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临床试验/NCT00742170
NCT00742170已完成1 期

Transdermal Electroacupuncture for Opioid Detoxification

Mclean Hospital2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2007年8月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
48
试验地点
2
主要终点
Percent of Participants Using Drugs

研究概览

简要总结

This single-blind, randomized clinical trial tests whether electroacupuncture, provided as an adjunctive treatment, improves outcomes among patients receiving inpatient opioid detoxification from opioids.

详细描述

Opioid dependence continues to be a major public health concern in the United States, with prescription opioid abuse rapidly becoming one of the nation's biggest drug problems. Although there have been substantial improvements in the pharmacological treatment of opioid dependence, many patients relapse soon after detoxification. In China and other countries, acupuncture has been effective in the treatment of heroin dependence. The current study tests whether electroacupuncture, provided as an adjunctive treatment, produces improved outcomes among patients receiving inpatient detoxification from opioids. The primary hypothesis is that participants who receive active electroacupuncture, compared to those receiving sham electroacupuncture, will experience milder withdrawal symptoms, report less opioid craving, and maintain abstinence from opioids for longer duration following discharge. This study will be a single-blind, randomized clinical trial in which participants will receive either active or sham electroacupuncture. Participants will be recruited from the inpatient unit at the Alcohol and Drug Abuse Treatment Program at McLean Hospital. Participants will receive thrice daily 30-minute electroacupuncture treatments for 4 days. The Han's Acupoint Nerve Stimulator device will be used to stimulate acupoints on one hand (LI4/P8) and opposite arm (P6/TE5). This device emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints. It does not use needles and has no harmful side-effects. Participants will be followed for 2 weeks following discharge. Assessments will occur daily during the treatment phase and weekly during the follow-up phase. Assessments will include clinical interviews, questionnaires, urine toxicology screens, and medical record review. The results of this study will indicate whether short-term electroacupuncture may be of benefit to individuals receiving inpatient detoxification from opioids.

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
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Current opioid dependence
  • Current buprenorphine detoxification
  • 18-59 years of age
  • English proficiency

排除标准

  • Acute mania, psychosis, or suicidality
  • Cognitive impairments precluding informed consent
  • Heart disease or contraindicated heart condition
  • Use of pace maker
  • History of seizure disorder
  • Current detoxification from alcohol or benzodiazepines
  • Inability to return to follow-up visits
  • For women, pregnancy

结局指标

主要结局

Percent of Participants Using Drugs

时间窗: 2 weeks following discharge

次要结局

  • Opioid Craving (Self-report)(at 2-weeks post discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Scott Lukas

Pharmacologist

Mclean Hospital

研究点 (2)

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