在一项随机临床试验中,男性的性取向差异延长释放纳尔特雷和布洛用于甲基胺使用障碍的随机临床试验
Jeremy D Kidd1, Sabrina L Smiley2, Phillip O Coffin3
1Department of Psychiatry, Columbia University Irving Medical Center, 1051 Riverside Drive, New York, NY10032, USA; New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY10032, USA.
Drug and alcohol dependence
|July 21, 2023
概括
延长释放的纳尔特雷克松加布罗在与男性和女性发生性关系 (MSM/W) 的男性中显示出对甲基胺使用障碍 (MethUD) 的疗效. 这种组合治疗对MSM/W有效,MSM/W是一个受MethUD影响不成比例的群体.
科学领域:
- 成 药物 药物 药物 药物
- 精神病学是一个精神病学.
- 临床药理学 临床药理学
背景情况:
- 甲基胺使用障碍 (MethUD) 与与女性发生性关系的男性 (MSW) 相比,不成比例地影响与男性和女性发生性关系的男性 (MSM / W).
- 这项研究是第一个MethUD药物试验,用于在这些组之间比较治疗效果.
研究的目的:
- 假设延长释放注射纳尔特雷克松加上口服延长释放布洛对MSM/W的有效性低于MSW.
- 评估延长释放纳尔特雷加布罗在治疗MSM/W.中MethUD中的疗效.
主要方法:
- 一个多站点,双盲,随机,安慰剂对照试验与一个连续的平行比较设计.
- 参与者 (N=246) 在第一阶段 (6周) 接受了活性治疗或安慰剂,而安慰剂无反应者在第二阶段 (6周) 重新随机化.
- 治疗反应被定义为在第一阶段和第二阶段结束时,在四个尿样中,≥3个甲基胺阴性尿样.
主要成果:
- 与MSW (n=95) 相比,MSM/W (n=151) 更有可能是西班牙裔,受过大学教育,并与艾滋病毒感染.
- 积极治疗的响应率在MSM/W (阶段1: 13.95%,阶段2: 23.26%) 中高于MSW (阶段1: 7.69%,阶段2: 3.57%).
- 对MSM/W (h=0.1479) 的治疗效果明显大于对MSW (h=0.0227) (p=0.04).
结论:
- 研究结果表明,延长释放纳尔特雷加布罗对于MSM/W与MethUD的疗效.
- 这种组合疗法在受MethUD重负的人群中是有效的.
- 需要进一步的前性试验来证实这些发现.
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