The ION+EMI Study: Intermittent Oral Naltrexone enhanced with an Ecological Momentary Intervention for Methamphetamine-using MSM

ION EMI 研究：间歇性口服纳曲酮通过生态瞬时干预增强使用甲基苯丙胺的 MSM

• 批准号: 10253657
• 负责人: Glenn-Milo Santos
• 金额: $ 32.98万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10253657
• 关键词: AIDS prevention; Accounting; Address; Adherence; Adult; Amphetamines; Anal Sex; Attenuated; Behavioral; Blood Circulation; Caring; Computers; Counseling; DSM-V; Data; Detection; Disease; Dose; Double-Blind Method; Ecological momentary assessment; Enrollment; Epidemic; Exposure to; FDA approved; HIV; HIV Seronegativity; HIV Seropositivity; HIV risk; Health behavior; High Prevalence; Individual; Infection; Interruption; Intervention; Intervention Studies; Laboratories; Lead; Measures; Methamphetamine; Naltrexone; Opioid Antagonist; Oral; Participant; Pathway interactions; Patients; Persons; Pharmaceutical Preparations; Pharmacology; Pharmacotherapy; Phase; Pilot Projects; Placebos; Population; Randomized; Regimen; Relapse; Reporting; Research; Risk Behaviors; Safety; Sampling; Schedule; Surveys; Testing; Time; Toxic effect; United States; Urine; Viral Load result; Visit; amphetamine use; antiretroviral therapy; base; cis-male; craving; double-blind placebo controlled trial; effective intervention; efficacy evaluation; efficacy trial; eligible participant; medication compliance; men who have sex with men; methamphetamine use; mu opioid receptors; neglect; pre-exposure prophylaxis; prevent; primary outcome; randomized trial; response; sexual risk behavior; sexually active; substance use; therapy adherence

Methamphetamine (meth) use is very common among MSM, particularly MSM living with HIV. Meth use among HIV-negative and HIV-positive MSM is up to 13 and 34 times more prevalent than in the general U.S. adult population, respectively. Meth use is independently associated with HIV-related sexual risk behaviors among MSM and can function as a barrier to ART and pre-exposure prophylaxis (PrEP) adherence. Thus, effective interventions to reduce meth use may also function as an important HIV prevention and care intervention by reducing substance-related HIV risk behavior, and optimizing ART and PrEP adherence. MSM comprise two-thirds of the new infections in the United States. Despite this continued domestic HIV epidemic and the high prevalence of meth use among MSM, few interventions have proven effective in this population. There are no FDA-approved pharmacotherapies for methamphetamine use, a major gap in the treatment field. We seek to address this gap by evaluating the efficacy of intermittent oral naltrexone enhanced with an ecological momentary intervention (ION+EMI) for meth use treatment. Naltrexone, a µ-opioid receptor antagonist, is a promising agent for meth-using MSM. Meth is rapidly metabolized to amphetamine in the bloodstream and naltrexone has shown efficacy in reducing relapse to amphetamine use. Additionally, emerging evidence suggests that ecological momentary interventions (EMI) that respond to in-the-moment contexts can lead to positive health behaviors, such as increasing medication dosing. A pilot study of intermittent naltrexone conducted by our group found that meth-using MSM who used at least 1 day per week had significantly greater reductions in meth-using days and sexual risk behaviors when treated with as-needed naltrexone, compared to placebo. In the pilot, participants reported taking study drug 64% of the days that they craved meth or anticipated meth use. To build on the results of this study, we propose to evaluate intermittent naltrexone to treat meth use in an efficacy trial enhanced by an EMI that responds to participant’s levels craving or anticipated meth use to provide in-the-moment medication reminders during periods when participants would most benefit from naltrexone. This proposal, entitled “The ION+EMI Study: Intermittent Oral Naltrexone enhanced with an Ecological Momentary Intervention for Methamphetamine-using MSM” is a double-blind, placebo-controlled phase 2b trial in which 54 meth-using MSM will be randomly assigned (2:1) to receive 12 weeks of as-needed intermittent oral naltrexone 50 mg enhanced with an EMA-informed EMI platform, or as-needed placebo with EMI. Primary outcomes will be assessed upon trial completion as measured by proportion of meth-positive urine samples (Aim 1); sexual risk behavior data, accounting for PrEP and viral load status, through monthly surveys via ACASI (Aim 2); and PrEP or ART adherence by drug levels or viral load test (Aim 3).

在MSM中，甲基苯丙胺（甲基苯丙胺）的使用非常普遍，尤其是患有艾滋病毒的MSM。 HIV阴性和HIV阳性MSM中使用的甲基苯丙胺使用分别比美国一般成年人群高达13倍和34倍。 MECM的使用与MSM中与HIV相关的性风险行为独立相关，并且可以充当艺术和暴露前预防（PREP）遵守的障碍。通过减少与物质相关的艾滋病毒风险行为以及优化艺术和准备依从性，减少甲基苯丙胺使用的有效干预措施也可以作为一种重要的HIV预防和护理干预措施。 MSM包括美国三分之二的新感染。尽管如此，国内艾滋病毒的流行仍在继续，在MSM中使用甲基苯丙胺的使用率很高，但很少有干预措施在该人群中有效。 没有FDA批准的药物疗法用于甲基苯丙胺的使用，这是治疗领域的主要差距。我们试图通过评估间歇性口服纳曲酮的有效性通过生态瞬时干预（ION+EMI）来解决这一差距。 Naltrexone是一种µ阿片受体拮抗剂，是使用MSM的有前途的药物。甲基苯丙胺在血液中迅速代谢为苯丙胺，纳曲酮显示出在减少苯丙胺使用的复发方面的有效性。其他新兴的证据表明，对瞬间背景的反应生态瞬时干预措施（EMI）可能会导致积极的健康行为，例如增加药物给药。与安慰剂相比，我们小组对我们小组进行的间歇性纳曲酮进行了试点研究发现，使用AS-NALTREXONE治疗时使用的MSM至少每周使用1天的MSM降低了，与安慰剂相比，使用了启用的纳曲酮。在飞行员中，参与者报告说，他们渴望甲基苯丙胺或预期使用甲基苯丙胺的日子的64％服用研究药物。为了基于这项研究的结果，我们建议评估间歇性纳曲酮在EMI的有效试验中治疗甲基苯丙胺的使用，该试验对参与者的渴望或预期的甲基苯丙胺的响应响应，以在参与者中最大程度地提醒Naltrexone受益时，以提供在现场药物中提供的药物提醒。 This proposal, entitled “The ION+EMI Study: Intermittent Oral Naltrexone enhanced with an Ecological Momentary Intervention for Methamphetamine-using MSM” is a double-blind, placebo-controlled phase 2b trial in which 54 met-using MSM will be randomly assigned (2:1) to receive 12 weeks of as-needed intermittent oral naltrexone 50 mg enhanced with an EMA信息的EMI平台，或与EMI相同的安慰剂。通过遇到尿液样本的比例来衡量，将在试验完成后评估主要结果 （目标1）;性风险行为数据，通过ACASI进行的每月调查，占预期和病毒负荷状况的占理解（AIM 2）；以及通过药物水平或病毒负荷测试的准备或艺术依从性（AIM 3）。