Status:
RECRUITING
Comparative Acute Effects of R-MDMA and S-MDMA in Healthy Participants
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Racemic ±3,4-methylenedioxymethamphetamine (MDMA) is a psychoactive substance and prototypical empathogen acutely inducing feelings of heightened mood, empathy, trust and closeness to others. These ac...
Detailed Description
MDMA is a racemic substance containing equal amounts of the enantiomers S(+)- and R(-)-MDMA. Preclinical research indicates that S-MDMA mainly releases dopamine (DA), norepinephrine (NE), serotonin (5...
Eligibility Criteria
Inclusion
- Age between 18 and 65 years
- Good understanding of the German language
- Understanding of procedures and risks associated with the study
- Willing to adhere to the protocol and signing of the consent form
- Willing to refrain from the consumption of illicit psychoactive substances during the study
- Willing not to operate heavy machinery within 48 h after administration of a study substance (including driving a car)
- Willing to use effective birth-control throughout study participation.
- Body mass index 18 - 34.9 kg/m2
Exclusion
- Relevant chronic or acute medical condition
- Current or previous major psychiatric disorder (e.g. bipolar disorder, schizophrenia), current depression or anxiety disorder
- Psychotic disorder or bipolar disorder in first-degree relatives
- Hypertension (SBP\>140/90 mmHg) or hypotension (SBP\<85 mmHg)
- Illicit substance use (not including cannabis) more than 20 times or any time within the previous month.
- Pregnancy or current breastfeeding
- Participation in another clinical trial (currently or within the last 30 days)
- Use of medications that may interfere with the effects of the study medication
- Tobacco smoking (\>10 cigarettes/day).
- Excessive consumption of alcoholic beverages (\>15 drinks/week)
Key Trial Info
Start Date :
July 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06905652
Start Date
July 29 2025
End Date
November 1 2026
Last Update
July 30 2025
Active Locations (1)
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1
University Hospital Basel
Basel, Canton of Basel-City, Switzerland, 4031