A Randomized Trail of Continues Methadone Maintenance Versus Detoxification in Jail
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Time to post release treatment engagement
研究概览
简要总结
Methadone maintenance treatment (MMT) has been shown to be effective in reducing drug use, criminal activity and recidivism. Given this effectiveness, maintaining individuals who are enrolled in community MMT when committed to the Department of Corrections for short term incarceration would improve post release outcomes. However, this is rarely practiced in the United States. Current practice at the Rhode Island Department of Corrections is to detox inmates on methadone within 30 days of being incarcerated. More than 75% of these individuals are incarcerated for less than six months. The period immediately after release from incarceration is a particularly high-risk time for HIV and other problems including drug relapse and overdose.
The investigators hypothesize that inmates who are incarcerated for 6 months or less will have better outcomes and cost the state less money if they are maintained on their methadone dose and relinked to their community clinic at release, than the current practice of detoxification.
详细描述
The purpose of this study is to compare the effectiveness of maintaining methadone treatment during short-term incarceration vs. methadone detoxification on continuing treatment post release, relapse, reducing HIV risk behaviors and reincarceration. Persons who inject opiates are at increased risk for HIV through both injection and sexual practices. A substantial proportion of opiate addicted persons are incarcerated and a majority of the nearly 8 million individuals released from a correctional setting each year have a history of addiction. The period immediately after release from incarceration is a particularly high-risk time for HIV and other problems including drug relapse and overdose. Methadone is the most widely used opiate replacement therapy in the United States. Despite its demonstrated benefit in decreasing drug use, criminal activity, and recidivism, some individuals on methadone treatment are reincarcerated each year. More than 75% of those individuals are incarcerated for less than six months. A program that maintains these individuals at a therapeutic dose increases the likelihood that they will successfully return to treatment upon release.
The following primary specific aims will drive this research:
- To determine the effect of maintaining methadone treatment during short-term incarceration vs. methadone detoxification on the time-to-post-release methadone treatment re-entry and relapse.
- To determine whether maintaining methadone treatment during short-term incarceration is more effective in reducing HIV risk behaviors (both injecting and sexual) than methadone detoxification upon community re-entry.
- To determine whether maintaining methadone treatment during short-term incarceration is more effective in reducing reincarceration than methadone detoxification.
- To determine the impact on cost of the first three specific aims.
Secondary aims will include determining the effect of methadone maintenance during short-term incarceration versus methadone detoxification on:
- retention in community based methadone treatment;
- the number of fatal and nonfatal overdoses; and
- criminal behavior
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •currently incarcerated at the RI Department of Corrections
- •enrolled in a Rhode Island methadone treatment program at the time of incarceration
- •currently maintained at the pre-incarceration methadone dosage level
- •estimated total incarceration time of < 6 months and > 1 week
- •willing to be randomized and to conduct follow-up interviews for 12 months
- •English or Spanish-speaking
- •able to give informed consent
- •age 18 years or older
- •willing to remain on MMT and continue MMT after release.
排除标准
- •pregnancy (pregnant women are maintained on pre-incarceration levels of methadone throughout their pregnancy for their health and the health of the fetus by the RI DOC, so are NOT eligible to be randomized to Arm 2)
- •not fulfilling all of the inclusion criteria.
结局指标
主要结局
Time to post release treatment engagement
时间窗: 30 days post release
Do individuals maintained on MMT during short term incarceration return to their community methadone clinic more rapidly than those who undergo methadone detoxification during short term incarceration? Individuals must return within 30 days of post release to be or be counted as not returning.
Reduction of HIV risk behaviors
时间窗: 12 months
To determine whether individuals maintained on MMT during short term incarceration report fewer HIV risk behaviors (both drug use and sexual) as compared to standard of care arm.
Time to relapse
时间窗: 30 days post release
To determine whether individuals maintained on MMT during short term incarceration report longer to relapse (or no relapse) to opiate use as compared to standard of care arm.
Cost effectiveness
时间窗: 12 months
To determine the costs, cost-effectiveness and cost-benefit associated with continuing methadone maintenance versus detoxification for jailed individuals. Variables to be assessed are: reincarceration, health care utilization (i.e. emergency room use, medications), subsidized housing,
次要结局
- Treatment retention(12 months)
- Fatal and nonfatal overdose(12 months)