Role of Dopamine, Serotonin and 5-HT2A Receptors in Emotion Processing
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Emotional enhancement as determined by fMRI
研究概览
简要总结
The study will test the effect of dopamine, serotonin, and direct 5-HT2A receptor stimulation on empathy, mood perception, and amygdala activity to fearful stimuli. In addition, we predict associations between subjective effects/alterations in emotion processing tests and functional imaging (fMRI) activity.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 25 and 50 years.
- •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 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.
- •Women of childbearing potential must have a negative pregnancy test at the beginning of the study. Pregnancy tests are repeated before each study session. Women and men must agree to use an effective form of birth control (double-barrier method).
- •Body mass index 18-29 kg/m2.
排除标准
- •Chronic or acute medical condition
- •Hypertension (>140/90 mmHg) or Hypotension (SBP<85 mmHg)
- •Current or previous major psychiatric disorder
- •Psychotic disorder in first-degree relatives
- •Illicit substance use (with the exception of cannabis) more than 10 times or any time within the previous two months.
- •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 (any psychiatric medications).
- •fMRI related criteria including: metal implants (clips from operations, cochlea, large red/yellow tattoos in the neck area)
- •Tobacco smoking (>10 cigarettes/day)
- •Consumption of alcoholic drinks (>10/week)
研究组 & 干预措施
Placebo, LSD, d-Amphetamine, MDMA
Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, lysergic acid diethylamide (LSD), d-Amphetamine or methylenedioxymethamphetamine (MDMA) and followed by all other drugs each separated by a wash-out phase
干预措施: LSD (Drug)
Placebo, LSD, d-Amphetamine, MDMA
Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, lysergic acid diethylamide (LSD), d-Amphetamine or methylenedioxymethamphetamine (MDMA) and followed by all other drugs each separated by a wash-out phase
干预措施: MDMA (Drug)
Placebo, LSD, d-Amphetamine, MDMA
Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, lysergic acid diethylamide (LSD), d-Amphetamine or methylenedioxymethamphetamine (MDMA) and followed by all other drugs each separated by a wash-out phase
干预措施: Amphetamine (Drug)
Placebo, LSD, d-Amphetamine, MDMA
Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, lysergic acid diethylamide (LSD), d-Amphetamine or methylenedioxymethamphetamine (MDMA) and followed by all other drugs each separated by a wash-out phase
干预措施: Placebo (Drug)
LSD, d-Amphetamine, MDMA, Placebo
Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, LSD, d-Amphetamine or MDMA and followed by all other drugs each separated by a wash-out phase
干预措施: LSD (Drug)
LSD, d-Amphetamine, MDMA, Placebo
Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, LSD, d-Amphetamine or MDMA and followed by all other drugs each separated by a wash-out phase
干预措施: MDMA (Drug)
LSD, d-Amphetamine, MDMA, Placebo
Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, LSD, d-Amphetamine or MDMA and followed by all other drugs each separated by a wash-out phase
干预措施: Amphetamine (Drug)
LSD, d-Amphetamine, MDMA, Placebo
Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, LSD, d-Amphetamine or MDMA and followed by all other drugs each separated by a wash-out phase
干预措施: Placebo (Drug)
d-Amphetamine, MDMA, LSD, Placebo
Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, LSD, d-Amphetamine or MDMA and followed by all other drugs each separated by a wash-out phase
干预措施: LSD (Drug)
d-Amphetamine, MDMA, LSD, Placebo
Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, LSD, d-Amphetamine or MDMA and followed by all other drugs each separated by a wash-out phase
干预措施: MDMA (Drug)
d-Amphetamine, MDMA, LSD, Placebo
Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, LSD, d-Amphetamine or MDMA and followed by all other drugs each separated by a wash-out phase
干预措施: Amphetamine (Drug)
d-Amphetamine, MDMA, LSD, Placebo
Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, LSD, d-Amphetamine or MDMA and followed by all other drugs each separated by a wash-out phase
干预措施: Placebo (Drug)
MDMA, LSD, Placebo, d-Amphetamine,,
Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, LSD, d-Amphetamine or MDMA and followed by all other drugs each separated by a wash-out phase
干预措施: LSD (Drug)
MDMA, LSD, Placebo, d-Amphetamine,,
Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, LSD, d-Amphetamine or MDMA and followed by all other drugs each separated by a wash-out phase
干预措施: MDMA (Drug)
MDMA, LSD, Placebo, d-Amphetamine,,
Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, LSD, d-Amphetamine or MDMA and followed by all other drugs each separated by a wash-out phase
干预措施: Amphetamine (Drug)
MDMA, LSD, Placebo, d-Amphetamine,,
Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, LSD, d-Amphetamine or MDMA and followed by all other drugs each separated by a wash-out phase
干预措施: Placebo (Drug)
结局指标
主要结局
Emotional enhancement as determined by fMRI
时间窗: 12 hours
Emotional enhancement (empathy, oxytocin, mood perception, fMRI amygdala blood oxygen level-dependent (BOLD) signal reactivity to fearful stimuli)
fMRI brain activity
时间窗: 1 hour
Associations between subjective effects/alterations in emotion processing with fMRI amygdala BOLD activity
次要结局
- Resting State fMRI(1 hour)
- Effect Modulation by personality traits (assessed with questionnaires),(12 hours)
- Effect Modulation by amygdala reactivity to fear (assessed in the fMRI)(12 hours)
- Effect Modulation by genetic polymorphisms (determined by genotyping of each subject)(12 hours)