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

自20世纪60年代以来，阿片成瘾在美国各地仍然很普遍 而且很大一部分用户参与了犯罪活动，以支持他们的习惯。释放后，从 监禁，复发阿片成瘾是非常普遍的，这导致更多的犯罪和重新 监禁。药物领域的治疗进展尚未惠及这一人群。 有效的药物，如美沙酮和丁丙诺啡，不被 检察官和法官。允许对最有效的治疗方法进行研究 对于受到法律约束的患者来说，很难获得治疗方法，因为知情同意 是有问题的。纳曲酮是一种阿片受体拮抗剂，已证明具有药理作用 预防阿片成瘾复发的疗效及临床报道 虽然很少使用，但在假释者群体中有效。最近，一个仓库配方带有一种 一个月的疗程已获得FDA批准用于酒精中毒的治疗。 这项研究的目的是确定每月注射纳曲酮是否对 在预防复发方面实用和有用，与通常的治疗相比。我们 还将监测艾滋病毒危险行为，以确定干预是否降低了艾滋病毒的风险 和丙型肝炎感染。这一合作项目将在六个治疗地点进行， 有大量有阿片成瘾史的假释犯。为了防止甚至 这是一种微妙的胁迫形式，假释官的转介将不被接受。在确定之后 所有志愿者通过尿检是不含阿片类药物的，并且目前没有使用阿片依赖 纳洛酮试验后，他们将被随机分到纳曲酮仓库或照常治疗(TAU)。 两组参与者将每月接受相同的随访，为期六个月 通过自我报告、尿检和头发分析来衡量阿片类药物的使用情况。额外的随机尿液 测试将在每月两次访问之间进行。 两组都将在6个月和12个月后进行重新评估。宾夕法尼亚大学 将是协调地点，每个地点将有一个随机目标为20名新患者 在3.5到4年的时间里，总共有360到400人参加。治疗结果将是 通过尿检、毛发分析、自我报告和继续治疗进行测量。两者都有 纳曲酮和对照组将获得相同的代金券激励，继续留在 程序。将进行效益-成本分析，以比较治疗成本与 在减少犯罪、重新监禁和医疗服务以及 就业增加。该项目将测试一种新疗法的益处，该疗法使用仓库药物治疗 防止阿片成瘾复发。如果成功，它将影响对 缓刑犯和假释犯，可能会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用来评估这项研究的好处 可以改善阿片成瘾患者生活的治疗。

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.