Treatment Studies Using Depot Naltrexone (4/6) Columbia Protocol Treatment Site

描述（由申请人提供）：自20世纪60年代以来，阿片类药物成瘾在美国一直很普遍，很大一部分使用者参与犯罪以支持他们的习惯。出狱后，阿片类药物成瘾的复发是很常见的，这导致更多的犯罪和再次入狱。药物治疗领域的进步尚未惠及这一人群。美沙酮和丁丙诺啡等有效药物并没有被检察官和法官很好地接受。由于知情同意是有问题的，因此在法律约束下很难获得对最有效治疗方法进行研究的许可。纳曲酮是一种阿片受体拮抗剂，已证明在预防阿片成瘾复发方面具有药理功效，据报道，尽管很少使用，但在假释人群中临床有效。最近，一种有效期为一个月的储存库制剂已获得FDA批准用于治疗酒精中毒。本研究的目的是确定每月注射纳曲酮在预防复发方面是否实用和有用，并与常规治疗进行比较。我们还将监测艾滋病毒风险行为，以确定干预是否降低艾滋病毒和丙型肝炎感染的风险。这一合作项目将在六个治疗地点进行，这些地点有大量有鸦片成瘾史的假释犯。为了防止哪怕是一种微妙的胁迫形式，假释官的推荐将不被接受。在通过尿液测试确定所有志愿者不含阿片类药物并且目前使用纳洛酮测试不依赖阿片类药物后，他们将被随机分配到储存纳曲酮组或常规治疗组（TAU）。两组参与者将在六个月内每月接受相同的随访，通过自我报告、尿检和毛发分析来测量鸦片使用情况。在每月就诊之间，将进行额外的随机尿检。6个月和12个月后，对两组进行重新评估。宾夕法尼亚大学将作为协调地点，每个地点将有一个随机化的目标，每年20名新患者，在3.5到4年的时间里，总共有360到400名参与者。治疗结果将通过尿检、毛发分析、自我报告和继续治疗来衡量。纳曲酮组和对照组都将获得同等的代金券奖励，以留在该计划中。将进行效益-成本分析，以比较治疗费用与减少犯罪、再监禁、医疗服务和增加就业方面的可量化效益。公共卫生相关性：该项目将测试使用储存药物预防阿片类药物成瘾复发的新治疗方法的益处。如果成功，它将影响对缓刑犯和假释犯的照顾，并可能缓解我们监狱过度拥挤的状况。这项研究的数据也可以被FDA用来评估这种治疗的益处，这种治疗可以改善阿片类药物成瘾患者的生活。

DESCRIPTION (provided by applicant): Opioid addiction has remained widespread throughout the United States since the 1960s and a large proportion of users are involved in crimes to support their habits. After release from incarceration, relapse to opioid addiction is very common and this leads to more crimes and re-incarceration. Treatment advances in the area of medications have not reached this population. Effective medications such as methadone and buprenorphine are not well accepted by prosecutors and judges. Permission to conduct research on the most effective treatment approaches is very difficult to obtain for patients under legal restraint because informed consent is problematic. Naltrexone, an opiate receptor antagonist, has demonstrated pharmacological efficacy in preventing relapse to opioid addiction and it has been reported to be clinically effective in parolee populations although it is rarely used. Recently a depot formulation with a one month duration has received FDA approval for the treatment of alcoholism. The purpose of this study is to determine whether a monthly injection of naltrexone is practical and useful in the prevention of relapse and when compared to treatment as usual. We will also monitor HIV risk behaviors to determine whether the intervention reduces risk of HIV and hepatitis C infections. This collaborative project will take place in six treatment sites where there is a large population of parolees with a history of opiate addiction. In order to prevent even a subtle form of coercion, referrals from parole officers will not be accepted. After determining that all volunteers are opiate free by urine test and not currently opiate dependent using a naloxone test, they will be randomized to depot naltrexone or Treatment as Usual (TAU). Participants in both groups will be given identical follow up monthly for six months with measures of opiate use by self-report, urine test and hair analysis. An additional random urine test will take place each month between monthly visits. Both groups will be re-evaluated six and 12 months later. The University of Pennsylvania will be the coordinating site and each site will have a randomization goal of 20 new patients per year over 3.5 to 4 years to accrue a total of 360 to 400 participants. Treatment outcome will be measured by urine tests, hair analysis, self-report and continuation in treatment. Both naltrexone and comparison groups will receive equivalent voucher incentives to remain in the program. A benefit-cost analysis will be conducted to compare the costs of the treatment with the quantifiable benefits in terms of reduced crime, re-incarceration and medical services and increased employment. PUBLIC HEALTH RELEVANCE: This project will test the benefits of a new treatment using a depot medication for preventing relapse to opioid addiction. If successful, it will influence the care given to probationers and parolees and likely relieve some of the overcrowding of our prisons. The data from this study can also be used by the FDA to evaluate the benefits of this treatment that could improve the lives of patients suffering from opioid addiction.