San Francisco Department of Public Health, San Francisco, CA, USA.
University of California San Francisco, San Francisco, CA, USA.
Addiction. 2018 Feb;113(2):268-278. doi: 10.1111/add.13950. Epub 2017 Aug 29.
BACKGROUND AND AIMS: Methamphetamine use is increasingly prevalent and associated with HIV transmission. Early-phase human studies suggested naltrexone reduced amphetamine use among dependent individuals. We tested if extended-release naltrexone (XRNTX) reduces methamphetamine use and associated sexual risk behaviors among high-risk methamphetamine-dependent men who have sex with men (MSM). DESIGN: Double-blind, placebo-controlled, randomized trial of XRTNX versus placebo over 12 weeks from 2012 to 2015. SETTING: San Francisco Department of Public Health, California, USA. PARTICIPANTS: One hundred community-recruited, sexually-active, actively-using methamphetamine-dependent MSM. Mean age was 43.2 years; 96% were male, 3% transfemale, and 1% transmale; 55.0% were white, 19.0% African American, and 18.0% Latino. INTERVENTIONS: XRNTX 380 mg (n = 50) or matched placebo (n = 50) administered by gluteal injection at 4-week intervals. MEASUREMENTS: Regression estimated average level and change in level of positive urines during the period 2-12 weeks (primary outcomes) and sexual risk behaviors (secondary outcome). FINDINGS: Ninety per cent of visits were completed. By intent-to-treat, participants assigned to XRNTX had similar differences during 2-12 weeks in methamphetamine-positive urines as participants assigned to placebo [incidence rate ratio (IRR) = 0.95, 95% confidence interval (CI) = 0.76-1.20; Bayes factor < 0.3]. Observed urine positivity declined from 78 to 70% in the XRNTX arm and 74 to 64% in the placebo arm. Adherence to injections was 96.7% in the XRNTX arm and 91.3% in the placebo arm. Sexual risk behaviors declined similarly among participants in both arms (all P > 0.05). There were no serious adverse events related to study drug and no differences in frequency of adverse events by treatment arm. CONCLUSIONS: Notwithstanding very high medication adherence for this study, extended-release naltrexone does not appear to reduce methamphetamine use or sexual risk behaviors among methamphetamine-dependent men who have sex with men compared with placebo.
背景与目的：甲基苯丙胺的使用呈上升趋势，并与 HIV 传播有关。早期的人体研究表明，纳曲酮可减少依赖个体对苯丙胺的使用。我们检测了缓释纳曲酮（XRNTX）是否可以减少高危甲基苯丙胺依赖的男男性行为者（MSM）中的甲基苯丙胺使用和相关的性风险行为。
设计：2012 年至 2015 年，对接受社区招募、有性活跃、正在使用的甲基苯丙胺依赖的 MSM 进行为期 12 周的双盲、安慰剂对照、随机试验，比较 XRNTX 与安慰剂。
地点：美国加利福尼亚州旧金山公共卫生部。
参与者：100 名社区招募的、有性活跃、正在使用的甲基苯丙胺依赖的 MSM。平均年龄为 43.2 岁；96%为男性，3%为变性女性，1%为变性男性；55.0%为白人，19.0%为非裔美国人，18.0%为拉丁裔。
干预措施：XRNTX 380mg（n=50）或匹配的安慰剂（n=50）每 4 周臀部注射一次。
测量：回归估计了 2-12 周期间阳性尿液的平均水平和变化（主要结局）和性风险行为（次要结局）。
结果：90%的就诊完成。按意向治疗分析，与安慰剂组相比，分配到 XRNTX 组的参与者在 2-12 周内的甲基苯丙胺阳性尿液差异无统计学意义[发生率比（IRR）=0.95，95%置信区间（CI）=0.76-1.20；贝叶斯因子<0.3]。XRNTX 组尿液阳性率从 78%下降至 70%，安慰剂组从 74%下降至 64%。XRNTX 组的注射依从率为 96.7%，安慰剂组为 91.3%。两组参与者的性风险行为均有类似下降（均 P>0.05）。没有与研究药物相关的严重不良事件，治疗组之间的不良事件频率也没有差异。
结论：尽管这项研究的药物依从性非常高，但与安慰剂相比，缓释纳曲酮似乎并不能减少甲基苯丙胺依赖的男男性行为者的甲基苯丙胺使用或性风险行为。
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