionals, we establish a model for TCM included in addiction treatment. Investigators will cooperate with Western medicine together , through common assessment scales to confirm the efficacy of traditional Chinese medicine and compare with current routine treatment. According to above experience, investigators provide a Standard Operation Procedure for TCM treatment for drug addiction and policy suggestion. For drug addiction , this factually achieves communication and integration of Chinese and Western medicine, and benefits the public.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Taipei
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Taipei county, Taipei, Taiwán
- Reclutamiento
- Department of Chinese Medicine, Taipei City Hospital, Linsen, Chinese Medicine, and Kunming Branch, Taipei, Taiwan
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Contacto:
- yu Kai-Chiang
- Número de teléfono: 8860978157553
- Correo electrónico: dau70@tpech.gov.tw
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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:
- Comply with Diagnostic Guidelines for Mental Disorders (DSM-V) for diagnosis of opioid use disorders
- Rules accepting Methadone Maintenance Therapy
- Patients between the ages of 20 and 65.
Exclusion Criteria:
- Unacceptable for research content.
- The detector cannot be completed.
- Unwilling to cooperate with acupuncture and ear beans.
- Those whose vital signs are unstable.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: electroacupuncture+auricular pressure
a group :electroacupuncture+auricular pressure for 20 minutes twice a week for 4 weeks
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electroacupuncture+auricular pressure for 20 minutes
Otros nombres:
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Comparador activo: auricular pressure
b group :auricular pressure for 20 minutes twice a week for 4 weeks.
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electroacupuncture+auricular pressure for 20 minutes
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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Pittsburgh Sleep Quality Index
Periodo de tiempo: 20 months
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The highest score in the whole questionnaire is 21 point, and the lowest score is 0 points.The lower the score, the better the sleep quality
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20 months
|
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Severity of Dependence Scale
Periodo de tiempo: 20 months
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The highest score in the whole questionnaire is 15 point, and the lowest score is 0 points.
The higher the score, the worse of the severity of dependence.
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20 months
|
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Visual analogue scale
Periodo de tiempo: 20 months
|
The highest score in the whole questionnaire is 10 point, and the lowest score is 0 points.
The higher the score, the more serious of the pain.
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20 months
|
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Clinical Opiate Withdrawal Scale
Periodo de tiempo: 20 months
|
The highest score in the whole questionnaire is 55 point, and the lowest score is 0 points.
The higher the score, the more serious of the Withdrawal symptom.
|
20 months
|
|
Beck Depression Inventory
Periodo de tiempo: 20 months
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The highest score in the whole questionnaire is 63 point, and the lowest score is 0 points.
The higher the score, the more serious of depression.
|
20 months
|
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Beck Anxiety Inventory
Periodo de tiempo: 20 months
|
The highest score in the whole questionnaire is 63 point, and the lowest score is 0 points.
The higher the score, the more serious of anxiety.
|
20 months
|
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The Short Form (36) Health Survey
Periodo de tiempo: 20 months
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The highest score in the whole questionnaire is 100 point, and the lowest score is 0 points.
The lower the score, the better quality of life.
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20 months
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Craving Scale
Periodo de tiempo: 20 months
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The highest score in the whole questionnaire is 108 point, and the lowest score is 0 points.
The higher the score, the more serious of craving behavior.
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20 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: YU Kai-Chiang, Chinese Medicine Center Medical Office
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TCHIRB-10601106
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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