Acute Effects of R- and S-MDMA in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Subjective effects I
研究概览
简要总结
Racemic ±3,4-methylenedioxymethamphetamine (MDMA) is a psychoactive substance and prototypical empathogen acutely inducing feelings of heightened mood, empathy, trust and closeness to others. These acute subjective effects of MDMA may be helpful to assist psychotherapy and MDMA is currently investigated in phase 3 trials as a possible treatment in post-traumatic stress disorder.
详细描述
MDMA is a racemic substance containing equal amounts of the enantiomers S(+)- and R(-)-MDMA. Preclinical research indicates that S-MDMA mainly releases dopamine, norepinephrine, serotonin, and oxytocin while R-MDMA may act more directly on 5-HT2A receptors and release prolactin. Animal studies also indicate that the two enantiomers act synergistically to produce the subjective effects of MDMA and that S-MDMA is mainly responsible for psychostimulation while R-MDMA may have fewer adverse effects and have greater prosocial effects. However, acute effects of S- and R-MDMA have never been validly examined in a human study. Therefore, the present study compares acute responses to R-MDMA, S-MDMA, MDMA, and placebo in a cross-over study in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 65 years.
- •Understanding of the German language.
- •Understanding the procedures and the risks that are associated with the study.
- •Participants must be willing to adhere to the protocol and sign the consent form.
- •Participants must be willing to refrain from taking illicit psychoactive substances during the study.
- •Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drink after midnight of the evening before the study session, as well as during the study day.
- •Participants must be willing not to drive a traffic vehicle or to operate machines within 48 h after substance administration.
- •Willing to use double-barrier birth control throughout study participation.
- •Body mass index between 18-29 kg/m2.
排除标准
- •Chronic or acute medical condition
- •Current or previous major psychiatric disorder
- •Psychotic disorder in first-degree relatives, not including psychotic disorders secondary to an apparent medical reason, e.g. brain injury, dementia, or lesions of the brain.
- •Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg)
- •Illicit substance use (not including cannabis) more than 20 times or any time within the previous month
- •Pregnant or nursing women.
- •Participation in another clinical trial (currently or within the last 30 days).
- •Use of medications that may interfere with the effects of the study medications.
- •Tobacco smoking (>10 cigarettes/day).
- •Consumption of alcoholic drinks (>15 drinks/week).
研究组 & 干预措施
125 mg MDMA
MDMA (125 mg)
干预措施: 3,4-methylenedioxymethamphetamine (Drug)
125 mg S-MDMA
S-MDMA (125 mg)
干预措施: S-3,4-methylenedioxymethamphetamine (Drug)
125 mg R-MDMA
R-MDMA (125 mg)
干预措施: R-3,4-methylenedioxymethamphetamine (125 mg) (Drug)
250 mg R-MDMA
R-MDMA (250 mg)
干预措施: R-3,4-methylenedioxymethamphetamine (250 mg) (Drug)
Placebo
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Subjective effects I
时间窗: 18 months
5 Dimensions of Altered States of Consciousness (5D-ASC) consisting of 94 items to be rated on a visual analog scale (0-100 mm), with higher values indicating stronger effects with higher scores representing more intense effects. Assessed once on each study day
Subjective effects II
时间窗: 18 months
Stimulation on the Visual Analog Scales (VAS) assessing the intensity and duration of the stimulant effect on a scale from 0 - 100 percent with higher scores representing more intense effects. Assessed 18 times on each study day
次要结局
- Plasma levels of S-MDMA(18 months)
- Autonomic effects I(18 months)
- Autonomic effects II(18 months)
- Autonomic effects III(18 months)
- Adverse effects(18 months)
- Mood after study day I(18 months)
- Mood after study day II(18 months)
- Mood after study day III(18 months)
- Mood after study day IV(18 months)
- Plasma levels of cortisol(18 months)
- Plasma levels of prolactin(18 months)
- Plasma levels of oxytocin(18 months)
- Plasma levels of vasopressin(18 months)
- Plasma levels of R-MDMA(18 months)
- Plasma levels of S-MDA(18 months)
- Plasma levels of R-MDA(18 months)
- Additional subjective effects I(18 months)
- Additional subjective effects II(18 months)
- States of Consciousness Questionnaire(18 months)
- Spiritual Realms Questionnaire(18 months)
- Psychological Insight Questionnaire(18 months)
- NEO-Five-Factor-Inventory (NEO-FFI)(Baseline)
- Freiburger Personality Inventory (FPI-R)(Baseline)
- Saarbrücker Personality Questionnaire (SPF)(Baseline)
- HEXACO personality inventory(Baseline)
- Defense Style Questionnaire (DSQ-40)(Baseline)