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临床试验/NCT03012373
NCT03012373Unknown不适用

Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts

Lu-Tung Christian Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Assessed the change of opioid craving

研究概览

简要总结

This is an open-label, randomized, 2-sequence, cross-over study evaluating the difference of efficacy between ear acupressure alone and ear acupressure plus electroacupuncture therapy both combined with methadone treatment services for heroin addicts.

详细描述

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 heroin addiction patients are needed. Since 1996, the World Health Organization (WHO) has classified acupuncture treatment indications, including drug abuse. The purpose of this study is to compare the difference of efficacy between ear acupressure alone and ear acupressure plus electrical acupuncture therapy both combined with standard methadone maintenance therapy to the heroin addicts.

Patients who receive methadone were randomly assigned to sequence A and B. Sequence A(n=20) receive ear Acupressure combined with electroacupuncture for four weeks, followed by one week wash-out period. Then ear acupressure alone for another four weeks.

Sequence B(n=20) receive EAR acupressure alone for four weeks first, and followed by one week wash-out period, then ear acupressure combined with electroacupuncture for another four weeks. Measures of methadone dosage and using the craving visual analog scale (VAS) to assess the craving severity for 8 weeks. Using the Short Form Health Survey (SF-36) and the Pittsburgh Sleep Quality Index (PSQI) to assess improvement of life quality and sleep quality. Using Beck anxiety and Depression inventory to evaluate emotional problems. Urine opiate screenings are provided after 4 weeks , 8 weeks treatment and 1 month after end of treatment, to screen opiate reuse.

The study hypothesis was acupuncture had more clinical efficacy than ear acupressure upon craving severity, life quality, mood stability ,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
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Fulfilled Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria for Opioid Use Disorder and had been received methadone maintenance treatment for more then one month.

排除标准

  • •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
  • •had epilepsy, cerebral vascular disease and brain injured history.

研究组 & 干预措施

Ear acupressure & Electroacupuncture (A)

Experimental

Electroacupuncture plus Ear acupressure or Ear acupressure alone for four weeks followed by an one week wash-out period. Then with crossover to the othe.

干预措施: Ear acupressure alone (Procedure)

Ear acupressure & Electroacupuncture (A)

Experimental

Electroacupuncture plus Ear acupressure or Ear acupressure alone for four weeks followed by an one week wash-out period. Then with crossover to the othe.

干预措施: Electroacupuncture plus ear acupressure (Procedure)

Ear acupressure & Electroacupuncture (B)

Experimental

Electroacupuncture plus Ear acupressure or Ear acupressure alone for four weeks followed by an one week wash-out period. Then with crossover to the othe.

干预措施: Ear acupressure alone (Procedure)

Ear acupressure & Electroacupuncture (B)

Experimental

Electroacupuncture plus Ear acupressure or Ear acupressure alone for four weeks followed by an one week wash-out period. Then with crossover to the othe.

干预措施: Electroacupuncture plus ear acupressure (Procedure)

结局指标

主要结局

Assessed the change of opioid craving

时间窗: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment

opioid craving scores on the Visual Analog Scale

次要结局

  • Assessed the change of life quality(Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment)
  • Assessed the change of emotion problem(Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment)
  • Opiate usage(Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment)
  • Assessed the change of sleep quality(Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment)

研究者

发起方
Lu-Tung Christian Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wen-Chen Ouyang

Superintendent

Lu-Tung Christian Hospital

研究点 (1)

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