Naltrexone for the treatment of Actively-Using Met-Dependent MSM with High-Risk B

纳曲酮用于治疗积极使用 Met 依赖性 MSM 且具有高风险 B 的患者

基本信息

批准号：
8152332
负责人：
Steven L Batki
金额：
$ 44.29万
依托单位：
PUBLIC HEALTH FOUNDATION ENTERPRISES
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-06-01 至 2017-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8152332
关键词：
AIDS prevention Adherence Alcohol dependence Alcohol or Other Drugs use Amphetamines Anal Sex Behavior Behavior Therapy Blood Circulation Clinical Computer Assisted Counseling Double-Blind Method Enrollment Epidemic Event FDA approved HIV Heroin Intervention Interview Measures Methamphetamine Methamphetamine dependence Monitor Naltrexone Opiate Addiction Opioid Opioid Receptor Oral Participant Patient Self-Report Persons Pharmaceutical Preparations Pharmacotherapy Placebos Population Preventive Intervention Public Health Randomized Randomized Controlled Trials Relapse Research Riboflavin Risk Reduction Safety San Francisco Sexual Partners Site System Target Populations Testing Time Urine Work active method arm high risk high risk sexual behavior male meetings men who have sex with men naltrexol sex risk sexually active standardize measure transmission process

项目摘要

DESCRIPTION (provided by applicant): There is an urgent public health need to develop effective pharmacotherapies for methamphetamine (meth) dependence. Globally, use of amphetamines is more common than heroin and opioids, with an estimated 16 to 51 million users worldwide and 1.3 million users in the U.S. in 2007.1 Use of meth (rapidly metabolized in the bloodstream to amphetamine) is up to 20 times more prevalent among men who have sex with men (MSM) than in the general U.S. population, and is a major contributor to the continued HIV epidemic. 2-4 Meth use is independently associated with high-risk sexual behavior and HIV seroconversion.5-7 Effective meth treatments therefore will not only reduce meth use, they may also serve as important HIV prevention interventions by reducing meth-driven sexual risk behavior. The lack of FDA-approved pharmacotherapies for meth dependence has limited treatment to behavioral interventions which may benefit from additional adjunctive pharmacologic treatment.8, 9 Furthermore, many meth users, including MSM, do not seek conventional drug treatment, reinforcing the need to develop new treatment modalities.10 Naltrexone, a 5-opioid receptor antagonist, is a highly promising agent that has shown efficacy in reducing relapse of amphetamine use among amphetamine-dependent, yet currently amphetamine- abstinent heterosexuals.11 We propose to expand upon this promising work to determine whether naltrexone will reduce methamphetamine use among actively using, meth-dependent MSM with high-risk sexual behavior through a double-blinded randomized controlled trial of naltrexone versus placebo. We will focus on MSM because of the disproportionate and intertwining epidemics of meth use and HIV in this population. The primary specific aims of this study are: 1) To determine the efficacy of oral naltrexone versus placebo in reducing meth use among actively-using, meth-dependent MSM with high-risk sexual behavior, as determined by the proportion of meth- metabolite positive urines by study arm. 2) To determine the efficacy of oral naltrexone versus placebo in reducing meth-associated sexual risk behavior as measured by: numbers of male anal sex partners, serodiscordant unprotected anal sex partners, and numbers of sex partners with whom meth was used, by study arm. 3) To evaluate the safety and tolerability of oral naltrexone versus placebo, as determined by adverse clinical event rates by study arm. 4) To determine the acceptability of oral naltrexone versus placebo by evaluating adherence via medication event monitoring systems (MEMS) caps, urine ss-naltrexol, urine riboflavin, and self-report. We will enroll 100 sexually active, meth-dependent MSM who will be randomized 1:1 to receive naltrexone or placebo for 12 weeks. All participants will receive substance use counseling and HIV risk-reduction counseling. PUBLIC HEALTH RELEVANCE: An efficacious treatment for active meth-dependent persons would greatly expand treatment options for meth dependence and have significant public health impact. In addition, among our target population of MSM with high rates of HIV transmission, reducing meth use may have a profound HIV prevention effect by reducing meth-driven sexual risk behavior.

描述（由申请人提供）：紧急公共卫生需要开发有效的甲基苯丙胺（METH）依赖性药物疗法。在全球范围内，苯丙胺的使用比海洛因和阿片类药物更普遍，估计全球16至5100万用户，在2007年，美国有130万用户在2007年在美国的使用（在血液中迅速代谢到苯丙胺）的使用率高达20倍的男性（MSM）比一般的人（MSM）高达20倍，而在美国一般人群中的贡献则是一般贡献的主要是一般的，并且是一名主要的杂物，并且是一名主要的人，并且是一名主要的人。 2-4甲基苯丙胺的使用与高风险的性行为和HIV血清转化是独立的。5-7有效的甲基甲基处理不仅会减少甲基苯丙胺的使用，还可以通过减少甲基苯丙胺驱动的性风险行为来充当重要的HIV预防干预措施。 The lack of FDA-approved pharmacotherapies for meth dependence has limited treatment to behavioral interventions which may benefit from additional adjunctive pharmacologic treatment.8, 9 Furthermore, many meth users, including MSM, do not seek conventional drug treatment, reinforcing the need to develop new treatment modalities.10 Naltrexone, a 5-opioid receptor antagonist, is a highly promising agent that has shown efficacy in reducing relapse of amphetamine use among amphetamine-dependent, yet currently amphetamine- abstinent heterosexuals.11 We propose to expand upon this promising work to determine whether naltrexone will reduce methamphetamine use among actively using, meth-dependent MSM with high-risk sexual behavior through a double-blinded randomized controlled trial of naltrexone versus placebo.由于该人群中甲基苯丙胺的使用和艾滋病毒的流行不成比例和交织的流行病，我们将重点关注MSM。这项研究的主要具体目的是：1）确定口服纳曲酮与安慰剂在减少具有高风险性行为的主动使用的，甲基疾病依赖性的MSM之间使用METH使用的功效，这取决于研究部门的甲基甲基甲基盐阳性尿液的比例。 2）确定口服纳曲酮与安慰剂在降低与甲基苯丙胺相关的性风险行为方面的疗效：男性肛门性伴侣的数量，精神错乱的未经保护的肛门性伴侣以及与甲基苯丙胺的性伴侣的数量。 3）评估口服纳曲酮与安慰剂的安全性和耐受性，这取决于研究部门的不良临床事件发生率。 4）通过通过药物事件监测系统（MEMS）帽，尿液SS-NELTREXOL，尿液核黄素和自我报告来评估粘附系统（MEMS）帽，确定口服纳曲酮与安慰剂的可接受性。我们将招募100个性活跃的，依赖甲基苯丙胺的MSM，他们将被随机分配1：1，以接受纳曲酮或安慰剂12周。所有参与者将获得毒品使用咨询和降低艾滋病毒风险咨询。公共卫生相关性：对积极甲基疾病依赖人的有效治疗将大大扩展甲基苯丙胺依赖的治疗选择，并产生重大的公共卫生影响。此外，在我们的艾滋病毒传播率高的MSM目标人群中，减少使用甲基苯丙胺的使用可能通过减少甲基苯丙胺驱动的性风险行为具有深远的艾滋病毒预防作用。