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

使用长效纳曲酮 (4/6) 哥伦比亚方案治疗站点的治疗研究

• 批准号: 7686108
• 负责人: Edward V. Nunes
• 金额: $ 38.19万
• 依托单位: NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-15 至 2014-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7686108
• 关键词: Active Sites; Address; Agonist; Alcoholism; Area; Authorization documentation; Baltimore; Buprenorphine; Chronic; Clinical Treatment; Clinical Trials; Coercion; Communities; Control Groups; Controlled Study; Cost-Benefit Analysis; Counseling; Crime; Criminal Justice; Data; Depot Preparation; Doctor of Medicine; Doctor of Philosophy; Drug Formulations; Drug Metabolic Detoxication; Drug usage; Economics; Effectiveness; Employment; Enrollment; Ethical Issues; Ethics; Evaluation; FDA approved; Foundations; Friends; Funding; Goals; HIV; Habits; Hair; Health Services; Hepatitis C; Hepatitis C Transmission; Heroin; Hospitals; Imprisonment; Incentives; Individual; Infection; Informed Consent; Injectable; Injection of therapeutic agent; Intervention; Intravenous; Legal; Life; Maintenance; Marketing; Measures; Medical; Methadone; Monitor; Morbidity - disease rate; Motivation; Naloxone; Naltrexone; Needle Sharing; New York; Online Systems; Opiate Addiction; Opiates; Opioid; Opioid Receptor; Oral; Outcome; Outcome Measure; Participant; Patient Self-Report; Patients; Pennsylvania; Performance; Persons; Pharmaceutical Preparations; Philadelphia; Placebos; Population; Prisons; Procedures; Productivity; Protocols documentation; Public Health; Randomized; Recording of previous events; Records; Recruitment Activity; Relapse; Relative (related person); Reporting; Research; Research Institute; Rhode Island; Risk; Risk Behaviors; Role; Sample Size; Sampling; Services; Site; System; Technology; Testing; Treatment Cost; Treatment Protocols; Treatment outcome; United States; Universities; Unsafe Sex; Urine; Virginia; Visit; addiction; alcohol and other drug; alcoholism therapy; caregiving; comparison group; cost; data management; design; disorder later incidence prevention; drug abuser; economic value; effective therapy; effectiveness trial; efficacy trial; follow-up; high risk; improved; innovation; meetings; mortality; parole; parolee; pilot trial; placebo controlled study; prevent; programs; psychosocial; public health relevance; restraint; social; symposium; treatment as usual; treatment effect; treatment program; treatment site; volunteer; voucher

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.

描述（由申请人提供）：自1960年代以来，阿片类药物成瘾一直在美国各地普遍存在，并且很大一部分用户参与了犯罪以支持其习惯。从监禁中释放后，对阿片类药物成瘾的复发非常普遍，这会导致更多的犯罪和重新监禁。药物领域的治疗进展尚未达到这一人群。检察官和法官没有很好地接受美沙酮和丁丙诺啡等有效的药物。在法律限制下，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。纳曲酮（Naltrexone）是一名阿片类药物拮抗剂，在防止阿片类药物成瘾的复发方面表现出了药理功效，据报道，尽管很少使用，但据报道它在假释群中具有临床有效性。最近，持续一个月的仓库配方已获得FDA批准用于治疗酒精中毒。这项研究的目的是确定每月注射纳曲酮是否实用，并且与像往常一样的治疗相比，在预防复发和治疗时是否有用。我们还将监测HIV风险行为，以确定干预措施是否减少了艾滋病毒和丙型肝炎感染的风险。该协作项目将在六个治疗网站上进行，在那里有大量的假释者，有鸦片成瘾的史。为了防止胁迫的微妙形式，假释官员的推荐将不会被接受。在确定所有志愿者都通过尿液测试而不含阿片类药物并且目前不使用纳洛酮测试依赖阿片类药物后，它们将被随机分为纳曲酮或治疗（TAU）。通过自我报告，尿液测试和头发分析的鸦片使用量度，两组的参与者每月每月进行相同的随访。每月访问之间将进行额外的随机尿液检查。两组将在六个月后重新评估。宾夕法尼亚大学将是协调地点，每个地点的随机目标每年将超过3.5至4年的20名新患者，总计360至400名参与者。治疗结果将通过尿液测试，头发分析，自我报告和治疗中的延续来衡量。 Naltrexone和比较组都将获得同等的代金券激励措施，以保留该计划。将进行福利成本分析，以将治疗的成本与犯罪，重新监禁和医疗服务减少以及增加就业增加的量化福利进行比较。公共卫生相关性：该项目将使用仓库药物来测试新治疗的好处，以防止阿片类药物成瘾复发。如果成功，它将影响给予缓刑者和假释者的关怀，并可能减轻我们监狱的某些人满为患。 FDA也可以使用这项研究的数据来评估这种治疗的好处，以改善阿片类药物成瘾的患者的生活。