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普遍存在，很大一部分使用者为了维持自己的习惯而参与犯罪活动。出狱后，阿片类药物成瘾复发很常见，这会导致更多的犯罪和再次入狱。药物领域的治疗进展尚未惠及这一人群。美沙酮和丁丙诺啡等有效药物并未被检察官和法官广泛接受。对于受法律约束的患者来说，很难获得对最有效治疗方法进行研究的许可，因为知情同意存在问题。纳曲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功效，据报道，尽管很少使用，但它对假释人群具有临床效果。最近，一种有效期为一个月的长效制剂已获得 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且有用，并与常规治疗进行比较。我们还将监测艾滋病毒风险行为，以确定干预措施是否可以降低艾滋病毒和丙型肝炎感染的风险。该合作项目将在六个治疗点进行，那里有大量有鸦片成瘾史的假释者。为了防止哪怕是微妙的胁迫，假释官的转介将不被接受。通过尿检确定所有志愿者均不含阿片类药物，并且通过纳洛酮测试确定目前没有阿片类药物依赖，他们将被随机分配到储存纳曲酮或常规治疗 (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、尿液测试和头发分析来衡量阿片类药物的使用情况。每月两次访视之间将进行一次额外的随机尿液测试。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中心，每个中心的随机目标是在 3.5 至 4 年内每年招募 20 名新患者，总共招募 360 至 400 名参与者。治疗结果将通过尿液测试、头发分析、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优惠券激励以留在该计划中。将进行效益成本分析，将治疗成本与减少犯罪、重新监禁和医疗服务以及增加就业等方面的可量化效益进行比较。公共健康相关性：该项目将测试使用长效药物预防阿片类药物成瘾复发的新疗法的益处。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情况。 FDA 也可以使用这项研究的数据来评估这种治疗方法的益处，这种治疗方法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.