NCT06905652

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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-HT), and oxytocin while R-MDMA may act more directly on 5-HT2A receptors and release prolactin (PRL). Animal studies also indicate that the two enantiomers act synergistically to produce the subjective effects of MDMA and that S-MDMA is mainly responsible for psychostimulation while R-MDMA may have fewer adverse effects and have greater prosocial effects. A human study conducted between 10/2022 and 01/2024 by our team compared the effects of R-MDMA, S-MDMA, and racemic MDMA revealing that both enantiomers have generally similar effects. However, the study did not administer equivalent doses of R- and S-MDMA. In the present study a single dose of R-MDMA and a single dose of S-MDMA, now adjusted and presumed to be equivalent, will be compared.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	R-3,4-methylenedioxymethamphetamine	A dose of 300mg enantiomeric R-MDMA will be administered.
DRUG	S-3,4-methylenedioxymethamphetamine	A dose of 100mg enantiomeric S-MDMA will be administered.
OTHER	Placebo	Placebo (Mannitol)

Timeline

• Start date: 2025-07-29
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2025-04-01
• Last updated: 2025-07-30

Locations

1 site across 1 country: Switzerland