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Efficacy of Electro-Acupuncture Therapy for Patients With Methadone Maintenance Treatment

16. marts 2019 opdateret af: Chung-Hua Hsu, Taipei City Hospital

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Taiwan
    • Taipei
      • Taipei county, Taipei, Taiwan
        • Rekruttering
        • Department of Chinese Medicine, Taipei City Hospital, Linsen, Chinese Medicine, and Kunming Branch, Taipei, Taiwan
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: electroacupuncture+auricular pressure
a group :electroacupuncture+auricular pressure for 20 minutes twice a week for 4 weeks
Procedure: electroacupuncture+auricular pressure,
electroacupuncture+auricular pressure for 20 minutes
Andre navne:
  • auricular pressure
Aktiv komparator: auricular pressure
b group :auricular pressure for 20 minutes twice a week for 4 weeks.
Procedure: electroacupuncture+auricular pressure,
electroacupuncture+auricular pressure for 20 minutes
Andre navne:
  • auricular pressure

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pittsburgh Sleep Quality Index
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Taipei City Hospital

Efterforskere

  • Ledende efterforsker: YU Kai-Chiang, Chinese Medicine Center Medical Office

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. april 2017

Primær færdiggørelse (Faktiske)

31. december 2018

Studieafslutning (Forventet)

31. december 2019

Datoer for studieregistrering

Først indsendt

2. oktober 2018

Først indsendt, der opfyldte QC-kriterier

16. marts 2019

Først opslået (Faktiske)

19. marts 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. marts 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TCHIRB-10601106

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Sleep Disorder (Disorder)

Kliniske forsøg med electroacupuncture+auricular pressure,

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Gabon

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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