Kolbrich Erin A, Goodwin Robert S, Gorelick David A, Hayes Robert J, Stein Elliot A, Huestis Marilyn A
Chemistry and Drug Metabolism, Intramural Research Program, National Institute on Drug Abuse, National Institutes of Health, Baltimore, MD 21224, USA.
J Clin Psychopharmacol. 2008 Aug;28(4):432-40. doi: 10.1097/JCP.0b013e31817ef470.
A randomized, within-subject, double-blind, inpatient study of the physiological and subjective effects of oral 3,4-methylenedioxymethamphetamine (MDMA) was conducted in human volunteers with previous MDMA experience. Placebo, low (1.0 mg/kg), and high (1.6 mg/kg) doses of oral MDMA were administered in a controlled inpatient setting at least 7 days apart to 6 African American (4 male, 2 female) and 2 white (both male) volunteers (mean [SE] age, 21.1 [0.8] years; weight, 77.2 [7.7] kg). 3,4-Methylenedioxymethamphetamine doses were 46 to 150 mg, in the range of typical recreational doses. Participants completed all sessions without clinically significant adverse events. 3,4-Methylenedioxymethamphetamine produced significant dose-dependent increases in heart rate (highest, 132 bpm), systolic (highest, 171 mm Hg) and diastolic (highest, 102 mm Hg) blood pressure, and subjective responses for energy level, closeness to others, mind racing, heightened senses, and high (evaluated by visual analog scales). Peak effects occurred 1 to 2 hours after dose, with no secondary peak. There were no significant effects on body temperature (measured at tympanic membrane), respiratory rate, or blood oxygen saturation (by pulse oximetry). Although most physiological and subjective parameters were significantly correlated with MDMA plasma concentrations, correlation coefficients were low and clinically insignificant, eliminating the ability to predict effects from single plasma concentrations. These findings suggest that oral MDMA in typical recreational doses produces short-term effects on cardiovascular function and subjective state but that temperature effects may result from interaction with environmental and subject factors.
对曾使用过3,4－亚甲基二氧甲基苯丙胺（MDMA）的人类志愿者进行了一项随机、受试者自身对照、双盲的住院研究，以观察口服MDMA的生理和主观效应。在住院受控环境中，对6名非裔美国人（4名男性，2名女性）和2名白人（均为男性）志愿者（平均[标准误]年龄21.1[0.8]岁；体重77.2[7.7]kg），至少间隔7天分别给予安慰剂、低剂量（1.0mg/kg）和高剂量（1.6mg/kg）的口服MDMA。MDMA剂量为46至150mg，处于典型娱乐剂量范围内。参与者完成了所有疗程，未出现具有临床意义的不良事件。MDMA产生了显著的剂量依赖性心率升高（最高达132次/分钟）、收缩压（最高达171mmHg）和舒张压（最高达102mmHg）升高，以及能量水平、与他人亲近感、思维奔逸、感觉增强和兴奋程度（通过视觉模拟量表评估）的主观反应。给药后1至2小时出现峰值效应，无二次峰值。对体温（通过鼓膜测量）、呼吸频率或血氧饱和度（通过脉搏血氧饱和度测定）无显著影响。尽管大多数生理和主观参数与MDMA血浆浓度显著相关，但相关系数较低且在临床上无显著意义，无法根据单一血浆浓度预测效应。这些发现表明，典型娱乐剂量的口服MDMA对心血管功能和主观状态产生短期影响，但体温影响可能是与环境和受试者因素相互作用的结果。
