Effects of MDMA (Ecstasy) and Methylphenidate (Ritalin) on Social Cognition
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Effects on social cognition (emotion recognition and empathy)
研究概览
简要总结
The purpose of this study is to assess and compare the effects of a single dose of 3,4-methylenedioxymethamphetamine (MDMA)and methylphenidate (MPH) on emotional and social cognition in healthy subjects. The investigators hypothesize that MDMA enhances affective perception for positive and impairs perception for negative emotional stimuli compared to placebo or MPH.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sufficient understanding of the German language
- •Subjects understand the procedures and the risks 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 xanthine-containing liquids (such as coffee, black or green tea, red bull, chocolate) after midnight of the evening before the study session. Subjects must agree not to smoke tobacco for 1 h before and 4 hours after MDMA administration.
- •Participants must be willing not to drive a traffic vehicle in the evening of the study day.
- •Women of childbearing potential must have a negative pregnancy test at the beginning of the study and must agree to use an effective form of birth control. Pregnancy tests are repeated before each study session.
- •Body mass index: 18-25 kg/m2
排除标准
- •Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG. In particular: Hypertension (>140/90 mmHg). Personal or first-grade history of seizures. Cardiac or neurological disorder.
- •Current or previous psychotic or affective disorder
- •Psychotic or affective disorder in first-degree relatives
- •Prior illicit drug use (except THC-containing products) more than 5 times or any time within the previous 2 months.
- •Pregnant or nursing women.
- •Participation in another clinical trial (currently or within the last 30 days)
- •Use of medications that are contraindicated or otherwise interfere with the effects of the study medications (monoamine oxidase inhibitors, antidepressants, sedatives etc.)
研究组 & 干预措施
MDMA, methylphenidate, placebo
Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but three treatment conditions in the same subject.
干预措施: 3,4-Methylenedioxymethamphetamine (Drug)
MDMA, methylphenidate, placebo
Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but three treatment conditions in the same subject.
干预措施: Methylphenidate (Drug)
MDMA, methylphenidate, placebo
Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but three treatment conditions in the same subject.
干预措施: Placebo (Drug)
结局指标
主要结局
Effects on social cognition (emotion recognition and empathy)
时间窗: 7 hours
次要结局
- Blood pressure (mmHg) and heart rate (beats per min)(7 hours)
- Subjective effects(7 hours)
- Neuroendocrine plasma levels(7 hours)
- Drug plasma concentration(7 hours)