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障碍在监狱和监狱囚犯中是一个严重的问题。在美国的囚犯， 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高得不成比例 疾病比他们的普通人群更多。为惩戒类物质的使用提供了稀缺的资源 在许多国家接受治疗，许多患有流行性出血热的囚犯仍然没有得到治疗。长效、注射剂的使用 纳曲酮(XR-NTX)可能是一种很有前途的释放前囚犯的治疗形式。纳曲酮阻断 对阿片类药物有醉人和增强作用，但没有阿片类药物的作用。这项拟议的五年研究将 关注是否会增加在患者居住地提供XR-NTX治疗的增加 依从性，从而影响药物的疗效。将在五个释放前监狱执行项目 由马里兰州公共安全和惩教署(MDPSCS)管辖：1) 大都会男士过渡中心(MTC)；2)巴尔的摩男士预放映单位(BPRU)；3)杰赛普预演 男性释放单位(JPRU)；4)巴尔的摩市惩教中心(BCCC)和5)马里兰州惩教所 妇女机构(MCI)。在初步筛查、知情同意和体检后， 每个设施的获释囚犯将按性别随机分组(N=240)到：条件1。XR- NTX-OTX(n=120)：在监狱中注射XR-NTX一次，然后在释放后每月注射六次 社区接受阿片类药物治疗；或条件2：XR-NTX+MmTX(n=120)：一次注射XR-NTX 在监狱中，随后每月在患者居住地的社区释放后注射六次。 所有参与者将通过尿液测试和纳洛酮和口服纳曲酮阴性测试确认不使用阿片类药物，以及 每月评估7个月和出狱后12个月。这项拟议的研究有两项 具体目标：目标1.比较两项研究条件：a)XR-NTX治疗依从性；b) 阿片类药物的使用；c)犯罪活动；d)再次逮捕；e)再次监禁；f)艾滋病毒危险行为(一、针头使用；二)。冒险 性行为)。目的2.确定释放后XR-NTX治疗的月数是否与 结果(上文a-f)，如果是这样，是否存在XR-NTX与非XR-NTX的平衡点？这会有帮助的 确定注射次数，由于XR-NTX成本，这一点很重要。刑事司法中的许多人 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)扩展 能力；和2)通过在居住地提供治疗来实施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