Comparative Acute Effects of R-MDMA and S-MDMA in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Subjective effects
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 has been 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 (DA), norepinephrine (NE), serotonin (5-HT), and oxytocin while R-MDMA may act more directly on 5-HT2A receptors and release prolactin (PRL). 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. A human study conducted between 10/2022 and 01/2024 by our team compared the effects of R-MDMA, S-MDMA, and racemic MDMA revealing that both enantiomers have generally similar effects. However, the study did not administer equivalent doses of R- and S-MDMA. In the present study a single dose of R-MDMA and a single dose of S-MDMA, now adjusted and presumed to be equivalent, will be compared.
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
- •Good understanding of the German language
- •Understanding of procedures and risks associated with the study
- •Willing to adhere to the protocol and signing of the consent form
- •Willing to refrain from the consumption of illicit psychoactive substances during the study
- •Willing not to operate heavy machinery within 48 h after administration of a study substance (including driving a car)
- •Willing to use effective birth-control throughout study participation.
- •Body mass index 18 - 34.9 kg/m2
排除标准
- •Relevant chronic or acute medical condition
- •Current or previous major psychiatric disorder (e.g. bipolar disorder, schizophrenia), current depression or anxiety disorder
- •Psychotic disorder or bipolar disorder in first-degree relatives
- •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.
- •Pregnancy or current breastfeeding
- •Participation in another clinical trial (currently or within the last 30 days)
- •Use of medications that may interfere with the effects of the study medication
- •Tobacco smoking (>10 cigarettes/day).
- •Excessive consumption of alcoholic beverages (>15 drinks/week)
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Other)
300mg R-MDMA
R-MDMA (300mg)
干预措施: R-3,4-methylenedioxymethamphetamine (Drug)
100mg S-MDMA
S-MDMA (100mg)
干预措施: S-3,4-methylenedioxymethamphetamine (Drug)
结局指标
主要结局
Subjective effects
时间窗: through study completion, an average of 18 months.
Any drug effect on the Visual Analog Scales (VAS) assessing the intensity and duration of the subjective effect on a scale from 0 - 100 percent with higher scores representing more intense effects 14 times each study day.
次要结局
- Autonomic effects I(Through study completion, an average of 18 months.)
- Autonomic effects II(Through study completion, an average of 18 months.)
- Plasma levels of oxytocin(Through study completion, an average of 18 months.)
- Plasma levels of R-MDMA(Through study completion, an average of 18 months.)
- Autonomic effects III(through study completion, an average of 18 months.)
- Plasma levels of S-MDMA(Through study completion, an average of 18 months.)
- Plasma levels of cortisol(Through study completion, an average of 18 months.)
- Plasma levels of prolactin(Through study completion, an average of 18 months.)
- Additional subjective effects I(Through study completion, an average of 18 months.)
- Additional subjective effects II(Through study completion, an average of 18 months.)
- Additional subjective effects III(Through study completion, an average of 18 months.)
- NEO-Five-Factor-Inventory (NEO-FFI)(Baseline)
- Freiburger Personality Inventory (FPI-R)(Baseline)
- Saarbrücken Personality Questionnaire (SPF)(Baseline)
- HEXACO personality inventory(Baseline)
- Defense Style Questionnaire (DSQ-40)(Baseline)
- Acute adverse effects(Through study completion, an average of 18 months.)
- Subacute adverse effects I(Through study completion, an average of 18 months.)
- Subacute adverse effects II(Through study completion, an average of 18 months.)
- Dose equivalence I(Through study completion, an average of 18 months.)
- Dose equivalence II(Through study completion, an average of 18 months.)
- Life satisfaction and well-being I(Through study completion, an average of 18 months.)
- Life satisfaction and well-being II(Through study completion, an average of 18 months.)
- Life satisfaction and well-being III(Through study completion, an average of 18 months.)
- Life satisfaction and well-being IV(Baseline/End of Study Visit)
- Empathogenic effects I(Through study completion, an average of 18 months.)
- Empathogenic effects II(Through study completion, an average of 18 months.)