This Phase 1 interventional trial (n=24) will explore the effects of MDMA-like substances in healthy subjects. Conducted by the University Hospital, Basel, Switzerland, the study’s principal investigator is Matthias E. Liechti, Prof. Dr. MD.
The primary aim is to directly compare the effects of MDMA (3,4-methylenedioxymethamphetamine) and its psychoactive metabolite MDA (3,4-methylenedioxyamphetamine) in healthy volunteers. This study is significant for being the first to concurrently evaluate the effects of these two substances using modern psychological and psychometric tests. Another focus is the assessment of lysine-conjugated forms of MDMA and MDA (lysine-MDMA and lysine-MDA) to see if slower-release formulations can mitigate rapid euphoria, anxiety, and blood pressure changes associated with standard MDMA/MDA.
Participants, aged 18-65 and in good health, will be recruited to partake in this study, which excludes those with major psychiatric disorders, recent illicit substance use, or heavy tobacco and alcohol consumption. The trial will use a two-factorial design to assess differences between MDMA and MDA, and their lysine versions, with a keen interest in the onset and intensity of drug effects. Set to be completed by December 2023 (but current status is ‘unknown’), this study aims to contribute substantially to the understanding of MDMA and MDA’s impact on serotonin (5-HT) and oxytocin release and their potential therapeutic applications.
Trial Details
Trial Number
Sponsors & Collaborators
University of BaselThe University of Basel Department of Biomedicine hosts the Liechti Lab research group, headed by Matthias Liechti.
Papers
Acute effects of MDMA, MDA, lysine-MDMA, and lysine-MDA in a randomized, double-blind, placebo-controlled, crossover trial in healthy participantsThis double-blind placebo-controlled crossover trial (n=23) compared equimolar doses of MDMA (100mg), MDA (92mg), and their lysine-conjugated prodrugs, finding MDA produced stronger, longer-lasting effects (6.1 vs 4.1 hours) with more psychedelic-like perceptions and adverse effects than MDMA, whilst Lys-MDA successfully delayed onset and peak effects, but Lys-MDMA failed to release MDMA and showed no effects.