Phase I randomised, triple‑blind, placebo‑controlled 5‑period crossover in healthy volunteers (n=23) comparing single oral MDMA, MDA, lysine‑MDMA, lysine‑MDA and placebo.
This randomized, triple‑blind, placebo‑controlled five‑period crossover in healthy volunteers directly compares the acute effects of MDMA and its metabolite MDA, and their lysine‑linked prodrugs, using single oral doses and modern psychometric and physiological measures.
Aims are to (1) characterise and directly compare subjective, cognitive and physiological effects of MDMA versus MDA and (2) test whether lysine‑conjugation (slow‑release prodrug) attenuates onset and peak effects; outcomes include psychometrics, vitals and safety/tolerability.
Single oral MDMA dose (MDMA-HCl 100 mg; 84.1 mg free base).
100 mg MDMA‑HCl (=84.1 mg MDMA free base)
Single oral MDA dose (93.9 mg MDA‑HCl; 78.0 mg free base).
93.9 mg MDA‑HCl (=78.0 mg MDA free base); mapped to placeholder compound
Single oral lysine‑MDMA prodrug (171.7 mg lysMDMA dihydrochloride; 84.1 mg MDMA free base).
Administered as 171.7 mg lysMDMA dihydrochloride (equals 84.1 mg MDMA free base)
Single oral lysine‑MDA prodrug (165.6 mg lysMDA dihydrochloride; 78.0 mg MDA free base).
165.6 mg lysMDA dihydrochloride (equals 78.0 mg MDA free base); mapped to placeholder compound
Placebo (mannitol) comparator.
Placebo (mannitol)