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）：为响应PA-12-127，寻求解决“治疗和预防服务的利用率、有效性、适当性和/或成本”的研究，本申请提出了一项开放标签、随机试验，将两种长效药物治疗相互比较，并与常规心理治疗进行比较。本研究将检查部分阿片类激动剂（丁丙诺啡，如Probuphine（R））和阿片类拮抗剂（纳洛酮，如Vivitrol（R））的储库制剂用于预防阿片类成瘾复发和监狱中阿片类依赖者的相关犯罪活动的可行性和实用性。美沙酮、丁丙诺啡或纳洛酮的药物治疗已被证明在管理阿片类药物成瘾方面有效。然而，美沙酮受到监管限制，口服纳洛酮的患者接受度较差，口服丁丙诺啡存在不依从性、误用和转移。大多数从监禁中释放的阿片类成瘾者没有坚持转介到社区治疗，大多数囚犯在释放后一个月内重新使用阿片类药物。通过克服药物依从性差的问题，长效药物疗法提供了有效预防复发和相关费用的手段，如急诊室就诊、工资损失、犯罪活动和重新监禁。然而，库存药物是昂贵的-超过500美元一个月-和这种投资的回报涉及毒品的罪犯还有待确定。研究设计包括一项为期4年的计划，以调查文图拉县监狱脱毒阿片类药物成瘾者样本中的两种长效药物。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;所有参与者都被称为社区手动指导的心理社会治疗。根据原始申请的审查者的建议，无药物治疗组作为“对照”条件，因此仅提供心理社会治疗。除了在试验的6个月干预阶段每两周进行一次尿液检查和医学管理（加上通过每周电话联系进行补充监测）外，受试者还将在随机化后1、6和12个月参加广泛评估。结果包括阿片类药物的使用（和其他物质的使用），犯罪活动以及与这三种情况相关的经济利益。成本分析将衡量和评估与Probuphine和Vivitrol药物治疗相关的资源，包括医务人员（医生/护士）、实验室和药物。其他费用，如与释放前戒毒和释放后检查有关的费用，在三种研究条件下都很常见。为了确定普罗布芬和Vivitrol的成本-效果比，将成本数据与关键临床有效性指标的变化进行比较（例如，复发时间、禁欲天数、再次停搏）。