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20世纪60年代以来，阿片类药物成瘾在美国一直很普遍