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.

抽象的 涉及阿片类药物使用的疾病是美国监狱和囚犯中的一个严重问题。 加拿大、澳大利亚以及许多欧洲和亚洲国家的阿片类药物使用率不成比例地较高 为基于矫正的药物使用提供的资源比一般人群稀缺。 在许多国家，许多患有 OUD 的囚犯仍未得到治疗。 纳曲酮（XR-NTX）可能是一种有前景的治疗释放前囚犯的方法。 这项为期五年的研究将具有阿片类药物的麻醉和增强作用，但没有阿片类药物的作用。 重点关注在患者居住地提供XR-NTX治疗的增加是否会增加 项目实施将在五个释放前监狱进行。 受马里兰州公共安全和惩教署 (MDPSCS) 管辖：1) 男性大都会过渡中心 (MTC)；2) 男性巴尔的摩预释放中心 (BPRU)；3) 杰瑟普预释放中心 (BPRU) 男性释放单位 (JPRU)；4) 巴尔的摩市惩教中心 (BCCC) 和 5) 马里兰惩教所 妇女机构 (MCI) 经过初步筛查、知情同意和体检后， 每个设施中的释放囚犯将按性别进行随机分组 (N=240)： 条件 1. XR- NTX-OTx (n=120)：在监狱中注射一次 XR-NTX，随后在释放后每月注射 6 次 阿片类药物治疗计划中的社区；或条件 2. XR-NTX+MMTx (n=120)：注射 1 次 XR-NTX 在监狱中，释放后每月在患者居住地的社区进行六个月的注射。 所有参与者都将通过尿液测试和纳洛酮和口服纳曲酮测试阴性来确认不含阿片类药物，并且 出狱后 7 个月和 12 个月每月进行评估 拟议的研究有两项。 具体目标： 目的 1. 比较两种研究条件：a) XR-NTX 治疗依从性； 使用阿片类药物； d) 再次被捕； e) 再次监禁；以及 f) 艾滋病毒危险行为（i. 针具使用；ii. 危险行为） 目标 2. 确定释放后 XR-NTX 治疗的月数是否与 结果（上面的 a-f），如果是这样，是否存在 XR-NTX 与非 XR-NTX 平衡的点，这会有所帮助？ 确定注射次数很重要，因为 XR-NTX 成本对刑事司法中的许多人来说很重要。 系统退出治疗，因此通过尝试以下方式增加提高依从性的方法：1）扩大 能力；以及 2) 通过在居住地提供治疗来实现准入可能会产生积极影响 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