Plasma Oxytocin Changes in Response to Low-dose MDMA vs. Placebo in Patients With Arginine Vasopressin Deficiency and Healthy Controls
NCT ID: NCT06789705
Last Updated: 2025-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2025-01-27
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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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.
MDMA
MDMA 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
Placebo will be prepared as identical gelatin capsules containing only mannitol filler and given at treatment visit.
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.
MDMA
MDMA 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
Placebo will be prepared as identical gelatin capsules containing only mannitol filler and given at treatment visit.
Interventions
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MDMA
MDMA 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
Placebo will be prepared as identical gelatin capsules containing only mannitol filler and given at treatment visit.
Eligibility Criteria
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Inclusion Criteria
1. Adult healthy controls
2. Matched for age, sex, Body mass index, and oestrogen replacement/menopause/hormonal contraceptives to patients
3. No medication, except hormonal contraception
Exclusion Criteria
2. Illicit substance use (except for cannabis) more than 10 times in lifetime or any time within the previous two months
3. Consumption of alcoholic beverages \>15 drinks/week
4. Tobacco smoking \>10 cigarettes/day
5. 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)
6. Uncontrolled arterial hypertension (\>140/90 mmHg) or hypotension (\<85mmHg)
7. Current or previous major psychiatric disorder (e.g., major depression, schizophrenia spectrum disorder)
8. Psychotic disorder in first-degree relatives
9. Regular intake of selective serotonin reuptake inhibitors or Monoamine oxidase inhibitors
10. Pregnancy and breastfeeding
11. Diagnosed Chronic Kidney Disease \> grade III (glomerular filtration rate \< 30ml/min)
12. Diagnosed liver cirrhosis or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) levels 2.5 times above the normal range
18 Years
ALL
Yes
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Mirjam Christ-Crain, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
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University Hospital Basel
Basel, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-01105; kt24ChristCrain3
Identifier Type: -
Identifier Source: org_study_id
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