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临床试验/NCT00574067
NCT00574067已完成3 期

Buprenorphine for Prisoners

Friends Research Institute, Inc.2 个研究点 分布在 1 个国家目标入组 213 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
213
试验地点
2
主要终点
Number of Days of Heroin Use

研究概览

简要总结

This five-year study examines the effectiveness of buprenorphine treatment provided to previously-addicted inmates(N=320; 160 males, 160 females) initiated in prison and continued in the community. The study also examines the extent to which the setting of post-release buprenorphine is provided.It is expected that participants receiving in-prison buprenorphine will have superior outcomes compared to participants who did not receive in-prison buprenorphine.

详细描述

Participants will be randomly assigned, within gender, to one of four treatment conditions: 1) buprenorphine and counseling in prison, with referral for continued treatment at an OTP upon release; 2) buprenorphine and counseling in prison, with referral for continued treatment at a CHC upon release; 3) counseling only in prison, with referral for buprenorphine and counseling at a OTP upon release; and 4) counseling only in prison, with referral for buprenorphine and counseling at a CHC upon release. Participants will be assessed at study entry and at 1, 3, 6, and 12 months following their release from prison. Outcome measures include: treatment entry and retention in the community, heroin use, cocaine use, HIV infection, HIV-risk behaviors, criminal activity, and employment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • pre-release prison inmate with 3-6 months remaining until planned release
  • history of heroin dependence(meeting DSM-IV criteria of heroin dependence at the time of incarceration and manifesting physical dependence during the year preceding incarceration
  • suitability for buprenorphine treatment as determined by medical evaluation
  • willingness to participate in the study
  • having a Baltimore address and planning to live in Baltimore after release from prison -

排除标准

  • evidence of kidney failure
  • evidence of liver failure
  • history of psychosis
  • having a pending parole hearing
  • unadjudicated charges that could result in additional prison time or transfer to another facility -

研究组 & 干预措施

Buprenorphine+OTP

Experimental

Buprenorphine and counseling in prison and continued at opioid treatment program (OTP) upon release.

干预措施: Buprenorphine +OTP (Drug)

Buprenorphine+CHC

Experimental

Buprenorphine and counseling in prison and continued at a community health center (CHC) upon release.

干预措施: Buprenorphine +CHC (Drug)

Counseling + OTP

Active Comparator

Counseling only in prison and Buprenorphine upon release at a opioid treatment program (OTP)

干预措施: Counseling +OTP (Drug)

Counseling + CHC

Active Comparator

Counseling only in prisons and Buprenorphine upon release at a community health center (CHC)

干预措施: Counseling +CHC (Drug)

结局指标

主要结局

Number of Days of Heroin Use

时间窗: 1 year

mean days used heroin during the past 30 days

Drug Abuse Treatment Entry and Retention in the Community

时间窗: 1 year

entered community treatment within 10 days of release from prison (yes vs. no)

次要结局

  • Criminal Activity(1 year)
  • Employment Status(1 year)
  • HIV Risk Behavior Needle Sharing(1 year)
  • Number of Days of Cocaine Use(1 year)
  • HIV Risk Behavior(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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