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监狱和监狱囚犯的严重问题。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较高 疾病比他们的一般人群。提供稀缺资源以用于基于校正的物质使用 许多国家的治疗以及许多具有OUD的囚犯仍未得到治疗。长效，可注射的使用 Naltrexone（XR-NTX）可能是释放前囚犯的一种有前途的治疗形式。纳曲酮阻止 阿片类药物的陶醉和增强作用，但没有类似阿片类药物的作用。这项拟议的五年研究将 专注于在患者居住地增加XR-NTX治疗是否会增加 依从性，因此是药物的效率。项目实施将发生在五个预释放监狱 在马里兰州公共安全和惩教服务部（MDPSCS）的管辖下：1） 男子大都市过渡中心（MTC）； 2）男性的巴尔的摩预发行单元（BPRU）； 3）Jessup pre- 男性的释放单元（JPRU）； 4）巴尔的摩市惩教中心（BCCC）和5）马里兰州惩教 妇女的机构（MCI）。初次筛查，知情同意和体检后， 每个设施中的囚犯将被盖住性别内随机（n = 240）至：条件1。xr- NTX-OTX（n = 120）：监狱中1次注射XR-NTX，然后在每月六次注射后发出释放后的XR-NTX 阿片类药物治疗计划的社区；或条件2。XR-NTX+MMTX（n = 120）：XR-NTX的一个注入 在监狱中，随后在患者居住地的社区释放后每月注射六次注射。 通过尿液测试，负纳洛酮和口服纳曲酮测试，所有参与者将被确认无优化，以及 从监狱获释后每月评估七个月零12个月。拟议的研究有两个 具体目的：AIM1。用以下方面比较这两个研究条件：a）XR-NTX治疗依从性； b） Opioid使用； c）犯罪活动； d）重新逮捕； e）重新监禁；和f）艾滋病毒风险行为（i。针头使用； ii。风险 性行为）。目标2。确定释放后XR-NTX治疗的月数与 结果（上面的A-F），如果是这样，是否有XR-NTXv。Non-XR-NTX等效脑的点？这会有所帮助 确定注射次数，因为XR-NTX成本很重要。刑事司法的许多人 系统退出治疗，因此通过尝试以下方法增加了改善依从性的方法：1）扩展 容量; 2）通过在其居住地提供治疗来实现访问可能会对 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