Effect of MDMA (Serotonin Release) on Fear Extinction
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
- Fear extinction measured by Fear-potentiated startle
研究概览
简要总结
Serotonin and oxytocin play a role in fear conditioning and fear extinction learning, psychological processes that are critically involved in psychiatric disorders such as posttraumatic stress disorder (PTSD). Specifically, administration of oxytocin has been shown to facilitate fear extinction in humans. Similarly, substances that release serotonin and oxytocin such as MDMA have been shown to enhance the extinction of fear memory in animals. However, there are no data on the effects of MDMA on fear extinction in humans. Therefore, the primary aim of this study is to investigate the role of acute serotonin release in the effects of fear extinction. MDMA will be used as pharmacological tool to induce serotonin release in this study.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 50 years.
- •Understanding of the German language.
- •Understanding 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.
- •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) of more than 5 times or any time within the previous month.
- •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)
- •Tobacco smoking (>10 cigarettes/day)
- •Consumption of alcoholic standard drinks (>10/week or >120 g ethanol/week)
研究组 & 干预措施
MDMA, Placebo
Cross-over within-subjects design with both treatment conditions, separated by a wash-out phase
干预措施: MDMA (Drug)
MDMA, Placebo
Cross-over within-subjects design with both treatment conditions, separated by a wash-out phase
干预措施: Placebo (Drug)
Placebo, MDMA
Cross-over within-subjects design with both treatment conditions, separated by a wash-out phase
干预措施: MDMA (Drug)
Placebo, MDMA
Cross-over within-subjects design with both treatment conditions, separated by a wash-out phase
干预措施: Placebo (Drug)
结局指标
主要结局
Fear extinction measured by Fear-potentiated startle
时间窗: 12 months
b) Fear-potentiated startle to conditioned stimuli
Fear extinction measured by Skin conductance response
时间窗: 12 months
a) Skin conductance response to conditioned stimuli
次要结局
- Plasma concentration of Oxytocin(12 months)
- Autonomic effects measured by Hearth rate(12 months)
- Subjective effects measured by Visual analog scales(12 months)
- Autonomic effects measured by Body temperature(12 months)
- Plasma concentration of MDMA(12 months)
- Autonomic effects measured by Blood pressure(12 months)
- Subjective effects measured by State-trait anxiety inventory for state (STAI-S)(12 months)