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

描述（由申请人提供）：青少年对海洛因和处方阿片类药物的依赖是一个严重和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（buprenorphine）和最近的缓释纳曲酮（XR-NTX）可用于治疗阿片类药物依赖，但只有两项针对青少年使用丁丙诺啡进行阿片类药物解毒的随机试验的数据有限，而在这一重要患者群体中使用XR-NTX的试验没有数据。本研究针对340名年龄在15-21岁的阿片类药物依赖青年进行了为期6个月、两组随机分配的XR- NTX与常规治疗（TAU）的疗效比较试验。这项研究将在山庄园治疗中心进行，这是一个社区治疗项目，参与了许多药物治疗青少年成瘾障碍的临床试验。重要的是，研究小组在成人和青少年中使用XR-NTX有丰富的经验，并发表了迄今为止唯一一份关于青少年使用XR-NTX的报告。TAU将包括美国提供给阿片类药物依赖青年的典型治疗方法，即丁丙诺啡用于治疗阿片类药物戒断，然后咨询是否继续使用丁丙诺啡。该研究的目的是：(1)根据以下3个月和6个月的结果，确定XR-NTX与TAU相比对阿片类药物依赖青年的相对有效性：a)治疗天数；B)阿片类药物使用；C)使用其他药物（可卡因和大麻）和酒精；D)犯罪行为和逮捕；e) DSM- IV定义的阿片类药物依赖复发；(2)观察XR-NTX对随访3个月和6个月时HIV药物和性危险行为以及6个月时HIV感染状况的影响；(3)评估XR-NTX与TAU在阿片类药物依赖青年中的成本、成本效益和成本效益。鉴于青少年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，这种应用具有高度的公共卫生意义。它具有高度创新性，因为它将提供有关XR-NTX在该患者群体中的有效性的新数据，并将提供新的成本效益数据。拟议项目的研究结果有可能通过减少这一弱势群体的阿片类药物使用及其附带问题，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.