Depot Pharmacotherapies for Opioid-Dependent Offenders: Outcomes and Costs

阿片类药物依赖者的储存药物疗法：结果和成本

• 批准号: 8727902
• 负责人: DAVID J FARABEE
• 金额: $ 6.96万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-06-01 至 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8727902
• 关键词: Abstinence; Accident and Emergency department; Address; Adherence; Administrator; Adoption; Adult; Adverse effects; Adverse event; Agonist; Alcohol abuse; Behavior; Behavior Therapy; Buprenorphine; Clinical; Communities; Control Groups; Cost Analysis; Costs and Benefits; County; Criminal Justice; Data; Drug Formulations; Drug Metabolic Detoxication; Drug abuse; Drug usage; Economics; Effectiveness; Employment; Female; Fostering; HIV risk; Health Personnel; Health Services Research; Implant; Imprisonment; Individual; Injection of therapeutic agent; Intervention; Interview; Intramuscular Injections; Investments; Jail; Manuals; Manufacturer Name; Measures; Medical; Meta-Analysis; Methadone; Monitor; Naltrexone; Narcotic Antagonists; Nurses; Opiate Addiction; Opiates; Opioid; Oral; Outcome; Participant; Patient Self-Report; Patients; Pharmaceutical Preparations; Pharmacotherapy; Phase; Physicians; Population; Prevention; Prisoner; Procedures; Protocols documentation; Public Health; Randomized; Records; Recruitment Activity; Relapse; Relative (related person); Reporting; Research; Research Design; Research Personnel; Resources; Risk Behaviors; Russia; Safety; Sampling; Savings; Schedule; Telephone; Testing; Time; Titan; Treatment Cost; Urine; Visit; Wages; arm; correctional system; cost; cost effectiveness; design; effectiveness measure; follow-up; male; multi-site trial; offender; open label; parity; prevent; prevention service; programs; psychosocial; randomized trial; response; social; subcutaneous; treatment as usual; trial comparing

DESCRIPTION (provided by applicant): In response to PA-12-127, seeking research addressing "utilization, effectiveness, appropriateness, and/or costs of treatment and prevention services," this application proposes an open-label, randomized trial of two depot pharmacotherapies compared to each other and to psychosocial treatment as usual. This study will examine the feasibility and utility of depot formulations of a partial opioid agonist (buprenorphine, as Probuphine(R)) and an opioid antagonist (naltrexone, as Vivitrol(R)) for preventing relapse to opioid addiction and associated criminal activity among opioid-dependent individuals in jail. Pharmacotherapy with methadone, buprenorphine, or naltrexone has been proven to be efficacious in managing opioid addiction. However, methadone is burdened with regulatory constraints, oral naltrexone has poor patient acceptance, and oral buprenorphine suffers from non-adherence, misuse, and diversion. The majority of opioid addicts released from incarceration do not follow through on referrals to treatment in the community, and relapse to opioid use occurs in the majority of prisoners within one month after release. By overcoming the problem of poor adherence to medication, depot pharmacotherapies offer means to effectively prevent relapse and associated costs, such as emergency room visits, lost wages, and criminal activity and re-incarceration. However, depot medications are expensive-exceeding $500 a month-and the return on this investment with drug-involved offenders has yet to be determined. The study design includes a 4-year plan to investigate the two depot medications in samples of detoxified opioid addicts in Ventura County Jail. Participants (N=150) will be randomly assigned to a 6-month intervention condition of Vivitrol (n=50), Probuphine (n=50), or no medication (n=50); all participants are referred to manual-guided psychosocial treatment in the community. As recommended by reviewers of the original application, the no-medication group serves as a "control" condition and thus is provided psychosocial treatment only. In addition to bi-weekly urine tests and medical management (plus supplemental monitoring via weekly telephone contact) during the 6-month intervention- phase of the trial, participants will participate in extensive assessments at 1, 6, and 12 months post- randomization. Outcomes include opioid use (and use of other substances), criminal activity, and economic benefits associated with the three conditions. The cost analysis will measure and value resources associated with the Probuphine and Vivitrol pharmacotherapies, including medical personnel (physician/nurses), labs, and medications. Other costs, such as those related to pre-release detoxification and to post-release check-ups, are common across the three study conditions. To ascertain cost-effectiveness ratios of Probuphine and Vivitrol, cost data will be compared to changes in key clinical measures of effectiveness (e.g., time to relapse, days of abstinence, re-arrest).

描述（由申请人提供）：针对PA-12-127的响应，寻求解决“治疗和预防服务的利用，有效性，适当性和/或成本”的研究，本申请提出了对两种仓库药物治疗的开放标签，随机试验，相比之下，对彼此的心理社会治疗相比，对此表示了。这项研究将研究部分阿片类动力学家（丁丙诺啡，如孔氨酸（R））和阿片类药物拮抗剂（Naltrexone（Naltrexone）作为Vivitrol（r））的可行性和实用性，以防止阿片类依赖性依赖阿片类药物的犯罪活动中的相关犯罪活动。美沙酮，丁丙诺啡或纳曲酮的药物疗法已被证明有效地管理阿片类药物成瘾。然而，美沙酮受到调节限制的负担，口服纳曲酮的患者接受度差，口服丁丙诺啡遭受了不遵守，滥用和转移。从监禁中释放的大多数阿片类药物上瘾者都不会遵循社区中治疗的转诊，并且在释放后一个月内，大多数囚犯都会发生重复使用阿片类药物。通过克服依从性不佳的问题，仓库药物治疗提供了有效防止复发和相关费用的方法，例如急诊室就诊，工资损失，犯罪活动和重新监禁。但是，仓库药物每月的昂贵$ 500，并且涉及毒品犯罪者的这项投资回报尚未确定。研究设计包括一项为期4年的计划，以调查文图拉县监狱中排毒阿片类药物的样本中的两种仓库药物。参与者（n = 150）将被随机分配到Vivitrol（n = 50），Probuphine（n = 50）或无药物（n = 50）的6个月干预条件下；所有参与者都被转介到社区中手动引导的心理心理治疗。根据原始应用程序的审阅者的建议，无药物组是“控制”条件，因此仅提供社会心理治疗。除了每两周一次的尿液测试和医疗管理（加上每周电话接触的补充监控）外，在试验的6个月干预阶段外，参与者还将在随机分组后1、6和12个月参加广泛的评估。结果包括阿片类药物使用（以及其他物质的使用），犯罪活动以及与三种条件相关的经济利益。成本分析将衡量与可能的资源和相关的资源，包括医疗人员（医师/护士），实验室和药物，包括医疗人员和药物治疗。在三个研究条件下，其他成本，例如与预释放排毒和释放后检查有关的成本。为了确定Probuphine和Vivitrol的成本效益比，将成本数据与关键临床有效性量度的变化进行比较（例如，复发时间，禁欲的日期，再犯罪）。