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

This crossover trial (n=24) investigates the acute effects of R- and S-MDMA compared to racemic MDMA and placebo in healthy subjects. The study conducted by the University Hospital Basel, Switzerland, focuses on understanding the distinct impacts of the enantiomers S(+)- and R(-)-MDMA.

MDMA, a racemic substance, is known for inducing feelings like heightened mood and empathy, which could assist psychotherapy, especially in treating post-traumatic stress disorder. This research, a Phase 1 interventional study, aims to dissect these effects by separately examining the S-MDMA, which primarily releases dopamine, norepinephrine, serotonin, and oxytocin, and R-MDMA, which may act more on 5-HT2A receptors and release prolactin. Preclinical studies suggest that S-MDMA contributes to psychostimulation, whereas R-MDMA might have greater prosocial effects and fewer adverse impacts.

The study commenced on October 1, 2022, and completed on January 13, 2024, with the participation of 24 individuals aged between 18 and 65, who met strict inclusion criteria, such as not consuming illicit psychoactive substances during the study and adherence to specific dietary and lifestyle restrictions. The trial excludes individuals with major psychiatric disorders, chronic medical conditions, or a history of significant substance use. The primary goal is to validly compare the responses to these substances in a controlled, safe environment, providing valuable insights into their individual and combined effects. The results could have significant implications for the use of MDMA in therapeutic settings.

Trial Details

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.

NCT Number NCT05277636

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