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临床试验/NCT01512433
NCT01512433已完成不适用

The Clinical Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts: A Randomized Controlled Trial

China Medical University, Taiwan2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
opioid craving

研究概览

简要总结

The purpose of this study is to investigate the efficacy of acupuncture therapy combined with standard methadone maintenance therapy to the heroin addicts.

详细描述

Methadone maintenance therapy for the treatment of heroin addicts for more than 40 years , and there are many studies confirm its effectiveness, such as reduced heroin addiction, reduced high-risk needle use, reduced criminal activity. But methadone also had side effects such as drowsiness, constipation, insomnia, nausea, vomiting, sweating and respiratory depression.Then the long-term heroin addicts may irregular to take methadone, which increase the risk of reuse heroin or other drugs. Since 1996, the World Health Organization (WHO) has classified acupuncture treatment indications, including drug abuse. The purpose of this study is to investigate the efficacy of acupuncture therapy combined with standard methadone maintenance therapy to the heroin addicts.

The study will be consisted of 60 heroin addicts and the inclusion criteria were: (1) age more then 20 years; (2) fulfilled Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for opiate dependence and had been received methadone maintenance treatment for more then one month. Subjects were excluded if they: (1) concurrent treatment with antidepressant or neuroleptic medication; (2) had taking acupuncture treatment in past 30 days; (3) had severe adverse effects or events history from receiving acupuncture treatment; (4) had any serious physical illness; (5) had a significant risk of suicide; (6) ear infection; (7) were pregnant or or a woman plan to pregnant; (8) had bleeding disorders or were taking anticoagulant drugs; (9) Human Immunodeficiency Virus (HIV) positive; (10) had epilepsy, cerebral vascular disease and brain injured history.The study used a randomized, placebo-controlled study design. Patients were randomly assigned to receive methadone with verum acupuncture condition (n = 30), methadone with sham acupuncture condition (n = 30). Treatments were offered 2 times weekly for 4 weeks. Weekly measures of methadone dosage and using the visual analog scale (VAS) to assess the craving severity for 4 weeks. Using the Short Form Health Survey (SF-36) and the Pittsburgh Sleep Quality Index (PSQI) to provide an assessment of quality of life and sleep quality over the previous 4 weeks.

The study hypothesis was acupuncture had clinical efficacy upon craving severity, life quality, reduced methadone dosage and sleep quality when provided as an adjunct to a standard methadone maintenance treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • fulfilled Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for opiate dependence and had been received methadone maintenance treatment for more then one month.

排除标准

  • concurrent treatment with antidepressant or neuroleptic medication
  • had taking acupuncture treatment in past 30 days
  • had severe adverse effects or events history from receiving acupuncture treatment
  • had any serious physical illness
  • had a significant risk of suicide
  • ear infection
  • were pregnant or or a woman plan to pregnant
  • had bleeding disorders or were taking anticoagulant drugs
  • Human Immunodeficiency Virus (HIV) positive
  • had epilepsy, cerebral vascular disease and brain injured history.

结局指标

主要结局

opioid craving

时间窗: four weeks

opioid craving scores on the Visual Analog Scale

次要结局

  • sleep quality(four weeks)
  • life quality(four weeks)

研究者

发起方
China Medical University, Taiwan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuan-Yu Chan

Principal Investigator

China Medical University, Taiwan

研究点 (2)

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