NCT05277636

Acute Effects of R- and S-MDMA in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• 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 is currently 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, norepinephrine, serotonin, and oxytocin while R-MDMA may act more directly on 5-HT2A receptors and release prolactin. 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. However, acute effects of S- and R-MDMA have never been validly examined in a human study. Therefore, the present study compares acute responses to R-MDMA, S-MDMA, MDMA, and placebo in a cross-over study in healthy subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	3,4-methylenedioxymethamphetamine	A dose of 125 mg racemic MDMA will be administered.
DRUG	S-3,4-methylenedioxymethamphetamine	A dose of 125 mg enantiomeric S-MDMA will be administered.
DRUG	R-3,4-methylenedioxymethamphetamine (125 mg)	A dose of 125 mg enantiomeric R-MDMA will be administered.
DRUG	R-3,4-methylenedioxymethamphetamine (250 mg)	A dose of 250 mg enantiomeric R-MDMA will be administered.
OTHER	Placebo	Placebo (Mannitol)

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-01-13
• Completion: 2024-01-13
• First posted: 2022-03-14
• Last updated: 2024-01-17

Locations

1 site across 1 country: Switzerland