- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Taipei
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Taipei county, Taipei, Taïwan
- Recrutement
- Department of Chinese Medicine, Taipei City Hospital, Linsen, Chinese Medicine, and Kunming Branch, Taipei, Taiwan
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Contact:
- yu Kai-Chiang
- Numéro de téléphone: 8860978157553
- E-mail: dau70@tpech.gov.tw
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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
Autres noms:
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Comparateur actif: 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
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Pittsburgh Sleep Quality Index
Délai: 20 months
|
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
|
20 months
|
Severity of Dependence Scale
Délai: 20 months
|
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.
|
20 months
|
Visual analogue scale
Délai: 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.
|
20 months
|
Clinical Opiate Withdrawal Scale
Délai: 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
Délai: 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 depression.
|
20 months
|
Beck Anxiety Inventory
Délai: 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
|
The Short Form (36) Health Survey
Délai: 20 months
|
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.
|
20 months
|
Craving Scale
Délai: 20 months
|
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.
|
20 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: YU Kai-Chiang, Chinese Medicine Center Medical Office
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TCHIRB-10601106
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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