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

MDMA

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 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.

Intervention / Treatment

  • Drug: 3,4-methylenedioxymethamphetamine
  • Drug: S-3,4-methylenedioxymethamphetamine
  • Drug: R-3,4-methylenedioxymethamphetamine (125 mg)
  • Drug: R-3,4-methylenedioxymethamphetamine (250 mg)
  • Other: Placebo

Condition or Disease

  • Healthy

Phase

Study Design

Study type: Interventional
Status: Not yet recruiting
Study results: No Results Available
Age: 18 Years to 65 Years   (Adult, Older Adult)
Enrollment: 24 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Jun 30, 2022
Primary Completion: Dec 31, 2023
Completion Date: Dec 31, 2023
Study First Posted: Mar 14, 2022
Last Updated: Mar 31, 2022

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

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.

Eligibility Criteria

Sex: All

More Details

NCT Number: NCT05277636
Acronym: R-S-MDMA
Other IDs: BASEC 2021-02386
Study URL: https://ClinicalTrials.gov/show/NCT05277636
Last updated: Jun 17, 2022