Health Services Research: Extended Release Naltrexone for Opioid-Dependent Youth

描述(申请人提供)：青少年对海洛因和处方阿片类药物的依赖是一个严重且日益严重的公共卫生问题，与过量死亡、艾滋病毒和肝炎感染、犯罪行为和逮捕有关。尽管丁丙诺啡和最近的缓释纳曲酮(XR-NTX)可用于治疗阿片依赖，但只有有限的数据来自两个在青年中使用丁丙诺啡进行阿片类药物戒毒的随机试验，没有来自在这一重要患者群体中使用XR-NTX的试验的数据。这项建议是一项为期6个月的两组随机分配的XR-NTX与常规治疗(TAU)的疗效比较试验，对象为340名15-21岁的阿片依赖青年。这项研究将在山庄治疗中心进行，这是一个社区治疗项目，参与了许多针对患有成瘾障碍的青少年的药物治疗的临床试验。重要的是，研究小组在成人和青年中使用XR-NTX有相当多的经验，并发表了迄今为止关于XR-NTX在青年中使用的唯一报告。Tau将包括为美国阿片依赖青少年提供的典型治疗方法，即丁丙诺啡治疗阿片类药物戒断，然后咨询使用或不使用丁丙诺啡。这项研究的目的是：(1)确定XR-NTX与TAU在以下3个月和6个月结果方面的相对有效性：a)治疗天数；b)阿片类药物使用；c)其他药物(可卡因和大麻)和酒精使用；d)犯罪行为和逮捕；e)复发到DSM-IV定义的阿片依赖；(2)检查XR-NTX对3个月和6个月随访时艾滋病毒药物和性危险行为以及6个月后艾滋病毒感染状况的影响；以及(3)评估XR-NTX与TAU在阿片依赖青年中的成本、成本-效果和成本-效益。鉴于青少年中阿片类药物使用和依赖的增长及其相关的公共卫生和安全问题，这一应用具有很高的公共卫生意义。它具有很高的创新性，因为它将提供关于XR-NTX在这一患者群体中的有效性的新数据，它将提供新的成本效益数据。拟议项目的发现有可能通过减少阿片类药物的使用及其在这一弱势群体中的附带问题来影响患者、公共卫生和公共安全。

DESCRIPTION (provided by applicant): Heroin and prescription opioid dependence among youth is a serious and growing public health problem that is associated with overdose death, HIV and hepatitis infection, criminal behavior and arrest. Despite the availability of buprenorphine, and, most recently, extended-release naltrexone (XR-NTX) for the treatment of opioid dependence, there are only limited data from two randomized trials of opioid detoxification with buprenorphine in youth and no data from trials using XR-NTX in this important patient population. This present proposal is a 6-month, two-group random assignment comparative effectiveness trial of XR- NTX v. Treatment as Usual (TAU) for 340 opioid-dependent youth ages 15-21. The study will be conducted at Mountain Manor Treatment Center, a community treatment program that has participated in a number of clinical trials of pharmacotherapy for youth with addictive disorders. Importantly, the study team has considerable experience using XR-NTX among adults and youth and has published the only report to date on the use of XR-NTX in youth. TAU will consist of the typical treatment approach provided to opioid-dependent youth in the US, namely buprenorphine for the treatment of opioid withdrawal followed by counseling with or without continued buprenorphine. The study's aims are: (1) to determine the relative effectiveness of XR-NTX compared to TAU for opioid- dependent youth in terms of the following 3- and 6-month outcomes: a) days in treatment; b) opioid use; c) other drug (cocaine and marijuana) and alcohol use; d) criminal behavior and arrests; and e) relapse to DSM- IV defined opioid dependence; (2) to examine the impact of XR-NTX on HIV drug- and sex-risk behaviors at 3- and 6-month follow-up and HIV infection status at 6-months; and (3) to evaluate the cost, cost-effectiveness, and cost-benefit of XR-NTX v. TAU among opioid-dependent youth. This application is of high public health significance given the growth of opioid use and dependence among youth and their associated public health and safety problems. It is highly innovative as it will provide novel data regarding the effectiveness f XR-NTX in this patient population and it will provide novel cost-benefit data. The proposed project's findings have the potential to impact patients, public health, and public safety by reducing opiate use and its collateral problems among this vulnerable population.