Adherence to HIV Therapy in Heroin Addicts: Oral vs Extended Release Naltrexone

海洛因成瘾者对艾滋病毒治疗的依从性：口服纳曲酮与缓释纳曲酮

• 批准号: 7756239
• 负责人: GEORGE Edward WOODY
• 金额: $ 47.24万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-18 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7756239
• 关键词: Adherence; Agonist; Alcohol or Other Drugs use; Appointments and Schedules; Behavior; Buprenorphine; CD4 Lymphocyte Count; Counseling; Development; Disease; Double-Blind Method; Drug Formulations; Drug Metabolic Detoxication; Drug usage; HIV; HIV therapy; Heroin; Heroin Dependence; Implant; Laws; Lead; Maintenance; Maintenance Therapy; Measures; Mediating; Medical; Methadone; Methods; Naltrexone; Obsessive compulsive behavior; Opiate Addiction; Opioid; Oral; Patients; Pharmaceutical Preparations; Placebos; Plasma; Randomized; Relapse; Research; Resistance; Risk Behaviors; Russia; Science; Symptoms; Tablets; Testing; Time; Treatment Failure; Treatment outcome; Universities; Urine; Viral Load result; Work; addiction; antiretroviral therapy; comparative efficacy; drug seeking behavior; experience; high risk behavior; improved; interest; meetings; prevent; primary outcome; programs; public health relevance; response; secondary outcome; therapy adherence; treatment response; trial comparing; viral resistance

DESCRIPTION (provided by applicant): Relapse to opioid addiction in patients with HIV contributes to drug-seeking behavior, non-adherence to antiretroviral therapy (ART), treatment failure, and the development of viral resistance. Successful addiction treatment should do the opposite. Opioid addicted patients receiving ART are often maintained on methadone or buprenorphine, but these medications are subject to regulatory limitations, do not always stop opioid use, are not available in many settings, and not acceptable to all patients. Naltrexone maintenance is another option that could be useful as it blocks opioid effects and prevents relapse if taken as directed. It has been available as a 50 mg tablet that is taken daily and was initially met with enthusiasm by clinicians; however enthusiasm waned when most patients stopped taking it and relapsed. Efforts to develop long-acting formulations that might overcome these problems were realized only very recently, and sustained release formulations are now available and have renewed interest in using it for opioid addiction treatment. These formulations may also facilitate adherence to ART in opioid addicted patients by preventing relapse. Accordingly, this project aims to test whether an implantable formulation that slowly releases naltrexone and blocks opioid effects for 3 months (IN) is more effective than 50 mg/day oral naltrexone (ON) for improving ART adherence and treatment outcome in opioid addicted patients who are beginning their first episode of ART. Russia is an ideal place to study IN since it has an approved product, most HIV patients are heroin addicts, Russian law does not permit agonist treatment, patient interest in naltrexone is high, and the collaborating research team at Pavlov Medical University has extensive experience with IN and ON. To test the hypothesis that IN results in better HIV treatment outcome than ON, we propose a 48-week, randomized, double blind, double- dummy trial comparing IN with ON in 200 recently detoxified heroin addicts beginning their first episode of ART in St. Petersburg. The primary outcomes will be the proportion of patients with a viral load of <400 copies at 24 and 48 weeks. We hypothesize that IN will work better than ON because it will be associated with less relapse and more adherence. PUBLIC HEALTH RELEVANCE: This study will assess the impact of oral naltrexone 50 mg/day vs. a sustained-release naltrexone implant on response to antiretroviral therapy (ART) in opioid addicted patients beginning ART in St. Petersburg, Russia. It will randomize 260 recently detoxified opioid addicts beginning ART to a 48-week course of biweekly drug counseling with oral naltrexone 50 mg/day + placebo naltrexone implant, or placebo tablet + naltrexone implant. The primary outcome will be response to ART as measured by reduction in viral load.

描述(申请人提供)：艾滋病毒患者对阿片成瘾的复发导致寻求药物行为、不坚持抗逆转录病毒治疗(ART)、治疗失败和病毒耐药性的发展。成功的成瘾治疗应该适得其反。接受抗逆转录病毒治疗的阿片成瘾患者通常使用美沙酮或丁丙诺啡维持治疗，但这些药物受到监管限制，并不总是停止使用阿片类药物，在许多情况下都无法获得，并不是所有患者都能接受。纳曲酮的维持是另一个可能有用的选择，因为它可以阻止阿片类药物的影响，如果按照指导服用，可以防止复发。它一直是每天服用50毫克的片剂，最初受到临床医生的欢迎；然而，当大多数患者停止服用并复发时，热情减弱了。开发可能克服这些问题的长效制剂的努力直到最近才得以实现，缓释制剂现已问世，并重新引起了将其用于阿片成瘾治疗的兴趣。这些制剂还可以通过防止复发来促进阿片成瘾患者坚持抗逆转录病毒治疗。因此，该项目旨在测试一种缓慢释放纳曲酮并阻断阿片类药物作用3个月的植入性制剂(IN)是否比每天50毫克的口服纳曲酮(ON)在改善阿片成瘾患者的ART依从性和治疗结果方面更有效，这些患者正在开始第一次ART。俄罗斯是研究IN的理想地方，因为它有批准的产品，大多数HIV患者是海洛因成瘾者，俄罗斯法律不允许使用激动剂治疗，患者对纳曲酮的兴趣很高，巴甫洛夫医科大学的合作研究团队对IN等有丰富的经验。为了验证IN比ON产生更好的HIV治疗结果的假设，我们提出了一项为期48周的随机、双盲、双模拟试验，比较IN和ON在圣彼得堡开始他们的第一次ART的200名最近戒毒的海洛因成瘾者。主要结果将是24周和48周时病毒载量为400拷贝的患者的比例。我们假设IN将比On更有效，因为它将与较少的复发和更多的坚持相关。公共卫生相关性：这项研究将评估在俄罗斯圣彼得堡开始抗逆转录病毒疗法(ART)的阿片成瘾患者中，每天口服纳曲酮50毫克与缓释纳曲酮植入物对抗逆转录病毒疗法(ART)反应的影响。它将随机选择260名最近戒毒的阿片成瘾者开始接受为期48周的药物咨询，每天口服纳曲酮50毫克+安慰剂纳曲酮植入物，或安慰剂片+纳曲酮植入物。主要结果将是通过病毒载量的减少来衡量对ART的应答。