Buprenorphine for Prisoners
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
- 是
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
Buprenorphine and counseling in prison and continued at opioid treatment program (OTP) upon release.
干预措施: Buprenorphine +OTP (Drug)
Buprenorphine+CHC
Buprenorphine and counseling in prison and continued at a community health center (CHC) upon release.
干预措施: Buprenorphine +CHC (Drug)
Counseling + OTP
Counseling only in prison and Buprenorphine upon release at a opioid treatment program (OTP)
干预措施: Counseling +OTP (Drug)
Counseling + CHC
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)
