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

长效纳曲酮用于释放前囚犯：流动治疗的随机试验

• 批准号: 10738933
• 负责人: Michael Scott Gordon
• 金额: $ 44.41万
• 依托单位: FRIENDS RESEARCH INSTITUTE, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10738933
• 关键词: Adherence; Asian; Australia; Baltimore; Canada; Cities; Communities; Correctional Institutions; Criminal Justice; Disease; Drops; European; Gender; General Population; HIV risk; HIV/AIDS; Imprisonment; Individual; Infection; Informed Consent; Injectable; Injections; Intoxication; Maryland; Medical; Naloxone; Naltrexone; Needles; Opioid; Oral; Outcome; Participant; Patients; Pharmaceutical Preparations; Prisoner; Prisons; Public Health; Randomized; Resources; Risk Behaviors; Safety; Services; System; Testing; Urine; Woman; addiction; cost; effectiveness evaluation; high risk sexual behavior; improved; innovation; medical examination; men; metropolitan; opioid treatment program; opioid use; opioid use disorder; overdose death; randomized trial; randomized, clinical trials; rearrest; reincarceration; residence; screening; substance use treatment; treatment adherence

Abstract 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.

摘要 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。美国的囚犯， 加拿大，澳大利亚和许多欧洲和亚洲国家的阿片类药物使用率不成比例地高 比一般人群更容易患上疾病为矫正使用药物提供的资源很少 在许多国家，许多患有OUD的囚犯仍然没有得到治疗。使用长效注射剂 纳洛酮（XR-NTX）可能是一种有前途的治疗释放前囚犯的形式。纳洛酮阻断了 阿片类药物的麻醉和强化作用，但没有阿片样作用。这项为期五年的研究将 重点关注在患者居住地提供XR-NTX治疗的增加是否会增加 从而影响药物的疗效。项目将在5个释放前监狱实施 在马里兰州公共安全和惩教服务部（MDPSCS）的管辖下：1） 大都会过渡中心（MTC）的男子; 2）巴尔的摩预释放单位（BPRU）的男子; 3）杰瑟普预- 男子释放股; 4）巴尔的摩市惩教中心和5）马里兰州惩教中心 妇女研究所。在初步筛选、知情同意和医学检查后， 每个设施的释放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，然后在释放后每月注射六次。 社区在阿片类药物治疗计划;或条件2。XR-NTX+MMTx（n=120）：注射一次XR-NTX 在监狱中注射，然后在释放后在患者居住地的社区中每月注射六次。 所有受试者将通过尿检和纳洛酮和口服纳洛酮检测阴性确认无阿片类药物， 每月进行一次评估，为期7个月，并在出狱后12个月进行评估。研究报告提出了两个 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）艾滋病毒风险行为（i.针头使用; ii.风险 性行为）。目标2.确定放行后XR-NTX治疗的月数是否与 结果（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。刑事司法中的许多人 系统退出治疗，因此增加了通过尝试以下方式提高依从性的方法：1）扩展 能力; 2）通过在其居住地提供治疗来实现可及性， 结果。

项目成果

A clinical protocol of a comparative effectiveness trial of extended-release naltrexone versus extended-release buprenorphine with individuals leaving jail.

• DOI: 10.1016/j.jsat.2020.108241
• 发表时间: 2021-09
• 期刊: Journal of substance abuse treatment
• 影响因子: 3.9
• 作者: Gordon MS;Mitchell SG;Blue TR;Vocci FJ;Fishman MJ;Murphy SM;Couvillion K;Maher K;Ryan D;Wenzel K;Danner ML;Jarvis DK
• 通讯作者: Jarvis DK