Long-acting naltrexone for pre-release prisoners: A randomized trial of mobile treatment

 描述（由申请人提供）：涉及阿片类药物使用的疾病是监狱和监狱囚犯中的一个严重问题。美国，加拿大，澳大利亚以及许多欧洲和亚洲国家的囚犯的阿片类药物使用障碍率比一般人群高得多。在许多国家，为基于矫正的药物使用治疗提供的资源很少，许多患有OUD的囚犯仍然得不到治疗。使用长效注射纳洛酮（XR-NTX）可能是释放前囚犯的一种有希望的治疗形式。纳洛酮阻断阿片类药物的致醉和强化作用，但没有阿片样作用。这项拟议的五年研究将重点关注在患者居住地提供XR-NTX治疗是否会增加依从性，从而提高药物的疗效。该项目将在哥伦比亚特区管辖的五个释放前监狱执行。 马里兰州公共安全和惩教服务部（MDPSCS）：1）男子大都会过渡中心（MTC）; 2）男子巴尔的摩预释放单位（BPRU）; 3）男子杰瑟普预释放单位（JPRU）; 4）巴尔的摩市惩教中心（BCCC）和5）女子马里兰州惩教所（MCI）。在初步筛选、知情同意和医学检查后，每个设施的释放前囚犯将在性别内被区组随机化（N=240）为：条件1。XR-NTX-OTx（n=120）：在监狱中注射一次XR-NTX，然后在阿片类药物治疗计划中在社区释放后每月注射六次;或条件2。XR-NTX+MMTx（n=120）：在监狱中注射一次XR-NTX，然后在患者居住地的社区释放后每月注射六次。所有参与者将通过尿检和阴性纳洛酮和口服纳洛酮测试确认无阿片类药物，并在出狱后的7个月和12个月内每月进行评估。该研究有两个具体目标：目标1。在以下方面比较两种研究条件：a）XR-NTX治疗依从性; B）阿片类药物使用; c）犯罪活动; d）再次逮捕; e）再次监禁;和f）HIV风险行为（i.针头使用; ii.危险的性行为）。 目标2.确定放行后XR-NTX治疗的月数是否与结局相关（上述a-f），如果是，是否存在XR-NTX与非XR-NTX平衡的点？这将有助于确定注射次数，这一点很重要，因为XR-NTX的成本很高。刑事司法系统中的许多人放弃治疗，因此增加了通过以下方式提高依从性的方法：1）扩大能力; 2）通过在其居住地提供治疗来实现可及性，这可能会对结果产生积极影响。

 DESCRIPTION (provided by applicant): Disorders involving opioid use are a severe problem among jail and prison inmates. Inmates in the US, Canada, Australia, and many European and Asian nations have disproportionately higher rates of opioid use disorders than their general populations. Scarce resources are provided for corrections-based substance use treatment in many nations, and many inmates with OUDs remain untreated. The use of long-acting, injectable naltrexone (XR-NTX) may be a promising form of treatment for pre-release prisoners. Naltrexone blocks the intoxicating and reinforcing effects of opioids, but has no opioid-like effects. This proposed five-year study will focus on whether the addition of providing XR-NTX treatment at a patients' place of residence will increase adherence and thus efficacy of the medication. Project implementation will occur at five pre-release prisons under the jurisdiction of the Maryland Department of Public Safety and Correctional Services (MDPSCS): 1) Metropolitan Transition Center (MTC) for men; 2) Baltimore Pre-Release Unit (BPRU) for men; 3) Jessup Pre- Release Unit (JPRU) for men; 4) Baltimore City Correctional Center (BCCC) and 5) Maryland Correctional Institution (MCI) for Women. Following initial screening, informed consent, and medical examination, pre- release prisoners at each facility will be block randomized (N=240) within gender to either: Condition 1. XR- NTX-OTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at an opioid treatment program; or Condition 2. XR-NTX+MMTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at the patient's place of residence. All participants will be confirmed opiate-free by urine test and negative naloxone and oral naltrexone tests, and evaluated monthly for seven months and 12 months after release from prison. The proposed study has two specific aims: Aim1. To compare the two study conditions in terms of: a) XR-NTX treatment adherence; b) opioid use; c) criminal activity; d) re-arrest; e) re-incarceration; and f) HIV risk-behaviors (i. needle use; ii. risky sexual behaviors). Aim 2. To determine if the number of months of post-release XR-NTX treatment is related to outcome (a-f above), and if so, is there a point at which XR-NTX v. Non-XR-NTX equilibrates? This would help determine the number of injections, important because of XR-NTX cost. Many individuals in the criminal justice system drop out of treatment and therefore increasing ways to improve adherence by attempting to: 1) expand capacity; and 2) implement access by providing treatment at their place of residence may positively impact outcomes.