RecruitingPhase 1NCT06905652

Comparative Acute Effects of R-MDMA and S-MDMA in Healthy Participants

Sponsor

University Hospital, Basel, Switzerland

Enrollment

24 participants

Start Date

Jul 29, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy

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 acute subjective effects of MDMA may be helpful to assist psychotherapy and MDMA has been investigated in phase 3 trials as a possible treatment in post-traumatic stress disorder.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria8

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 Criteria10

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)