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临床试验/NCT00375102
NCT00375102已完成2 期

Acupuncture and the Relaxation Response for Homeless Veterans With Substance Abuse

VA Boston Healthcare System2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2006年11月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
67
试验地点
2
主要终点
Changes in self-reported substance craving rating from baseline to 10 week

研究概览

简要总结

This one-year pilot study has two specific aims: 1. to determine the feasibility of conducting a randomized controlled trial of acupuncture and the relaxation response for substance abuse among homeless veterans who are in a domiciliary care program, and 2. to collect and analyze pilot data to estimate the effect size for planning a future larger study to fully test the hypothesis of the effectiveness of acupuncture and the RR in reducing cravings for substances (alcohol and drugs), and the corollary effects on quality of life.

详细描述

Substance abuse is one of the most important risk factors for homelessness. A high proportion of the US homeless population are veterans, in large part due to the high prevalence of substance abuse among veterans. Thus, effective substance abuse treatment in veterans is essential to preventing homelessness, as well as reintegrating those already homeless. Traditional substance abuse therapies have shown inconsistent effectiveness, suggesting a need for alternative therapies. Acupuncture and the relaxation response (RR) are two commonly used complementary and alternative medicine modalities that have shown benefit in some studies. However, they have not been studied in homeless veterans who have completed detoxification treatment and are in early remission. Acupuncture and the RR share common features, yet have distinct differences. Acupuncture has to be administered by acupuncturists, while RR elicitation is a self-care strategy that can be learned and practiced anytime and anywhere. We propose a pilot study to determine the feasibility of conducting a three-arm randomized controlled trial on veterans in the Bedford Domiciliary Care for Homeless Veterans program and to collect pilot data for planning future larger studies to test the effectiveness of acupuncture and the RR in reducing substance craving and improving anxiety and quality of life.

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
None

入排标准

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

入选标准

  • Have a substance abuse or dependence problem of any type of substance
  • Stay in the domiciliary for at least 10 weeks after the study entry to complete the study.

排除标准

  • Schizophrenia or psychotic diagnoses
  • Bleeding disorders (hemophilia or thrombocytopenia)
  • An allergy to metals (needles).

结局指标

主要结局

Changes in self-reported substance craving rating from baseline to 10 week

时间窗: baseline and 10 week follow up

次要结局

  • Changes in anxiety level from baseline to 10 week(baseline and 10 week follow up)
  • Changes in quality of life from baseline to 10 week(baseline and 10 week follow up)

研究者

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

Bei-Hung Chang

Health Research Scientist

VA Boston Healthcare System

研究点 (2)

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