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).

甲基苯丙胺（冰毒）的使用在男男性接触者中非常普遍，尤其是携带艾滋病毒的男男性接触者。hiv阴性和hiv阳性的男男性接触者中使用冰毒的比例分别是普通美国成年人的13倍和34倍。甲基苯丙胺的使用与男男性接触者中与艾滋病毒相关的性危险行为独立相关，并可作为抗逆转录病毒治疗和暴露前预防（PrEP）依从性的障碍。因此，减少冰毒使用的有效干预措施也可以作为一项重要的艾滋病毒预防和护理干预措施，通过减少与物质相关的艾滋病毒风险行为，并优化抗逆转录病毒治疗和PrEP依从性。男同性恋者占美国新感染人数的三分之二。尽管国内艾滋病毒持续流行，男男性行为者中使用冰毒的比例很高，但很少有干预措施在这一人群中被证明是有效的。