Feasibility and acceptability of a phase II randomized pharmacologic intervention for methamphetamine dependence in high-risk men who have sex with men.
Feasibility and acceptability of a phase II randomized pharmacologic intervention for methamphetamine dependence in high-risk men who have sex with men.
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DOI：
10.1097/qad.0b013e328336e98b
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发表时间：
2010-04-24
期刊：
影响因子：
--
通讯作者：
Colfax GN
中科院分区：
文献类型：
--
作者：
Das M;Santos D;Matheson T;Santos GM;Chu P;Vittinghoff E;Shoptaw S;Colfax GN
为了确定是否积极使用，甲基苯丙胺（甲基）依赖的男性与男性发生性关系（MSM）可以招募和保留在药物干预试验，以及参与者将坚持研究程序的程度，包括药物依从性。安非他酮与安慰剂的II期随机双盲试验。30名依赖于甲基苯丙胺、性活跃的MSM被随机分为两组，每天接受安非他酮XL 300 mg或安慰剂，持续12周。参与者每周接受物质使用咨询，每周提供尿液样本，并完成每月的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（不同MEMS帽开口的数量除以预期剂量的数量）和自我报告来测量依从性。90%完成了试验：89%的每月ACASI完成，81%的研究访视参加，81%的尿液样本收集。MEMS帽的依从性为60%，自我报告为81%，治疗分配无显著差异。阳性尿样的中位数为5.5/11（50%）。两组参与者报告的性伴侣中位数下降相似（P = 0.52）。未发生严重不良事件，并且按治疗分配的不良事件无显著差异（P = 0.11）。在药物干预中招募和保留积极使用，甲基依赖的MSM是可行的。安非他酮耐受性良好。研究参与率和保留率较高，但是，研究药物依从性仅为中度。研究结果支持一个更大的试验，提高了依从性的支持，以评估安非他酮和其他药物干预在这一人群中的冰毒依赖的疗效。
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. 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.
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影响因子：
12.7
作者：
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通讯作者：
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5
作者：
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