The Better THAN Study: Targeting Heavy Alcohol with Naltrexone among MSM

The Better THAN 研究：纳曲酮针对 MSM 中的重度酒精

• 批准号: 8795591
• 负责人: Glenn-Milo Santos
• 金额: $ 27.96万
• 依托单位: PUBLIC HEALTH FOUNDATION ENTERPRISES
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8795591
• 关键词: AIDS prevention; AIDS/HIV problem; Accounting; Adverse event; Age; Alcohol consumption; Alcohol dependence; Alcohols; American; Attenuated; Back; Behavior assessment; Behavioral; Cessation of life; Clinical; Clinical Trials; Computers; Counseling; Data; Dose; Drug Formulations; Effectiveness; Enrollment; Epidemic; Event; FDA approved; Glucuronides; Goals; HIV; HIV Infections; HIV risk; Health; Heavy Drinking; High Prevalence; Individual; Intervention; Measures; Medical Electronics; Methamphetamine; Methods; Modeling; Monitor; Multiple Partners; Naltrexone; Opioid Receptor; Oral; Outcome Study; Participant; Patient Self-Report; Patients; Pharmaceutical Preparations; Placebos; Population; Prevalence; Prevention strategy; Preventive Intervention; Randomized; Recruitment Activity; Regimen; Reporting; Research Design; Respondent; Rewards; Risk; Risk Behaviors; Safety; Sampling; Schedule; Sexual Partners; Social Interaction; Social Network; Surveys; Target Populations; Testing; Text; Time; TimeLine; Toxic effect; Unsafe Sex; Urine; alcohol abuse therapy; alcohol effect; alcohol intervention; alcohol research; arm; base; binge drinker; binge drinking; cost; double-blind placebo controlled trial; drinking; drug efficacy; economic cost; effective intervention; efficacy trial; high risk; interest; male; medication compliance; men; men who have sex with men; monitoring device; neglect; response; screening; sex risk; sexually active; social; surveillance data; treatment effect

DESCRIPTION (provided by applicant): In response to RFA-RM-13-009, we propose to evaluate the efficacy of targeted dosing of oral naltrexone among non-dependent binge-drinking MSM at risk for acquiring or transmitting HIV. Binge drinking (defined for men as drinking five or more drinks on one occasion), also known as heavy episodic drinking, is highly prevalent in the US. In 2010, the overall estimated prevalence of binge drinking (past 30 days) was 17%. Binge drinking accounts for more than half of the 80,000 annual deaths attributed to excessive alcohol consumption. In 2006, the economic costs of binge drinking exceeded $170 billion in the US. National HIV Behavioral Surveillance data indicate that 57% of men who have sex with men (MSM) reported binge drinking (past 30 days). Binge drinking among MSM has been independently associated with unprotected sex and HIV infection. Binge drinking is by far the most prevalent exposure attributed to HIV infections among MSM, who comprise over half of the 56,300 new HIV infections in the US in 2006. Thus, effective interventions to reduce binge drinking among MSM may function as an important HIV prevention intervention by reducing alcohol-related sexual risk behaviors. Despite the high prevalence of binge drinking and the continued domestic HIV epidemic among MSM, few alcohol interventions have been proven to be effective in this population. Oral naltrexone is a low-cost FDA-approved medication for alcohol dependence with few toxicities. Naltrexone is a opioid receptor antagonist that attenuates the rewarding effects of alcohol. The standard daily regimen for oral naltrexone hampers compliance and alternate regimen schedules have been proposed to increase effectiveness of the drug and expand the population that may benefit from this pharmacologic intervention. One promising approach is the intermittent, targeted administration of naltrexone, whereby individuals take the medication as-needed, in anticipation of heavy drinking. Preliminary studies have observed that targeted naltrexone is efficacious in reducing heavy alcohol use, particularly for men. However, there have been no efficacy studies that have assessed targeted naltrexone among binge-drinking MSM and no trials aimed at reducing associated HIV risk behaviors. The aims of this study are to evaluate the efficacy of targeted naltrexone in binge-drinking MSM. Research Design: This is a double-blind, placebo-controlled trial of 120 binge-drinking MSM to 12 weeks of naltrexone 50mg, to be taken in anticipation of heavy drinking. Ethnically and racially diverse participants will be recruited using Respondent Driven Sampling. MSM will be seen weekly for alcohol-metabolite urine testing, study drug dispensing and brief counseling for alcohol use. Safety assessments and behavioral surveys will be completed monthly. Efficacy on alcohol consumption and alcohol-associated sexual risk behaviors (Aims 1-3) will be assessed using weekly time-line follow-back, screening for ethyl glucuronide (EtG)-positive urines, and computer administered monthly interventions. Tolerability and acceptability (Aim 4) will be assessed through tracking of adverse events and medication adherence. GEE models will be fitted to estimate treatment effects on repeated study outcomes.

描述（由申请人提供）：为了响应RFA-RM-13-009，我们建议评估非依赖性暴饮暴食的靶向剂量的疗效，以获取或传播HIV的风险。暴饮暴食（一种定义为男性饮用五种或更多饮料），也称为大量情节性饮酒，在美国非常普遍。 2010年，暴饮暴食的总体估计患病率（过去30天）为17％。暴饮暴食占每年80,000人死亡中的一半以上，归因于饮酒过量。 2006年，美国饮酒的经济成本超过1700亿美元。全国艾滋病毒的行为监测数据表明，与男性发生性关系的男性中有57％的人报告了暴饮暴食（过去30天）。 MSM之间的暴饮暴食与未受保护的性别和艾滋病毒感染有关。暴饮暴食是迄今为止归因于MSM中艾滋病毒感染的最普遍的接触，他在2006年在美国的56,300种新的HIV感染中，超过一半，在2006年美国的56,300种新的HIV感染中，MSM的有效干预措施可以通过减少与酒精相关的性风险行为来减少重要的艾滋病毒预防干预措施。尽管暴饮暴食的患病率很高，并且在MSM中持续的国内HIV流行，但事实证明，很少有酒精干预在该人群中有效。口服纳曲酮是一种低成本FDA批准的药物，用于酒精依赖性，毒性很少。纳曲酮是一种阿片类药物受体拮抗剂，可减弱酒精的奖励作用。已经提出，已经提出了口服纳曲酮的标准每日方案和替代方案计划，以提高药物的有效性，并扩大可能受益于这种药理干预措施的人群。一种有希望的方法是断断续续的，有针对性的纳曲酮给药，个人服用了需要的药物，以期饮酒。初步研究已经观察到，靶向纳曲酮可以有效地减少大量酒精的使用，尤其是对于男性。但是，尚无疗效研究在暴饮暴食的MSM中评估了靶向的纳曲酮，并且没有旨在减少相关HIV风险行为的试验。这项研究的目的是评估靶向纳曲酮在暴饮暴食中的疗效。研究设计：这是一项双盲，安慰剂对照的试验，对120次暴饮暴食的MSM至12周的纳曲酮50mg，可预期大量饮酒。将使用受访者驱动的抽样来招募种族和种族多样的参与者。每周都可以看到MSM，以进行酒精代谢物测试，研究药物分配和简短的饮酒咨询。安全评估和行为调查将每月完成。饮酒和与酒精相关的性风险行为的疗效（AIM 1-3）将使用每周的时间线跟随，筛查乙基葡萄糖醛酸乙酯（ETG）阳性尿液的筛查以及计算机管理的每月干预措施。可耐受性和可接受性（AIM 4）将通过跟踪不良事件和药物依从性进行评估。 GEE模型将适合估计对重复研究结果的治疗效果。