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: 8437265
• 负责人: Edward V. Nunes
• 金额: $ 26.43万
• 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 2015-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8437265
• 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; HIV risk; 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; Maintenance; 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; probationer; programs; psychosocial; restraint; social; symposium; treatment as usual; treatment effect; treatment program; treatment site; volunteer; voucher

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.

自1960年代以来，阿片类药物成瘾一直在美国各地普遍存在 大部分用户参与犯罪以支持其习惯。释放后 监禁，对阿片类药物成瘾的复发非常普遍，这导致了更多的犯罪和犯罪 监禁。药物领域的治疗进展尚未达到这一人群。 美沙酮和丁丙诺啡等有效的药物并未得到很好的接受 检察官和法官。允许对最有效治疗的研究 由于知情同意，在法律限制下，患者很难获得方法 是有问题的。纳曲酮是鸦片受体拮抗剂，已证明了药理 防止阿片类药物成瘾复发的功效，据报道是临床上的 尽管很少使用假释人群，但有效。最近一个仓库公式 一个月的持续时间已获得FDA批准用于治疗酒精中毒。 这项研究的目的是确定纳曲酮的每月注射是否是 实用和有用，可预防复发，并且与往常一样。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的风险 和丙型肝炎感染。这个协作项目将在六个治疗网站举行 有大量的假释者，有鸦片成瘾的史。为了防止 一种微妙的胁迫形式，将不接受假释官员的推荐。确定后 所有志愿者均通过尿液测试免费鸦片，而目前却不使用鸦片依赖 纳洛酮测试，它们将像往常一样被随机分配给核纳曲酮或治疗（TAU）。 两组的参与者将每月每月进行六个月的随访，并 通过自我报告，尿液测试和头发分析的鸦片使用量度。额外的随机尿液 测试将在每月访问之间的每个月进行。 两组将在六个月后重新评估。宾夕法尼亚大学 将是协调站点，每个站点的随机目标为20个新患者 超过3.5至4年的年份，总计360至400名参与者。治疗结果将是 通过尿液检查，头发分析，自我报告和治疗中的延续来衡量。两个都 Naltrexone和比较组将获得等效凭证激励措施，以保留在 程序。将进行福利成本分析，以将治疗的成本与 在减少犯罪，重新监禁和医疗服务方面，可量化的好处以及 就业增加。该项目将使用仓库药物来测试新治疗的好处 防止阿片类药物成瘾复发。如果成功，它将影响给予的护理 缓刑者和假释，可能会缓解我们监狱的一些人满为患。 FDA也可以使用这项研究的数据来评估这一点的好处 可以改善阿片类药物成瘾患者的生活的治疗。