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

自20世纪60年代以来，阿片类药物成瘾在美国一直很普遍。 并且很大一部分用户参与犯罪以支持他们的习惯。退役后 监禁，阿片类药物成瘾复发是非常常见的，这导致更多的犯罪和重新 监禁。药物治疗领域的进展尚未惠及这一人群。 有效的药物，如美沙酮和丁丙诺啡，并没有得到很好的接受， 检察官和法官。允许进行最有效治疗的研究 在法律的约束下，患者很难获得知情同意， 有问题纳洛酮是一种阿片受体拮抗剂， 在预防阿片类药物成瘾复发方面的疗效， 对假释犯有效，但很少使用。最近，一种长效制剂， 一个月的持续时间已获得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洛酮是否 与常规治疗相比，在预防复发方面是实用和有用的。我们 还将监测艾滋病毒的危险行为，以确定干预措施是否降低了艾滋病毒的风险 和丙型肝炎感染。该合作项目将在六个治疗地点进行， 有大量的假释犯有鸦片成瘾史。为了防止甚至 这是一种微妙的胁迫形式，假释官的推荐不会被接受。在确定 所有志愿者通过尿检均不含阿片类药物，并且目前使用 在纳洛酮试验中，他们将被随机分配至贮库型纳洛酮组或治疗组（TAU）。 两组受试者将每月接受相同的随访，持续6个月， 通过自我报告、尿检和毛发分析来衡量阿片类药物的使用情况。一次额外的随机尿液 测试将在每月访视之间每月进行。 两组将在6个月和12个月后重新评估。宾夕法尼亚大学 将作为协调研究中心，每家研究中心的随机化目标为20例新患者， 在3.5至4年的时间里，累积总共360至400名参与者。治疗结果将是 通过尿检、毛发分析、自我报告和继续治疗来测量。两 纳洛酮和对照组将获得同等的代金券奖励， 程序.将进行获益-成本分析，以比较治疗的成本， 在减少犯罪、重新监禁和医疗服务方面的可量化效益， 增加就业。该项目将测试一种使用长效药物的新治疗方法的益处， 防止阿片类药物成瘾复发。如果成功，它将影响到给予 缓刑犯和假释犯，并可能缓解我们监狱的一些过度拥挤。 这项研究的数据也可以被FDA用来评估这种方法的好处。 治疗可以改善阿片类药物成瘾患者的生活。

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. 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.