Naltrexone for Opioid Dependent Released HIV+ Criminal Justice Populations

纳曲酮用于阿片类药物依赖释放的艾滋病毒刑事司法人群

• 批准号: 9135641
• 负责人: SANDRA Ann SPRINGER
• 金额: $ 14.99万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-30 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9135641
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Adherence; Adoption; Adverse effects; Agonist; American; Anti-Retroviral Agents; Attitude; Buprenorphine; CD4 Lymphocyte Count; Caring; Communities; Criminal Justice; DSM-IV; Data; Detection; Disease; Drug Formulations; Drug abuse; Epidemic; Evidence based intervention; Evidence based treatment; Generations; Geographic Locations; Goals; HIV; HIV risk; HIV-1; Health; Healthcare Systems; Healthy People 2010; Highly Active Antiretroviral Therapy; Human immunodeficiency virus test; Imprisonment; Individual; Injection of therapeutic agent; Intervention; Jail; Life; Methadone; Methodology; Minority; Morbidity - disease rate; Naltrexone; Narcotic Antagonists; Opiate Addiction; Opioid; Opioid Rotation; Outcome; Outcome Study; Persons; Pharmaceutical Preparations; Placebo Control; Placebos; Population; Prisoner; Prisons; Public Health; Quality of life; RNA; Randomized; Randomized Controlled Trials; Recruitment Activity; Regulation; Relapse; Reporting; Research; Research Personnel; Risk; Risk Behaviors; Safety; Site; Societies; Substance abuse problem; System; Testing; Therapeutic; Time; Traction; Treatment outcome; Urine; Viral; Viral Load result; addiction; behavioral outcome; community setting; craving; disorder later incidence prevention; experience; health disparity; high risk; improved; innovation; interest; meetings; metropolitan; mortality; novel; overdose death; parity; placebo controlled study; primary outcome; public health relevance; randomized placebo controlled trial; secondary outcome; standard of care; transmission process; uptake

DESCRIPTION (provided by applicant): HIV and drug abuse is concentrated within the criminal justice system (CJS) resulting in 26% of all HIV+ prisoners nationally being released to the community annually. Therefore, the CJS is an important place to target and empirically test interventions that address the Seek, Test, Treat and Retain (STTR) strategy to reduce HIV transmission within the community. STTR requires that HIV is maximally suppressed, resulting in decreased infectiousness; HIV+ prisoners successfully achieve maximal suppression during incarceration. Three 3 months post-release, however, viral suppression is lost mostly as a consequence of relapse to opioids - opioid dependence (OD) is present in 50% of HIV+ prisoners nationally and 70-85% in the Northeast. Opioid relapse is associated with decreased HAART adherence, discontinuation of HAART and increased HIV risk behaviors in the setting of viral replication - the perfect storm for HIV transmission. Effectively treating OD interrupts this relationship and has great potential to improve HIV outcomes; our team has confirmed this benefit using buprenorphine. Opioid substitution therapy, especially methadone, has had limited uptake within the CJS due to philosophical, safety, regulatory and staffing concerns. Therefore, strategies examining the efficacy of naltrexone (NTX), an opioid antagonist, to improve adherence and retention in care, has great appeal to benefit the individual, but also to reduce HIV transmission within the community. Our specific aim is to conduct a placebo-controlled RCT of depot NTX (d-NTX) for HIV+ prisoners with OD who are transitioning to the community. The placebo-control methodology further strengthens any findings that should be demonstrated. HIV treatment (HIV-1 RNA levels, CD4 count, ART adherence, retention in care), substance abuse (time to relapse to opioid use, % opioid negative urines, opioid craving), adverse side effects and HIV risk behavior (sexual and drug-related risks) outcomes will be compared in 150 subjects within CJS in New Haven, Hartford and Springfield. Subjects will be randomized 2:1 to d-NTX or d-placebo for 6 months and observed for 12 months. This therapeutic approach has great appeal by the CJS, given the ease of monthly injections, lack of diversion, few side effects and no antagonistic philosophical concerns about its use. The strength of this proposal is the team of researchers experienced in HIV, addiction and the CJS, the novel use of treating OD as a means to improve HIV outcomes, over 20 years of conducting research in the CJS and the novelty of using d-NTX for the treatment of OD. If this placebo-controlled trial of d-NTX among released HIV+ CJS-involved persons with OD demonstrates efficacy and safety, it is likely to become an evidence-based intervention to intervene with released HIV+ prisoners. As such, the individual, our health care system and society have a high likelihood to benefit - especially on the reduction of HIV within the community.

描述（由申请人提供）：艾滋病毒和毒品滥用集中在刑事司法系统（CJS）中，导致全国所有艾滋病毒+囚犯中的26％每年被释放给社区。因此，CJS是针对和经验测试干预措施的重要场所，该干预措施解决了寻求，测试，治疗和保留（STTR）策略，以减少社区内的HIV传播。 STTR要求艾滋病毒受到最大抑制，从而导致感染力降低。艾滋病毒+囚犯在监禁期间成功实现了最大抑制。释放后三个三个月，病毒抑制主要是由于阿片类药物复发的结果 - 阿片类药物依赖（OD）在全国50％的艾滋病毒+囚犯中存在，东北地区70-85％。阿片类药物复发与HAART依从性的降低，HAART停产以及在病毒复制的环境中增加的HIV风险行为有关 - 艾滋病毒传播的完美风暴。有效地处理OD会中断这种关系，并具有改善HIV结局的巨大潜力；我们的团队使用丁丙诺啡确认了这一收益。由于哲学，安全，监管和人员处理，阿片类药物替代疗法，尤其是美沙酮，在CJS中的吸收有限。因此，研究阿片类药物拮抗剂Naltrexone（NTX）的效力，提高护理中的依从性和保留率的策略非常吸引人，以使个人受益，同时减少社区内的HIV传播。我们的具体目的是针对正在过渡到社区的OD的艾滋病毒+囚犯进行安慰剂对照的RCT（D-NTX）。安慰剂控制方法进一步增强了应证明的任何发现。 HIV治疗（HIV-1 RNA水平，CD4计数，艺术依从性，保留在护理中），药物滥用（是时候复发到阿片类药物使用，％阿片类药物，尿液，阿片类药物的渴望），不良副作用和HIV风险行为（性和药物相关的风险）将在纽黑文和Springford的CJS中进行比较。受试者将被随机分为2：1至D-NTX或D-placebo 6个月，并观察到12个月。考虑到每月注射，缺乏转移，副作用很少，对其使用的抗衡哲学问题，这种治疗方法对CJS具有很大的吸引力。该提案的优势是研究人员在HIV，成瘾和CJ中经历的团队，将OD视为改善HIV结果的一种新颖的方法，在CJS进行了20年的研究，以及使用D-NTX治疗OD的新颖性。如果在释放的HIV+ CJS涉及的人中，D-NTX的安慰剂对照试验表现出疗效和安全性，那么它很可能成为基于证据的干预措施，以干预释放的HIV+囚犯。因此，个人，我们的医疗保健系统和社会很有可能受益 - 尤其是在社区内减少艾滋病毒的情况下。

项目成果

Gender differences among criminal justice-involved persons living with HIV interested in extended-release naltrexone treatment.

• DOI: 10.1080/08897077.2021.1900984
• 发表时间: 2021
• 期刊: Substance abuse
• 影响因子: 3.5
• 作者: Biondi BE;Frank CA;Forray A;Springer SA
• 通讯作者: Springer SA

Erratum to “Correlates of retention on extended-release naltrexone among persons living with HIV infection transitioning to the community from the criminal justice system” [Drug Alcohol Depend. 157 (2015) 158–165].

勘误表“艾滋病毒感染者从刑事司法系统过渡到社区时保留缓释纳曲酮的相关性”[药物酒精依赖。

• DOI: 10.1016/j.drugalcdep.2016.02.009
• 发表时间: 2016
• 期刊: Drug and alcohol dependence
• 影响因子: 4.2

Corrigendum to 'An evaluation of hepatic enzyme elevations among HIV-infected released prisoners enrolled in two randomized placebo-controlled trials of extended release naltrexone' [Journal of Substance Abuse Treatment 47 (2014) 35-40].

“对参加两项缓释纳曲酮随机安慰剂对照试验的 HIV 感染释放囚犯肝酶升高的评估”的勘误表 [Journal of Substance Abuse Treatment 47 (2014) 35-40]。

• DOI: 10.1016/j.jsat.2017.03.008
• 发表时间: 2017
• 期刊: Journal of substance abuse treatment
• 影响因子: 3.9
• 作者: Vagenas,Panagiotis;DiPaola,Angela;Herme,Maua;Lincoln,Thomas;Skiest,DanielJ;Altice,FrederickL;Springer,SandraA
• 通讯作者: Springer,SandraA

The relationship between reincarceration and treatment of opioid use disorder with extended-release naltrexone among persons with HIV.

HIV 感染者的再监禁与缓释纳曲酮治疗阿片类药物使用障碍之间的关系。

• DOI: 10.1016/j.dadr.2023.100159
• 发表时间: 2023-06
• 期刊: Drug and alcohol dependence reports
• 作者: Parchinski, Kaley;Di Paola, Angela;Wilson, Allison P;Springer, Sandra A
• 通讯作者: Springer, Sandra A