Plasma Oxytocin Changes in Response to Low-dose MDMA vs. Placebo in Patients With Arginine Vasopressin Deficiency (Central Diabetes Insipidus) and Healthy Controls - the OxyMAX Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve in plasma oxytocin level
研究概览
简要总结
The investigator hypothesize that low-dose MDMA (3,4-methylenedioxymethamphetamine) will produce a sufficiently strong oxytocin stimulation in healthy controls and no relevant increase in patients. This study will confirm previously published data and provide important safety data with low-dose MDMA stimulation testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The order of the two MDMA doses is predefined in a randomization list. The randomization list is not known to the participants, the investigators and the study nurses involved in the trial. Participants and study personnel involved in supervising the session will be blinded to treatment order. The order is balanced.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Participation in a trial with investigational drugs within 30 days
- •Illicit substance use (except for cannabis) more than 10 times in lifetime or any time within the previous two months
- •Consumption of alcoholic beverages >15 drinks/week
- •Tobacco smoking >10 cigarettes/day
- •Cardiovascular disease (coronary artery disease, heart failure Left ventricular ejection fraction <40%, stroke in the last 3 months, atrial fibrillation/flatter, Wolff-Parkinson-White-Syndrome)
- •Uncontrolled arterial hypertension (>140/90 mmHg) or hypotension (<85mmHg)
- •Current or previous major psychiatric disorder (e.g., major depression, schizophrenia spectrum disorder)
- •Psychotic disorder in first-degree relatives
- •Regular intake of selective serotonin reuptake inhibitors or Monoamine oxidase inhibitors
- •Pregnancy and breastfeeding
- •Diagnosed Chronic Kidney Disease > grade III (glomerular filtration rate < 30ml/min)
- •Diagnosed liver cirrhosis or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) levels 2.5 times above the normal range
研究组 & 干预措施
3,4-methylenedioxymethamphetamine (MDMA) and Placebo
In this arm, first MDMA is given and after a wash-out phase of at least 10 days, Placebo will be administered.
干预措施: MDMA (Drug)
3,4-methylenedioxymethamphetamine (MDMA) and Placebo
In this arm, first MDMA is given and after a wash-out phase of at least 10 days, Placebo will be administered.
干预措施: Placebo (Other)
Placebo and 3,4-methylenedioxymethamphetamine (MDMA)
In this arm, first Placebo is given and after a wash-out phase of at least 10 days, MDMA will be administered.
干预措施: MDMA (Drug)
Placebo and 3,4-methylenedioxymethamphetamine (MDMA)
In this arm, first Placebo is given and after a wash-out phase of at least 10 days, MDMA will be administered.
干预措施: Placebo (Other)
结局指标
主要结局
Area under the concentration-time curve in plasma oxytocin level
时间窗: up to 6 weeks
Area under the concentration-time curve in plasma oxytocin level from baseline oxytocin measurement (before MDMA intake) to 5 hours after a single administration of 25 mg or 50 mg MDMA in patients with Arginine Vasopressin deficiency as compared to healthy controls.
次要结局
- Peak change in oxytocin plasma level(up to 6 weeks)
- Time course of plasma oxytocin levels(up to 6 weeks)
- Time course of plasma MDMA concentration(up to 6 weeks)
- Recognition of emotions and body expressions in the Emotion from Body expression and Emotion from Face (EmBody/EmFace) task(up to 6 weeks)
- Number of adverse effects(up to 6 weeks)
- Time course of plasma Adrenocorticotropic hormone (ACTH)(up to 6 weeks)
- Subjective/emotional effects assessed on numeric analogue scales (NASs)(up to 6 weeks)
- Recognition of emotions and body expressions in the face emotion recognition task (FERT)(up to 6 weeks)
- Anxiety level with the State-Trait Anxiety Inventory (STAI-S)(up to 6 weeks)
- Anxiety level with the State-Trait Anxiety Inventory (STAI-T)(at baseline)
- Number of complaints(up to 6 weeks)
- Time course of plasma copeptin(up to 6 weeks)
- Time course of plasma cortisol(up to 6 weeks)
- Time course of plasma prolactin(up to 6 weeks)
- Time course of plasma neurophysin I(up to 6 weeks)
- Depression level using the Beck-Depressions-Inventory II (BDI-II)(up to 6 weeks)
- Alexithymia level using the Toronto-Alexithymia-Scale 20 (TAS-20)(up to 6 weeks)
- General physical & mental health using the Patient-Reported Outcomes Measurement Information System (PROMIS)(up to 6 weeks)
- Time course of plasma glucose(up to 6 weeks)
- Assessments of clinical variable body temperature(up to 6 weeks)
- General physical & mental health using the posterior-pituitary quality of life questionnaire (PP-QoL)(up to 6 weeks)
- Autistic traits level using the Autism-Spectrum Quotient Test (AQ)(up to 6 weeks)
- Eating disturbances level using the Three-Factor Eating Questionnaire-Revised 18 Item (TFEQ-R18)(up to 6 weeks)
- Assessments of clinical variable blood pressure(up to 6 weeks)
- Resting energy expenditure (REE) in kcal per 24 hours, time course of plasma glucose, insulin and c-peptide, subjective saturation effects assessed on a 10-point NAS.(up to 6 weeks)
- Time course of plasma insulin(up to 6 weeks)
- Assessments of clinical variable heart rate(up to 6 weeks)
- Assessments of laboratory variable potassium(up to 6 weeks)
- Time course of plasma c-peptide(up to 6 weeks)
- Subjective saturation effects(up to 6 weeks)
- Assessments of laboratory variable plasma sodium(up to 6 weeks)