预防分娩后的甲基胺使用与微缩孕激素试验 (PROMPT):一个试点随机对照试验协议
Marcela C Smid1,2, Natasha Seliski2,3, Jasmin E Charles1,2
1Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, University of Utah Health, 30 N. Mario Capecchi Drive, Floor 5 South, Salt Lake City, UT, USA.
这项试点研究探讨了微化孕激素,以预防甲基胺使用障碍 (MUD) 患者产后复发. 它评估了可行性,安全性和初步疗效,为更大规模的试验铺平了道路.
科学领域:
- 生殖精神病学是一种精神病学.
- 成 药物 药物 药物 药物
- 神经内分泌学神经内分泌学
背景情况:
- 产后期是甲基胺使用障碍 (MUD) 复发的高风险.
- 微化孕激素在减少对其他物质的渴望方面表现有前途.
- 这项研究调查了孕激素在预防产后甲基胺使用 (MU) 的潜力.
研究的目的:
- 评估招募和随机选择患有MUD的产后患者的可行性.
- 评估微化孕激素的安全性和初步疗效.
- 检查阿洛普雷格纳诺隆水平与甲基胺嗜好之间的联系.
主要方法:
- 试点双盲安慰剂受控随机试验.
- 在24个月内招募40名患有MUD的产后患者.
- 随机选择1:1至400毫克口服微化孕激素或安慰剂每天12周.
主要成果:
- 可行性以80%的入学目标实现来衡量可行性.
- 通过副作用,心理健康和并发症来评估安全性.
- 通过比较甲基胺复发率和时间来评估有效性.
结论:
- 为潜在的干预提供关键数据,以防止产后MU复发.
- 建立了对MUD微化孕激素大规模疗效试验的基础.
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