Safety pharmacology of acute MDMA administration in healthy subjects
Safety pharmacology of acute MDMA administration in healthy subjects
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DOI：
10.1177/0269881117691569
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发表时间：
2017-05-01
影响因子：
4.1
通讯作者：
Liechti, Matthias E.
中科院分区：
文献类型：
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作者：
Vizeli, Patrick;Liechti, Matthias E.
3,4-亚甲二氧基甲基苯丙胺（MDMA；摇头丸）正在 MDMA 辅助心理治疗中进行研究。本研究使用同一实验室对 166 名健康受试者进行的 9 项双盲、安慰剂对照、交叉研究的数据，描述了单剂量 MDMA（75 或 125 mg）给药的安全药理学特征。主观影响的持续时间为 4.2 +/- 1.3 小时（范围：1.4-8.2 小时）。 125 毫克 MDMA 剂量比 75 毫克剂量产生更好的药效。 MDMA 产生中度和短暂的不良药效评级，女性的不良药效高于男性。 MDMA 分别使 33%、29% 和 19% 的受试者的收缩压升高至 >160 mmHg、心率 >100 次/分钟、体温 >38 摄氏度。与 75 mg 剂量相比，服用 125 mg MDMA 后患有高血压 (>160 mmHg)、心动过速和体温 >38°C 的受试者比例均显着增加。根据投诉清单评估，MDMA 的急性和亚急性不良反应具有剂量依赖性，且在女性中更为常见。使用后 EOS 29 +/- 22 天时，MDMA 不会影响肝或肾功能。没有发生严重不良事件。总之，摇头丸主要产生急性积极的主观药物效应。不良的主观药物效应和其他不良反应在女性中更为常见。在身体和精神健康的受试者以及医疗环境中，MDMA 给药总体上是安全的。然而，心血管疾病患者的 MDMA 风险可能更高，对于精神疾病患者的研究仍有待研究。
3,4-Methylenedioxymethamphetamine (MDMA; ecstasy) is being investigated in MDMA-assisted psychotherapy. The present study characterized the safety pharmacology of single-dose administrations of MDMA (75 or 125 mg) using data from nine double-blind, placebo-controlled, crossover studies performed in the same laboratory in a total of 166 healthy subjects. The duration of the subjective effects was 4.2 +/- 1.3 h (range: 1.4-8.2 h). The 125 mg dose of MDMA produced greater good drug effect' ratings than 75 mg. MDMA produced moderate and transient bad drug effect' ratings, which were greater in women than in men. MDMA increased systolic blood pressure to >160 mmHg, heart rate >100 beats/min, and body temperature >38 degrees C in 33%, 29% and 19% of the subjects, respectively. These proportions of subjects with hypertension (>160 mmHg), tachycardia, and body temperature >38 degrees C were all significantly greater after 125 mg MDMA compared with the 75 mg dose. Acute and subacute adverse effects of MDMA as assessed by the List of Complaints were dose-dependent and more frequent in females. MDMA did not affect liver or kidney function at EOS 29 +/- 22 days after use. No serious adverse events occurred. In conclusion, MDMA produced predominantly acute positive subjective drug effects. Bad subjective drug effects and other adverse effects were significantly more common in women. MDMA administration was overall safe in physically and psychiatrically healthy subjects and in a medical setting. However, the risks of MDMA are likely higher in patients with cardiovascular disease and remain to be investigated in patients with psychiatric disorders.