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仍然很普遍，很大一部分用户参与犯罪以支持他们的习惯。从监禁中释放后，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，并不为检察官和法官所接受。在法律的限制下，患者很难获得对最有效治疗方法进行研究的许可，因为知情同意是有问题的。纳洛酮是一种阿片受体拮抗剂，已证明在预防阿片类药物成瘾复发方面具有药理学疗效，据报道，纳洛酮在假释人群中具有临床有效性，但很少使用。最近，具有一个月持续时间的储库制剂已获得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洛酮是否在预防复发方面是实用和有用的，并且与常规治疗相比。我们还将监测艾滋病毒风险行为，以确定干预措施是否降低了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，那里有大量有阿片成瘾史的假释犯。为了防止即使是微妙的胁迫形式，假释官的转介将不被接受。在通过尿液检测确定所有志愿者均无阿片类药物，并且使用纳洛酮检测确定目前无阿片类药物依赖性后，将其随机分配至长效纳洛酮组或按剂量治疗（TAU）组。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、尿检和毛发分析测量阿片类药物的使用情况。在每月访视之间，每月将进行额外的随机尿液检查。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是在3.5至4年内每年20例新患者，以招募总计360至400例受试者。治疗结果将通过尿检、毛发分析、自我报告和治疗持续进行测量。纳洛酮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、重新监禁和医疗服务以及增加就业等方面的可量化效益。公共卫生相关性：该项目将测试一种使用长效药物预防阿片类药物成瘾复发的新治疗方法的益处。如果成功的话，它将影响对缓刑犯和假释犯的照顾，并可能缓解我们监狱的过度拥挤。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.