HIV Prevention Section, San Francisco Department of Public Health, CA 94102, USA.
AIDS. 2010 Apr 24;24(7):991-1000. doi: 10.1097/qad.0b013e328336e98b.
To determine whether actively using, methamphetamine (meth)-dependent men who have sex with men (msm) could be enrolled and retained in a pharmacologic intervention trial, and the degree to which participants would adhere to study procedures, including medication adherence. study design: phase ii randomized, double-blind trial of bupropion vs. placebo.
Thirty meth-dependent, sexually active MSM were randomized to receive daily bupropion XL 300 mg or placebo for 12 weeks. Participants received weekly substance use counseling, provided weekly urine specimens, and completed monthly audio-computer assisted self-interview (ACASI) behavioral risk assessments. Adherence was measured by medication event monitoring systems (MEMS) caps (the number of distinct MEMS cap openings divided by the number of expected doses) and self-report.
Ninety percent completed the trial: 89% of monthly ACASIs were completed, 81% of study visits were attended, and 81% of urine samples were collected. Adherence by MEMS cap was 60% and by self-report was 81% and did not differ significantly by treatment assignment. The median number of positive urine samples was 5.5 out of a possible 11 (50%). Participants in both arms reported similar declines in the median number of sex partners (P = 0.52). No serious adverse events occurred and there were no significant differences in adverse events by treatment assignment (P = 0.11).
It is feasible to enroll and retain actively using, meth-dependent MSM in a pharmacologic intervention. Bupropion was well tolerated. Study participation and retention rates were high, however, study drug medication adherence was only moderate. Findings support a larger trial with improved adherence support to evaluate the efficacy of bupropion and other pharmacologic interventions for meth dependence in this population.
确定是否可以招募和保留积极使用、甲基苯丙胺（冰毒）依赖的男男性行为者（MSM）参加药物干预试验，以及参与者遵守研究程序的程度，包括药物依从性。
为期 12 周的安非他酮与安慰剂随机、双盲 II 期试验。
30 名冰毒依赖、有性行为的 MSM 被随机分为每日接受安非他酮 XL300mg 或安慰剂治疗 12 周。参与者每周接受一次药物使用咨询，提供每周尿液样本，并完成每月音频计算机辅助自我访谈（ACASI）行为风险评估。通过药物事件监测系统（MEMS）帽（独特的 MEMS 帽开口数除以预期剂量数）和自我报告来衡量依从性。
90%的参与者完成了试验：每月 ACASI 的完成率为 89%，研究就诊的出席率为 81%，尿液样本的采集率为 81%。通过 MEMS 帽的依从性为 60%，通过自我报告的依从性为 81%，与治疗分配无显著差异。可能出现 11 次阳性尿液样本的中位数为 5.5 次（50%）。两组参与者报告的性伴侣中位数数量都有类似的下降（P=0.52）。未发生严重不良事件，治疗分配无显著差异（P=0.11）。
招募和保留积极使用、甲基苯丙胺依赖的 MSM 参加药物干预试验是可行的。安非他酮耐受性良好。研究参与率和保留率较高，但研究药物的用药依从性仅为中等水平。研究结果支持开展更大规模的试验，以提高对该人群中安非他酮和其他药物干预治疗甲基苯丙胺依赖的疗效评估。
