- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Taipei
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Taipei county, Taipei, 대만
- 모병
- Department of Chinese Medicine, Taipei City Hospital, Linsen, Chinese Medicine, and Kunming Branch, Taipei, Taiwan
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연락하다:
- yu Kai-Chiang
- 전화번호: 8860978157553
- 이메일: dau70@tpech.gov.tw
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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
다른 이름들:
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활성 비교기: 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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pittsburgh Sleep Quality Index
기간: 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
기간: 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
기간: 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
기간: 20 months
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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.
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20 months
|
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Beck Depression Inventory
기간: 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.
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20 months
|
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Beck Anxiety Inventory
기간: 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.
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20 months
|
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The Short Form (36) Health Survey
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: YU Kai-Chiang, Chinese Medicine Center Medical Office
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .