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.
Adult healthy controls
Matched for age, sex, Body mass index, and oestrogen replacement/menopause/hormonal contraceptives to patients
No medication, except hormonal contraception
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
Crossover
MDMA
DrugMDMA will be administered in a single dose of 50 mg (2 capsules of 25 mg MDMA) or 25mg (1 capsule of 25 mg MDMA, 1 capsule containing only mannitol filler) and given at treatment visit.
Placebo
Other interventionPlacebo will be prepared as identical gelatin capsules containing only mannitol filler and given at treatment visit.
Area under the concentration-time curve in plasma oxytocin level
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.
Peak change in oxytocin plasma level
Peak change in oxytocin plasma level assessed for MDMA and placebo between patients and healthy controls
Time course of plasma oxytocin levels
The outcome will be descriptive. The p-value for the treatment effect will be adjusted for multiple testing using the Bonferroni-Holm procedure. The time course of plasma and urine measures after intake of MDMA or placebo will be visualized by means of line plots and box-plots for patients and healthy controls.
Time course of plasma MDMA concentration
The outcome will be descriptive. The p-value for the treatment effect will be adjusted for multiple testing using the Bonferroni-Holm procedure. The time course of plasma and urine measures after intake of MDMA or placebo will be visualized by means of line plots and box-plots for patients and healthy controls.
Subjective/emotional effects assessed on numeric analogue scales (NASs)
NAS (e.g.,any drug effect, good drug effect, bad drug effect, trust, etc., 0-10) will be repeatedly used to assess subjective alterations in consciousness over time. NAS will be presented as a range from 0 to 10 marked with "not at all" on the left and "extremely" on the right. The following NAS will be used: "any effect", "good effect", "bad effect", "liking", "high", "happy", "fear", "stimulated", "feeling close to others", "concentration", "thinking", "open", "trust", "want to be with other people", "loss of sense of time", and "the boundaries between myself and my surroundings seemed to blur". Scales will be administered before and repeatedly after substance administration and will take 2 minutes to answer.
Click on the lead sponsor to view all of their trials.
