Clinical Research Comparing Effects Of Novel MDMA Matches In Healthy Patients Begins In Switzerland

The clinical trial investigating the effects of MDMA analogs in healthy volunteers led by PI Prof. Dr. Matthias Liechti and supported by psychedelics biotech company Mind Medicine Inc. MNMD has begun patient dosing. 

Taking place at the University Hospital Basel (UHB), this Phase 1 investigator-initiated study seeks to understand how substances similar to MDMA, particularly MDA, Lys-MDMA and Lys-MDA work on people that don’t have a mental health diagnosis.

The 18-month trial will divide the cohort between groups that will be given the drugs and a placebo group, and compare results through pharmacokinetics and psychological and psychometric tests.

More specifically, the randomized, placebo-controlled, double-blind, five-period crossover study will enroll 24 healthy subjects who will receive MDMA (100mg), MDA (93.9mg), Lys-MDMA (171.7 mg), Lys-MDA (165.6 mg) and placebo. 

It is primarily set to determine acute subjective effects using Visual Analog Scales (VAS) assessing the intensity and duration of subjective effects on a scale, with higher scores representing more intense effects as well as plasma levels of MDMA and MDA each day throughout the total study period.

Dr. Liechti explained that, although amphetamines like MDMA and MDA induce “mainly positive subjective and mood-enhancing effects,” they may also produce negative subjective drug effects, “particularly at the onset of response." 

On the other hand, Lys-MDMA and Lys-MDA are prodrugs that are slowly metabolized to MDMA and MDA, “offering a novel and controlled delivery system of these active substances with potentially improved pharmacological properties.” 

The study aims to investigate the potential to better control the substances’ bioavailability, slow the effect onset and reduce possible adverse effects of MDMA and MDA by using the two prodrugs. 

Additionally, the trial will also look at the effects of MDA in direct comparison with MDMA, something that has never been done at a clinical stage before, according to Dr. Liechti. 

On behalf of MindMed, its executive president Dr. Miri Halperin Wernli stated that the collaboration entitles the company to exclusive rights to the data from the study, which they hope “will enhance our understanding of the therapeutic properties involved in the induction of positive mood in a way that may help optimize the treatment model for our R(-)-MDMA drug candidate."

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