Depot Pharmacotherapies for Opioid-Dependent Offenders: Outcomes and Costs

描述(由申请人提供)：为了回应PA-12-127，寻求关于“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的随机试验，对两种仓库药物疗法进行相互比较和照常进行心理社会治疗。这项研究将审查部分阿片激动剂(丁丙诺啡，如异丙酚(R))和阿片拮抗剂(纳曲酮，如Vivitrol(R))在监狱中预防阿片成瘾复发和相关犯罪活动的仓库配方的可行性和实用性。美沙酮、丁丙诺啡或纳曲酮的药物治疗已被证明在控制阿片成瘾方面有效。然而，美沙酮受到监管限制，口服纳曲酮患者接受性差，口服丁丙诺啡存在不依从性、误用和转移。大多数从监禁中获释的阿片成瘾者没有坚持转诊到社区接受治疗，大多数囚犯在获释后一个月内复发使用阿片类药物。通过克服服药依从性差的问题，仓库药物疗法提供了有效防止复发和相关成本的手段，如急诊室就诊、工资损失、犯罪活动和重新监禁。然而，仓库药物非常昂贵--每月超过500美元--而且这笔投资在涉及毒品的罪犯身上的回报尚未确定。研究设计包括一项为期4年的计划，在文图拉县监狱戒毒的阿片成瘾者样本中调查这两种仓库药物。参与者(N=150)将被随机分配到维维特罗(n=50)、普罗布芬(n=50)或不用药(n=50)的6个月干预条件下；所有参与者都被转介到社区接受手动指导的心理社会治疗。正如最初申请的评审者所建议的那样，未用药组作为一种“对照”状态，因此只提供心理社会治疗。在为期6个月的干预阶段，除了两周一次的尿检和医疗管理(加上每周电话联系的补充监测)，参与者还将在随机化后的1、6和12个月参加广泛的评估。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普罗布芬和维维特罗药物疗法相关的资源，包括医务人员(医生/护士)、实验室和药物。其他费用，如与出院前戒毒和出院后检查相关的费用，在三种研究条件下都是常见的。为了确定普罗布芬和维维特罗的成本-效果比，成本数据将与关键的临床有效性衡量标准(例如复发时间、禁欲天数、再次被捕)的变化进行比较。

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).